Dive Brief:
- FDA formally announced it will convene an advisory panel meeting on Feb. 12 to review surgical mesh devices for transvaginal pelvic organ prolapse repair. The meeting is part of an effort to identify concerns about the devices and strengthen regulatory oversight to protect patients, the agency said.
- Earlier versions of surgical mesh products were removed from the market after a history of adverse events, including malfunctions, injury and death. But FDA said it wants to enable those who need the devices to benefit from them.
- The committee will discuss and make recommendations regarding the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. The public, including patients, has an opportunity to comment and may submit input through Feb. 11 to the electronic filing system at https://www.regulations.gov.
Dive Insight:
Only three transvaginal mesh products remain on the market, and FDA will consider additional regulatory actions based on feedback from the advisory committee meeting. The agency has said that improving the safety net for women's health is a top priority in its broader plan to boost postmarket surveillance of medical devices.
FDA Commissioner Scott Gottlieb first announced the agency would hold a meeting on safety and effectiveness of surgical mesh intended for transvaginal pelvic organ prolapse repair in a statement Nov. 20. But the agency has now laid out further details.
"The advisory committee meeting will seek expert opinion regarding the available evidence of the benefits and risks of mesh for transvaginal POP repair and provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions," Gottlieb said in November.
FDA in 2011 issued a safety communication identifying concerns about use of surgical mesh for transvaginal repair of pelvic organ prolapse. After an advisory panel meeting was conducted, the agency ordered 34 manufacturers to conduct postmarket surveillance studies, resulting in most of the companies choosing to stop marketing the products.
Pelvic mesh products by Johnson & Johnson and Boston Scientific cost those companies millions of dollars in legal claims and are now off the market.
FDA said there are four studies ongoing for five devices. In 2016, the agency reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into Class III, which requires premarket regulatory approval (PMA).
PMA applications were mandated by July 2018. That led to all manufacturers ending marketing of surgical mesh for transvaginal repair of posterior compartment prolapse. The three surgical mesh products that remain on the market currently are for transvaginal repair of anterior compartment prolapse. FDA is reviewing their PMA applications.
At the Feb. 12 meeting, the advisory committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, risks and benefits of mesh placed transvaginally in the anterior vaginal compartment and to identify the appropriate patient population and physician training needed for these devices.
