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Transvaginal Mesh Lawsuits Raise Questions About FDA's Medical Device Review Process

December 31, 1969

With the number of transvaginal mesh lawsuits rising, the effectiveness of the Food and Drug Administration's medical review process has once again come into doubt. Apparently, defective medical lawsuits against Johnson & Johnson involve a vaginal implant that was based on a similar mesh product that was taken off the market for safety reasons more than 10 years ago. That product was called ProteGen, by Boston Scientific Corp. So why then did the FDA keep approving these new mesh products?

Questions about whether the FDA has been doing its job as watchdog started to surface in the wake of the mass recall announced last year by DePuy Orthopaedics, a J & J subsidiary, of its defective hip implant devices. Medtronic's recall of its Sprint Fidelis defibrillators following over allegedly more than a 100 deaths didn't help either.

Please do not hesitate to contact our Anaheim defective medical device lawyers if you believe that you could have a case.

According to National Women's Health Network police director Amy Allina, as reported in, the FDA's 510(k) process for approval lets manufacturers obtain product clearance if it cites similarity to a device that had been previously approved. The next device can then be cited to cleared the next one, and so one. Allina says that if the first approved medical device was recalled, the FDA won't then link it back to devices that were approved after even if they were based on the recalled product. The FDA uses the 510(k) process to approve 90% of device applications annually. The vaginal mesh products, artificial hip implants, and the Medtronic defibrillators all made it through the (510)k process.

Just recently, Boston Scientific put out a class 2 recall of its Pinnacle Pelvic Floor Repair Kits over concerns that the mesh product might detach during surgery. The transvaginal mesh product is supposed to help strengthen and stabilize the pelvic floor to treat pelvic organ proplapse.

More than 600 products liability lawsuits have been filed against vaginal mesh makers, including the one filed a couple of weeks ago by one woman against Boston Scientific. She says that because the Pinnacle pelvic mesh that was implanted in her was defective and that she sustained permanent physical injury as a result. She is seeking $1.5 million in compensatory damages for emotional trauma, medical bills, pharmaceutical costs, disability, loss of enjoyment of life, and pain and suffering.

The FDA recently warned that serious complications related to transvaginal mesh used in treating POP rare are not uncommon. Complications may include organ perforation, infection, or bleeding. Removing this medical device once implanted can be a painful and complicated process that may require numerous surgeries while placing the patient at risk of even more health complications.

Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process,, October 20, 2011

J&J Vaginal Mesh Approved by FDA Based on Similar Device Recalled in 1999, Bloomberg, October 19, 2011

More Blog Posts:

Public Citizen Wants Transvaginal Mesh Recalled by Food and Drug Administration, California Injury Lawyers, August 25, 2011

California Defective Medical Device Cases: Lawsuits Filed by Patients Injured by Recalled DePuy ASR Hip Replacement Systems, California Injury Lawyers, August 22, 2011

Woman Files California Vaginal Mesh Lawsuit in Los Angeles Superior Court, California Injury Lawyers, July 5, 2011

Our Orange County, California products liability lawyers are not afraid to go after large manufacturers to make sure our clients obtain the Anaheim defective medical device damages that they are owed. Contact Howard Law, PC today.