Lawsuits Over Urinary Incontinence Treatment Highlight Debate Over FDA Device Approval Process

The New York Times on Tuesday examined how recent lawsuits against the makers of ObTape, a vaginal sling for treating stress urinary incontinence, have raised questions about FDA's processes for reviewing and clearing new medical devices. The device is a mesh-like sling that is inserted under the urethra. Although FDA "approves" new drugs, it "clears" medical devices, such as the sling, after limited testing if they are considered "substantially equivalent" to a device already in use. According to the Times, ObTape received approval because it was deemed similar to two vaginal slings already on the market, both of which also were cleared under the "substantially equivalent" guidelines. However, ObTape in fact had significant differences from the already approved devices, both in terms of how it was inserted and the material used to make it, the Times reports. In addition, one of those slings had been cleared because it was similar to another vaginal sling that was recalled after it was found to cause substantial harm to patients.

The Times reports that the differences between ObTape and its predecessors were substantial enough that the company obtained a patent and promoted the product to surgeons as an innovative design that could be used in a surgical approach to reduce the risk of bladder puncture. Meanwhile, FDA began receiving reports of adverse events in women with the device, many of which involved the mesh breaking through the vaginal wall. Many experts now say that the mesh material was too dense to permit tissues and capillaries to grow through it. Instead of becoming fully incorporated in the body, the device became engulfed and rejected, they say. After receiving reports of similar problems with other vaginal slings made of a similar material, FDA in 2008 issued an alert noting that physicians should inform patients about the potential complications, including pain during sexual intercourse and scarring.

Mentor, the maker of ObTape, ended sales of the product in 2006 but maintains that there is nothing wrong with the device. John Lewis, an attorney representing the company, said that patients are warned about the complications, which he called "well known" and "inherent to a surgical procedure that has helped thousands and thousands of people live a better life" (Rabin, New York Times, 5/5).


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