On August 24th, 2007, the Federal Drug Administration (FDA) issued an order to Johnson & Johnson to halt sales of its medical device called Gynecare Prolift, a vaginal mesh device. In the letter, the FDA stated that the company could not market the device without further safety studies, as thousands of cases were reported involving mesh failures in treating pelvic organ prolapsed (POP) and stress urinary incontinence (SUI).
“If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act,” the order clearly stated.
The letter was unsealed recently as part of pending lawsuits in the state court of New Jersey. Other lawsuits can be filed as part of the multidistrict litigation (MDL) in Charleston, West Virginia.
Johnson & Johnson, along with several other medical device manufacturers, have come under fire recently because of mesh device failures in several patients, particularly women, who suffer prolapsed organs. J&J’s Prolift device in particular was sold for three years before it was approved by the FDA. The manufacturer stated that they were within their rights, citing the FDA’s 510(k) process, which allows them to market new products that are similar to previously approved products. The FDA did not specifically approve the Gynecare Prolift device until 2008.
An increasing number of lawsuits has put pressure on Johnson & Johnson, which voluntarily pulled four mesh devices from the market earlier this month.
If you or a loved one has a transvaginal mesh device to assist with POP or SUI, and have suffered further complications because of the implant, you may be entitled to compensation. The Strom Law Firm, LLC, has an experienced female lawyer on staff who specializes in vaginal mesh cases. Please contact us today for a free consultation. We can get you on the road to recovery. 803.252.4800.