In August 0f 2007 the FDA told Johnson and Johnson(JNJ) in a letter to halt Gynecare Prolift sales until it determined if the device was “substantially equivalent” to other mesh products. The agency cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue. Court records reveal that Johnson & Johnson continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device.
J&J began selling the the vaginal mesh known as Prolift in 2005 without filing a new application. The company determined it was substantially similar to a device which already had been approved by the FDA called Gynemesh. The FDA disagreed with J&J’s opinion and demanded a new application. This lead to the letter in 2007 telling them to stop the sale of Prolift vaginal mesh.
Vaginal Mesh Complaints
On June 5, J&J announced it will stop selling four vaginal mesh implants including the Prolift. They clarified it wasn’t a recall and expressed confidence in the safety and effectiveness of the devices. The sales of the product have dropped significantly with the media’s coverage of the organ perforation caused by this product. Doctors and patient don’t want to use it. In short, its a move based on the product’s profitability, not the patients’ safety.
Vaginal mesh devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. The FDA estimated nearly 300,000 were used in U.S. women in 2010. The company is the defendant in more than 1,400 lawsuits claiming organ perforation, pain, scarring and nerve damage was cause by the vaginal mesh.
An FDA database shows 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift. In July, an agency report found deaths, injuries or malfunctions tied to Prolift mesh inserted vaginally increase more than quadrupled.
Dangerous Products Law Suit
To understand drug manufacturers, you need only read matter of fact statements like harmful and deadly side effect only effect 0.5 percent of sales. They are in business to make money and a lack of profitability on their dangerous products is what motivates them to stop selling them.
If you or some one you love was serious injured from vaginal mesh, contact an attorney immediately.