Ethicon Gynecare Vaginal Mesh Sold After FDA Said to Stop Sales

Recently revealed information suggests that Johnson & Johnson not only sold their Ethicon Gynecare Prolift vaginal mesh without obtaining FDA approval, but that the medical device maker also defied an order by the agency not to sell the device once the marketing activities were discovered. 

According to a report by Bloomberg News, records exchanged during the discovery process in the Ethicon Gynecare vaginal mesh litigation includes an August 2007 FDA letter to Johnson & Johnson, demanding that the company stop selling the vaginal mesh. However, the company continued to sell the Prolift mesh for another nine months, before the FDA eventually approved the device.

The letter told Johnson & Johnson’s Ethicon unit that it could not market the Gynecare Prolift mesh until it had addressed 16 potential deficiencies and received final approval. The letter came after the FDA discovered that the device was being sold without having gone through even the FDA’s fast track 510(k) approval process.

Gynecare Prolift Vaginal Mesh Introduced in 2005, But Not FDA Approved until 2008

Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008, three years later. The FDA did not discover that the device was on the market until 2007, when the manufacturer asked for approval for a related mesh device, which are both used to provide support for the bladder and other pelvic organs to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Despite the indication from the FDA in 2007 that sales of the Ethicon Gynecare vaginal mesh should be stopped, Johnson & Johnson kept selling the device while negotiating with the FDA to obtain approval.

Johnson & Johnson has admitted that it decided on its own that its Gynecare Prolift was substantially equivalent to an earlier vaginal mesh it had marketed. It also decided, on its own, that the device would fall under the auspices of 510(k) approval, but did not actually go to the FDA and get that approval, instead determining that its own judgment was good enough. The company has said that too much is being read into the FDA letter ordering it to stop.

Ethicon Gynecare Vaginal Mesh Linked to Problems, Lawsuits

Earlier this month, Johnson & Johnson indicated that they were planning to “cease commercialization” of the Ethicon Gynecare Prolift mesh and other vaginal mesh products, amid mounting lawsuits and thousands of problems reported by women, including instances where the mesh eroded through the vagina, caused infection, pelvic pain and other complications.

Between the time when the company began illegally selling the mesh and the FDA granting approval in May 2008, there were at least 123 adverse event reports submitted to the FDA in association with the product.

Johnson & Johnson now faces an estimated 1,400 vaginal mesh lawsuits over Ethicon’s Gynecare products, alleging that the company failed to adequately warn women or their doctors about the risk of complications.

Similar lawsuits have been filed against other companies that manufacture surgical mesh for repair of pelvic organ prolapse and stress urinary incontinence, including C.R. Bard, Boston Scientific and American Medical Systems (AMS).

The transvaginal mesh products are designed to help treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but in July 2011 the FDA issued a transvaginal mesh warning, indicating that they had received thousands of complaints of injuries and complications, and that they could find no evidence that transvaginal mesh kits used for repair of POP provided any benefit over other available means of treatment.