Scotland May Ban Vaginal Mesh Implants

The Scottish Parliament has received a petition requesting the total ban of the use of transvaginal mesh implants within the country. The request was filed by the Holyrood Public Petition Committee, which was prompted to take action by the thousands of reports of serious complications that have developed in women who received the surgical implants to treat pelvic organ prolapse or stress urinary incontinence. Currently, a moratorium that temporarily prohibits the use of vaginal mesh is already in place for all of the United Kingdom, including Scotland.

Backlash against vaginal mesh in the U.K.

The Scottish government began investigating claims of serious complications from transvaginal mesh implants in 2014. The independent review concluded with recommendations that doctors avoid “routinely” recommending vaginal mesh to their patients. This led many critics to decry the independent review, saying that it didn’t go far enough in denouncing the surgical implants.

As of July 2018, a separate independent review was accepted by the U.K. Department of Health and Social Care and National Health Service. The Independent Medicines and Medical Devices Safety Review recommended a complete, temporary halt to all vaginal mesh surgeries in the United Kingdom, including Scotland. The moratorium is set to stay in place until March 2019. At that point, it may transition into a permanent ban. This is dependent on whether it can be determined that the potential benefits of vaginal mesh outweigh the risks.

The review board chair, Baroness Julia Cumberlege, released a statement saying, “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly.” She went on to note that certain conditions intended to mitigate the risks must be put in place before the moratorium could be lifted.

These conditions include requiring the identification and accreditation of all medical facilities that intended to perform surgical procedures with vaginal mesh (including treatment of the complications and removal of the mesh, as well as implantation of the mesh). Another condition is that all surgeons who intended to perform mesh surgeries must be appropriately trained and experienced. Every procedure and each resultant complication must be reported to a national registry.

State of transvaginal mesh procedures in the U.S.

Across the pond, transvaginal mesh has received a similar outcry by public health advocates. The FDA released a safety communication in 2011, which states that the agency had received thousands of adverse event reports between January 2008 and December 2010 alone. The FDA also concluded that transvaginal mesh didn’t offer superior benefits compared to traditional surgical methods of correcting pelvic organ prolapse.

Not long afterward, in early 2012, the FDA ordered manufacturers of vaginal mesh implants to conduct extensive studies and trials to explore the safety profile of the implants. Several manufacturers stopped selling the products after that point.

More than 100,000 transvaginal mesh lawsuits have been filed against a handful of manufacturers in the U.S. The plaintiffs commonly claim that the vaginal mesh implants weren’t accompanied by adequate warnings or safety information. Mesh implants sold by companies like Ethicon, Boston Scientific, and C.R. Bard were under fire for allegedly causing complications like mesh migration, erosion of the mesh into the vagina, organ perforation, infections, and severe, long-lasting pain.

Additional resources:

1. Scottish Government, Independent Review of Transvaginal Mesh Implants, https://www.gov.scot/About/Review/Transvaginal-Mesh-Implants
2. NHS Inform, Transvaginal Mesh Implants, https://www.nhsinform.scot/tests-and-treatments/non-surgical-procedures/transvaginal-mesh-implants