Johnson & Johnson Continued to Sell Vaginal Mesh After Told to Stop By FDA

Court records filed in the multi-district litigation (MDL) case in West Virginia recently show that Johnson &Johnson continued to sell its vaginal mesh implant for nine months after the Food and Drug Administration (FDA) told it to halt sales. The agency told J&J to stop selling its product in August of 2007 so that the FDA could look into potential risk of organ perforation–what many women have experienced as a result of the implantation of the device.
The FDA said in a letter to J&J that it could not market its Gynecare Prolift device until it provided information about 16 “potential deficiencies.” By failing to stop marketing the device, J&J was in violation of the Federal Food, Drug and Cosmetic Act.
This new discovery certainly lends strength to the hundreds of cases that have been filed against J&J around the country. Many of those cases have been consolidated in the MDL court under a single just in West Virginia.
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J&J began selling Prolift in 2005 without filing a new application with the FDA, instead claiming that the device was substantially similar to other mesh on the market. The FDA, however, required J&J to go through the formal new application process. One of the most troubling recent revelations in mesh litigation is that all of the transvaginal mesh kits on the market were approved under this expedited FDA process and were based on a product that had been pulled from the market years before because of concerns over the product.
Events like these have caused congress to look into further legislating the FDA approval process for medical devices such as mesh. This, however, is little consolation for the thousands of women who have been surgically implanted with defective devices.
J&J has now announced that it will stop selling all four of its transvaginal mesh products. However, J&J denies that this is a “recall” of its products and claims that the devices were safe for the purpose for which they were marketed.
The FDA received many reports of complications from J&J’s product from 2004 to 2007. The complaints include those of infection, abscess, and organ perforation. In my experience in these cases, many of these complaints have required additional surgery–anywhere from revisions to total hysterectomies.
If you believe you have had mesh implanted transvaginally because of urinary incontinence or pelvic organ prolapse, please call Corey Ann Finn at (502) 882-6000 or send her an email at corey@jonesward.com to discuss your potential case today.