Johnson & Johnson has recently come under intense scrutiny from consumers and doctors alike after it was discovered that it continued to sell a vaginal mesh implant (Gynecare Prolift) for nine months after U.S. regulators told the company to stop marketing the device. The implant, which surgeons thread through vaginal incisions to treat incontinence or pelvic organ prolaspse, was reported to have resulted in 123 complaints involving malfunctions, deaths, and serious injuries from 2005 to May 15, 2008. Organ perforation was also deemed a potential high risk. Pursuant to such data, the U.S. Food and Drug Administration told J&J in a letter on August 24, 2007 to halt sales of the Gynecare Prolift until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA insisted J&J was not to “market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval.” While the device received such approval in May 2008, the company is currently facing more than 1,400 vaginal mesh lawsuits by women who said the mesh caused organ perforation, pain, and scarring and nerve damage.
J&J began selling the Prolift vaginal mesh implant in 2005 without filing a new application for approval after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA. However, the FDA disagreed with this interpretation, and requested a new application that prompted questions in the August 2007 letter. Prolift sales continued despite the request, and J&J was ultimately barred from sanctions as the FDA determined that the company applied the guidance in good faith and “promptly complied” when the agency required a new application.