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Most Medical Devices Bypass Clinical Testing

Oct 1, 2013

A new report warns that not all medical devices are tested for safety prior to market release—a longstanding issue that has led to increasing controversy, especially concerning implants, such as metal-on-metal hip replacement systems and transvaginal mesh products.

According to a report by Newsmax Health, device makers need only file paperwork with the U.S. Food and Drug Administration (FDA) and pay a $4,000 fee. In fact, it is only when the device is on the market and problems are reported—post-market surveillance—that the FDA becomes involved.

Consumer Reports recently highlighted the case of an orthopedic surgeon who had a metal-on-metal hip device implanted under the belief that the all-metal product would be stronger than traditional ceramic- or plastic-on-metal implants. However, following the procedure, the surgeon began experiencing vision problems, hearing loss, significant pain, anxiety, and other issues, and had to undergo revision surgery to have the device removed and replaced, according to Newsmax Health. Following his revision surgery, the surgeon’s health started to improve at once. One year later, the device that had been implanted inside his body was removed from the market. The British Medical Journal described metal-on-metal hip implants as “one of the biggest disasters in orthopedic history.”

As a class, metal hips have become the subject of safety concerns due to a manufacturer’s ability to use the FDA’s fast-tracked 510(k) route, which bypasses clinical testing. Research reveals that metal hips tend to fail more often than other hip implants, although they were precisely created for their supposed increased durability and longevity.

“Only if there’s no other choice should you use implantable devices. I think that’s probably a pretty good general rule,” prominent neurosurgeon Russell Blaylock, M.D., told Newsmax Health. Dr. Blaylock expressed concerns about the metals used in many of today’s devices. “The neurosurgeons and orthopedic surgeons are putting screws and plates in virtually everything,” he explained. “There’s a considerable amount of literature on cobalt and nickel absorption producing significant neurological effects as well many other effects such as autoimmune disorders and immune dysfunction.” When a medical device must be removed, the process often involves multiple surgeries.

Dr. Blaylock noted that, in some cases, there are alternatives. For example, some patients diagnosed with bladder prolapse might be better treated with pelvic exercises compared to surgical mesh implants.

Prior research revealed there was no difference in the cure rates for vaginal prolapse repair with and without use of mesh. This, after three years of follow-up, according to a prior HealthDay News report. The FDA has also indicated that some of the complications associated with transvaginal mesh devices may include bleeding; dyspareunia (pain during sexual intercourse); exposure, extrusion, or protrusion (mesh erosion through the vagina); infection, organ perforation, pain, and urinary problems.

Defibrillator wires, artificial hips and knees, and leaky drug pumps have also been tied to premature failure, according to the Star Tribune. Lawsuits and injury reports continue to mount over these devices, and patients and their families allege serious, often life-altering complications; severe pain; and even death. And, consider this: 25 to 40 medical devices are recalled annually over high risk, a classification that indicates use of the recalled device risks patients’ lives.

Yet, despite increasing injury reports and litigation, device makers continue to spend large to push products to doctors, according to the Star Tribune. “We’re not talking about computers or cars or toasters,” said Lisa McGiffert, director of the Consumers Union’s Safe Patient Project, a group that campaigns for improved medical practices. “We’re talking about things that go inside people’s bodies.”

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