Medical Board Of Western Australia and Petros

Case

[2007] WASAT 42

15 FEBRUARY 2007


JURISDICTION     :   STATE ADMINISTRATIVE TRIBUNAL

STREAM:   VOCATIONAL REGULATION

ACT: MEDICAL ACT 1894 (WA)

CITATION:   MEDICAL BOARD OF WESTERN AUSTRALIA and PETROS [2007] WASAT 42

MEMBER:   JUDGE J CHANEY (DEPUTY PRESIDENT)

MS F CHILD (MEMBER)
DR K MCKENNA (SENIOR SESSIONAL MEMBER)
PROF M KAMIEN (SESSIONAL MEMBER)

HEARD:   16 - 18 AUGUST 2006, 13, 15 NOVEMBER 2006

DELIVERED          :   15 FEBRUARY 2007

FILE NO/S:   VR 304 of 2005

BETWEEN:   MEDICAL BOARD OF WESTERN AUSTRALIA

Applicant

AND

PETER PETROS
Respondent

Catchwords:

Disciplinary proceedings - Medical practitioner - Delay in complaint - Whether abuse of process ­ Allegation of gross carelessness or incompetency ­ Alleged failure to warn of risks ­ Intravaginal slingplasty procedure ­ Whether particular warnings were required ­ Whether warnings given ­ Whether warning adequate

Legislation:

Medical Act 1894 (WA), s 13(1)(c)
State Administrative Tribunal Act 2004 (WA), s 47

Result:

Application dismissed

Category:    B

Representation:

Counsel:

Applicant:     Ms W Buckley

Respondent:     Mr GH Murphy SC and Mr G Pynt

(16-18 August)

Mr G Pynt (13 and 15 November)

Solicitors:

Applicant:     Sparke Helmore Lawyers

Respondent:     Pynt & Partners

Case(s) referred to in decision(s):

Briginshaw v Briginshaw (1938) 60 CLR 336

F v R (1983) 33 SASR 189

Gill v Walton (1991) 25 NSWLR 190

Herron v McGregor & Ors (1986) 6 NSWLR 246

Jago v District Court of New South Wales (1989) 168 CLR 23

Jemielita v Medical Board of Western Australia (Unreported, Supreme Court of Western Australia, Library No 920584)

Maloney v Commissioner for Railways (NSW) (1978) 18 ALR 147

Reibl v Hughes (1980) 2 SCR 880

Rogers v Whitaker (1992) 175 CLR 479

Rosenburg v Percival (2001) 205 CLR 434

REASONS FOR DECISION OF THE TRIBUNAL

Summary of Tribunal's decision

  1. The Medical Board of Western Australia referred a complaint of gross carelessness or incompetency to the Tribunal concerning Dr Peter Petros, a medical practitioner specialising in urogynaecology.  The allegations related to three patients whom Dr Petros treated in 1994, 1998 and 2000 respectively.  He carried out various procedures on each patient, including a procedure known as intravaginal slingplasty.  Following the procedures, each patient experienced significant ongoing gynaecological problems.  The Board brought a complaint that Dr Petros had failed to warn each of the patients as to the possible complications of his proposed treatment. 

  2. Dr Petros argued that, because of the lengthy delays in bringing the complaints, he was unfairly prejudiced in his ability to defend the allegations.  He sought to have the complaints struck out as an abuse of process.  After hearing evidence as to the circumstances leading to the delay, the Tribunal declined to strike out the complaints, and proceeded with the hearing. 

  3. The Tribunal was not called upon to decide whether there was a causal connection between the problems suffered post‑operatively by the patients, and the operations which had been performed.  Rather, it examined whether the complications referred to were the subject of warnings to each patient, and if not, whether they should have been.  The Tribunal also considered whether any failure to warn amounted to gross carelessness or incompetency as alleged by the Board.

  4. The Tribunal concluded that Dr Petros did warn of some of the complications, and that, in the case of others, the evidence did not support a finding that a warning should have been given.  The Tribunal was critical of some aspects of the way Dr Petros conveyed risks to his patients, but it was not satisfied that he was guilty of gross carelessness or incompetency.  Accordingly, the application was dismissed. 

The allegations against Dr Petros

  1. Dr Petros is a registered medical practitioner and a specialist gynaecologist.  As well as his medical degree, and his specialist fellowships, he has been awarded the qualification of doctor of surgery by the University of Western Australia in 1999, and doctor of medicine by the University of Sydney in 2004.  He holds positions of Emeritus Consultant at Royal Perth Hospital, adjunct professor at the University of Western Australia and Docent (Reader) University of Uppsala, Sweden.  The Medical Board of Western Australia (the Board) lodged an application with the Tribunal in June 2005 alleging that Dr Petros is guilty of infamous or improper conduct in the professional respect, or alternatively is guilty of gross carelessness or incompetency.  At the outset of the hearing, the Board abandoned the allegation of infamous or improper conduct and indicated that it relied entirely on the allegation of gross carelessness or incompetency.  The application initially particularised the grounds of the allegation by reference to four patients, but, again at the commencement of the hearing, the Board indicated that it did not wish to proceed in relation to the allegations concerning one of those patients.

  2. The Tribunal acceded to a request by the Board, which was not opposed by the respondent, that the names of the three patients not be published, in order to preserve the confidentiality of their medical history.  There is clearly no requirement in the public interest for the identities for the patients to be revealed, and accordingly they will be referred to in these reasons as P, M and K respectively. 

  3. The basis of the Board's allegation is set out in the application as follows:

    "1.On or around 11 October 1994 the Respondent performed an urethroplexy, modified Manchester repair, anterior repair and cystoscopy on P.

    2.On or around 16 November 1998 the Respondent performed an operation for urinary incontinence, possibly an intravaginal slingplasty, on M.

    3.On or around 8 and 22 August 2000 the Respondent performed a sacroplexy perineal repair and intravaginal slingplasty repair on K.

    4.Prior to the performance of the surgery described in paragraphs 1 to 4, the Respondent failed to obtain an informed consent from P, M and K by failing to warn them that:

    P

    4.1if complications arose following the surgery, that only the Respondent could remove tapes inserted into the vagina during the urethroplexy, modified Manchester repair, and anterior repair;

    4.2the removal of the tapes in the Respondent's medical rooms would be painful and may require surgical intervention;

    4.3following the removal of the tapes sexual intercourse may be painful;

    4.4the tapes may become infected and may require antibiotic and surgical treatment;

    4.5severe pain may be experienced following surgery.

    M

    4.6following the insertion of tapes during the intravaginal slingplasty there maybe abscess formation;

    4.7the formation of abscesses would result in pain and surgical treatment;

    4.8tape rejection may be experienced, which would require treatment with antibiotics and possibly surgical intervention;

    4.9removal of the tapes could be difficult and painful.

    K

    4.10sexual intercourse following the sacroplexy perineal repair and intravaginal slingplasty repair may be painful;

    4.11insertion of tapes during the sacroplexy perineal repair and intravaginal slingplasty repair may result in serious infection;

    4.12abscesses may form;

    4.13ongoing back pain may occur;

    4.14there were consequences associated with tape rejection.

    5.In addition prior to the surgery described in paragraphs 1 to 4 the Respondent failed to secure informed consent from P, M and K by failing to warn them:

    5.1that the intravaginal slingplasty procedure was a new, or relatively new, procedure being performed in Western Australia by the Respondent, may still be undergoing trials and evaluations to determine its reliability;

    5.2of the complications and failures, which had been experienced and reported with the intravaginal slingplasty procedure;

    5.3of the alternative procedures or therapies to the intravaginal slingplasty procedure, which might be employed to deal with female urinary incontinence, and their complications and success rates in the long term;

    5.4of the circumstances under which the intravaginal slingplasty procedure was being performed including the nature and extent of supervision by a recognised professional body and peer review evaluation;

    5.5of the complications and risks, which might be expected to be associated with the intravaginal slingplasty procedure;

    5.6that there was an opportunity to discuss the Respondent's recommendation for the intravaginal slingplasty procedure with another doctor, who was fully informed with the intravaginal slingplasty procedure, so as to allow the discussion of any concerns with such an independent advisor;

    5.7that there was sufficient time to consider the Respondent's recommendation for the intravaginal slingplasty procedure, and if desired to seek a second opinion."

  4. The Board also provided further particulars of a number of the paragraphs set out above, but it is not necessary to set those particulars out in full. 

  5. Dr Petros denies that he is guilty of gross carelessness or incompetence as claimed.  He admits that he performed operations on the named patients.  In relation to P, he says that he performed an intravaginal slingplasty and modified Manchester repair rather than the procedures described in par 1 of the application. 

  6. In relation to M, he accepts that he performed an intravaginal slingplasty and that he performed the procedures described in par 3 on K.  He denies that he failed to properly warn the patients of relevant matters, and relies upon consent forms signed by each of the patients, and his standard procedures in relation to patients generally, and literature in the form of pamphlets, which he believed was given to at least some of the patients, containing information about the proposed procedures.  He denies that he failed to warn the patients that the procedure was relatively new.  In respect of some of the matters of which the Board suggests the patients should have been warned, Dr Petros does not accept that warnings were required. 

The abuse of process argument

  1. When the Board's application first came on for directions, counsel for Dr Petros advised the Tribunal that he sought to apply, pursuant to s 47 of the State Administrative Tribunal Act 2004 (WA) (SAT Act) to strike out the application as an abuse of process. Essentially, Dr Petros' contention was based on the proposition that the procedures in question occurred so long ago, and the delay by the patients, or by the Board, or both, in referring the complaints to him resulted in unfair prejudice to him in having to deal with the applications. As can be seen, the operation performed on P took place on 11 October 1994, the procedure on M on 16 November 1998, and the procedures on K on 8 and 22 August 2000 respectively. It is common ground that the Board sent a copy of each of the complaints made by K, M and P to Dr Petros on 23 March 2004, a period of some nine and a half years after the operation on P, five and a half years after the operation on M, and approximately three and a half years after the operation on K. The complaints made to the Board by the patients generally related to the procedure carried out and the standard of Dr Petros' care, rather than failures to warn of risks. The Board, on investigating the complaints, formulated the present allegations and first conveyed these allegations to Dr Petros on February 2004.

  2. The applicant sought to have the question of abuse of process dealt with as a preliminary issue.  He contended that it would be unfair to him to require him to meet, by way of expert evidence and full hearing, all of the issues arising in the proceedings, if, as he contended, the proceedings should be struck out as an abuse of process.  The Board opposed that course.  It was apparent to the Tribunal that the issue of abuse of process could only be determined with the benefit of evidence as to the reasons for any delay on the part of patients, or the Board, in pursuing their complaints.  The Board was, quite properly, concerned that the patients ought not to be required to give evidence on more than one occasion, given the nature of the issues.  Accordingly, the Tribunal determined that the proper course was not to have a separate hearing of a preliminary issue, but rather to structure the hearing so that evidence relevant to the question of abuse of process could be called and the Tribunal would rule on the abuse of process issue, with the hearing to be completed on a subsequent date if the abuse of process argument was decided against Dr Petros.  In order to avoid the patients being required to give evidence on more than one occasion, the Tribunal directed that the patients would give all of their evidence both as to the substantive issues, and as to any reasons for delay in referring their complaints to the Board, at the one time. 

  3. Dr Petros contended that the delay in the bringing of the complaints results in prejudice to him, such that it is unfair to proceed with the hearing of the complaints.  The prejudice identified is both a general presumption of prejudice said to arise from the delay, and actual prejudice in that Dr Petros has no independent recollection of what information he orally communicated to each of the patients.  His recollection is dependent upon what he told patients as a standard protocol from time to time and his interpretation of notes taken from the files of each of them.  He contended that none of the potential witnesses he might call about information given to the patients has any independent recollection of those patients, nor what information pamphlets might have been given to them.  Further he said that although he has his files for each of the patients, he cannot independently recall whether the patient said anything which might throw a different light on the purport of any of the documents or the files. 

  4. In Herron v McGregor & Ors (1986) 6 NSWLR 246, the Court of Appeal in New South Wales stayed disciplinary proceedings against certain medical practitioners on the ground that the delay on the part of the complainants in making their complaints unfairly prejudiced the medical practitioners and constituted an abuse of process. In that case, McHugh JA (as he then was) said (at 254 – 255):

    "Since no time limit has been laid down under the Act, a complaint may be made at any time unless the institution of the proceedings in the circumstances is oppressive and an abuse of process.  Nevertheless, while the Act contains no time limitation for lodging a complaint it does not follow that a complainant, with knowledge of the facts, can stand by and allow time to pass.  The public interest requires that complaints be lodged and dealt with as expeditiously as possible: see Birkett v James (at 329).  A person with reasonable ground for complaint, therefore, should pursue it with reasonable diligence. Memories fade.  Relevant evidence becomes lost.  Even when written records are kept, long delay will frequently create prejudice which can never be proved affirmatively.  As the United States Supreme Court said in Barker v Wingo (at 532) 'what has been forgotten can rarely be shown'.  In some cases delay makes it simply impossible for justice to be done: Birkett v James (at 317-318, 327).  In R v Lawrence [1982] AC 510 at 517, Lord Hailsham LC pointed out that: 'Where there is delay the whole quality of justice deteriorates.' The difficulties in ascertaining the truth about a matter after time has done its work are vividly portrayed by Street CJ in the Report of the Royal Commission of Inquiry into Certain Committal Proceeding Against K E Humphreys (July 1983).  His Honour said (at 9‑10):

    'In the intervening five or six years, rumours waxed and waned.  In some cases suspicion underwent subtle change to belief, which itself progressed to reconstruction, which in turn escalated to recollection.  No presently stated recollection could be safely assumed not to have progressed upwards and not to be the product of one of these earlier stages.  The sheer frailty of human memory of necessity required a most anxious and critical appraisal of the evidence of the witnesses, no matter how credit‑worthy they might be.  It became apparent that in the years since August 1977 the recollections even of those with undoubted first‑hand knowledge have in some instances faded, in some instances fermented, and in some instances expanded.  Moreover, in many cases the realisation of the significance— indeed, the enormity — of what had occurred has tended to transmute into a more or less cynical acceptance of what had, or was believed or rumoured to have, taken place.'"

  5. Counsel for Dr Petros relied on the propositions identified by McHugh J.  He submits that determination of the allegations of a failure to warn of, in total, 35 separate matters, relies upon, at least in part, evidence as to what was said in conversations as long as 12 years ago.  He contended that the inevitable distortion of recollections over time leads to the conclusion that the Tribunal could not fairly reach the degree of satisfaction required to establish the charges as explained by Dixon J in Briginshaw v Briginshaw (1938) 60 CLR 336 at 361‑2. The position, it is contended, is aggravated by the fact that Dr Petros had no reason to try to recall his dealings with these patients until the Board's allegations, in their present form, were conveyed to him in February 2005. Although the patients initially complained in March 2004 to the Board, their letters of complaint focussed upon the nature of the procedure utilised by Dr Petros, rather than a failure to warn of risks. The allegation of gross carelessness or incompetency by failing to warn of risks appears to have been a complaint formulated by the Board on reviewing the matter over the period from the initial complaint by the patients until February 2005.

  6. In Jago v District Courtof New South Wales (1989) 168 CLR 23 at 60‑61, Deane J identified five main heads of relevant circumstances and considerations for a court in deciding whether proceedings should be stayed on the grounds of delay. They were "(i) the length of delay; (ii) reasons given by the prosecution to explain or justify the delay; (iii) the accused responsibility for and past attitude to the delay; and (iv) proven or likely prejudice to the accused. The fifth is the public interests in the disposition of charges of serious offences and in the conviction of those guilty of crime". Although those five factors do not constitute a code, and other factors may influence a decision whether to stay proceedings, as Dean J observed, they are convenient reference points to determine whether proceeding with the case may lead to unfairness.

The length of the delay

  1. In this case, although the failure to warn each of the three patients has been brought in a single application, the only connection between the three patients is that they underwent similar procedures allegedly without adequate warnings as to the associated risks.  There is, however, a substantial difference between the periods between the operations and the communication of the allegations to Dr Petros (February 2005).  In the case of P, that period is ten years 4 months.  In the case of M, six years and 3 months and in the case of K, four years 6 months. 

  2. Although there is no statutory limitation period for professional or disciplinary proceedings against medical practitioners, the period in relation to K is well within the limitation period for bringing actions for professional negligence, namely six years.  In Herron v McGregor, McHugh JA said:

    "In civil and summary criminal cases, therefore, it hardly seems possible for a court to say that an action brought within the limitation period is oppressive because mere delay in commencing the proceeding has prejudiced the defendant or accused person: cf Birkett v James (at 322). The limitation period represents the legislature's judgment as to what the public interest requires after taking into account the relevant factors including the prejudice which delay may create

    Nevertheless, in my opinion the courts have power to stay an action, though brought within the relevant limitation period or even though not governed by such a period, if the conduct of the plaintiff or prosecutor is oppressive to the defendant or accused person."

  1. In our view, delay of the nature involved in relation to K is not, of itself, sufficient to suggest a basis for concluding the proceedings are an abuse of process.  Although the period in relation to M is just beyond the limitation period, we are similarly of the view that the period of delay, of itself, is not suggestive of an abuse of process.  The period in relation to P is substantial and raises concerns as to whether a complaint after such a long period can be fairly dealt with.

The explanation for the delay

  1. In her evidence, P explained that she had a series of problems following the surgery by Dr Petros.  She consulted other practitioners, and eventually returned to Dr Petros in November 1994 when he removed tapes and tubes which had been inserted in her vagina in the original operation.  She continued to experience problems thereafter, but was preoccupied by her requirement to care for her three children, one of whom was severely disabled and required her constant care until his death in December 1997.  She was, not surprisingly, deeply affected by her son's death, her mother‑in‑law's death in February 1997, and her mother's death in January 1998.  She was treated by another gynaecologist in December 1999 and was unwell throughout 2000 and 2001.  She had further surgery in 2001 and underwent procedures in October 2002 and November 2003.

  2. In April 2003, P learned that Dr Petros was being sued by another patient.  She attended court to observe those proceedings and saw Dr Petros at that time.  In November 2003 she attended a meeting at the Health Consumers Council at which a number of Dr Petros' former patients attended and spoke.  She then determined that she should make her complaint to the Board.  She said that she had not earlier made a complaint because she was preoccupied with caring for her children and because it was only when she became aware of the other proceedings that she became confident that her "complaint would be heard". 

  3. In the case of M, she too complained of problems following Dr Petros' surgery.  In May 1999 she consulted another gynaecologist who recommended removal of the tapes inserted in the slingplasty procedure.  In June 1999, Dr Petros examined her and suggested a second operation.  M had concerns about her treatment on that occasion and sought a second opinion from the other gynaecologist.  As a result of the advice of that gynaecologist, the proposed second operation by Dr Petros was cancelled.  She has had a series of medical problems since that time, including undergoing various gynaecological procedures.

  4. M wrote to Dr Petros in August 1999 complaining of her treatment by him although that letter did not, perhaps not surprisingly, make any complaint of a failure to warn. 

  5. In May 2003, M saw an article about the litigation in which Dr Petros was involved.  That prompted her to contact the solicitors acting for the plaintiff in that matter, and she learnt of a forum to be held by the Health Consumers Council in July 2003 for women in a similar position.  That meeting did not take place until November 2003, and in the meantime, M engaged solicitors and issued proceedings against Dr Petros.  Following the Health Consumers Council forum, she realised that she could make a complaint to the Board and took that course in March 2004.  She said that she did not realise before the Health Consumers Council meeting that it was open to her to make a complaint to the Board. 

  6. After her operations in August 2000, K returned to see Dr Petros in September 2000 for a follow up.  She was unhappy with the way he treated her at that appointment.  She continued to experience problems following the operations, and saw Dr Petros at his surgery on 26 February 2001 when Dr Petros advised her she would need a third operation.  She underwent a further operation on 29 March 2001.  She underwent treatment with another doctor during 2001, but continued to see Dr Petros between June and December 2001.  She underwent a further operation by Dr Petros on 7 February 2002 but continued to have ongoing problems thereafter.  She then lost faith in Dr Petros and consulted another gynaecologist in May 2002.  She had a series of procedures between June 2003 and April 2004. 

  7. Like the other patients, K saw the article in The West Australian concerning the District Court proceedings.  She attended the District Court to watch those proceedings, and subsequently attended the Health Consumers Council meeting which led to her making a complaint to the Board.  Although she provided the detail of that complaint to the Health Consumers Council in December 2003, it was not forwarded to the Board until March 2004 along with the other complaints. 

Dr Petros' responsibility for the delay

  1. There is no suggestion that Dr Petros is in any way responsible for the delay in the reference of the matters to the Board, or the lapse of time between the Board receiving the complaints and formulating the allegations against him.

Prejudice

  1. Apart from a general presumption of prejudice resulting from inordinate delay of the type referred to by McHugh JA in Herron v McGregor, Dr Petros submits that the delay creates actual prejudice to him which renders a fair hearing impossible.  The suggestion that some general presumption of prejudice arises from delay was rejected by the High Court  in Jago v District Court (see Dean J at 59, Brennan J at 54 and Gill v Walton (1991) 25 NSWLR 190 per Gleeson CJ at 198). Rather, actual prejudice must be demonstrated, although practical effects of delay of the nature outlined by McHugh JA may lead to actual prejudice. The prejudice to Dr Petros is said to arise from his lack of any independent recollection of information he orally communicated to each of the patients. He complains he is forced, in defending the allegations, to rely upon his recollection of what he told patients as a standard protocol from time to time, and what might have been contained in pamphlets given to them. With the passage of time, it has proved difficult, if not impossible, to identify the particular pamphlets which might have been given to these particular patients.

  2. Counsel for Dr Petros indicated that his client's response to the particular warnings, which he is alleged to have failed to give, falls into three categories.  The first category is those which he says, relying on his standard protocol, that he did, in substance, give.  The second are those where he accepts he did not give the relevant warning, but asserts that such a warning was not necessary.  The third category is those where Dr Petros cannot say whether or not he gave the relevant warning because of his lack of independent recollection of the particular conversations. 

  3. It is in the third category that the prejudice claimed by Dr Petros may manifest itself. 

Public interest

  1. It is well recognised that there is a public interest that those accused of wrongdoing in a professional respect should be subjected to proper disciplinary proceedings. The jurisdiction of the Tribunal in relation to the discipline of medical practitioners is a protective jurisdiction - that is, it exists principally for the protection of the public. The jurisdiction of courts, and of the Tribunal under s 47 of the SAT Act, to stay or strike out proceedings on the basis that delay will prevent a fair hearing is an exceptional jurisdiction. It is only those cases where a fair hearing cannot be provided that the public interest in having complaints properly disposed of outweighs the public interest in ensuring that litigants receive a fair hearing.

Are the proceedings an abuse of process?

  1. The touchstone of every case concerning a stay by reason of delay is fairness - see Jago v District Court per Mason CJ at 33.

  2. In our view, there is no basis for contending that the proceedings in relation to K can constitute an abuse of process.  The period between the relevant procedure and the complaint to the Board could not be described as inordinate delay.  It is to be expected that where a complaint is made in relation to warnings leading to a medical procedure, it will only be after the risks to which the warnings relate have come to pass that a patient is likely to consider complaining.  K continued under Dr Petros' care for almost two years after the initial operation.  It is quite understandable that she would not have made a complaint about Dr Petros during the period he was endeavouring to resolve her ongoing problems. 

  3. Dr Petros asserts, and we accept, that he has no independent recollection of the particular conversations that he had with K leading up to the procedures in August 2000.  All he can rely on is his standard protocol, and his notes from his file.  That is not an uncommon situation in respect to litigation against busy medical practitioners who see large numbers of patients in any year.  It is likely that recollection of individual conversations will be difficult for such practitioners after periods much shorter than the statutory limitation period.  Any prejudice, arising from the lack of independent recollection, is likely to arise to some degree in any case where a complaint is not made very shortly after the conversation concerned, and this case is not, in that sense, exceptional. 

  4. Although the period is longer in relation to M, and significantly longer in relation to P, the position in which Dr Petros finds himself is not greatly different from the position in relation to K.  His files in relation to P and M are available.  Dr Petros has given evidence of his standard protocol at the relevant time.  In our view, Dr Petros is not in any significantly different position in relation to M and P from the position in respect of K. 

  5. The explanation of the patients as to why they delayed is understandable.  In each case, the patient focussed upon attempts to deal with and remedy their ongoing health problems.  In each case, it was publicity concerning another claim against Dr Petros which caused them to form the view that their problem was not an isolated one, and, in that context, that they should make a complaint to the Board.  The fact that their complaints did not identify the particular allegations which the Board now brings is not surprising.  Members of the public might be expected generally not to be alive to the professional obligation of medical practitioners to obtain informed consent by the use of appropriate warnings as to risk.  The fact that the Board, or those advising it, reformulated the complaints by focussing upon the consent process is unsurprising. 

  6. We recognise the force in the submission made by counsel for Dr Petros that patients themselves are likely to have given thoughtful consideration to what was, or was not, said in their consultations with Dr Petros, only after the allegations of failure to warn were being formulated by the Board - that is, many years after the conversations concerned.  That is a matter that needs to be borne in mind in assessing the reliability of their evidence, particularly in the context of the application of the "Briginshaw" standard of proof.

  7. Dr Petros contended that there were four courses open to the Tribunal in dealing with the application to strike out the proceedings as an abuse of process.  The first was to dismiss all allegations in relation to all three patients.  The second was to dismiss some of the allegations in relation to all three patients.  The third was to dismiss some or all of the allegations in relation to particular patients, and the fourth was to allow all allegations to proceed.

  8. As we have said, we see no basis for striking out the allegations relating to K.  If any allegations were to be struck out, there seems no sensible basis to strike out the allegations relating to warnings which Dr Petros was able to positively depose to giving, nor those which he accepts he did not give.  All that remains are those allegations relating to M and P where Dr Petros says he is unable to say whether or not he did give warnings.  In that regard, as we have said, we do not think that Dr Petros was in any worse position than in respect of that category of allegations relating to K.  The delay in relation to K was not inordinate, and the difficulty which Dr Petros finds himself would exist in any case where precise allegations of failure to warn were not made very shortly after the relevant conversation, accept, perhaps, those cases where warnings were fully documented.

  9. Having heard the evidence of the patients, and Dr Petros' response to that evidence, and given the availability of the files in relation to all three patients, we do not consider that there is any unfairness to Dr Petros in proceeding to hear all matters.  To strike out some selected allegations when many other allegations would remain would not substantially alter the course of the proceedings.

  10. The issues raised by Dr Petros as to the reliability of evidence of the witnesses are matters to be borne in mind in assessment of that evidence having regard to the relevant standard of proof.  Otherwise, in our view the public interest in the proper consideration of allegations of professional misconduct favours a full consideration of all allegations brought by the Board rather than a selective examination of some of those allegations.  We therefore decline to strike out any of the allegations as an abuse of process.

Gross carelessness or incompetency

  1. The allegations against Dr Petros are brought under s 13(1)(c) of the Medical Act 1894 (WA), alleging that he is guilty of gross carelessness or incompetency. Owen J, in Jemielita v Medical Board of Western Australia (Unreported, Supreme Court of Western Australia, Library No 920584), endorsed the following explanation of those expressions:

    "The Board is of the view that gross carelessness or incompetency in section 13(c) of the Act means gross carelessness or inability by the practitioner to attend to the requirements of a patient either at all or with reasonable skill and care.  In the context of s 13 it is necessary that the carelessness or incompetency should assume a scale of gravity which is sufficiently serious to warrant denunciation by professional colleagues of good repute and competence and have reached the scale that such other practitioners regarded as intolerable and deserving of punishment and disciplinary action as falling so short of an acceptable standard of clinical care that disciplinary action is warranted for the protection of the public."

  2. His Honour went on to say:

    "The respondent also held that the concept of incompetency involved an unfitness to practice the particular field of medicine which is under examination or an inability to perform the techniques or reach the judgments needed for the proper practice of medicine in that field.  The concept of gross carelessness involves unacceptable conduct without any intentional wrong doing on the part of the practitioner.  It also suggests that the practitioner is unable to give the care required or is indifferent to the need for such care notwithstanding that he may have the intellectual and technical ability to supply the care that is required.

    In my view, the Board has correctly identified the appropriate meanings of those phrases as they apply to disciplinary proceedings and to standards of professional conduct required of medical practitioners.  I should add one small point.  The concept of 'carelessness' may not be endemic to the practitioner's affairs generally.  It may be limited to individual, perhaps sporadic, incidents.  However, the concept of incompetency seems to suggest a more generalised deficiency in the way in which a practitioner handles his professional affairs."

Duty to warn of risks

  1. It is well established that the law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment (Rogers v Whitaker (1992) 175 CLR 479 at 483). The Court in Rogers v Whitaker said that

    " … a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. This duty is subject to the therapeutic privilege."

  2. It must be borne in mind that the authorities dealing with a duty to warn were decided in a context of claims in negligence.  In that context, the Court in Rogers v Whitaker agreed with King CJ in F v R (1983) 33 SASR 189 who in turn had agreed with the following passage from a judgment of the Supreme Court of Canada in Reibl v Hughes (1980) 2 SCR 880 at 894‑895:

    "To allow expert medical evidence to determine what risks are material and, hence, should be disclosed and, correlatively, what risks are not material is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including the question whether there has been a breach of that duty.  Expert medical evidence is, of course, relevant to findings as to the risks that reside in or are a result of recommended surgery or other treatment.  It will also have a bearing on their materiality but this is not a question that is to be concluded on the basis of the expert medical evidence alone.  The issue under consideration is a different issue from that involved where the question is whether the doctor carried out his professional activities by applicable professional standards. What is under consideration here is the patient's right to know what risks are involved in undergoing or foregoing certain surgery or other treatment."

  3. That passage contemplates a different role for evidence of other practitioners in the context of determining whether a practitioner's conduct meets applicable professional standards, in this case whether a failure to warn constitutes gross carelessness or incompetency, as compared to a context of negligence.  As will become evident, the Tribunal heard evidence from several well qualified medical experts concerning whether particular warnings should have been given before Dr Petros' treatment of P, M and K.  The witnesses did not agree about the necessity to warn of many of the matters the subject of allegations in these proceedings.  No witness proffered an opinion that a failure to warn of any particular matter fell so far short of professional standards that disciplinary action was warranted.  The task for the Tribunal is to assess the expert evidence and to determine whether there was a failure to give adequate warnings, and if so, whether that conduct amounts to gross carelessness or incompetency as described in Jemielita.  Accordingly, the issues for determination in this case are:

    i.whether warning of the particular matter was in fact given, and if not,

    ii.whether the particular warning alleged should have been given in the particular circumstances of each particular case, and if so  

    iii.whether the failure to give it assumed "a scale of gravity that other practitioners would regard as intolerable or deserving of punishment or disciplinary action, or as falling so short of an acceptable standard of clinical care that disciplinary action is warranted for the protection of the public". 

  4. In approaching the question of the requirements of reasonable care, Barwick CJ, in Maloney v Commissioner for Railways(NSW) (1978) 18 ALR 147 at 148, observed that "perfection or the use of increased knowledge or experience embraced in hindsight after the event should form no part of the components of what is reasonable in all the circumstances. That matter must be judged in prospect and not in retrospect". Care in considering matters "through the prism of hindsight" was also urged by Gleeson CJ in Rosenburg v Percival (2001) 205 CLR 434 at [16]. The same care, at least, is required in the context of professional disciplinary proceedings.

  1. It is against that framework that the allegations against Dr Petros, and the evidence, must be considered.

The IVS procedure

  1. Stress incontinence is a condition where a patient loses urine by increasing pressure within the abdomen by coughing, laughing, straining or sneezing.  Urge incontinence is a condition resulting from bladder instability.  It is possible to treat incontinence surgically and non‑surgically.  Non‑surgical treatment involves pelvic floor rehabilitation by methods such as electro‑therapy, exercise or bladder training.  Over the years, more than 150 operations have been described for the surgical treatment of incontinence.  Two of those procedures in common use prior to, and during, the 1990s were procedures known as the Burch Colposuspension and Pubo‑urethral sling procedure.  In Perth, a procedure known as the "Murray‑Cato" procedure was performed.  It was also, apparently, performed in Auckland, but was not performed elsewhere in the world.  It was similar to the Burch Colposuspension but involved a different surgical technique.

  2. The intravaginal slingplasty procedure (IVS) was developed to correct female urinary incontinence.  It was a variation of other sling procedures that had been previously used.  In broad terms, it involves the placement of tape within the vagina to stimulate the growth of scar tissue which then acts as a ligament to retain the form of the pelvic structures.  The procedure is based upon what Dr Petros refers to as the Integral Theory.  A book published in 2004 by Dr Petros describes the fundamental principle of the Integral Theory as being that the "restoration of form (structure) leads to restoration of function".  IVS involves the use of what is referred to as "tension free" tape.  The tape is "tension free" in that it is not anchored to any part of the anatomy, unlike other tape procedures such as the Pubo‑urethral sling procedure.

  3. Dr Petros performed the first IVS procedure at Royal Perth Hospital in 1988.  He subsequently jointly developed the procedure with the late Prof Ulf Ulmsten of the University of Uppsala in Scandinavia, and in Australia. 

  4. On 28 July 1993, the Royal Perth Hospital Ethics Committee formally approved the "tension free" tape procedure and determined that it would be withdrawn from trial status and could be employed at Royal Perth Hospital as standard clinical practice.  The earlier use of the tension free tape procedure by Dr Petros had been carried out under the supervision of the Royal Perth Hospital Ethics Committee.  After 1993, Dr Petros performed the operations routinely at Royal Perth Hospital as standard clinical practice.

  5. In the course of the development of the operation, Dr Petros designed a "tunnelling" instrument for use in the IVS procedure.  Following investigation, the Australian Medical Association was involved in marketing the IVS instrument for a period of some 18 months. 

  6. Over the years since 1993, Dr Petros and others have performed thousands of IVS procedures.

  7. Many of the previous surgical methods for treating female incontinence were designed to elevate and fix the bladder neck, and anchor it to another part of the anatomy.  It was common ground amongst the experts who gave evidence at the hearing that those procedures were heavily invasive, and involved lengthy stays in the range of 5 to 10 days in hospital.  Unlike other methods of treatment, including the Burch Colposuspension, the IVS patient does not require an indwelling catheter following the procedure.  The IVS procedure is minimally invasive, and usually involves only day surgery with the patient able to go home either the same day or the next day. 

The nature of the case against Dr Petros

  1. It was apparent from the evidence of P, M and K that they had suffered a series of ongoing pelvic problems following their treatment by Dr Petros.  It was also apparent that Dr Petros' manner caused them concern, and in some cases, offence.  Their initial letters of complaint to the Medical Board had expressed concern they had been subjected to a procedure that was inappropriate.  Concerns of that nature are not, however, the subject of investigation in these proceedings.  As the respondent's counsel rightly submitted, it is important to bear in mind that there is no allegation against Dr Petros that:

    a)he should not have performed the IVS procedure on P, M and K;

    b)he should not have recommended that those patients undergo the IVS procedures;

    c)he carried out any of the procedures negligently;

    d)he was negligent in any post operative follow up or treatment, nor that;

    e)the IVS procedures carried greater risks of injury or complication beyond procedures such as Burch Colposuspension, Pubo‑vaginal sling procedures or the Murray‑Cato procedure.

  2. Rather, it is necessary to look at each of the alleged failures, and to consider the issues referred to (at [46]) above.

The allegations relating to P

  1. P was aged 41 when she attended Dr Petros' surgery in June 1994.  P had graduated from nursing in 1976.  She worked as a nurse for approximately 4 years before the birth of her first child.  During that time she undertook a renal course while working at a urology hospital in England.  She worked only for a brief time after the birth of her first child in 1981.  P saw Dr Petros three times, on 15 June 1994, 24 June 1994 and 23 September 1994 before he performed a procedure.  At the first attendance, Dr Petros gave P a document entitled "Keyhole Vaginal and Incontinence Surgery".  That is a letter apparently prepared for referring doctors to explain the new procedure.  It commences "these new 'keyhole surgery' techniques are now being used throughout Scandinavia for the cure of urinary incontinence".  P said that she was "very attracted" to the prospect of same day or overnight surgery.  She said that simplicity of the procedure and an overnight stay were very important to her because she was providing full time care to her disabled son at that time, as well as two other small children.  She said that a lengthy stay in hospital would have been very difficult for her and her family to deal with.  She recalled that her general practitioner also informed her that a short period of recuperation associated with the operation performed by Dr Petros may suit her due to her family circumstances. 

  2. Dr Petros also provided P with a document entitled "Normal Position of Organs".  This document contained a diagram of the pelvic organs.  It explained the process leading to incontinence, and the purpose of the proposed surgical procedure.  It purported to explain why old methods led to poor results and required lengthy catheterisation.  As to the "new methods" the document stated "the keynote to the new methods I am using is precision.  However, as the difference between success and failure may be as little as 3 millimetres of tissue, 20% of patients may need an adjustment, ie a tightening at a later stage".  Dr Petros recalled, and it is clear from the copy of the document, that he explained the proposed procedure by reference to the diagram, and made certain jottings on it in the course of that explanation. 

  3. Dr Petros also gave P a document entitled "Patient Information Sheet".  That document provided information as to the nature of certain testing which would be done prior to surgery.  In relation to surgery it said:

    "SURGERY

    The surgical techniques we are using are minimally invasive, and are performed under very light anaesthesia.  There is no need for postoperative catheterization.  These techniques are already practised in several centres in Sweden, Norway, Finland, and also, Perth Western Australia.  The techniques have been specially developed over several years, and encompass, over 1,000 operations.  Generally the patient is discharged on the day following the operation and returns to work with only a few limitations within 7 days.  These include lifting children, heavy weights and no vaginal intercourse for 6 weeks."

  4. The document also advised that there is a failure rate with surgery in up to 20% of patients "ie, the sutures may tear out or the strengthening of one part of the vagina may divert the pressure onto another part, causing further weakness".  However, it advised that if such a complication occurs, it can "be readily corrected with a minimal procedure, these matters will be clarified during discussions with doctor".

  5. P confirmed that, when she saw Dr Petros, there was discussion of the fact that 20% of patients may need an adjustment.  The adjustment being "described to me as tightening at a later stage, and that the operation may have to be repeated in some instances". 

  6. P said that Dr Petros did not inform her during the first consultation of any risks associated with the proposed surgery, "although he did advise that there was a slight risk of infection and pain behind the 'bone' following the surgery". 

  7. As noted above, Dr Petros has no independent recollection of the meetings he had with P, or indeed the other patients K and M.  He did, however, describe his usual procedure on first consultation with a patient.  That procedure involves his secretary providing the patient with a questionnaire for completion prior to the appointment.  He commences the consultation by explaining why the referring doctor has made the referral.  He takes a general medical history, and an obstetric and gynaecological history.  He reviews the questionnaire and goes through the questions with the patient.  If clarification is required it is obtained by asking relevant questions of the patient.  Where problems have been identified in the questionnaire, Dr Petros explains the likely cause of those problems.  He then conducts an examination and ultrasound explaining relevant findings as the examination proceeds.  He records the results of the examination in the patient's folder and then, the patient having dressed and returned to her seat, he explains preliminary findings and advises that a more detailed and objective assessment, including a 24 hour urinary diary, a 24 hour pad test and urodynamics testing will be required.  He tells the patient that those tests will be organised by his nurse or secretary.

  8. Dr Petros then forwards a letter to the referring doctor enclosing a pamphlet which illustrates and describes the scientific basis for the surgical and non‑surgical procedures practised at his clinic.  Various versions of that pamphlet have been produced going back to a period sometime prior to 4 July 1995.

  9. Having compiled the letter to the referring doctor (which is a pro forma letter to which some handwritten comments are usually added), Dr Petros takes the patient back to the front desk and advises the secretary or nurse of the required testing.  Various information is then provided to the patient in relation to that testing. 

  10. Following the testing, the patient attends a further appointment.  Urodynamic testing is performed by Dr Petros' nurse.  When that is completed, Dr Petros sees the patient and discusses the data contained in or reflected by the questionnaire, ultrasound, and various tests.  He completes a diagnostic summary sheet in front of the patient, and speaks to the patient about his conclusions. 

  11. Dr Petros says his usual procedure then is to inform the patient of her surgical and non‑surgical treatment options.  He points out the differences between the tension free tape procedure and the Burch and Murray‑Cato suspension procedures.  He says he does not refer to the other surgical procedures by name but makes reference to the requirement for a large abdominal incision and a 7‑10 day stay in hospital. 

  12. Dr Petros said that if a patient decides at the consultation to have surgery, he takes a standard consent form from his bookshelf and shows the patient a diagram on the foot of the page.  A consent form signed by P in September 1994 did not contain a printed diagram, but a handwritten diagram appears on that version.  The consent form signed by P on 23 September 1994 reads:

    "Dear Patient,

    The operation discussed with you have been developed over the last seven years, in association with the world renowned urogynaecology department, University of Uppsala, Sweden.

    Using entirely new techniques which can create artificial ligaments, it is possible to reduce what was previously a major painful operation, involving up to two weeks hospital stay, to a minor procedure performed through a 1cm incision.  There is very little pain and you will be able to return to normal activities, often within days.

    It is important to realize that the principal reason for your incontinence is that the tissues around your vagina are damaged and therefore cannot properly close off the bladder.  Repairing damaged tissues is like sewing into frayed cloth.  It means that the success rate, as published, has been between 85% and 90%.  However, because the tissues are damaged, it may never be possible to achieve a 100% dry state, there may be a few drops of urine lost every now and then, in some patients.

    For the same reasons the incontinence may occasionally worsen, generally due to internal sutures tearing out.  Although it may be alarming to the patient, it can usually be corrected by a very minor procedure.

    Please contact me anytime, either at the office 474 1966 or a [sic] home 384 8064, should you have any post‑operative problems. 

    Yours sincerely"

  13. Dr Petros said that he uses the diagram to illustrate to the patient how he proposes to strengthen the weak or damaged structures by implanting a tape or by direct repair.  He said that that is an interactive process with the patient.  He explains the manner in which the implanted tape promotes the development of an artificial ligament.  As part of his assessment protocol, he discusses with each patient the results of each investigation of the patient.

  14. Dr Petros said that his standard procedure is that, at the consultation, and before the patient signs the consent form, he takes the patient through the contents of the consent form, highlighting some of the important information.  Dr Petros said that, at some stage during the course of the consultation, he tells a patient that:

    "a.The 'tension free' tape procedure is new technology;

    b.I developed the 'tension free' tape procedure with Professor Ulmsten at Royal Perth Hospital and the University of Uppsala;

    c.The 'tension free' tape procedure follows a different system to the traditional abdominal procedures.  This allows us to improve many symptoms which are not normally considered as curable by those who practise traditional methods;

    d.Unlike the traditional procedures which involve a 6"/10 centimetre abdominal incision, the 'tension free' tape procedure involves small 1 centimetre incisions.  Because I make smaller incisions, there is much less risk of major complications such as haemorrhage, clots or infection;

    e.The 'tension free' tape procedure has much less pain post‑operatively than the traditional procedures;

    f.Unlike traditional procedures, the 'tension free' tape procedure does not require post‑operative catheterisation.

    Consequently, the patient can go home the same day as the procedure or the next day, compared with the traditional procedures which involve a 7 to 10 day stay in hospital;

    g.There is very little that can go wrong with the 'tension free' tape procedure itself.  I tell the patient that the only 2 things that can go wrong during the procedure are perforation of the bladder by the instrument I use in the procedure and excessive bleeding.  These rarely happen, but if they do I will control it;

    h.The 'tension free' tape procedure does not always work because we operate on weak or damaged tissue.  If the procedure fails, we can have a second or third attempt at it.  The maximum successful outcome can never be more than 80% to 90% of cases.

    I tell the patient that the procedure is like sewing into frayed cloth, as this vividly illustrates to my female patients why the procedure might fail.  I also say that repairing one part of the vagina can case pressure on another part and if that other part is weak it can blow out;

    i.The main problem with the 'tension free' tape procedure is that there's a 5% chance that the patient might develop an excessive tissue reaction to the implanted tape which will result in the body rejecting the tape.  If the tape is rejected, the patient will know about it because tape rejection is associated with a thick yellow vaginal discharge.  Tape rejection does not involve pain.

    I tell the patient not to be alarmed by (or not to worry about) tape rejection because I can generally deal with rejected tape as an office (outpatient) procedure by easily removing the tape altogether or snipping off part of it.

    j.Because of the risk of sutures tearing out, for at least 6 weeks post‑operatively the patient should not do any heavy lifting, exercise, squatting or straining.  She should avoid opening her legs or bending down without bending her knees.  The patient, when bending, needs to keep her legs together and bend at the knees.  She should swing her knees when getting in and out of a car;

    k.The patient should not have intercourse for 6 weeks post‑operatively because I do not want the sutures to be interfered with.  If the patient expresses dismay on being told this, I suggest that she and her partner use the period as an opportunity to explore and do other things which are important between them, but no sexual penetration;

    l.Patients usually experience very little pain post‑operatively, but if there is severe pain, the patient should contact me immediately;

    m.Generally there is some bleeding of dark blood for a few days post‑operatively but the patient should not worry about this.  If the bleeding is excessive, the patient should contact me immediately;

    n.If the patient has a temperature post‑operatively, she must contact me immediately;

    o.If the patient experiences anything abnormal post‑operatively, she must contact me immediately;

    p.If the patient is worried about anything, she must contact me immediately;

    q.The patient should feel free to ring me anytime day or night if she has a problem.  I give my home telephone number to the patient on the relevant information pamphlets that patients get before I perform any procedure on them;

    r.The patient needs to see me a week after the procedure.  If the patient feels really well and believes it would be a waste of time seeing me, then she should ring me to discuss how the procedure has gone.

    If I do not hear from a patient within a week of the procedure, my secretary tells me that that is the case and I immediately ring the patient to find out what is happening.  I usually make a note of my telephone call in the patient's folder;

    I follow up the patient in this fashion because it's day surgery.  There are certain complications that can occur 4 or 5 days after surgery, such as thrombosis or infection and we need to have contact with the patient during this period to make sure the recovery is progressing in circumstances where the patient is not under supervision in a hospital;

    s.About other issues, including admission to hospital, which hospital, post‑operative visit, hospital, anaesthetic and surgeon fees and return to work."

  15. Dr Petros asserted that, what he tells patients, is an important matter for him.  He said "I tried to limit my discussion to the main complications only, as I believe that excessive information may divert the patient's attention from the core issues which are vital to surgical success, such as the patient's expectations in relation to recovery and what the patient can and cannot do post‑operatively".

Allegations 4.1 and 4.2

  1. It was alleged that Dr Petros failed to warn P that, if complications arose during surgery, only the respondent could remove tapes inserted into the vagina during her operation, and that removal of the tapes in the respondent's rooms would be painful and may require surgical intervention. 

  1. In closing submissions, counsel for the Board abandoned these allegations.  She conceded that the evidence, as it had emerged at the hearing, would not support a conclusion that warnings of the nature asserted were required to be given.  We need not deal further with them.

Allegation 4.3

  1. P underwent IVS, a modified Manchester repair and laparoscopy on 11 October 1994.  It is alleged that Dr Petros should have warned P that, following the removal of the tapes, sexual intercourse may be painful.  Dr Petros admits that he did not say, and would not have said, that sexual intercourse may be painful following removal of the tapes.  His contention is, however, that, based on his knowledge and experience at that time, no warning to that effect was necessary. 

  2. P said, and we accept, that she did experience a number of long term adverse symptoms including pain on intercourse after the surgery.  She has had a number of procedures relating to her pelvic problems from around 1999 through to 2003.  We note, in this regard, that, in the questionnaire completed prior to her first consultation, in response to the question "do you have deep pain on intercourse?" P placed a tick to answer "yes 50% or more".  Whether the pain experienced post‑operatively was a continuation of the pre‑existing condition, or was somehow causally related to the operation, was not a matter investigated in the course of the hearing.

  3. The operation on P involved the temporary implantation of teflon tapes and two anterior and two posterior silicon tubes.  The tubes were inserted to buttress the retaining sutures in the vagina.  It was intended to remove both the tapes and the tubes after about 6 weeks.  In fact the two posterior tubes and a teflon tape were removed on 31 October 1994, when P attended Dr Petros with complaints of problems following the surgery. 

  4. Dr Ian Hocking is a consultant gynaecologist holding a number of senior positions in South Australia.  He has some 40 years experience in the practise of obstetrics and gynaecology.  He is a member of a group of pelvic surgeons known as the Association of Ambulatory Vaginal and Incontinence Surgeons (AAVIS) which was formed in 1997 and has some 250 members worldwide.  He has been President of a AAVIS since 2005.  He has performed the IVS procedure since 1996, and carried out approximately 700 IVS procedures. 

  5. Dr Hocking gave evidence that Dr Petros should have suggested to P that she not have sexual intercourse for about 6 weeks following the procedure.  That advice was contained in the patient information sheet which P acknowledged Dr Petros gave her during one of the consultations.  It also forms part of what Dr Petros says he tells patients as part of his usual procedure. 

  6. Dr Hocking also gave evidence that, in the case of permanently implanted tape (which is his only experience) pain and discomfort with sexual intercourse after 6 weeks occurs very occasional, but is temporary.  He said that his experience is that the level of discomfort or pain reduces with the passage of time, but may last for up to 3 months following surgery.  He considered that a practitioner with Dr Petros' knowledge and experience could reasonably have considered it unnecessary to warn P that following removal of the tapes sexual intercourse may be painful. 

  7. Dr Andrew Korda is also a very experienced obstetrician and gynaecologist who has held a number of senior positions in that field in Sydney.  He has over 35 years experience.  He does not, and has not, performed the IVS procedure as part of his practice.  He does perform what is referred to as the TVT procedure, which is a tension free vaginal tape procedure which he said evolved from the IVS procedure.  Dr Korda was called by the Board.  He expressed the opinion that:

    "The specific risks of IVS insertion are the possibility of vascular injury, urethral erosion, bowel perforation, nerve injury, haematoma formation, bladder perforation, urethral injury, vaginal perforation, tape erosion, post‑operative voiding difficulty, the development of 'detrusa overactivity', purulent vaginal discharge, dyspareunia, pain in the bladder, vagina, rectum, buttock and rectal pain, and recurrent urinary tract infections."

  8. Dyspareunia is pain on intercourse. 

  9. The basis upon which Dr Korda concluded that dyspareunia was a recognised risk of the IVS procedure was challenged in cross‑examination.  Dr Korda provided a lengthy report, dated 29 March 2005, which went into some detail as to alternative forms of surgical treatment for female incontinence and then dealt with a number of specific questions put to him related to the allegations against Dr Petros.  As Dr Korda's report acknowledges by appropriate attribution, a significant amount of the statistical information to which he refers was derived from an article by Chaliha and Stanton in the British Journal of Obstetrics and Gynaecology, December 1999, Volume 106 at pages 1238‑1245.  In his report, Dr Korda had the following to say about dyspareunia:

    "The incidence of dyspareunia is between 0.1% and 4%.  Chronic groin pain occurs in about 12% of women after Culposuspension, but may be relieved by cutting the suture on the affected side, which may also result in recurrence of incontinence.  Chronic pain has not been reported after TVT insertion, although leg pain has been reported after the transobturator insertion of TVT. 

    Severe pain has been reported after IVS insertion in 14% of cases."

  10. With the exception of the figure of 14% in relation to IVS insertion, Dr Korda drew upon a table in the Chaliha and Stanton report for the statistics quoted.  The figures of 0.1% and 4% relate to reported findings concerning Burch Colposuspension, as does the figure of 12%.  The figure of 14% for IVS cases has no attribution.  The Chaliha and Stanton article contains no analysis of complications of the IVS procedure.  In our view, the assertion by Dr Korda as to a relatively high level of dyspareunia consequent upon an IVS procedure does not provide a sufficient foundation upon which to conclude that a warning of dyspareunia should have been given.  The basis for the conclusion is not disclosed.  It is obviously not based on Dr Korda's personal experience, since he has never performed the operation concerned.  It is contrary to the experience of both Dr Petros and Dr Hocking.  Although P gave evidence that she experienced pain on intercourse following the operation, given the history of dyspareunia prior to the operation, that evidence is not sufficient by itself, to conclude that dyspareunia was a result of the IVS procedure and a risk of which Dr Petros should have provided a warning. 

  11. Accordingly, the foundation upon which the allegation of the failure to warn is based, is not made out in relation to allegation 4.3.

Allegation 4.4

  1. This allegation is that Dr Petros should have warned that tapes may become infected and may require antibiotic and surgical treatment. 

  2. The tape used in P's operation was a 2 millimetre teflon tape, which Dr Petros referred to as a multi‑filament tape.  His experience, both experimentally and clinically, is that mono‑filament tape, such as is used in some other procedures, has a propensity to adhere to the vaginal wall, making it very difficult to remove.  His preference is a multi‑filament tape which, he says, behaves in a different way by creating a cylinder around it, making it easily removable.  He said that his experience was that if there was a problem with the multi‑filament tape, it would not require surgical treatment to remove it.

  3. Dr Korda's evidence was that "infection" is a possible risk or complication associated with the IVS procedure.  He does not identify specifically the nature of the infection to which he refers, that is, whether it is a reference to the general risk of infection that is part of any operation, or some additional risk associated with the particular procedure.  Both Dr Petros and Dr Hocking expressed the view that infection has not been shown to be a problem with the tape used by them in treating stress incontinence.  Dr Hocking observed that the risk of infection generally is reduced with the administration of prophylactic antibiotics during surgery.  Dr Hocking did not consider that there was any basis for a requirement to give a warning that the tapes may become infected.

  4. In her evidence‑in‑chief, P said that Dr Petros did inform her that there was a slight risk of infection.  There is no basis in the evidence for concluding that any greater warning was called for, based on Dr Petros' knowledge and experience at that time (and indeed since). 

  5. In the circumstances, allegation 4.4 is not made out.

Allegation 4.5

  1. It is alleged that Dr Petros should have warned P that "severe pain may be experienced following the surgery".  Again, Dr Petros accepts that he did not tell P that that may be the case. 

  2. Dr Korda identifies "pain in the bladder, vagina, rectum, buttock and rectal pain" as specific risks of IVS insertion.  Again, both Dr Hocking and Dr Petros said that severe pain following surgery was not their experience.  As mentioned earlier, no basis for Dr Korda's assertion that severe pain had been reported in 14% of IVS cases is identifiable in the evidence. 

  3. The foundation for the proposition that Dr Petros should have warned P that severe pain may be experienced following surgery is not established on the evidence. 

The allegations relating to M

  1. M first attended Dr Petros around 27 July 1998.  While she was in the waiting room she saw a copy of a newspaper article referring to "revolutionary new technology and surgical techniques jointly developed at Royal Perth Hospital and the academic hospital at the University of Uppsala, Sweden".  The article reported that the operation is "based on a new medical theory on how the bladder works".  M, who was then around 66 years old, then saw Dr Petros and another doctor who was with him.  She was examined and told she required an operation which Dr Petros described as a "sling" operation.  She said that Dr Petros told her about another operation for her urinary incontinence, but told her that that operation would require a hospital stay of 2‑3 weeks.  Because she had no private health insurance, she was referred to Royal Perth Hospital for the operation. 

  2. On 12 November 1998, M signed a Royal Perth Hospital consent form for the procedure.  She underwent the procedure on 16 November 1998, which included an IVS procedure, sacroplexy, muscle flap repair and anterior bridge. 

  3. At her original attendance on Dr Petros on 27 July 1998, M brought with her a completed patient questionnaire.  Dr Petros believes he would have observed his standard protocol about the nature of the procedures he intended to perform and the risks and benefits associated with it.  Dr Petros completed a diagnostic summary sheet, and although he has no independent recollection, he believes that he would have taken her through that as he completed it. 

  4. Dr Petros' notes of his attendance on M on 27 July 1998 include a notation "discussed op and complications".  Dr Petros identified that as a reference to his giving his standard advice, a proposition which we accept.

  5. Dr Petros said that he did not give M his standard consent form, or arrange to provide any of the pamphlets relating to the procedures that he intended to perform, because the procedure was going to be performed at Royal Perth Hospital.  He was therefore not certain who would be performing the procedure and did not consider it appropriate for him to give the patient information pamphlets if somebody else was going to operate on her. 

  6. M, who like the other complainants gave her evidence frankly and to the best of her ability, accepted during cross‑examination that she could not remember whether Dr Petros discussed the questionnaire with her.  The notations on the questionnaire suggest that there was a discussion of the nature described by Dr Petros as his usual procedure, of the various answers to the questionnaire.  We have no difficulty concluding that Dr Petros made the various notations on the questionnaire which are in his handwriting in the course of a discussion with M.  Not surprisingly, M has no recollection of the content of that discussion. 

Allegation 4.6 and 4.7

  1. These two allegations are that M should have been warned that, following an insertion of the tapes during the IVS, there may be abscess formation which would result in pain and surgical treatment. 

  2. Following the operation by Dr Petros, M had a number of ongoing problems.  She consulted other medical practitioners in relation to some of those problems.  She said that, after the IVS procedure, she developed an unpleasant discharge from her vagina, and also experienced abscesses in her vagina.  The abscesses were very painful. 

  3. In his list of "specific risks" of IVS insertion, Dr Korda did not include abscess formation.

  4. The Board's solicitors put certain questions to him for the purposes of his report.  One of those listed five specific problems, one of which was "formation of abscesses on the vaginal wall" and asked whether "any of the following possible risks and/or complications [are] associated with the IVS procedure".  Dr Korda's response was that all five "have been described as complications of the IVS procedure".  No indication was given as to where the description of abscesses as a complication of the IVS procedure was to be found.  It may be that Dr Korda was drawing upon information provided by a presentation by Dr Peter Henderson at John Flynn Hospital on 6 December 2003.  His report contains several references to that presentation, and to reported complication rates.  Dr Korda also draws upon information reported by Baessler, Hewson, Tunn, Qatawneh and Maher entitled "Intravaginal Sling Distress" published in the International Urogynaecology Journal 2003.  In the detailed references to each of those studies, no mention is made of abscess formation as a complication of IVS procedure.  Even if it were, the publications post date, in M's case by some 5 years, the events the subject of these proceedings. 

  5. In the opinion of Dr Hocking, a competent practitioner would have warned M about the possibility of tape rejection.  Dr Petros says that his standard procedure is to tell patients that there is a chance that "the patient might develop an excessive tissue reaction to the implanted tape which will result in the body rejecting the tape" and that the rejection will be associated with a thick vaginal discharge.  Dr Hocking says the tape rejection may produce a "sterile" abscess which is easily treated by drainage and either local incision or complete removal of the tape. 

  6. We are satisfied that, in light of Dr Petros' notation in M's notes that he discussed complications, the probability is that he discussed the possibility of tape rejection.  Just how the discussion between M and Dr Petros proceeded in the consultation prior to the operation cannot be satisfactorily established.  Not surprisingly, Dr Petros has no independent recollection of the conversation.  In cross‑examination M acknowledged that she could not recall the nature of discussions with doctors who more recently treated her, and operated on her as to the risks associated with those procedures.  She readily accepted that, being more distant in time, her recollection of her conversations with Dr Petros are similarly uncertain.

  7. It does appear that the extent to which Dr Petros explained the manifestations and consequences of tape rejection varied from patient to patient, depending upon the level of interest and the questions of the patient.  That is an aspect of Dr Petros' evidence which is of concern to the Tribunal.  The expression "tape rejection" tells a patient little about the consequences of that rejection.  In the Tribunal's view, a practitioner in Dr Petros' position should provide some detail as to the symptoms of which a patient may be at risk in the event of tape rejection.

  8. Dr Petros' standard procedure, as outlined by him, does deal with what appears to be the most common consequence of tape rejection, namely a thick vaginal discharge.  It would appear that that consequence is fairly easily treated by removal of the tape and is usually pain free.  The type of abscess to which Dr Hocking refers to is a sterile abscess unlikely to cause the level of discomfort and pain apparently suffered by M in the years following her operation.  Whether the specific problem suffered by M was, in 1998, a recognised risk of the IVS procedure, or was even causally related to the IVS procedure, is not established on the evidence. 

  9. On the evidence, we are satisfied that Dr Petros did discuss complications of the operation with M.  We have no reason to consider that he did not discuss the complications which he considered material in light of his knowledge and experience of the operation, and of published material available at the time.  It may be, although we cannot determine with confidence, that Dr Petros did not explain as fully the consequences and symptoms associated with the risks he discussed.  Tape rejection may well be an example of that.  Even if, however, Dr Petros should have more explicitly or effectively explained the consequences of the risks she identified, we would not categorise that failure as gross carelessness or incompetency.  The failure would not, on the evidence we have seen, reach the level of breach of his duty to satisfy the test explained in Jemielita

Allegation 4.8

  1. This allegation is that Dr Petros should have warned M that tape rejection may be experienced which would require treatment with antibiotics and possibly surgical intervention. 

  2. For the reasons explained in relation to allegations 4.6 and 4.7, we do not consider this allegation to be made out.  We are satisfied that Dr Petros is likely to have discussed tape rejection.  The allegation is that tape rejection "would require treatment with antibiotics and possibly surgical intervention".  A number of publications by both Dr Petros and Prof Ulmsten published between 1993 and 1996 reported that any infection could be treated orally with antibiotics and without surgical intervention.  There is no basis for the suggestion that surgical intervention was an appreciable risk of tape rejection, other than by the relatively easy office procedure of tape removal about which Dr Petros is very likely to have told his patients.

  3. The allegation is not made out.

Allegation 4.9

  1. It is alleged that Dr Petros failed to warn M that removal of the tapes could be difficult and painful.  Dr Petros accepts that he did not warn M of that, but asserts that he had no cause to do so, and that it would have been contrary to his own knowledge and experience. 

  2. Dr Korda gave evidence that removal of tape can be difficult.  We note, however, that in response to several questions answered in his report of 7 February 2006 as to what risks should be disclosed to a patient prior to IVS procedure, he did not identify the possibility of difficult and painful removal of the tapes as a matter in respect of which a warning should be given.

  3. A deal of the expert evidence from various witnesses explored the issue of tape rejection in respect to various different types of tape that have been used as both the IVS and TVT procedures have developed.  There appears to be different complication rates associated with different types of tape.  Dr Korda accepted that when a decision to have surgery has been made, a doctor should discuss the procedure with the patient, including "what the published results of surgery are and, when possible, what the operating surgeons own results are".  Dr Hocking expressed the view that "if a particular practitioner's experience in the removal of tapes was that removal was not difficult or painful, then the practitioner would not be expected to warn the patient that removal of the tapes could be difficult or painful".

  4. In relation to this allegation, we are unable to confidently identify any published information, as at 1998 when the operation on M occurred, which would suggest that a warning to the effect suggested should have been given.  We have no reason to reject Dr Petros' evidence that his experience, bearing in mind the type of material he was using was that tape removal was not difficult or painful.  In the circumstances, we are not satisfied that any basis is made out for a requirement that the warning should have been given to M.

The allegations related to K

  1. K arranged a referral to Dr Petros in June 2000, after reading an article in the West Australian as to how he had helped a 38 year old flight attendant deal with incontinence.  She attended Dr Petros' surgery on 12 June 2000, and filled in a questionnaire.  At the time, K was 60 Years old.  The questionnaire contains a number of notations which Dr Petros says, and we accept, were made by him in the course of working through the questionnaire with K during the consultation.

  2. K presented with a number of symptoms including difficulties emptying her bladder, feeling bloated after small meals, excessively frequent urination, inability to sleep after using a toilet at night time, a discharge, and some incidents of incontinence.

  3. At the first consultation, Dr Petros told K that she would require two operations.  The first would be a sacroplexy perineal repair.  Dr Petros explained the operation by reference to a diagram on his consent form.  That form was different from the form used in relation to P in 1994 which is set out above.  The form signed by K read as follows:

    "Dear Patient

    The operation discussed with you has been developed over the last ten years at Royal Perth Hospital in association with the world renowned Urogynaecology Department, University of Uppsala, Sweden.

    We diagnose specific areas of damage in the front or back of vagina.  By targeting these, it is possible to reduce what was previously a major painful operation, involving up to two weeks hospital stay, to a minor procedure performed through a 1cm incision.  If both parts of the vagina need surgery, we recommend repair of only one at a time.  Frequently this is sufficient to correct most of the problem.  Simultaneous repair may actually worsen symptoms, as may tearing out of internal sutures (in approximately 5% of cases).  Generally, there is very little pain and you will be able to return to normal activities, often within days.

    Please note: Occasionally repair in the back part of vagina may be painful if the muscles pull the tissues too tightly after surgery.

    Tape rejection 1% to 3%

    It is important to realize that the principal reason for your incontinence is that the tissues around your vagina are damaged and therefore the muscles cannot properly close off the bladder.  Repairing damaged tissues is like sewing into frayed cloth.  As the tissues are damaged, absolute success rate for surgery cannot be higher than 85% to 90%.  If some urine continues to be lost post‑operatively, do not despair.  The operation is performed in such a way as to promote further tightening over the next 6‑12 months.

    Failure to correct symptoms, though alarming to the patient, can usually be corrected by a very minor procedure.

    Please contact me anytime, either at the office 9474 1966 or at home 9384 8064, should you have any problems. 

    Yours sincerely"

  4. K could not remember everything that was said in her discussions with Dr Petros.  She recalled him telling her that it was a delicate operation and that if it did not work, he could redo it.  She said that she remembered him drawing lines and going through the document with her. 

  5. K was also given three pamphlets by Dr Petros' secretary.  One was entitled "Information for Patients Undergoing Surgery".  That pamphlet provided information in relation to the requirements for hospital admission, treatment in the first 24 hours, precautions to be taken following discharge from hospital and possible symptoms that may be experienced post‑operatively.  It mentioned the possibility of low backache and pain in the back passage for a period of 4‑5 days, and of a discharge which may be a sign of tape rejection, but otherwise did not deal with complications of surgery. 

  6. K had no recollection of any discussion with Dr Petros concerning complications of surgery. 

  7. K had not retained copies of, and did not remember the details of, the other two pamphlets she received.  Ms Carole Yelas was Dr Petros' secretary from 1990 through until 2004.  Her role included providing referring doctors, and patients with various pamphlets produced by Dr Petros' practice from time to time.  Ms Yelas had no independent recollection of her dealings with K, although K recalled her as "Carole" and confirmed that she was given pamphlets by her.  Based on her usual practices and notations made by her on K's file, Ms Yelas was confident that, in addition to the pamphlet "Information for Patients Undergoing Surgery", she gave K pamphlets entitled "Intravaginal Slingplasty" and "Vaginal Repair".  In her witness statement K said that she had not been given those two pamphlets.  However, when shown copies of those two pamphlets during cross‑examination, K accepted that they were possibly the two other pamphlets supplied to her, but she could not specifically recall their contents.  The evidence of Ms Yelas supports a finding that those were the two pamphlets given to K.

  8. The "Intravaginal Slingplasty" pamphlet contains an introduction which includes "although major complications are not common, they may be disabling and even life threatening, and may require further surgery to correct.  This can lead to prolonged recovery time and even permanent disability".  It then explains the essential nature of the procedure, information concerning admission to hospital, information concerning the recovery period and precautions to take on discharge, and requirements for follow up.  The pamphlet advises that "the results of any operation cannot be guaranteed but cure of incontinence is achieved in 90%.  A subsequent small operation may be necessary to improve the results.  As the fibrous tissue around the tape contracts, the result can continue to improve gradually over many months".  It then sets out the following in relation to complications:

    "Complications

    Complications are rare, but it must be understood and accepted that these can occur.  The complications that can occur include but are not limited to the following:

    a)Infection – there may be a simple infection of the urine or wound requiring antibiotics alone.  However, a pelvic abscess could develop requiring drainage.

    b)Haemorrhage – this is extremely rare.

    c)Injury to Bladder – the instrument inserting the tape may pierce the bladder as it is passed up behind the pubic bone.  If seen immediately, it is withdrawn and the bladder heals up without further treatment, much as it does with a supra‑pubic catheter.

    d)Fistula Formation – if the tape passes through the bladder, there would be a leakage around the abdominal scar.  Removal of the tape allows this to heal.

    e)Retention of Urine – this is rare but may occur if the sutures have been tied too tight.  Removal of one suture will overcome this problem.

    f)Deep Venous Thrombosis – a possible complication of any surgery, but much less likely with this type of operation where you are mobilized almost immediately.

    g)Rejection of the Tape – in 5% there will be tape rejection, which can occur even several months after the operation.  This will lead to a heavy yellow vaginal discharge and the tape will need to be removed.  This is a tissue reaction, not an infection."

  9. The pamphlet in relation to vaginal repair follows the same format as the "Intravaginal Slingplasty" pamphlet.  In relation to complications, its states:

    "Complications

    Complications are rare, but it must be understood and accepted that these can occur.  The complications that can occur include, but are not limited to:

    a)Infection – there may be a simple infection of the urine or pelvis requiring antibiotics alone.  However, a pelvic abscess could develop requiring drainage.

    b)Haemorrhage – this is extremely rare, but is watched postoperatively.

    c)Retention of Urine – this is rare, but if it did occur, a catheter would need to be inserted.

    d)Injury to Bladder – during dissection, an incision may be made in the bladder.  This would be repaired and a catheter inserted.

    d)Fistula Formation – if the tape passes through the bladder, there would be a leakage around the abdominal scar.  Removal of the tape allows this to heal.

    e)Injury to Ureter – the ureter which brings urine from the kidney to the bladder may be kinked or tied.  This could cause pain in the kidney and possible fistula formation, and would require and [sic] abdominal operation to correct and reimplant it into the bladder.

    f)Injury to Bowel – if there is an enterocoele, the bowel could be caught by a suture, and this would require and [sic] abdominal incision to correct.

    g)Deep Venous Thrombosis – a possible complication of any surgery, but much less likely with this type of operation where you are mobilized almost immediately.

    It must be emphasized that complications are extremely rare with this type of surgery, and most of the above have not yet been encountered."

  10. Dr Korda described the "Intravaginal Slingplasty" pamphlet as having a "reasonable list of complications associated with insertion of the tape".  He considered the pamphlet "Vaginal Repair" also lists the complications associated with vaginal repairs and that "although these lists are not all inclusive, they do provide a reasonable list of relevant material risks".

  11. On 8 August 2000, K underwent an operation for reconstruction of the posterior ligaments and sacroplexy perineal repair.  On 22 August 2000, she underwent a reconstruction of the anterior ligaments and IVS.  Following the second operation, she experienced back pain different from the coccyx pain that she had previously experienced.  She also experienced pain on intercourse.  She returned to Dr Petros in February 2001, complaining of those symptoms.  On 29 March 2001, she underwent a repair of the anterior vault prolapse, again performed by Dr Petros.  Following that operation, she continued to experience difficulties with sexual intercourse and back pain.

  12. K returned to Dr Petros on a number of occasions and on 7 February 2002 underwent a further operation for the division of a fibrous adhesion band in the posterior vaginal wall.  Although her original incontinence problem had been resolved, K continued to suffer back pain and dyspareunia.  In May 2002, she consulted other medical practitioners and was found to have developed a number of abscesses.  She has undergone several other operations which have included the removal of lengths of tape.  Her problems are ongoing. 

Allegation 4.10

  1. It is alleged that Dr Petros should have warned K that sexual intercourse following the sacroplexy perineal repair and IVS may be painful.

  2. We have explained, in relation to allegation 4.3 relating to P, why an allegation of this nature was not made out.  K's sacroplexy perineal repair and IVS procedure were carried out on 8 and 22 August 2000 respectively.  That was some 6 years after P's operation.  Notwithstanding that 6 year difference, there is, nothing in the literature prior to 2000 which supports the proposition that the warning should have been given.  For the reasons explained in relation to allegation 4.3, allegation 4.10 is not made out.

Allegation 4.11

  1. It is alleged that Dr Petros should have warned K that insertion of tapes during the sacroplexy perineal repair and IVS repair may result in serious infection.  The pamphlets, which we have found to have been given to K, did warn of the possibility of infection and the possibility of pelvic abscesses.  The extent to which the written material provided by Dr Petros might have been the subject of discussion between Dr Petros and K is not possible to determine.  We accept that Dr Petros' experience was that "serious" infection was not a recognised complication of the IVS procedure.  In our view the allegation is not made out.

Allegation 4.12

  1. It is alleged that Dr Petros should have warned K that "abscesses" may form.  The pamphlets given to K do mention the possibility of abscess formation.  Dr Korda accepts that those pamphlets, which we have found to have been given to K, contain a reasonable list of the relevant material risks. 

  2. Counsel for the Board contended that it is not sufficient simply to have a secretary provide pamphlets to a patient, but rather a doctor's obligation is to ensure that the patient fully understands the nature and extent of the risks being disclosed.  There is no doubt that the duty to warn encompasses an obligation to communicate effectively the material risks.  It is open to debate, however, whether oral or written disclosure is more effective.  It may be that the combination of both is a preferable course.  Written communication may be the better method of disclosure for some patients, and oral communication better for others.  If, as may well have been the case, Dr Petros' communication to K of the material risks was not optimally effective, it does not follow that he is guilty of gross carelessness or incompetency.  Dr Petros' standard procedure involved an interactive process with his patients, as well as the distribution of pamphlets.  He did not rely only on the warning contained in his pamphlets.  The use of pamphlets to supplement his oral exchanges was an appropriate system.

  3. Allegation 4.12 is not made out.

Allegation 4.13

  1. It is alleged that Dr Petros should have warned that "ongoing back pain may occur". 

  2. Dr Korda did not list back pain as one of the general risks of the IVS procedure.  Back pain was one of the five "possible risks and/or complications" about which the Board's solicitors asked Dr Korda to comment in his report.  His response was that all five of those matters have "been described as complications of the IVS procedure".  He did not, however, point to any basis for that conclusion.  Throughout his report he makes a number of references to the "material risks of undergoing these operative procedures", but does not identify back pain as one of those risks. 

  3. In our view, there is no sufficient foundation made out on the evidence for the proposition that back pain is a potential complication of the sacroplexy procedure in respect of which a warning should have been given. 

Allegation 4.14

  1. It is alleged that Dr Petros should have warned that "there were consequences associated with tape rejection". 

  2. The precise consequences to which this allegation is directed are not clear.  We have already expressed concern, in the context of our discussion of allegation 4.6 and 4.7, as to the extent that Dr Petros' explanation of the consequences of "tape rejection" depended upon the questions asked by a patient.  We are satisfied, however, that the topic of tape rejection was a matter raised by Dr Petros with patients as part of his general routine.  The pamphlets which were given to K mentioned rejection of the tape, and the common consequence of that rejection, namely a heavy yellow vaginal discharge and the need for removal of the tape.  In the absence of any clear statement by the applicant as to what further consequences should have been disclosed (beyond the specific matters already alleged), there is no basis for any adverse finding in relation to this allegation. 

The general allegations

  1. There are seven matters which the Board alleges Dr Petros should have warned each of P, M and K. 

Allegation 5.1

  1. The Board alleges that Dr Petros should have warned the three patients that the IVS procedure was a new, or relatively new, procedure being performed in Western Australia by Dr Petros, and may still be undergoing trials and evaluations to determine its reliability. 

  2. There is abundant evidence that Dr Petros generally promoted the procedure as being new and recently developed by him with Prof Ulmsten.  Each of the patients acknowledged during cross‑examination that they were aware that the procedure was relatively new. 

  3. The second part of this allegation is that the patients should have been warned that the procedure "may still be undergoing trials and evaluations to determine its reliability".  Particulars of this allegation were sought and given.  Those particulars refer to various research studies, and research papers, published by Dr Petros, Prof Ulmsten and others between 1990 and 2003.  No doubt, the IVS procedure, and the materials used, have been the subject of developments and improvements since it was first performed.  As Prof Maddern, the Chairman of the organisation known as the Australian Safety of New Interventional Procedures in Surgery, said in evidence, all surgical procedures are the subject of constant review and evolution.

  4. By the time P consulted Dr Petros, the procedure had received Ethics Committee approval at Royal Perth Hospital for use as standard clinical practice.  As we have observed above, there is no allegation in these proceedings that the procedures undertaken by Dr Petros were inappropriate.  Given that Dr Petros made it clear that the process was relatively new, we do not consider that a failure to disclose details of the ongoing (and entirely appropriate) monitoring of the procedure would be said to constitute gross carelessness or incompetency. 

Allegation 5.2

  1. It is alleged that Dr Petros should have warned each of the patients "of the complications and failures, which have been experienced and reported with the IVS procedure".  The applicant particularised the complications and failures said to be the subject of this allegation.  Some of those, such as dyspareunia, abscess formation, sling rejection and purulent vaginal discharge are already dealt with above.  A number of others such as haemorrhage, wound infection, osteitis pubis, urogenital fistulae, prolapse, chronic suprapubic pain and "effect on quality of life" are not matters which Dr Korda asserts should be treated as the specific risks of IVS insertion. 

  2. Dr Hocking, in his evidence, went through each of the alleged complications.  In respect of most, he expressed an opinion that it was unnecessary to warn of a significant number of the matters particularised.  In many cases his opinion was based on the view that the conditions particularised are either not a risk associated with the IVS procedure, or were small risks which are easily treatable if they manifest themselves.  At the hearing, and in the evidence, very little specific attention was directed to the specific matters particularised in relation to allegation 5.2, unless the complication was one dealt with in the specific allegations.  A number of the complications are not complications of which any of the three patients complain.  The foundation upon which the Board relies to support the proposition that particular complications should have been the subject of warning was not clearly enunciated.  In the circumstances, there is no basis upon which the Tribunal could conclude that warnings should have been given in respect of all of the matters listed, and if so, whether there was a failure to give the warnings which could be categorised as gross carelessness or incompetency.  The allegation is not made out. 

Allegation 5.3

  1. It is alleged that Dr Petros should have warned each of P, M and K that alternative procedures or therapies to the IVS procedure might be employed to deal with female urinary incontinence, and their complications and success rates in the long term.

  2. This allegation was also particularised.  It was said that Dr Petros should have identified simple measures of treatment such as:

    a)general advice regarding moderating fluid intake, including inter alia caffeine and alcohol;

    b)pelvic floor exercises;

    c)electrical stimulation;

    d)bladder retraining;

    e)drug therapy.

  3. It is also asserted he should have advised of the availability of Culposuspension and Pubo‑urethral sling procedures.  It is said that Dr Petros ought to have informed the complainants in 1994, 1998 and 2000 respectively that the Culposuspension operation and Pubo‑urethral sling procedures were the most effective treatments for urodynamic stress incontinence with cure rates of 84% and 82‑83% respectively.  The particulars do not identify what complications of those alternative procedures ought to have been disclosed. 

  1. There is no suggestion in the evidence that the "simple measures" identified in the particulars would have been appropriate for these patients.  Dr Petros formed the view that surgical intervention was necessary, and, as observed above, it is not suggested by the Board that the treatment was inappropriate.  There is no basis for the contention that Dr Petros should have identified treatment modalities which would, apparently, have been of no benefit to the patients.  With respect to the alternative procedures, Dr Petros' evidence was that, without mentioning the particular procedures involved, he did explain that alternative procedures would involve a longer period of hospitalisation and more invasive surgery.  Dr Petros' evidence was that the most common procedure in Perth at the relevant time was the Murray‑Cato procedure, and not the procedures identified in the particulars. 

  2. In our view, the allegation as particularised, is not made out.

Allegation 5.4

  1. It is alleged that Dr Petros should have warned each of the patients of the circumstances under which the IVS procedure was being performed, including the nature and extent of supervision by a recognised professional body and peer review evaluation. 

  2. Particulars of this allegation were provided, those particulars assert that Dr Petros should have informed each of K, M and P that:

    i)there were no independent studies or evaluations conducted on the IVS procedure;

    ii)there were no peer review studies apart from the original papers describing the IVS procedure written or co‑written by Dr Petros and AAVIS (which was only formed in 1997);

    iii)there was no good quality evidence available to determine the safety and ethicacy of the IVS procedure;

    iv)until 1999 there were no medium term follow up research studies or audits of the complications, risks or ethicacy of the IVS procedure;

    v)there is no long term follow up research studies or audits on the complications, risks or ethicacy of the IVS procedure;

    vi)the IVS procedure was not used by the majority of gynaecologists; and

    vii)there was no independent evidence and no evidence from randomised control studies confirming the percentage risks or complications from the IVS procedure.

  3. The particulars also assert that the Board will rely on various published papers dating from 1993 to 2004 as to what "the respondent should have said regarding the nature and extent of supervision by a recognised professional body and peer review evaluation".  The way the case against Dr Petros is particularised makes it very difficult to identify with precision what it is said Dr Petros should have told these patients.  For example, Dr Petros obviously could not have told P, in 1994 about events which only occurred a number of years later. 

  4. Prof Madden expressed the view that, when a procedure is new or developing, it is highly desirable that a patient be informed that its place in the established surgical practice has yet to be determined.  He said that it is important that the patient be aware that the outcomes and the evidence associated with the procedure may well be lacking and that changes and improvements are likely to occur in the light of experience gained in conducting the procedure on patients during the early and developing phase of the technology. 

  5. Dr Hocking expressed the view that it was sufficient for a competent practitioner with Dr Petros' knowledge and experience to have informed the patient that the IVS procedure was a new or relatively new procedure that had been pioneered in Perth with a Swedish professor in Sweden, and of his own experience with the procedure, including success rate and risks and complications.  That is, of course, essentially what Dr Petros did disclose to the patients. 

  6. It follows, as a matter of logic, that if a procedure is a "new" procedure long term follow up results will not be available.  By the time Dr Petros saw P, he had been undertaking the procedure for around 6 years.  Twelve months earlier it had been withdrawn from trial status by the Royal Perth Hospital Ethics Committee.  It had clearly gone beyond an experimental stage, although, like all surgical procedures, was the subject of ongoing review and assessment.  It is clear that Dr Petros was mindful of the need to gather and publish results as part of that development process. 

  7. Being satisfied that the procedure was appropriate for the three patients, having explained that the procedure was a "new" procedure, having explained his background with Prof Ulmsten in its development, and having identified what, in his experience, were the material complications of which patients should be aware, we are not satisfied that more was required of Dr Petros by way of disclosure of the process of peer review evaluation. 

Allegation 5.5

  1. It is said that Dr Petros should have warned each of the patients of the complications and risks, which might be expected to be associated with the IVS procedure.  It is not easy to see how this allegation differs materially from allegation 5.2.  It may be that allegation 5.5 is directed to risks that might be expected but had not been experienced or reported.  However, the particulars of the risks referred to in allegation 5.5 recite the same complications as the particulars to allegation 5.2.  On that basis, the observations made in relation to allegation 5.2 deal with this allegation.

Allegation 5.6

  1. It is asserted that Dr Petros should have advised each of P, M and K that there was an opportunity to discuss the respondent's recommendation for IVS procedure with another doctor, who was fully informed with the IVS procedure, so as to allow the discussion of any concerns with such an independent advisor.

  2. There was no foundation in the evidence for the proposition that Dr Petros was obliged to inform the patients in the terms suggested.  In all three cases, there was ample opportunity for patients to consult other practitioners if they so wished.  There was some 4 months between P's first consultation and her operation.  She had two further consultations in that period.  There was also a period over 4 months between M's first consultation and her operation, and 3 months in the case of K.  The allegation has no substance. 

Allegation 5.7

  1. It is alleged that Dr Petros should have informed each of the patients that "there was sufficient time to consider the respondent's recommendation for the IVS procedure, and if so desired to seek a second opinion".

  2. Like allegation 5.6, there is no substance in this allegation.  As a matter of fact there was sufficient time to seek a second opinion if any of the patients had wished to.  It is an odd allegation to say that Dr Petros should have "warned them" of that fact. 

Conclusion

  1. There is no doubt that each of P, M and K experienced distressing and at times debilitating problems in the period after their treatment by Dr Petros.  Given the nature of the enquiry in these proceedings, the Tribunal was not called upon to consider the causal relationship between Dr Petros' treatment and each patient's subsequent problems.  It is clear that each of the patients was concerned with Dr Petros' manner.  The question for determination is, however, whether Dr Petros was guilty of gross carelessness or incompetency in failing to warn each patient as to certain matters.  For the reasons explained above, the Tribunal is not satisfied that the allegations are made out.  There may well be room for criticism of the way Dr Petros communicated the relevant risks to these patients.  As an example, we have observed that he may have assumed that too much was conveyed by the expression "tape rejection".  On the other hand, we are satisfied that Dr Petros was alive to his obligation to disclose material risks and complications of the surgery.  We cannot be satisfied on the evidence that he failed to do so.  In the circumstances, the allegations against Dr Petros should be dismissed.

Orders

1.The application is dismissed.

I certify that this and the preceding [163] paragraphs comprise the reasons for decision of the State Administrative Tribunal.

___________________________________

JUDGE J CHANEY, DEPUTY PRESIDENT

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Cases Citing This Decision

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Cases Cited

7

Statutory Material Cited

2

Prothonotary v Del Castillo [2001] NSWCA 75
Briginshaw v Briginshaw [1938] HCA 34
Briginshaw v Briginshaw [1938] HCA 34