Untested Pelvic Mesh Highlights Concerns Over FDA Process

Posted on July 26, 2011

Janet Holt told media sources that she believed she just had some sort of infection “down there.” But her doctor told her that she was in need of an operation, explaining that her bladder had slipped out of place and created an uncomfortable condition called pelvic organ prolapse, which is common among women as they age.

Her doctor claimed he could fix the condition by creating a kind of “nest” to hold her organs in place. Holt doesn’t recall him ever telling her that he would use surgical mesh to do so. But, he was the doctor, so Holt, a 50-year-old from San Antonion, TX, allowed the operation.

More than four years later the medical device implanted to help her has created many new problems for Holt, sparking constant pain and requiring seven more operations while surgeons attempted to remove the mesh, which had eroded into her vagina, piece by piece.

Holt’s case has now become the centerpiece cited in concerns about the government process that allows medical devices, like surgical mesh made from the same material as Rubbermaid containers, to be used and implanted in patients with no previous testing.

Holt, now 54, has had to cut back working in her family’s five restaurants, can no longer ride horses and can no longer play baseball with her grandson. She said, “I don’t think I’m going to get any better.”

Many medical devices are not bound by the restrictions of prescription drugs, which have to be proven safe and effective before they’re sent to market. Only about 10 percent of medical devices, the ones deemed to have the highest risk like breast implants and implantable pacemakers, are required to be tested on humans before they are distributed for large scale use. Surgical mesh that is used to support organs that slip out of place over time does not fit into that category. But that may be changing soon.

The FDA was spurred into initiating their second warning concerning the device in less than three years due to the growing number of surgical mesh-associated complications in women. The agency will convene a panel of outside experts later this year to advise whether more rigorous testing should be done to the mesh.

The Institute of Medicine, an independent nonprofit group that advises policymakers as well as the public, is issuing a major report on whether the approval process of these devices optimally protects patients and promotes innovation to better public health. But it’s not just surgical mesh that they’re focusing on. A recent analysis of recalls spared concerns over how the FDA clears thousands of devices to be used. The study focused on 113 recalls from 2005 through 2009 for devices that the FDA found could cause potentially serious health problems or death.

Of those devices, only 21 were required to have been tested on patients prior to receiving FDA approval. Manufacturers of 80 recalled devices were only responsible for showing how they were similar to devices already on the market to get approval through the FDA’s 510(k) approval process. The eight remaining devices weren’t required to undergo any FDA review at all.

“Consumers are justifiably upset when their cars, toasters, and baby food bottles are recalled. Recalls makes us all question the safety of the products we take for granted. But what about the products permanently implanted inside our bodies?” asked Dr. Rita Redberg and Dr. Sanket Dhruva of the University of California, San Francisco. They added that many patients assume that the implants have been thoroughly tested before becoming available. “It is sad and troubling to learn that we cannot count on this assurance for some medical devices.”

The FDA’s most recent warning said complications associated with surgical mesh in procedures like Holt’s are a continuing area of concern. The FDA emphasized, “Serious complications are not rare.”

The warning specifically noted mesh implanted through the vagina instead of the abdomen to fix pelvic organ prolapse or stress urinary incontinence, urine leakage during physical activity.

As a Los Angeles wrongful death attorney, I feel this is an important issue and hope to help shed some light on the subject. More on this in tomorrow’s blog.

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