The FDA Has Warned That Serious Complications Linked To Transvaginal Mesh Are Not Rare.
The FDA issued a Public Health Notification (dated October 20, 2008) that the agency had received some 1,000 reports of adverse events related to the use of transvaginal surgical mesh. At that time, the FDA advised that, “though rare, these complications can have serious consequences.”
Recently, in 2011, the FDA issued an IMPORTANT UPDATE notice to doctors and transvaginal mesh patients, stating that serious complications associated with the use of surgical mesh were not rare. The FDA changed its position on the risk of complications from “rare” to “not rare” after 2,875 injuries relating to the mesh were reported between 2008 and 2010.
The most common side effect reported to the FDA is vaginal mesh erosion, a potentially serious and painful complication involving the mesh that can cause the skin to split.
The potentially dangerous side effects became apparent in 2009 when a clinical trial was stopped prematurely after 15 % of the women implanted with the mesh suffered vaginal mesh erosion within a period of only three months.
Women who received a transvaginal mesh implant for Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) and had complications after surgery. Women who received a transvaginal mesh implant have reported serious complications such as:
The manufacturers involved in the production of the Transvaginal Mesh include American Medical Systems, Boston Scientific, Bard, Johnson & Johnson (Ethicon), Coloplast, Caldera Medical, Cook Medical and Tyco Healthcare.
If you or a loved one has had Transvaginal Mesh implanted and are experiencing any of these complications, please contact one of the experienced defective product attorney’s at the Stampfle Law Firm by calling 1-843-839-3377 today!