A Scottish Health Board Votes to Suspend Sales of Transvaginal Mesh Implants

Jane Akre
June 16, 2014
Elains Holmes testifies

Elains Holmes testifies

After an effective campaign where women spoke directly to a Scottish Parliamentary Committee, a Scottish Health Board has decided to ban the use of transvaginal mesh implants used as a treatment for pelvic organ prolapse.

This is the first board to suspend the plastic mesh implants reports the Sunday Mail’s reporter Marion Scott here.

The board’s medical director has called for a halt to the use of polypropylene transvaginal mesh as a treatment for prolapse and has called for a review of surgical “tape” or TVT (transvaginal tape) used to treat stress incontinence.

Dumfries & Galloway is the first board to make that decision. NHS (National Health Service) serves a population of 148,190 inside a 2,400 square mile area says its website here. In Scotland the publicly funded healthcare system the NHS is overseen by the Cabinet Secretary of Health and Well-being who is currently Alex Neil. There are 14 geographically-based NHS Boards in Scotland.

Marion Scott, reporter Sunday Mail

Marion Scott, reporter Sunday Mail

Last week women told their stories of pain and permanent injuries. (background story is here). You can watch the link to the hearing here.

Marion Scott, a reporter for the Sunday Mail, has run a fearless series of reports on the victims of transvaginal mesh and her front page stories have gathered attention to the health crisis.

As many as 30 percent of women who are implanted with transvaginal mesh suffer chronic pain, infections, mesh migration and perforation of organs, nerve damage and a host of other complications. The U.S. mesh manufacturers are facing about 70,000 lawsuits in the U.S. where the majority of transvaginal meshes remains on the market.

The Scottish women women had petitioned the government (here) asking for a registry of mesh injuries and asking that the procedures be suspended until questions can be answered and improved safety consent forms can be written so women have a complete understanding of the complications that potentially accompany the use of transvaginal tape.

They also requested that doctors be required to report adverse events instead of the voluntary system that exists in Scotland, similar to what occurs in the U.S.

Dr. Angus Cameron, the board’s medical director, tells the paper “It is obvious from national and international studies that the rate of long-term severe complications is relatively high and we feel that the benefit/risk ratio that is now apparent does not support the use of meshes.”

Health Secretary Alex Neil will not mandate sales of transvaginal tape be suspended because of concerns of lawsuits by manufacturers. He will explain before a Public Petitions Committee on Tuesday.

Scottish Mesh Survivors Karen Neil says “this is the breakthrough we have been waiting for.”

See their Facebook group here.

Adam Slater, Mazie Slater Katz Freeman

Adam Slater, Mazie Slater Katz Freeman

Attorney Adam Slater, who represented Ethicon mesh victim Linda Gross a who was awarded an $11.1 million by a New Jersey jury last year, says he wants to go to Scotland at his own expense and present evidence to the Scottish Parliament.

Slater said: “In the course of investigating mesh cases over the past six years, I have amassed new evidence which I believe has not been made available and will be unknown by those presenting testimony to the committee.”

He believes mesh complications are much larger than what has been reported in the States and elsewhere. He told the paper he has documentation showing mesh makers paid for the non-reporting of complications by the inventor of transvaginal tape.

Slater says the mesh manufacturers continue to influence professional organizations such as the American Urogynecologic Society (AUGS) and the American College of Obstetricians and Gynecologists (ACOG) through financial conflicts of interest.

In the U.S. the FDA has opened up a 90 day period for public comment reclassifying transvaginal mesh for pelvic organ prolapse as “high-risk” requiring studies and clinical trials to assure safety before it can be sold. Critics say the mesh makers understand their products will not survive clinical trials and that will end any innovation.

The comment period and reclassification does not include transvaginal "tape" used to treat stress urinary incontinence.#

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