In the wake of news that Johnson & Johnson had been selling its Gynecare mesh implants for years without FDA approval, the transvaginal mesh manufacturer has now announced that it is recalling most products in its Gynecare line. This includes the Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift + M, all made by J&J subsidiary Ethicon. One other product—the Gynecare Gynemech will stay on the market, but with modifications to its labeling.
Connected to the recall, Johnson & Johnson has requested that the FDA exempt it from the requirement to conduct safety studies related to transvaginal mesh implants. That requirement was imposed by the FDA earlier this year on makers of transvaginal mesh products due to the extremely high number of adverse events reports that the agency had received. At the time of mandating the studies, the FDA had received upwards of 3,500 reports of injuries and complications linked to transvaginal mesh implants.
Those complications are now relatively well-known. The most frequent complication with trasnvaginal mesh include the mesh erosion (also called exposure, extrusion or protrusion) through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. These complications, according to the FDA, are not rare and there is little evidence to suggest that transvaginal mesh offers any benefits over traditional treatment methods for pelvic organ prolapse.
News that J&J is recalling a major portion of their transvaginal mesh products also coincides with the first jury verdict in favor of a woman who suffered complications from a transvaginal mesh implant. Just this week, a California jury awarded $5.5 million in damages for a woman who suffered incontinence and chronic pain after receiving the Avaulta Plus vaginal implant, made by Bard. The lawsuit against Bard is just one in hundreds now being brought against makers of transvaginal mesh, including Bard, J&J, Boston Scientific Corp. and American Medical Systems of Endo Pharmaceutical Holdings Inc. Here at Inserra & Kelley we are currently handling a significant number of claims for women injured by this defective product.
A partner with Inserra & Kelley, Attorneys At Law since 1993, Craig Kelley focuses on personal injury law with a large emphasis on motorcycle and bicycle related cases and claims with the goal of first helping clients heal and then getting speedy resolution of their disputes.