Product News and Recalls

Vaginal mesh wasn’t approved when it was implanted in woman

When Linda Gross of South Dakota had a Gynecare Prolift medical device implanted in 2006, it didn’t have FDA clearance. During her trial against manufacturer Johnson & Johnson, Gross’ lawyer testified that the doctor who performed the operation was unaware of that fact.

According to an article in the Asbury Park Press, her lawyer told the jury: “If he had been warned and given that information, he wouldn’t have used it with Linda. It wouldn’t have gotten in her body.”

The device in question is called a transvaginal mesh implant, which is used to treat urinary incontinence and pelvic organ prolapse by shoring up weakened muscles.

Gross, 47, alleges that she had to quit her nursing job because of the chronic pain she suffered as a result of getting the implant. Hers is the first of about 1,800 lawsuits to go to trial, from plaintiffs who claim they suffered problems related to the implants including infection and organ perforation.

The story says the Gynecare Prolift was approved under an FDA loophole that allows medical devices to go on the market without clinical testing, based on their alleged similarity to products that were already approved.

Johnson & Johnson’s Ethicon unit began selling the Prolift in 2005, after determining on its own that the implant was substantially similar to one of its own products already approved by the FDA. The FDA later declared that Prolift sales began “without appropriate” clearance, and required a new application in August 2007.

The company faced no sanctions because the FDA determined that acted in good faith and promptly complied when the agency required a new application. But Gross’ lawyer claims internal documents show the company was aware of health risks connected to the product even before it went on the market.

If you have 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.

See the story here: