Living with Leakage
Posted on May 12, 2009 in Our Blog,Patient Care
Childbirth and aging can have some unpleasant effects on your bladder, but you may want to think twice before undergoing any medical procedures to fix the problem. Nobody wants to leak urine, so it’s understandable that women suffering from stress urinary incontinence would turn to medical alternatives, such as a vaginal sling–a mesh device inserted under the urethra designed to stop leakage. The problem is, many of these slings have turned out to be dangerous and faulty.
The most current sling causing problems is ObTape, made by Mentor Corp., which is owned by Johnson & Johnson. ObTape was taken off the market in 2006, but Mentor denies that the product was faulty. Complaints about ObTape began soon after the device received approval from the Food & Drug Administration (FDA), totaling 266 complaints to the FDA beginning in 2004. The problem, it seemed, was the material used to make ObTape. The composition and thickness of the material was such that human tissue could not grow through it, and complications, including extrusion of the tape, bloody discharge, and pain, arose.
Many question the FDA’s approval process for medical devices. While the FDA must approve pharmaceutical drugs, it is only required to clear medical devices. Very little testing is required, and if a device is similar to any device that has already cleared the FDA, then the road is open for the new device.
Women across the nation who have suffered ill effects from vaginal slings are currently involved in lawsuits. If you or someone you know is a victim of a faulty vaginal sling, it might be worth your while to contact an attorney to learn about your options.