Proposed Federal Guidelines Would Help Ensure Safety of Transvaginal Mesh Devices
Transvaginal mesh manufacturers have come under fire for several years after the FDA reviewed thousands of claims from women stating that transvaginal mesh products were incompatible with human tissue and caused more serious complications than they solved.
Finally, in response to the complaints and lawsuits, the Food and Drug Administration proposed on Tuesday, April 29th, a new set of safety regulations around the manufacturing of transvaginal mesh devices.
The proposal comes three years after the FDA first concluded that women who have transvaginal mesh or surgical mesh implants have more health complications than women who undergo traditional surgery with stitches. An analysis from the agency showed that 10% of women experience mesh erosion – in which the device cuts or sinks into the surrounding tissue and begins to degrade – within the first year after surgery. More than half of those women require follow-up surgeries to remove the mesh, which can often take two or three surgeries when the mesh has eroded into tissue.
The FDA has so far found no evidence to back up transvaginal mesh manufacturers’ claims that their devices are an improvement over traditional surgeries.
“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,” said William Maisel, chief scientist for the FDA’s device center.
The new safety guidelines would prohibit transvaginal mesh manufacturers from using the 510(k) process to fast-track approval of their devices. The 510(k) regulation allows medical devices that are structurally similar to previously-approved devices to get on a “fast-track” approval process to get to market faster. Transvaginal mesh manufacturers have used this process based on a Gynecare ProLift device, which was approved in 1996, but then recalled due to safety problems in 1999.
Instead, the guidelines require transvaginal mesh manufacturers to submit clinical data that proves their devices are safe for use, specifically to treat chronic pelvic organ prolapse and incontinence issues.
There are currently more than 22,000 personal injury lawsuits involving transvaginal and surgical mesh devices, with Johnson & Johnson’s Ethicon division facing the most lawsuits in a multidistrict litigation (MDL).
The Strom Law Firm Fights for Women in Transvaginal Mesh Personal Injury Case
Transvaginal mesh kits were initially produced to help with pelvic organ prolapse and stress urinary incontinence. Several varieties of mesh kits exist, but transvaginal mesh specifically was supposed to produce less scarring and pain, because the procedure was less invasive. However, vaginal mesh slings can cause a host of problems, including organ perforation, infection, internal scarring, continued organ prolapse, and bleeding. If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800