The government of the United Kingdom (U.K.) has agreed to conduct a retrospective audit of all women in that country who have undergone transvaginal mesh surgery since 2005.
According to The Guardian. the audit is the first of its kind in the country and is intended to provide a definitive look at the number of women who were adversely affected by the implants.
The country’s National Health System estimates that more than 100,000 women in the U.K. have received transvaginal mesh devices to treat pelvic organ prolapse or stress urinary incontinence. Officially, the rate of complications has been placed at 1-3%, but some studies suggest that the true rate could run as high as 15%.
The audit, which is to be completed by April, comes as patient advocates call on U.K. medical device regulators to ban transvaginal mesh.
“After two decades of mesh use with poor audit, the government is finally hearing the voices of women whose lives have changed beyond repair,” Kath Sansom, founder of the group, Sling the Mesh, told The Guardian.
The U.S. Food & Drug Administration (FDA) began reviewing transvaginal mesh in 2008, amid an increasing number of reports linking the implants to serious and life-changing complications, including:
In July 2011, the FDA warned that transvaginal mesh complications associated with pelvic organ prolapse repair were not rare, a position that represented a significant change from the agency’s earlier stance.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the devices ineligible for the agency’s 510(k) clearance program. This program allowed the implants to come to market without undergoing human clinical trials.
Tens of thousands of women throughout the United States have filed transvaginal mesh lawsuits since the FDA issued its first warning in 2008. These lawsuits accuse device manufacturers of failing to conduct proper testing to ensure the safety and efficacy of their implants. Plaintiffs further claim that the defendants concealed the dangers associated with the devices and failed to provide doctors and patients with adequate warnings of their risks.
31 transvaginal mesh trials been convened in the ensuing years, with plaintiffs prevailing in 23 cases. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.