It appears after six years and thousands of lawsuits for transvaginal mesh injuries, the U.S. Food and Drug Administration (FDA) is proposing to reclassify the surgical mesh for pelvic organ prolapse (POP) repair to a “high-risk device.” Med Page Today, a news service for physicians, published an article titled: “FDA Wants High-Risk Label for Transvaginal Mesh” stating that the reclassification will require the device to meet the pre-market requirements and mandate an FDA review of safety and effectiveness prior to considering approval for the marketplace. The agency also wants to reclassify certain instruments used to perform POP repair as “intermediate-risk devices,” as opposed to the current low-risk designation.
William Maisel, MD, of the FDA’s Center for Devices and Radiological Health, gave a statement on the FDA’s position. “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.” Maisel believes that if the proposals are finalized, the FDA will then require manufacturers to provide premarket clinical data to demonstrate reasonable safety assurances and effectiveness for surgical or transvaginal mesh products used in transvaginal pelvic organ prolapse (POP) repair.
Transvaginal mesh is a synthetic or biologic material that has been permanently implanted in women to repair pelvic organ prolapse (POP). The article states the FDA proposal does not affect surgical mesh used to treat the following procedures:
- Stress Urinary Incontinence (SUI)
- Abdominal POP repair
- Hernia repair
- Other nonurogynecologic indications
Many critics, including Michael Carome, director of Public Citizen’s Health Research Group, a Washington-based public health advocacy group believe the proposed timeline for full implementation of the FDA’s order will still take several more years and come “too little too late” for those victims whose lives have irreparable damage as a result of transvaginal mesh products. A previous blog post highlights appalling transvaginal mesh injury stories and statistics:
- The mesh is causing serious injuries in hundreds of thousands of women across the country.
- More than 3,000 lawsuits a month are being filed against the makers of transvaginal mesh.
- There are currently more than 40,000 surgical mesh lawsuits already filed in multi-district litigation in federal court in Charleston, West Virginia.
When medical device manufacturers put profits ahead of patient safety and their products fail and cause harm, they must be held accountable.
We anticipate more transvaginal mesh lawsuits will be filed as transvaginal mesh devices continue to fail nationwide. As transvaginal mesh injury attorneys, we encourage individuals injured by defective transvaginal mesh implants to contact our firm to determine if you have a valid medical device case. We aggressively go after manufacturers of defective medical devices and hold them accountable for their negligence.
Federal Register: FDA’s Proposal: https://www.federalregister.gov/articles/2014/05/01/2014-09907/reclassification-of-surgical-mesh-for-transvaginal-pelvic-organ-prolapse-repair-and-surgical
Federal Register: FDA’s Proposal for POP instruments: https://www.federalregister.gov/articles/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ