Breaking News ~ J & J Sold Vaginal Mesh Implant Without FDA Approval
March 21 ~ Bloomberg is reporting (here) that major medical device maker Johnson & Johnson (J&J) sold the Gynecare Prolift surgical mesh for three years before it was approved by the U.S. Food and Drug Administration (FDA). The mesh is now the subject of more than 550 lawsuits, reports Bloomberg.
Prolift is a pre-cut mesh made of nonabsorbable polymer which includes needles on the end of the mesh to help surgeons implant it in a blind procedure through the vagina (transvaginally). It is used to hold up organs that have prolapsed or fallen in the female patient.
Introduced in March 2005, J & J called the Gynecare Prolift a “innovative and effective surgical option” to help hold up pelvic muscles that could no longer support female organs. But when J & J sought approval for a related product in 2007 (Prolift +M), the FDA finally discovered the Prolift had been sold for two years. Instead of sanctions, the agency finally cleared both devices in May 2008.
Bloomberg reports the FDA MAUDE database of complications shows there were 123 complaints concerning the Prolift device from 2005 until May 2008 when it was finally cleared.
510(k) Fast Track
That’s not the way it is supposed to work. A company such as J & J is supposed to submit paperwork seeking a 510(k) approval for marketing through the FDA. Already dubbed the fast-track to device approval, not seeking approval speeds up the process even further.
After an exchange of paperwork, the company receives a green light to sell their product. Bloomberg reports it could sell the Prolift without approval because it deemed the surgical mesh was similar to a device already being sold but the FDA has disagreed with that claim saying the sale began “without appropriate” clearance.
With hundreds of lawsuits pending, the news may ultimately count against the world’s second-biggest health care device and products maker. Of late, J & J has been hit with litigation over its DePuy metal hip, and defective over-the-counter drugs. The company has admitted to bribery or the illegal marketing of drugs.
A spokesman for J & J tells Bloomberg the company did apply the “relevant FDA guidance and based on safety and effectiveness”of Gynemesh (cleared in 2002 for hernia repair) and that “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”
A call into Matthew Johnson, corporate communications for J & J by MDND went unanswered by publishing time.
Johnson & Johnson has always contended that its devices for pelvic organ problems are the most studies on the market. Last July, the FDA reported a five-fold increase in deaths, injuries and malfunctions of surgical mesh used in women for prolapse organs.
Lawsuits over Prolift are pending in Atlantic City, New Jersey have generated more than 2.3 million pages of documents says the news source, with lawyers seeking to interview company officials including Gary Pruden and Sheri S. McCoy who headed the pharma and consumer products divisions. Attorneys interviewed feel the knowledge of executives may be directly relevant to establishing the liability of J & J. Not surprisingly, the company is fighting the deposition request of its executives.
MDND reported last August (here) that a trial study of Prolift mesh was stopped before its conclusion in August of 2009 when 15.6% of participants experienced mesh erosion, or a wound breakdown from infected mesh. #