A woman has just filed a lawsuit over the Johnson & Johnson Prolift mesh transvaginal mesh device over claims that, among other issues, the device was sold without U.S. Food and Drug Administration (FDA) approval.
The lawsuit was brought in the District Court in Lod, Israel, on behalf of the plaintiff and with a request for the court to certify the claim as a class action suit for NIS 6 billion—or about $1.7 billion—on behalf of about 60,000 women in Israel who allegedly experienced similar injuries tied to the Prolift mesh, according to Jewish Business News.
The female plaintiff alleges that, in August 2006, she underwent a surgical procedure to relieve vaginal pain and was implanted with the Prolift mesh. The court documents indicate that, since 1996, there have reports involving women worldwide who have been implanted with the Prolift mesh who suffered from an array of injuries, including profuse vaginal discharge and related physical damage, such as bleeding, bed sores, recurring infection, perforation of the urinary tract during implantation, incontinence, and severe pain, Jewish Business News reported.
The lawsuit claims that the Prolift mesh has been marketed since March 2005, including in Israel, without FDA approval, and that, in March 2012, the FDA issued a statement that Johnson & Johnson marketed the Prolift without agency approval. The lawsuit claims also indicate that, after about six years of marketing the Prolift, Johnson & Johnson began recalling the device and discontinued its manufacture of the device. The lawsuit claims also include that many other claims have been filed involving the Prolift and substantial settlements have been made, according to Jewish Business News.
In this case, the plaintiff alleges that the Prolift caused her, and many other women in Israel, severe harm. In her specific case, she alleges that she experienced most of the injuries tied to the Prolift as well as increased lower abdominal pain, recurring infections, increased bleeding, bed sores, and urinary tract damage, Jewish Business News reported.
Last year, Bloomberg.com reported that Johnson & Johnson’s Ethicon unit introduced the Gynecare Prolift in March 2005, describing the device in its annual report as an “innovative and effective surgical option” for weakened pelvic muscles. According to Bloomberg.com, the FDA stated that it learned of the Prolift in 2007, when the device maker sought approval for a related product. Both devices received FDA clearance in May 2008.
The device maker asserted that it could market the Prolift without agency approval because it was similar to a previously approved device, the Gynecare Gynemesh, according to FDA spokeswoman, Morgan Liscinsky, in a March 16, 2012 email. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said, according to Bloomberg.com.
Device makers may seek FDA clearance through a 510(k) application should a device be substantially similar to a so-called “predicate” or already approved device. The FDA required that Johnson & Johnson submit the 510(k) in 2007 for the Prolift, said Liscinsky, when the FDA learned of the Prolift after the device maker cited it in July 2007 as the predicate device for the Prolift+M, she noted, according to Bloomberg.com.