Not All Medical Devices Undergo Clinical Testing

medical_device_lack_of_testingNot all medical devices are tested for safety before they are released to market, a long-discussed issue that has given rise to increased controversy, especially concerning metal-on-metal hip implant devices and transvaginal mesh products.

Device makers are only required to file paperwork with the U.S. Food and Drug Administration (FDA) and pay a $4,000 fee, according to Newsmax Health. Only after a device is on the market and has been tied to increased injury reports—so-called “post-market surveillance”—the agency becomes involved.

For example, a case involving a defective metal-on-metal hip implant device was highlighted by Consumer Reports and concerned an orthopedic surgeon who agreed to be implanted with the device believing the metal device offered greater durability than earlier ceramic- or plastic-on-metal implants. Soon after, the surgeon began suffering from vision problems, hearing loss, significant pain, anxiety, and other issues and underwent revision surgery to remove and replace the metal implant. HIs health improved and one-year later, his original device was recalled. The British Medical Journal described the issue involving the defective hip as “one of the biggest disasters in orthopedic history.”

Metal-on-metal hips, as a class of medical devices, have become the subject of safety concerns given that clearance was received via the FDA’s fast-tracked 510(k) route, which does not mandate clinical testing should a device to be substantially similar to a previously approved device. Studies have found that metal hips tend to fail more often than other implants, even though the devices were created for greater 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,” the distinguished neurosurgeon, Russell Blaylock, M.D., told Newsmax Health. Dr. Blaylock expressed concerns about the metals used in today’s medical devices. “The neurosurgeons and orthopedic surgeons are putting screws and plates in virtually everything,” he noted. “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 requires removal, multiple surgeries are often required.

Dr. Blaylock noted that, in some cases, there are choices. Some patients diagnosed with bladder prolapse, for example, might be cured with pelvic exercises instead of being implanted with transvaginal surgical mesh. “Most of the time, if a doctor is making big money implanting a device, he’s not going to suggest pelvic exercise,” Dr. Blaylock pointed out. “Patients need to understand the dangers of complex surgery,” he said, according to Newsmax Health.

Research has found that there is no difference in cure rates between vaginal prolapse repair with and without mesh, according to a study that involved three years of follow-up, HealthDay News previously reported. The FDA has also stated that some of the complications tied to 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 been associated with premature failure, according to the Star Tribune. Lawsuits and injury reports are mounting over these devices and patients and their families have alleged serious, sometimes life-altering complications; severe pain; and even death. What’s more, 25-40 medical devices are recalled each year over high risk, a classification that indicates that use of the recalled device may put patients’ lives at risk.

Despite increasing injury reports and legal action, the makers of medical devices are still spending large amounts of money to push their products, 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 fights for improved medical practices. “We’re talking about things that go inside people’s bodies.”

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