FDA Wants Transvaginal Mesh Classified As High Risk
Marilyn McGoldrick on Apr 30, 2014 2:23:00 PM
The Food and Drug Administration (FDA) has proposed that surgical mesh used vaginally for Pelvic Organ Prolapse (POP) be classified as a “high-risk” device and that manufacturers accordingly must submit scientific evidence that their transvaginal mesh is safe and effective.
Many mesh manufacturers have been sued for serious failures in their products over the last three years, including Johnson & Johnson’s subsidiary Ethicon, American Medical Systems, Boston Scientific and C.R. Bard to name a few. As litigation progresses, there have been a number of jury verdicts and settlements announced. In 2013, a New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Federal test trials have been set in cases against Ethicon, Boston Scientific and American Medical Systems.
Currently, transvaginal mesh (TVM) is classified as a “moderate-risk” medical device (Class II). This was the original classification, as TVM was deemed similar to another type of mesh long used to treat hernias. Accordingly, TVM received fast-track approval from the FDA. Now that thousands of women have been injured by these products, manufacturers will have to submit data within 90 days showing that their transvaginal mesh products are safe and effective (Class III).
Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common medical conditions in women who have had children, and in older women. The internal structure that supports the bladder, uterus, bowel, and other pelvic organs becomes so weak or stretched that those organs can slip into the pelvic floor. The most common method of implanting transvaginal mesh is through the vagina.
Transvaginal mesh has been controversial for years. Women implanted with the mesh have complained of multiple side effects following surgery including severe pain, mesh erosion, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The FDA’s own analysis (pdf link) found that 10% of patients suffered from mesh erosion within 12 months of implantation, and half of those required followup surgery, sometimes even 2 or more additional surgeries. Women who experience these symptoms after receiving a transvaginal mesh implant should consult their doctor.
Thornton Law Firm is actively litigating all types of transvaginal mesh cases against manufacturers across the country. If you have suffered complications from a transvaginal mesh implant, contact the experienced surgical mesh attorneys at Thornton Law Firm for a free consultation. You can tell us your story online or call Attorney Marilyn McGoldrick at 1-888-341-1405 for a confidential evaluation of your legal rights.