Late last night, June 4th comes news from Bloomberg, that medical device maker, Johnson & Johnson (J&J) plans to stop selling four transvaginal mesh implants in the face of hundreds of lawsuits and more to come.
Ethicon, a unit of J&J, told a federal judge in West Virginia that it has requested the official approval from the U.S. Food and Drug Administration (FDA) to stop selling or “commercializing “the devices. That information was contained in a letter filed with the Charleston, West Virginia U.S. District Court of Judge Joseph Goodwin, who is overseeing thousands of product liability cases against four mesh manufacturers that have been consolidated in multidistrict litigation (MDL) in his court.
This is huge news and might signal the beginning of the end of the marketing of transvaginal mesh devices.
In October 2008, the FDA came out with its first warning that mesh implants could cause complications such as organ perforation, mesh migration, infection and death but that the cases were rare.
The agency did a turnabout in July 2011 saying mesh complications were not rare and that the benefits may not outweigh the risks.
Still mesh manufacturers continued to profit from the polypropylene material placed in women to treat the “conditions” of prolapse and incontinence, causing in some women, far worse life-altering complications.
Sold With No Approval
You’ve heard about one of the meshes to be removed from the market in the news lately. In a bold move, J &J began selling the Gynecare Prolift in 2005, among those to be pulled, without seeking any regulatory approval of any kind.
Why did J&J do that? After all the 510(k) approval process does not require any heavy lifting or clinical trials to prove safety, but J&J did not even submit the Gynecare Prolift through the 510(k) speedy approval process.
The company said it didn’t think it needed to file a new 510(k) submission under FDA rules because the Prolift was similar enough to another mesh it sold, the Gynemesh PS, which it marketed in 2002.
What did the FDA do when it found out a major medical device maker, who has teams of lawyers who know the rules, had skirted those very rules? Nothing. It approved the Prolift and another device J & J was trying to put on the market. No sanctions at all.
Prolift was also the focus of a study in August 2009 that had to be halted because the mesh erosion complication rate was too high – 15.6% – which exceeded the highest limit for allowable complications at 15%.
The writing has been on the wall for transvaginal mesh makers. J&J and 31 other mesh makers were ordered by the FDA last January to start following the complication rate of mesh implants because the agency has really no idea how widespread the problem is.
We do know from our clients how devastating and life-altering the complications are. And removal of mesh is extremely difficult, if not impossible. Many women will never be the same.
This is a little bright news in a very dark chapter for defective medical devices and the unfortunate patients who have them permanently implanted. Litigation will continue beginning with the first state defective product litigation in November and the first federal bellwether case in February of 2013. Unfortunately, they are only the first of thousands of personal injury cases due to defective vaginal mesh.
Perhaps others makers will see the writing on the wall and soon follow the lead of J & J.