FDA Tags Transvaginal Mesh With “High Risk” Classification
Transvaginal mesh implants used to repair pelvic organ prolapse have been reclassified as “high risk” by the U.S. Food & Drug Administration (FDA), after a years-long review determined that the devices are associated with a high rate of adverse events. However, the agency has chosen not to ban or recall the implants.
“While the FDA acknowledges that these devices do pose significant risks, these risks must be weighed against their potential benefits,” an FDA spokesperson told the New York Daily News following yesterday’s announcement. “For this reason, the FDA does not believe that banning surgical mesh for transvaginal POP repair is warranted at this time.”
Transvaginal Mesh Manufacturers Ordered to Submit PMA Applications
Previously, transvaginal mesh used in prolapse repair had been categorized by the FDA as a Class II, or moderate risk, medical device. Implants currently on the market were approved via the agency’s 510(k) program, which allows a device to come to market without the benefit of human clinical trials. However, the FDA has been investigating the safety of pelvic mesh for several years now, amid growing reports of pelvic pain, organ perforation and other serious complications.
The FDA first alerted the public to the serious risks associated with these devices in 2008. In July 2011, the agency issued a second alert after it received thousands of additional reports of injuries associated with transvaginal mesh. In April 2014, the FDA proposed reclassifying vaginal mesh used to treat pelvic organ prolapse as high-risk medical devices.
Designation as a Class III, or high risk, medical device means that transvaginal mesh intended for use in prolapse repair will be subject to greater regulatory scrutiny, and no longer eligible for the 510(k) program. Yesterday, the FDA also ordered manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh used in transvaginal prolapse repair. Among other things, the PMA applications will require manufacturers to address concerns about severe pelvic pain and organ perforation. Manufacturers of devices already on the market will have 30 months to submit their applications.
Transvaginal Mesh Litigation
Since the FDA first raised the alarm about transvaginal mesh, tens of thousand of lawsuits have been filed against Ethicon, Inc., C.R. Bard, American Medical Systems, Boston Scientific and other device manufacturers. Many cases have settled, and a number have gone to trial – some of which resulted in multimillion-dollar judgements for plaintiffs. Just last month, for example, a jury in the Philadelphia Court of Common Pleas awarded more than $12 million in compensatory and punitive damages to a woman who suffered severe complications related to Ethicon’s Gynecare Prolift pelvic mesh.
Despite these verdicts and settlements, thousands of transvaginal mesh lawsuits remain to be litigated. Women who suffered serious complications following prolapse repair that involved the use of a mesh implant may be eligible to pursue their own claim. To learn more, please call 877-779-1414 to schedule a free, no-obligation case review with the legal staff at Bernstein Liebhard LLP.