Vaginal Sling Lawsuit

According to an article in the NY Times, Amber Suriani had just turned 40 when she noticed she was experiencing urinary discharge. As an avid athlete, Suriani didn’t want these embarassing occurrences affecting her active lifestyle so she sought medical advice. Her doctor diagnosed the problem as stress urinary incontinence and recommended surgery to correct the problem. After being assured that it was a fairly minor procedure that would correct the problem, Suriani agreed to have a vaginal sling inserted under her urethra. The surgery was performed with no complications and Suriani returned to a normal lifestyle until a few months later she noticed bloody vaginal discharge. She was understandably concerned that she may have cancer so she went back to her doctor. Surgery was performed to remove part of the offending sling that, according to her doctor, was causing the problem. Unfortunately, Suriani’s difficulties only grew worse. The sling continued to cause problems and growing pain. Since then, she’s endured four more surgeries to remove the offending portions of the sling.
The vaginal sling, manufactured by ObTape (acquired by Johnson & Johnson), was designed to treat female urinary incontinence. It didn’t fix the problem in Suriani’s case. It exacerbated the problem to the point she decided to take legal action against the company. The medical device company stopped selling the device in 2006 but insists that it was a good device that helped thousands of women.
As the Times article points out, the problems encountered with this medical device bring more scrutiny upon the FDA’s guidelines and methods for allowing medical devices to be sold in this country. Unlike pharmaceutical drugs, the FDA “clears” medical devices rather than approves them. The criteria for clearance is minimal. The new device need only be similar in design and use as previously cleared medical devices. In other words, the medical device is never tested or approved as safe and effective, a standard by which drugs are approved.
This is a clear gap in the FDA’s regulatory process. Medical devices should be approved only after they are demonstrated to be safe, reliable, and effective. Hopefully, passage of the 2009 Medical Device Safety Act will spur agency action to toughen standards for medical devices.