News & Resources

Ethicon Inc., a wholly owned subsidiary of Johnson & Johnson, has decided to cease marketing and producing four types of vaginal mesh implants.  The Ethicon vaginal mesh products are currently the subject of lawsuits filed by thousands of women across the U.S. who believe that the mesh caused serious, permanent internal injuries.  Ethicon disclosed that they would “stop commercializing” the Gynecare TVT Secur mesh, Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System, and the Prolift+M Pelvic Floor Repair System, in a pair of letters sent to a federal judge in West Virginia and state judge in New Jersey who currently preside over vaginal mesh lawsuits.

The decision to phase out the vaginal mesh implants from the market comes at the same time as the products have come under additional scrutiny.  Last July, the FDA released a Public Health Notice citing 3,979 reports of injury, death and malfunction related to mesh implants between 2005 and 2010, including 2,874 incidents between 2008 and 2010 alone.  The FDA concluded its report by stating that “serious complications associated with surgical mesh of transvaginal repair…are not rare.”  In response to these studies, the FDA sent letters to 35 manufacturers ordering new safety studies on their vaginal mesh products.  The FDA also stated it may reclassify the devices in a higher-risk category that requires clinical trials in people before the products are approved. 

This is not the first time Johnson & Johnson’s vaginal mesh products have been associated with controversy.  Earlier this year, it was discovered Ethicon’s Prolift was sold for three years before obtaining proper FDA approval.  The company argued formal approval of the device was not necessary because it was substantially similar to a device already on the market.  Using the controversial 510(k) approval process, Johnson & Johnson began selling the product in 2005 without conducting any studies showing its safety and efficacy.  

Johnson & Johnson’s recent history of consumer safety with products other than the vaginal mesh is equally appalling.  In January 2010, the FDA issued a letter questioning the company’s quality control of its drugs and concerns about Johnson & Johnson’s manufacturing facilities, which lead to a recall of 136 million bottles of infant and children’s liquid medication products.  Johnson & Johnson also recalled its ASR metal-on-metal hip replacement system due to serious safety concerns in August 2010.  Months before the recall Johnson & Johnson stated that it was "phasing out" the metal hip due to "slowing sales." 

Apparently, this is becoming a familiar course of action for the company.