Some women have experienced transvaginal mesh organ perforation, according to adverse event reports. This serious complication occurs when the mesh device penetrates the wall of an organ, causing intense pain and other symptoms. The complication can even become fatal. Women have reported bowel, bladder and vaginal wall perforation from transvaginal mesh implants. Some do not experience symptoms for weeks after the perforation occurs, posing an even bigger problem -the longer the perforation goes undetected, the more damage it may cause.
FDA Says Transvaginal Mesh Organ Perforation Reports Skyrocketed In Recent Years
Between 2008 and 2010, organ perforation was one of the most common transvaginal mesh complications reported to the U.S. Food and Drug Administration, the agency reported in 2011. Other complications included infection, bleeding, urinary problems and pain during sexual intercourse. While less common, the FDA also received reports of vaginal scarring/shrinkage, neuro-muscular problems and recurrent pelvic organ prolapse – a condition transvaginal mesh is supposed to treat.
Many of the transvaginal mesh side effects women have experienced have required surgical treatment and hospitalization. However, the FDA said some of the mesh-related complications patients experienced could not be resolved through surgery.
These complications also encouraged the FDA to issue warnings against transvaginal mesh implants. First in 2008, the federal health agency alerted consumers of the possible risks associated with the devices. However, at that time, the FDA said the complications were “rare,” though serious. Three years later, in 2011, the FDA amended that warning.
FDA Issues New Warning Regarding Transvaginal Mesh Organ Perforation Risks
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” a July 2011 notice on the FDA’s website said. “This is a change from what the FDA previously reported on Oct. 20, 2008.” Because organ perforation was repeatedly reported to the FDA as a serious complication women were experiencing from transvaginal mesh implants, the FDA asked health care providers to take extra care in identifying these side effects.
If you suffered a transvaginal mesh organ perforation injury, start your free TVM claim review today. An experienced attorney will contact you to discuss your case and see if you may qualify for financial compensation from the manufacturer.