Texas Injury Lawyers Blog
Johnson & Johnson has announced it will phase out the sale of four mesh surgical products used to treat pelvic prolapse, hernia, and bladder control problems in women. Johnson & Johnson’s Ethicon unit will reportedly stop selling Gynecare Prosima, Gynecare TVT Secur, Gynecare Prolift, and Gynecare Prolift+M by the end of the first quarter of 2013. Although the company maintains that each of the products are safe for use, the nation’s Food and Drug Administration (FDA) has warned consumers in the past about potential health and safety issues related to the products.
Approximately 75,000 patients had surgical mesh implanted in order to prevent pelvic prolapse last year. Patients in several states have filed hundreds of products liability lawsuits over pain, infection, and scarring allegedly caused by the vaginal mesh products. The FDA previously warned that 10 percent of pelvic mesh consumers will experience exposure or erosion of the mesh within one year after surgery. More than half of those women require at least one follow-up surgery. Oftentimes, more than one surgery is required. Additionally, the FDA stated there was no reason to believe the implants are associated with a better outcome than traditional pelvic prolapse surgery.
Because other similar surgical mesh products were already approved for use by the FDA, vaginal mesh was approved via the FDA’s fast-track process. The process generally leads to faster approval because it requires less stringent safety testing than traditional approval routes. Earlier this year, the FDA ordered six companies, including Johnson & Johnson, to conduct a safety review of vaginal mesh products. In a public statement, Johnson & Johnson announced it would not recall the company’s pelvic mesh products. The company also stated its decision to discontinue the sale of the products was due to market conditions and was unrelated to safety or efficacy.
Potential pelvic surgical mesh lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for side effects such as infection, bleeding, urinary incontinence, vaginal scarring, and pain for patients who were implanted with the products. If you or a loved one experienced medical complications after receiving a pelvic mesh implant, you should contact a skilled San Antonio lawyer experienced with transvaginal surgical mesh cases to discuss your rights.