July 13, 2011
Urgent FDA Update: Patients warned against using TVM
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 (TVM). 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.
TVM 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 approximately ten percent of women who have received TVM 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.
Motley Rice lawyer, Jonathan Orent and Fidelma Fitzpatrick represent hundreds of clients allegedly harmed by transvaginal mesh/ sling products in hundreds of filed cases against such large corporations as Boston Scientific, American Medical Systems, Inc. (AMS), C.R. Bard, Inc., and Johnson & Johnson. Jonathan serves as co-liaison counsel in In re Bard Litigation in New Jersey state court and as the liaison between this litigation and the Bard Avaulta multidistrict litigation in West Virginia federal court.
Learn more about how Motley Rice device lawyers are fighting on behalf of patients who may have suffered injuries or complications related to defective medical devices.