June 6, 2012
Discontinued Sales Of J&J Vaginal Mesh Products
Connie K. Ho for redOrbit.com
Johnson and Johnson (J&J) recently announced that they would end sales of versions of surgical mesh products that were used to decrease the intensive pelvic discomfort of women; the decision was made following a number of complaints as well as reports of injuries and deaths.The surgical mesh products in question are generally implanted in women to help improve damaged or weakened tissue and to offer support for those who had pelvic organ prolapse (POP). POP is diagnosed in patients where the tissue holding the pelvic is weak, becoming stretchy and bulgy in the vagina. Prolapse can occur in patients who have undergone childbirth, menopause, or a hysterectomy. The mesh was also used to assist those with stress urinary incontinence, which is a condition with a severe overactive bladder.
On Tuesday, June 5, J&J spokesman Matthew Johnson stated that the company asked the U.S. Food and Drug Administration (FDA) if they could stop the sales of four related products within the next 120 days. This time period would allow hospitals and surgeons to find suitable alternatives. The product liability litigation is currently overseen by Judge Carol Higbee of New Jersey Superior Court in Atlantic City and federal Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, including lawsuits involving Boston Scientific Corp and C R Bard Inc.
On Monday, June 4, the Ethicon division of J&J sent a letter to Higbee and Goodwin describing the request the company had made to the FDA regarding the discontinued sale of the mesh products. J&J also asked that the requirements for other studies on Gynecare products be suspended. Previously in January, the FDA had requested more studies be done on the vaginal mesh products.
"Ethicon has no present intention to commercialize these products in the future," the company commented in a letter described in a Reuters article.
According to the FDA, in 2010 7,500 females had mesh repairs for POP and around 200,000 patients had transvaginal repairs for stress urinary incontinence. The FDA also stated that there were more than 1,500 cases that reported malfunction with the mesh between 2008 to 2010, including situations where the mesh eroded into the vagina or caused internal bleeding and infection. In recent years, people have sued the device makers of the surgical mesh products, alleging organ damage and other similar injuries due to the devices. There are currently thousands of lawsuits pending against Ethicon.
Over the next three to nine months, J&J has stated that it will discontinue sales of the products like Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System, and Gynecare Prosima Pelvic Floor Repair System on a region-to-region basis in its global markets. The company will end sales as a result of negative publicity about the vaginal mesh devices and not due to the lawsuits.
"This is not a recall; it's a global discontinuation," Johnson said.
The decision by J&J could also be due to the company´s desire to prevent more lawsuits against devices.
"I think the timing of everything is going to make it very hard for them to convince the jury that they don't believe safety isn't tied to their decision (to discontinue)," Jeffrey Grand, a lawyer at Bernstein Liebhard in New York who is representing some of the women suing the mesh makers, noted in the Reuters article. "(And) from our perspective, this is a fantastic development ... We're happy (the surgical mesh devices) won't be on the market and hurting more women."
According to the Wall Street Journal, the decision to cut the surgical mesh products, sold under J&J´s Ethicon unit, follows actions taken on other problematic products. The products that have had manufacturing problems include the bottle caps of children´s Tylenol and other over-the-counter medication, contact lenses, as well as some hip implants.