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Wednesday, March 15, 2017

Pelvic Surgical Mesh Scandal: FDA Wrongly Cleared Predicate Device

Dr Peter Petros said he warned women about the 'very frightening' symptoms of his procedure 

Joanne McCarthy  FiDA highlight

15 Mar 2017, 5 a.m.
A DOCTOR whose invention is at the centre of a global medical scandal told a court in 2004 that women could experience “very frightening” symptoms after a pelvic surgical procedure he developed, but that was “how the operation works”.

“Even though it’s not harmful to the patient it can be quite frightening, that suddenly they get this thick yellow discharge that can be very smelly and it can be very frightening to a patient. So I make sure that I tell them about it,” Dr Peter Petros told a Western Australian court after a woman took civil action against him following mesh surgery using nylon tape.

Judge Roger Macknay awarded the woman more than $136,000 after finding Dr Petros “undoubtedly” failed to warn her of risks associated with Dr Petros’s intravaginal slingplasty (IVS) procedure, based on his “integral theory” to treat urinary incontinence.

The woman, 45 when she had the surgery in 1997, suffered “significant” injury which had a “substantial” effect on her life, with symptoms continuing over the long term, Judge Macknay found.

Dr Petros’s mesh delivery device through a woman’s vagina, the IVS tunneller, which was later developed by a subsidiary of Tyco Healthcare and incorrectly cleared for use in America in 2001 for both urinary incontinence and prolapse in women after childbirth, became the “predicate case” which major medical device companies used to “clear” and market multiple other pelvic mesh devices for prolapse.

Investigation: Dr Peter Petros

Global legal cases brought by women alleging serious injuries after pelvic mesh surgery are estimated to cost $20 billion.

In a paper in 2012 Dr Petros distanced himself from the global mesh scandal, saying his “early experimental studies” had been “wrongly” used as “an intellectual cornerstone to justify the use of mesh in prolapse surgery”.

During the 2004 Western Australian court case Dr Petros denied being “somewhat blinded” to possible risks associated with his (IVS) surgical procedure.

“Can you accept as a possibility that because of your personal and financial stake in this procedure that you may perhaps be somewhat blinded as to the adverse elements associated with it? You see it as your baby and you can’t see any bad elements?” the woman’s barrister, Geoffrey Hancy, put to Dr Petros.

Dr Petros replied: “Absolutely not. The role of the scientist is to seek the truth, whether it’s good or bad. That’s the way it is.”

The court was told Dr Petros received a royalty of about $15 per instrument for the IVS tunneller and he performed about 400 operations a year. 

Judge Macknay found Dr Petros had “a proprietary attitude towards the IVS procedure, as well as great pride in events associated with its development”.

In his dealings with the woman Dr Petros “was concerned to extol what he perceived to be the many advantages of the IVS procedure rather than to point out, in a balanced and neutral manner, both possible beneficial and adverse outcomes and the risks”.

“The defendant did not, it would seem, and apparently still does not, believe there was or is any real detriment associated with ‘his’ procedure,” Judge Macknay said.

Dr Petros “lacked to some extent a complete understanding of the obligation owed by a medical practitioner to a patient who was contemplating surgery”, and was “at times argumentative, anxious to debate, unwilling to answer questions as put, anxious to display his knowledge”, the judge found.

Specialists who gave evidence said the IVS procedure had no independent studies to support it in 1997 and the majority of specialists who performed surgery to treat incontinence did not use the procedure.

By 2003 Newcastle obstetrician/gynaecologist Dr Alan Hewson and his Brisbane colleague Dr Chris Maher said the IVS procedure “cannot be recommended” after treating women dealing with complications after its use, and because of the lack of independent evidence of its safety and efficacy.    

Dr Petros’s name no longer appears on the Australian Health Practitioner Regulation Agency register. He did not respond to questions from the Newcastle Herald about whether he had retired in November. 

The NSW Health Care Complaints Commission advised the Herald it has finalised an investigation of complaints against him and has referred the case to “the Director of Proceedings for the consideration of appropriate disciplinary action”.

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