the vaginal sling and slumping FDA efficacy

The failure of ObTape is a reminder of another failure: the FDA.

A vaginal sling inserted under the urethra, ObTape is designed to eliminate urine leakage in women who suffer from urinary incontinence. Turns out, the sling can work its way up into the vaginal wall, create painful and bloody discharge, and must be removed piece by piece through a series of surgeries. One victim is unsure that she will ever live a life without pain, or have enjoyable sex with her husband, ever again.

The New York Times reports:

The lawsuits raise new questions about the process by which the F.D.A. reviews new medical devices. While it “approves” drugs, it merely “clears” medical devices with minimal testing if they are deemed “substantially equivalent” to devices already in use.

The process has been criticized by the agency’s scientists and in a recent Government Accountability Office report concluding that most devices on the market have never been proved safe and effective.

In ObTape’s case, the chain of similarity claims can be traced back to an older product that caused so much harm it was taken off the market. That recall did not stop the F.D.A. from clearing a new generation of vaginal slings whose only claim to safety was their similarity to the flawed device. FULL ARTICLE