Medical expert quits mesh implant review group

By Lucy Adams FiDA highlight

Political correspondent, BBC Scotland

• March 15, 2017

An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned.

The consultant, who does not wish to be named, stepped down following the revelation that an entire chapter of the final report had been removed.

It follows the resignation of two patient representatives who claimed the report had been watered down.

Health Secretary Shona Robison said no evidence would be hidden.

Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.

What's the issue with mesh implants?

Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.

There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.

In 2014 former health secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.

Patients representatives Olive McIlroy and Elaine Holmes have already resigned from the review group

An interim report published in October 2015 did not advocate a blanket ban on mesh implants but noted that some women do experience serious complications and it made suggestions for reducing the risks. The final report is expected shortly.

Earlier this month, the BBC revealed that an expert member of the review group had written to its chairwoman, raising concerns about the final draft.

The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.

Patients representatives Olive McIlroy and Elaine Holmes, who have both suffered complications as a result of such surgery, resigned from the review earlier this month, claiming that the final report now lacked integrity and independence.

Responding to the latest resignation, Health Secretary Shona Robison said clinical experts sometimes disagreed on complex medical matters.

She said: "I want to reassure the Scottish Mesh Survivors Group their views have been heard, and I want them to remain at the centre of the crucial work.

"I have been clear that all evidence must be made publicly available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.

"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."

Ms Robision is due to meet Olive McIlroy and Elaine Holmes later this week to discuss their concerns.

In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.

Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.

http://www.bbc.com/news/uk-scotland-39279028?SThisFB

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”.

http://www.theherald.com.au/story/4524242/doctor-denies-being-blind-to-mesh-risk/?cs=305

Lady Parts, Greg Abbott and JNJ Deceptive Trade Practices Mesh Up

 Greg Abbott Not Totally Afraid of Lady Parts,Takes on Big Pharma Over Vaginal Mesh

By Amy Silverstein

Published Fri., Jul. 11 2014 at 7:08 AM

Future Texas Governor Greg Abbott hates nothing more than he hates abortions, Planned Parenthood and other women's-health-related things, leading the Texas Democratic Party to describe him as "public enemy number one for women in Texas." But now, in a major national fight pitting women's health advocates against a corporate giant, Abbott appears to have jumped in bed with women and their bodies.

For the past two years, the Texas Attorney General's office has been quietly leading an investigation into Johnson & Johnson's Ethicon subsidiary, after thousands of women nationwide alleged in lawsuits and complaints to the FDA that the company's pelvic mesh products are defective.

As I reported in a recent feature story on mesh, Ethicon and other companies thought they'd discovered a new, easy way to cure poor bladder control and similar health ills common in aging women and women who have had babies. The fix, rushed to the market in the late 90s, is a surgical device made out of plastic surgical mesh, inserted through the vagina. Patients have complained en masse that the "fix" destroyed their sex lives, worsened their incontinence and caused horrendous pain. More than 17,000 lawsuits have been filed against Ethicon alone.

The FDA was slow to respond, but in 2011 regulators finally issued a warning that complications from some of the mesh surgeries are "not rare." The FDA has yet to issue a formal recall.

Abbott, meanwhile, is investigating Johnson & Johnson under the Texas Deceptive Trade Practices-Consumer Protection Act. In a demand letter sent in April, the Attorney General asked Johnson & Johnson for physical samples of the mesh, detailed data on the material it's composed of, a list of all websites sponsored by Johnson & Johnson discussing the mesh and other data. That's only the latest request for information, following up on a separate demand the Attorney General sent in March 2013. The whole investigation began two years ago, the AG's office tells Unfair Park.

The investigation became public after a group of Texas women wrote a letter to Abbott asking him to crack down on the company, only to find out that he's already looking into it, as WFAA reported.

Women's health aside, Texas and other states have its own reasons to investigate this. "You, as a tax-payer, you're paying for the Medicare patients who have had this thing in," Dr. Daniel Elliott, a surgeon at the Mayo Clinic who treats women suffering mesh complications, told us a few months ago. "Then the patient has all these complications, and you as the taxpayer are paying for their original surgery and you're paying for all these treatments afterwards. It's a huge financial burden on the system."