After reviewing a number of adverse event reports, the U.S. Food and Drug Administration is recommending that vaginal mesh implants be reclassified as a Class III device. The FDA has become increasingly concerned over the safety of these devices in the face of mounting lawsuits from women who say they suffered serious injuries caused by transvaginal mesh.
Vaginal mesh was first approved in 1996 to treat women suffering from pelvic organ prolapse, a condition in which the pelvic floor muscles deteriorate and weaken. Pelvic organ prolapse is most commonly associated with stress urinary incontinence and can be caused by childbirth, weight gain or other physical changes.
Under FDA guidelines, Class III devices must meet stricter approval requirements since they represent a greater safety risk to patients than a Class I or Class II device. Manufacturers of Class III devices are subject to premarket approval unless they can prove that their product fits the requirements imposed by the FDA’s 510(k) system. Under the 510(k) rule, a Class III device may be approved if the manufacturer can prove that there is a similar product already for sale on the market.
The move to reclassify vaginal mesh implants is part of an ongoing FDA safety review of these devices. The safety review was initiated after the FDA received an estimated numerous complaints from women who say they suffered serious pain, swelling, infection, tissue damage and other complications after receiving one of the implants.
In July 2011, the FDA issued an updated safety communication warning women and physicians of the potential health risks associated with mesh implants. In that communication, the FDA stated that the risk of complications was not rare and that the use of vaginal mesh to treat pelvic organ prolapse may expose women to greater risks than traditional repair methods.
In addition to enforcing stiffer approval restrictions, the FDA also ordered 33 vaginal mesh device manufacturers to conduct additional research on the safety and efficacy of these products. Two of the biggest targets of the FDA’s scrutiny are Johnson & Johnson and C.R. Bard, who both face numerous lawsuits in connection to a vaginal mesh device. The Johnson & Johnson Company is being sued over complications stemming from its Ethicon Gynecare system while Bard is facing pending litigation involving its Avaulta mesh system.
Women who have suffered serious side effects after being implanted with one of these systems are being urged to contact an experienced personal injury attorney to discuss their legal rights. The vaginal mesh injury attorneys at Nadrich & Cohen LLP are currently providing no-cost, no-obligation case evaluations to women in all 50 states who believe they may have a claim for compensation.
If you or someone you love has questions about filing a vaginal mesh injury lawsuit, call us today at 1-800-718-4658. You can also complete a confidential online contact form by visiting our online Mesh Resource Center. The time you have to file a claim is limited so don’t hesitate to contact us today.