This week the FDA responded to concerns about the safety of mesh implants to treat pelvic organ prolapse (POP) in women. They have been reclassified with its highest risk category and manufacturers of existing products must submit premarket approval applications within 30 months. According to a statement by the FDA, the applications are required “to support the safety and effectiveness” of the mesh products.
POP is caused when the bladder, bowel and uterus are no longer supported by weakened or stretched pelvic floor muscles. Women may develop POP as a result of childbirth, hysterectomy, or menopause. If left untreated, POP can cause pain and urinary leakage.
In the 1990s, gynecologists started using surgical mesh transvaginally to repair POP, reinforcing pelvic muscles and reducing recuperation time. The FDA okayed the first mesh device for this purpose in 2002 and now 5 different manufacturers market a transvaginal mesh product. Unfortunately, the FDA began to log increased reports of adverse events among patients treated with transvaginal mesh. Complications include pain during intercourse, infection and organ perforation. In 2011, they recommended that more data was needed.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
These final requirements include reclassifying transvaginal POP mesh treatment from Class II to the higher risk Class III and requiring premarket approval applications by July 5, 2018. These orders apply only to mesh used in POP repair and not other surgical mesh uses.
Transvaginal Mesh Lawsuits
Women that have suffered because of transvaginal mesh implants are filing lawsuits against the manufacturers of these devices. Johnson & Johnson and Boston Scientific are currently defendants in suits alleging the mesh products have caused pain and injury. Last spring, Boston Scientific paid $119M to settle around 3000 cases and recently, Johnson & Johnson was ordered to pay a woman plaintiff $12.5M after a jury determined she had be seriously injured by their Ethicon Profit mesh implant. Another leading manufacturer, Endo International, has announced that they will be settling cases instead of dragging them out in court.
We are still excepting cases on behalf of women that may have suffered unfairly because of a potentially defective medical device. If you have had POP repair done with transvaginal mesh, you too might qualify for a financial claim. You can find out instantly by simply calling our toll-free legal hotline, 855-776-5299. You will receive a free evaluation of your situation and no-obligation information on how to proceed with your claim. Join thousands of women that have decided they have a legal right to be heard! As there may be a time limit to file your case, please contact us now to reserve your consultation.