June 4, 2012 ~ Breaking news! Bloomberg is reporting (here) that Johnson & Johnson (J&J) has requested the paperwork to stop selling four different types of transvaginal mesh in the face of hundreds of lawsuits.
The Ethicon unit of J & J told a federal judge in West Virginia that it has requested the official form from the U.S. Food and Drug Administration (FDA) to stop selling or “commercializing” the devices. That information was contained in a letter filed today with U.S. District Judge Joseph Goodwin in Charleston, West Virginia, the federal judge overseeing the consolidated product liability lawsuits against four makers of synthetic transvaginal mesh.
MDND reported last August (here) that a trial study of Prolift mesh, one among those to be pulled, was stopped before its conclusion in August of 2009 when 15.6% of participants experienced mesh erosion, or a wound breakdown from infected mesh.
You’ll recall in January 2012, the FDA ordered about 30 makers of synthetic mesh, along with J & J, to do post- market studies on women implanted to determine the amount of organ damage, infection, mesh migration and other complications. There are no pre-market comparable studies on safety and efficacy as they are not required before marketing transvaginal mesh.
Sold Without Approval
This news marks more trouble for J & J, whose Ethicon division makes the Gynecare Prolift. Earlier this year it was reported that the company began selling Prolift in 2005 bypassing any regulatory approval by the FDA.
What was the defense? The company said it didn’t think it needed to file a new 510(k) submission under FDA rules, which is customary for Class II medical devices to be approved for sale. The Prolift was similar enough to another mesh it sold, the Gynemesh PS, which was marketed beginning in 2002, according to the company.
In response, the FDA did not press for any sanctions and instead approved both the Prolift and a new mesh, the Prolift +M in May 2008.
State lawsuits over Prolift are also pending in Atlantic City, New Jersey and have generated more than 2.3 million pages of documents with lawyers seeking to interview company officials including Gary Pruden and Sheri S. McCoy who headed the pharma and consumer products divisions. J & J is fighting the deposition of the executives even thought McCoy left J & J to head Avon after she was bypassed to be CEO by Alex Gorsky last month.
Matthew Johnson, a spokesman for Ethicon did not return calls to Bloomberg. He has never returned a call to MDND. Part of the J & J, Ethicon, Gynecare creed states:
“We hold ourselves accountable to the highest standards to ensure that our interactions with health care professionals, institutions and non-profit organizations are conducted in an appropriate manner. To that end, we regularly review and improve our practices as part of an ongoing commitment to ensure ethical and transparent interactions with medical professionals.”
Ethicon Gynecare products
MDND, March 21, J&J Sold Vaginal Mesh Implant Without FDA Approval
MDND, August 21, 2011, Study Halted Due to Mesh Complications