J&J Finally, Sort of, Stops Sale of Pelvic Repair Mesh Products
J&N’s Ethicon division is halting sales, world-wide, of Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+ mesh products. These surgical meshes are among a class of products made by various companies whose safety and effectiveness were the subject of an FDA “Public Health Notification” on October 20, 2008, and an updated PHN on July 13, 2011. According to the FDA, erosion of mesh through the vagina is the most common complication, and can require multiple repair surgeries. Also, contraction or shrinkage of the mesh (causing vaginal shortening, vaginal tightening, and vaginal pain), a previously unidentified risk, was reported in growning numbers.
J&N disclosed to shareholders recently that hundreds of lawsuits have been filed alleging failures and other compliactions from its mesh products. J&N will stop selling most of its mesh products, depleting stocks between June 2012 and March 2013. According to J&J’s press release, “This is not a product recall and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viiability in ligh of changing market dynamics, and is not related to safety or efficacy.”
About 75,000 women had pelvic organ prolapse surgery with mesh inserted through the vagina in 2010.
Contrast what J&J’s communications department says with the language in the FDA’s safety alert. The FDA says: “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare . . . it is not clear that transvaginal pelvic organ prolapse (POP) repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” The FDA reported that mesh implants were associated with higher rates of pain, bleeding, and infection, than with stiches alone. Ten percent of women experienced vaginal wall erosion or exposure of the mesh within 12 months of having the mesh implanted.
The FDA ordered J&N and five other companies to start rigorous studies to track mesh complications. J&J told the judge overseeing the product liability litigation that the FDA will probably waive the requirement to do the studies once it phases out the products. I hope the FDA forces J&J to complete a post-market safety study of the mesh products regardless. That will inform the thousands of women who received a J&J mesh product (and their doctors/surgeons) about potential complications.
If you or a loved one was harmed by a vaginal mesh product, you may want to consult a lawyer to discuss your legal rights. Bailey & Greer, Memphis dangerous drug and medical device lawyers, can handle your questions and your case if you need us.
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Since graduating magna cum laude in 2005 from the University of Memphis School of Law, Thomas has helped make a difference in the lives of victims of serious personal injury, wrongful death, and professional negligence. Thomas has extensive trial experience in both state and federal court. Among other victories in the courtroom, Thomas obtained several impressive jury verdicts and settlements
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