FDA Warns Patients & Doctors about Transvaginal Mesh
On July 13, 2011, the Food and Drug Administration (FDA) issued an urgent public notice advising patients and their healthcare providers to consider alternatives to transvaginal mesh. The advisory also noted that the FDA will be meeting to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.
Transvaginal Mesh is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), conditions that may occur after childbirth and pregnancy. In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.
Recent research shows that at least ten percent of women who have received vaginal mesh implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications such as dyspareunia.
We represent dozens of clients allegedly harmed by transvaginal mesh and bladder sling products in filed cases against numerous large corporations as including C.R. Bard, Inc., Ethicon, Gynecare, Johnson & Johnson, Boston Scientific and American Medical Systems (AMS). In fact, our attorneys have been named liaison counsel (lead counsel) in the cases against Ethicon, Gynecare and Johnson & Johnson and we are actively ltiigating against other manufacturers as well.