Scottish Inquiry into Transvaginal Mesh Mess Called a Whitewash

Holmes and McIlroy, The Scotsman

Mesh Medical Device News Desk, April 3, 2017 ~ Unlike the U.S., the transvaginal mesh mess, in Scotland is front page news.

The government conducted an investigation into the hundreds of injuries there, but the report is falls short of expectations, say campaigners.

They call it a “Whitewash” report that anti-mesh campaigners in Scotland now refuse to sign onto.

The report was supposed to be an official Scottish inquiry into polypropylene transvaginal mesh in Scotland - why was it imported and what were doctors and patients promised about its safety and efficacy.

Instead, Mesh campaigners are looking at a judicial review to examine whether the government acted "perversely" in considering lifting the mesh suspension.

Johnson & Johnson (Ethicon) and American Medical Systems transvaginal mesh was used on an estimated 1,500 women a year in Scotland between 2000 and 2014.

An interim report issued 17 months ago, (here) recognized the dangerous complications of using untested polypropylene pelvic mesh. This new report does an about-face.

Olive McIlroy and Elaine Holmes are campaigners who are among the hundreds of women in Scotland to receive the implants. Like many of the other women, their lives have been devastated after what was promised to be a simple 20 minute minimally-invasive procedure to treat incontinence. Holmes is in a wheelchair, McIlroy on crutches.

The campaign group, Scottish Mesh Survivors, encouraged a Scottish government review of what’s been described as the biggest medical scandal since thalidomide. Petitioning Parliament and speaking directly to lawmakers, the campaigners became so vocal the country issued a moratorium on the use of transvaginal mesh.

Alex Neil

The independent review, headed by Neil Findley and former health secretary, Alex Neil, of opposing parties, has fallen short of expectations.

Now Holmes and McIlroy refuse to associate with it. Here is the Scottish Independent Review.

*The inquiry concludes in the surgical treatment of pelvic organ prolapse, (POP) “current evidence does not indicate any additional benefit from the use of transvaginal implants over native tissue repair.”

*When it comes to treatment for incontinence the language is wiggly. “Women must be offered all appropriate treatment, which includes mesh and non-mesh as well as the information to make informed choices,” it says.

*The report suggests a retropublic approach to surgery rather than transobturator.

*“If we do not carry the confidence and trust of our patients, these reports will not be worth the paper that they are written on,” Alex Neil told Holyrood magazine.

*The report is as notable for what it omits. There is no mention of the 140,000 or so product liability lawsuits filed in the U.S. against seven mesh makers. It does not include evidence of the dangers of transvaginal mesh, which includes nerve damage, chronic pain and infection, mesh shrinkage and erosion, among them.

BBC on Scottish Petition, June 2014

Marion McBeth of Scottish Mesh Survivors tells MND the report is a complete betrayal of everything the women fought for.

"The Mesh campaigners feel betrayed and disgusted that the report has been published with missing evidence and safety warnings withheld. They are so angry they have distanced themselves from it completely and are now threatening legal action called a judicial inquiry in which a law lord will be appointed to question whether the decisions made by the Health Secretary Shona Robison are so perverse they are actionable.

The justice she will also examine whether there was bias within the set up of the inquiry members- which there most certainly was given Mesh injured patients were supposed to be at the heart of the inquiry when in fact they faced a barrage of opposition from pro-Mesh surgeons appointed to the review along with government officials facing the biggest medical claim in Scottish legal history."

If the judge believes the government acted perversely then the judge can overturn the government's decision. The judge can also look at whether there was any improper influence or whether those taking part in the review had overwhelming links to industry for example. If the judge rules there was bias then again the government can face legal action to have the review overturned or challenged.

As it now stand, the report allows the current moratorium to be lifted once so-called “safeguards” are in place. The Scottish version of the U.S. Food and Drug Administration is the Medicines & Healthcare products Regulatory Agency or MHRA. Government regulators insist it is up to MHRA to impose a ban on transvaginal mesh.

According to the Scotsman (here), Both McIlroy and Holmes are not surprised about the report’s shortcomings. They noted they were not invited to meetings they knew that were taking place. One of the clinicians, Dr. Lesley Wilkie, resigned from the inquiry. The enthusiasm that met them initially when they first addressed Parliament had cooled.

Marion Scott, Daily Mail reporter, June2014

Opposition party leaders have backed the mesh-injured women and have pledged the scandal will be raised again in parliament. Labour leader Kezia Digdale described it as a 'national scandal and disgrace.' Health committee chairman Neil Findlay has told the SNP government that 'this fight is far from over- these women are not going away!' And Conservative MSP Jackson Carlaw has described it as a 'whitewash'

Mesh is still used but in the EU it is being upgraded from class II to III. In the U.S. only pelvic organ prolapse mesh, an implant larger than that used for incontinence, has been upgraded to the highest level of concern, class III.

Headlines in Scotland

In Scotland, since the publicity generated by Scottish Mesh Survivors, there have still been about 400 implants procedures in recent years. Holmes and McIlroy are concerned informed consent is still inadequate in Scotland.

About 420 women there have filed lawsuits with more coming forward weekly. Thompsons law firm is handling the cases.

McBeth and the others are still hopeful.

Mesh campaigners are determined to fight on for justice stove and a judge may now have the final say on deciding whether the government should lift the suspension on a procedure which has inflicted life changing injury on so many women around the world.

At least then campaigners can be assured there will be no bias or conflict of interest from pro-mesh surgeons.

Cheers jane. It's not over till the fat lady sings and I've not uttered a single note. Lol. X