The US Food and Drug Administration ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.
The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016.
As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of
premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the US.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
In 2002, the first mesh device for transvaginal repair of POP was cleared for use as a class II moderate-risk device. About 1 in 8 women has surgery to repair POP over her lifetime, and a subset of these surgeries are completed transvaginally with the use of surgical mesh.
Two manufacturers have been marketing three surgical mesh products for transvaginal repair of POP. In reviewing the PMAs submitted by the two manufacturers, the agency determined they failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh, the agency said in a press statement.