Johnson & Johnson sold its Gynecare Prolift vaginal mesh for three years without obtaining approval for the product, according to a March 21 report by Bloomberg. The Prolift mesh, which the U.S. Food and Drug Administration (FDA) eventually approved for use in 2008, is now the source of about 550 personal injury lawsuits in the U.S., filed by women who allege the product malfunctioned and harmed them.
To gain FDA approval, manufacturers of medical devices such as surgical mesh and bladder slings must demonstrate that the products either have passed required clinical tests for safety and efficacy or are sufficiently similar to already-cleared devices – a process known as the 510(k) or fast-track method.
However, according to the Bloomberg report, Johnson and Johnson unit Ethicon skipped the FDA approval process completely and took its Gynecare Prolift mesh directly to market in March 2005, saying the product didn’t need approval because it was similar enough to an approved device. According to Bloomberg, FDA spokeswoman Morgan Liscinsky said earlier this month that the “FDA disagreed with this assertion,” concluding distribution began “without appropriate clearance.”
The FDA only learned that the Prolift mesh existed in July 2007, when Johnson & Johnson sought approval for another device, the Prolift+M, citing the unapproved mesh as a predicate, Bloomberg reported. The company’s unauthorized marketing of the mesh could be a considerable factor in the personal-injury lawsuits it faces over the product.
However, Johnson & Johnson’s illicit sale of the medical device isn’t completely uncharacteristic. The company, which is the world’s second largest health care products manufacturer, “already has endured recalls of artificial hip implants and over-the-counter drugs,” Bloomberg explains.
“Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.”
Bloomberg did not say what penalties, if any, Johnson & Johnson faces for its failure to comply with federal regulations in its illegal sale of Prolift mesh.
Doctors typically use transvaginal mesh such as Johnson & Johnson’s Prolift to correct problems associated with pelvic organ prolapse and stress urinary incontinence. The mesh is inserted in the patient to hold internal organs (usually the bladder and uterus) in place. The device, which the FDA says is used in about 40 percent of prolapse surgeries, replaces the traditional method of correcting the condition with stitches and staples.
However, since its debut on the market thousands of women have claimed the mesh has malfunctioned. Reported injuries associated with transvaginal mesh products include organ and tissue perforation, bleeding, persistent pain, ripping of the vaginal walls, bleeding, infection, and urinary problems.