Georgia will receive $3.4 million under a national settlement with a medical device company and its subsidiary over their product called transvaginal mesh, state Attorney General Chris Carr said.
More than 40 states have signed on to the $117 million settlement with the companies, Johnson & Johnson and Ethicon. The settlement does not affect the thousands of individual lawsuits filed by patients.
Transvaginal mesh was put forward partially as a solution to hold organs in place if they slipped after childbirth or aging, a condition called prolapse. But plaintiffs say patients weren’t adequately told that the implant could disintegrate into human flesh and cause complications, given how much the companies knew about that.
Johnson & Johnson and Ethicon did not admit liability or misconduct.
The Food and Drug Administration eventually reclassified the mesh as a high-risk device. This year the FDA ordered companies to stop selling the product for prolapse patients.
In addition to paying the money, the companies must take certain actions:
They can’t say that implantation “may” prompt flesh to react to the mesh as a foreign body. They have to say it “will” cause a foreign body reaction, and that the effects may vary and may be ongoing.
They have to detail the risks, including permanent dysfunction going to the bathroom or pain with intercourse or loss of sexual function.
They have to explain that surgery to fix the mesh failure has its own risks and may not solve the problem.
Ethicon may not promote the mesh as “FDA approved” unless it’s true.
Carr said a multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and scarring.
“We think this settlement sends a strong message,” Carr said in a statement.
About the Author
