Johnson & Johnson announced that it will stop marketing several vaginal mesh medical device products in the aftermath of the filing of hundreds of lawsuits alleging the products caused serious complications. Over 1,000 lawsuits are currently pending against Ethicon, Inc., the Johnson & Johnson subsidiary that manufactures the vaginal mesh implants. The discontinued products include Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System and Gynecare Prosima Pelvic Floor Repair System.
The surgical mesh medical device is implanted in women to correct weakened or damaged tissue, provide support in pelvic organ prolapse cases, and to treat severe stress urinary incontinence. According to the Food and Drug Administration (FDA), in 2010 approximately 75,000 women received vaginal mesh implants for pelvic organ prolapse and another 200,000 received transvaginal mesh implants for stress urinary incontinence. From 2008 to 2010, the FDA received more than 1,500 reports of complications connected to the mesh implants, including infection, bleeding and erosion of the mesh into the vagina. This was a five-fold increase in complaints reported between 2005 to 2007.
Earlier this year, the FDA sent letters to manufacturers of surgical mesh products, ordering new safety studies. Johnson & Johnson asked the FDA for permission to suspend this requirement for additional studies for the products that will be discontinued.
Many of the vaginal mesh implants were cleared for marketing by the FDA under a process known as 501(k), which allows the manufacturer to sell the implant if it is proved to be similar to products already on the market. The FDA has indicated that it may reclassify this medical device in a higher-risk category that would require the manufacturer to complete clinical trials before the FDA approves the product for sale.
For more information, contact the transvaginal surgical mesh attorneys at Clark, Perdue & List.
Source: Reuters, “J&J to stop selling controversial vaginal implants,” Anna Yukhananov, June 5, 2012.