Vaginal Mesh Implants May Be Banned in Scotland, Amid High Rate of Complications and Problems
Due to the continuing risk of complications from vaginal mesh implants, which have caused injuries for tens of thousands of women worldwide in recent years, a petition has been filed in Scotland, which calls for the country to ban the use of surgical mesh for repair of pelvic organ prolapse or stress urinary incontinence.
The Holyrood Public Petition Committee has filed a request with the Scottish Parliament indicating that vaginal mesh implants should be barred from use in that country. The petition follows a review by a government committee which was criticized for downplaying the risks of vaginal mesh.
The petition also comes amid a moratorium on the use of vaginal mesh throughout the entire United Kingdom, of which Scotland is a part. The moratorium was announced in July after recommendations by the Independent Medicines and Medical Devices Safety Review was accepted by the U.K. Department of Health and Social Care and National Health Service (NHS) England.
In the United States, manufacturers of transvaginal mesh have faced over 100,000 product liability lawsuits in recent years, each raising similar concerns that the devices were introduced without adequate research or warnings.
Design defects associated with surgical mesh sold by Ethicon, C.R. Bard, Boston Scientific and other manufacturers have been linked to reports of severe complications among women, including infections, erosion of the mesh into the vagina and organ perforation.
The litigation over vaginal mesh products has been one of the largest mass torts in recent years, with the number of cases beginning to increase rapidly after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.
After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women. Since then, a number of manufacturers have decided to stop making the devices to avoid the need to spend money studying the safety of products they have sold for years.
The government in Scotland launched its own review of vaginal mesh problems in 2014. However, the independent review recommendations sparked controversy when it recommended that doctors do not “routinely” recommend vaginal mesh surgery. Critics called the findings a “whitewash” that downplayed the severity of vaginal mesh risks.
Even without the petition, vaginal mesh face a potential ban in the U.K.
The U.K.’s temporary suspension will stay in place until March 2019, and it may become a permanent ban if specific circumstances are not identified that can show the benefits of using vaginal mesh to treat stress urinary incontinence exceed the potential health risks.
The conditions for lifting the moratorium include every procedure being reported to a national database, with complications also reported to a registry that tracks each procedure and patient. The review board will also require that all surgeons who undertake the implantation procedures be properly trained and only perform the procedure if they do so on a regular basis.
The review board will also require identification and accreditation of all specialist centers that conduct stress urinary incontinence mesh procedures, including implantation, removal, and treatment of complications.
In the U.S., following several years of litigation, various different manufacturers have reached vaginal mesh settlements to resolve groups of claims involving problems with products manufactured by Endo’s AMS, C.R. Bard, Boston Scientific, Ethicon and others.