A recent investigation by Consumer Reports indicates that transvaginal mesh was not tested before it was released to the market. Transvaginal mesh is just one of many defective medical devices that the Food and Drug Administration (FDA) allowed onto the market without adequate testing to determine whether they are safe.
Manufacturers were able to bypass testing requirements because of a regulatory loophole that does not require testing for devices that a company claims are similar to products that were already approved.
Transvaginal mesh is a type of synthetic mesh used to treat vaginal prolapse, a condition in which a woman’s organs drop out their normal position within the pelvis. When a patient receives a transvaginal mesh implant, surgeons remove some of the stretched pelvic tissue and then insert the mesh to support the repair.
The problem with transvaginal mesh is that it has a high complication rate that makes it more dangerous than traditional, nonmesh procedures.
Complications from transvaginal mesh include:
- Vaginal scarring and shrinkage
- Urinary problems
- Organ perforation
- Severe pain and emotional distress
Most women who suffer from transvaginal mesh complications must have multiple painful corrective surgeries and may suffer from residual pain or permanent disabilities as a result of this defective product.
“I’m 54 years old and it has totally ruined my life,” said one woman who received a transvaginal mesh implant. “I was in such pain I couldn’t sit, I couldn’t stand, and I could hardly walk.”
Source: Consumer Reports, “CR Investigates: Dangerous medical devices,” May 2012 edition