On June 5, 2012, Bloomberg published an article regarding a June 4 letter submitted by Johnson & Johnson to the judge overseeing the Ethicon, Inc. Pelvic Repair System Product Liability Litigation (MDL No. 2327). In the letter, Johnson & Johnson stated its intent to discontinue sales of four vaginal mesh implant models. The decision was reached following numerous suits filed against the company due to claims of injuries sustained from implantation of these vaginal mesh implants.
The implants, marketed and sold by Johnson & Johnson’s Ethicon unit, include the Prolift, Prolift+ M, TVT Secur and Prosima vaginal mesh implants. Ethicon will continue to sell a fifth vaginal mesh implant, the Gynecare Gynemesh, although it will change the label to restrict the implant’s use to abdominal implantations.
Johnson & Johnson has submitted a request to the U.S. Food and Drug Administration (FDA) that will allow the company to stop “commercializing” the devices. A spokesperson for Ethicon further indicated that Ethicon will stop selling the four vaginal mesh implant models worldwide. According to the article, the FDA has yet to respond to Johnson & Johnson’s request.
Johnson & Johnson has faced FDA scrutiny and criticism in the past regarding its vaginal mesh implants. In January 2012, the FDA ordered Johnson & Johnson and other vaginal mesh manufacturers to assess the health problems that may arise from use of these medical devices. Furthermore, in March 2012, the FDA stated that for three years Johnson & Johnson had sold the Gynecare Prolift without first receiving the appropriate regulatory approval from the agency.
Vaginal mesh implants were intended to correct weakened pelvic muscles and to treat incontinence in women. However, some women who have had these devices implanted have suffered from serious injury and pain caused from the shrinking and erosion of the vaginal implants that can take place over time.
Although Ethicon will discontinue selling the four vaginal mesh implants, the company announced that it will not issue a recall of the devices that have already been implanted or sold.
See the full Bloomberg article at: