Friday, September 2nd, 2011
The FDA recently issued a warning about serious complications linked to transvaginal mesh, tape, slings, and other transvaginal implants manufactured by nine different companies. These products are used regularly in pelvic prolapse surgeries, bladder lifts and surgeries to treat urinary incontinence.
As early as 2008, the FDA released a public health notification about complications associated with TVM implants and recommended special training on surgical placement techniques. The FDA issued a public notice in 2011 to doctors and TVM patients after close to 3,000 cases of injuries relating to the mesh were reported between 2008 and 2010.
One of the most common side effect reported to the FDA is vaginal mesh erosion. Erosion of the mesh can cause serious harm to women. Other side effects include vaginal bleeding or discharge, infection, vaginal extrusion, pain, organ perforation, nerve damage, or recurrence of pelvic organ prolapse or stress urinary incontinence - the very problem the TVM implants are intended to fix.
TVM cases have been consolidated for centralized management in Atlantic County, New Jersey and there is an MDL for the C.R. Bard Avaulta transvaginal mesh in West Virginia.