Will Transvaginal Mesh and Bladder Slings be Recalled From the Market?
A number of health experts and consumer protection groups have called for a recall of transvaginal mesh and bladder sling products designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), due to the risk of serious and debilitating complications.
Despite tens of thousands of reports involving injuries, it does not appear that the FDA will be issuing a surgical mesh recall.
Rather than removing the products from the market, the agency announced in April 2014 that it was reclassifying the mesh as a high-risk medical device, which will require manufacturers to conduct rigorous pre-market studies before introducing new products.
Studies May Determine Whether Recall Is Issued
In July 2011, the FDA issued a warning about the risk of bladder sling and surgical mesh complications, including:
- Erosion Into The Vagina
- Organ Perforation
- Return of Urinary Problems
The FDA has indicated that it appears that there is no benefit to having a transvaginal mesh implant when compared to more traditional ways of treating POP. While the safety review is still ongoing, FDA officials have indicated that the agency is having trouble finding a reason that these dangerous products should continue to be used, and many doctors have stopped implanting the products.
In January 2012, the FDA told all transvaginal mesh manufacturers that it would require new postmarketing studies and clinical trials on vaginal mesh products in order to help determine if they are a health threat or whether they have any actual benefits.
Shortly after the announcement, Ethicon withdrew several of its transvaginal mesh products from the market, including the Prolift, Prolift+M, Prosima and TVT Secur. Ethicon specifically asked that the withdrawal allow them to avoid being part of the agency’s efforts to answer questions as to whether the products were safe for women.
C.R. Bard has also removed the Avaulta pelvic mesh from the market for the same reasons, citing a desire to avoid the clinical trials, which could shed light on problems inherent with all vaginal mesh products.
In April 2014, the FDA finally took steps to address the risk of surgical mesh problems and prevent manufacturers from introducing products under the controversial 510k fast-track approval process, where new medical devices are allowed onto the market as long as they are “substantially equivalent” to another previously approved device.
Lawsuits Over Failure to Recall Vaginal Mesh Products
Consumers have raised valid questions about why these studies were not required before the products were introduced, and how the vaginal mesh has not been recalled until the products are determined to be safe and effective.
Thousands of women throughout the United States are now pursuing a vaginal mesh or bladder sling lawsuit, alleging that the manufacturers placed their desire for profits before consumer safety my not fully studying the surgical mesh products, warning about the risk of problems or issuing a surgical mesh recall as soon as it became apparent that the products carry substantial risks and may provide no benefits over alternative treatments.
The transvaginal mesh lawyers at Saiontz & Kirk, P.A. are reviewing individual lawsuits by women who suffered severe complications after being implanted with a transvaginal mesh. All claims are handled on a contingency fee basis, meaning there are no out-of-pocket expenses. The product liability lawyers at Saiontz & Kirk, P.A. are only paid if a recovery is obtained.
If you, a friend or family member has suffered complications due to a vaginal mesh implant, you could be entitled to compensation through a bladder sling lawsuit. Request a free consultation and claim evaluation.