Safety concerns over the use of vaginal mesh to treat pelvic organ prolapse prompted the FDA advisory panel to come out in favor of a more rigorous premarket approval process. Although no votes have been taken yet, the panel informally indicated they would favor reclassifying the mesh devices from a medium risk category (Class II) to a high risk category (Class III), which would require the devices to get premarket approval with the FDA as well as require the manufacturers to prove the safety and effectiveness of the products on an ongoing basis.
The panel heard from several patients who said they had been harmed by the devices. These individuals echoed the same horrible experiences we have heard from other women reporting life-altering complications.
Janet Holt testified that
The mesh shrank 30% and eroded into the vaginal wall. Each step you take rubs the open wound against the other side. It is complete torture.
According to Marian Goldberg,
Who among you will volunteer for a permanently implanted device that cuts through your genitalia, your urethra, or your rectum? I don’t see anyone rushing to sign up on the dotted line…Why haven’t you taken these products off the market?
Although the FDA is urging closer scrutiny of pelvic mesh, the advisory panel stopped short of pulling vaginal mesh from the market, despite the pressure from Public Citizen and other consumer groups.