According to Bloomberg, Johnson & Johnson continued selling a vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered the company to stop.
In a letter from August, 2007, the FDA told Johnson & Johnson to halt sales of Gynecare Prolift until the agency decided whether the device was “substantially equivalent” to other products on the market. The letter cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
But the company continued to market the device without sanctions, and the FDA approved it in May of 2008. Now Johnson & Johnson is facing more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage.
The Bloomberg report quotes an attorney representing 150 of those plaintiffs as saying: “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it. It’s egregious that J&J was selling the device without clearance.”
The FDA’s 2007 letter was part of a group of documents filed under seal in state court in Atlantic City, New Jersey, which was recently made public.
The FDA’s controversial “substantial equivalence” provision allows for products to be approved without clinical testing, based on their ostensible similarity to products that are already on the market.
Johnson & Johnson began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA. The FDA disagreed with the company’s interpretation and required a new application.
If you’ve received a vaginal mesh implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a mesh lawyer to discuss your legal rights.