January 8, 2016
On Monday, January 4th, the FDA released two final orders which increased the regulation of surgical mesh used to repair pelvic organ prolapse (POP). The orders were developed in order to strengthen the data requirements for the device.
The timeline below briefly summarizes the history of the use of surgical mesh:
Over the past several years there has been a substantial upsurge in the number of adverse events related to the device’s use in the transvaginal repair of POP. According to a recent press release, “the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”
In response to the increase in complications, the FDA has taken a number of actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair. These actions include:
Earlier this week the FDA finalized both orders that were proposed more than a year and a half ago. The orders will:
The Agency’s goal is to reduce the risks related with the use of these devices. By requiring manufacturers to address the safety concerns, pelvic pain, and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness, we are hopeful that these requirements will help FDA achieve its goal.
The FDA published a press release to announce the finalization of the orders. In the announcement, William Maisel, MD, PhD, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health (CDRH), said “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
The timeline for compliance was addressed by FDA in the press release as follows:
“Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.”
In addition, the release explicitly states that the orders apply only to mesh devices marketed for the transvaginal repair of POP, and they do not apply to surgical mesh for other indications (e.g. stress urinary incontinence (SUI) or abdominal repair of POP).
For additional information on pelvic organ prolapse (POP), visit the FDA's website here.
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