Although it has not coerced a recall of the transvaginal mesh surgical device, the U.S. Food and Drug Administration has proposed measures that were intended to improve patient safety. The proposals were introduced in April while more than 40,000 federal transvaginal mesh lawsuits filed against seven different manufacturers were consolidated before the U.S. District Court for the Southern District of West Virginia.
If the orders go into effect, transvaginal mesh, when used to correct pelvic organ prolapse, would be reclassified from a moderate-risk device to a high-risk device and manufacturers would be required to submit a premarket approval application so that the agency can evaluate the mesh’s safety.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” FDA Deputy Director William Maisel said. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”
Transvaginal mesh victims have suffered serious complications for which additional surgery in many cases has been required. They have been on an agonizing path. Pain and infection are the tip of the iceberg. Erosion of the mesh through the vagina, organ perforation and urinary problems have been among the conditions victims have experienced. There were also reports of recurrent prolapse, neuro-muscular problems and vaginal scarring/shrinkage.
Transvaginal mesh lawsuits generally allege that the surgical mesh products posed an unreasonable risk as a result of the manner in which they were designed, made and marketed and that manufacturers failed to adequately warn patients of the increased risks of serious injury.
Transvaginal mesh surgery is often performed from a “kit,” the safety of which is also an FDA regulatory priority.
“Many mesh products,” the FDA wrote, “come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).
The experienced transvaginal mesh attorneys at Reich & Binstock want to see that justice is served for surgical mesh victims. If you are one, then you can count on Reich & Binstock to fight hard on your behalf.