Has there been a transvaginal mesh recall in the U.S.?
While there has not been an FDA mandated recall of vaginal mesh devices, Boston Scientific voluntarily recalled 20,000 units of their ProteGen mesh about three years after being approved by the FDA in 1996, citing reports of problems with the devices. In addition, the FDA issued a recall of certain types of Boston Scientific’s Pinnacle mesh kits in August 2011.
The FDA is still reviewing reports of transvaginal mesh complications and the risks associated with these products. On January 4th, 2012, the FDA required manufacturers to submit plans for studies and clinical trials to the FDA that will address safety and effectiveness concerns with transvaginal mesh products, further pressuring the medical device makers to take action.
Consumer Group Petitions for Recall
Public Citizen, a non-profit organization, issued a petition to the Food and Drug Administration on August 25th, 2011, calling for a recall of all transvaginal mesh products "made of non-absorbable synthetic material." Dr. L. Lewis Wall, a professor of obstertrics and gynecology at Washington University in St. Louis, and Dr. Daniel Elliott, a urologic surgeon at the Mayo Clinic, signed on as co-petitioners.
Injured by transvaginal mesh or sling?
The transvaginal mesh lawyers at Girard Gibbs investigate cases of women across the country who have experienced health complications after receiving a transvaginal mesh implant. If you or a loved one suffered transvaginal mesh injuries, you may have a legal right to pursue financial compensation for your injuries or other damages. Fill out the form to the right or call (866) 981-4800 for a free and confidential consultation concerning your possible transvaginal mesh lawsuit.
Why Girard Gibbs?
Girard Gibbs is a national litigation firm representing consumers, investors, employees, and small businesses in cases involving consumer protection, personal injury, securities, antitrust, and employment laws. The firm’s senior partners, Daniel Girard and Eric Gibbs, have been selected for inclusion in The Best Lawyers in America® 2012 and Northern California Super Lawyers, and have earned AV-Preeminent ratings from Martindale-Hubbell, recognizing them in the highest class of attorneys for professional ethics and legal skills.
