Mentor ObTape Fast-Track Approval QuestionedMay 5, 2009 | Parker Waichman LLP
A new report is raising questions about the fast-track approval of the Mentor ObTape. According to The New York Times, the device has become the subject of numerous lawsuits since Mentor Corporation removed it from the market in 2006.
The Mentor ObTape, used to treat stress urinary incontinence, is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall. The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis.
Almost as soon as the ObTape was introduced in 2003, patients who received it began to complain of serious complications. The most common of these injuries were vaginal erosions, basically the breakdown of the tissue that makes up the vaginal wall. This is an extremely painful condition that leads to chronic vaginal discharge and infection. The design of the Mentor ObTape also caused erosions of the urethra, and it allowed the device to cut into the vaginal wall, causing extreme and painful vaginal extrusions.
Mentor Corp., which was recently acquired by Johnson & Johnson, took the ObTape off the market in 2006. However, according to The New York Times, to this day the company maintains that there is nothing wrong with the device.
But earlier this year, the Food & Drug Administration (FDA) warned that it had received thousands of reports of complications resulting from the use of devices like the Mentor ObTape. Treatment of the complications included IV therapy, blood transfusions, drainage of hematomas or abscesses, and additional surgical procedures, in some cases to remove the mesh, the agency said.
According to The New York Times, the Mentor ObTape was approved through the 510K process, which means it claimed that its product was so similar to ones already on the market it didn’t need complete testing. A 510K approval - also known as "fast-track" approval - allows a device maker to avoid human clinical trials.
In this case, Mentor claimed the ObTape was similar to two other devices already on the market - Johnson & Johnson’s Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System. According to The New York Times, those devices also underwent 501K approval, based on the assertion that they were similar to Boston Scientific's Protegen sling. Shockingly, the Protegen sling had been removed from the market in 1999 after the FDA classified it as an “adulterated and misbranded” product, the Times said.
Asked by the Times why it would clear a product based on a recalled predecessor, the FDA replied via email that “Any legally marketed device can serve as a predicate for a premarket submission.”
As we've reported before, many patient advocates question the 501K approval process, and are seeking to have it reformed. Earlier this year, a report by the Government Accountability Office (GAO) found that many older devices - including some that served as predecessor devices in 501K approvals - had never been proven safe and effective. In April, the FDA responded to that report, and said it would be reviewing the safety of 25 types of devices not subject to rigorous testing in the past.