Know the Realities, Risks of Medical Implants
Fast-Track Approval of Medical Devices Endangers Patients
About one in 10 Americans have at least one medical device implanted. These run the gamut in size and effect, including everything from artificial joints and heart valves to contact lenses and birth control devices.
Many people assume that the Food and Drug Administration (FDA) requires rigorous testing of medical devices before they are approved. However, many high-risk devices on the market have undergone no clinical testing, thanks to an approval process called the 510(k) program. If a manufacturer can prove that its product is “substantially equivalent” to an existing product, it can avoid stringent premarket testing. While the 510(k) clearing process provides patients quick access to new products, there is an unsettling consequence: Medical devices can be implanted in patients without requiring manufacturers to prove safety and effectiveness. In fact, 602.5 million devices were recalled in 2021, the highest total ever recorded.
Defective Medical Devices Can Be Deadly
A comprehensive joint investigation of the global medical devices industry that included the AP, NBC, and over 50 other media outlets recently attempted to uncover precisely how many Americans are affected by faulty medical devices. Reporters collected and analyzed millions of medical records, recall notices, and other product safety warnings, in addition to interviewing doctors, patients, researchers, and company whistleblowers. The media partners found that between 2008 and 2018, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA. Here are just a few examples of more notable defective medical devices that have caused harm to patients:
-Knee and Hip Replacements – Clinical evidence continues to show that the design of some knee and hip replacement implants is seriously flawed. Newer metal-on-metal hip replacements have failed, causing a condition called metallosis. This severe condition created by metal leaking into the body can destroy muscles, tendons, and ligaments and harm the heart and lungs.
-Surgical Mesh Complications – Surgical mesh, composed of synthetic materials, is permanently implanted in patients to repair weak or damaged tissue. But certain procedures can cause life-changing health complications, including mesh erosion when the device migrates from its point of placement and cuts through the soft tissues of other organs. Depending on the placement of the mesh, complications can cause pain, internal bleeding, the fusion of organs, or nerve damage.
-Spinal Cord Stimulators – Spinal cord stimulators are small computers surgically wired into the spinal cord. They often treat chronic pain by sending electrical pulses to mask or interrupt nerve signals before they get to the brain. However, a recent study from the Journal of the American Medical Association concluded the devices were no better than a placebo for treating some chronic pain. And many patients with failed spinal cord stimulators have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia.
Protect Yourself with These 4 Tips
These four tips from Consumer Reports can help protect you or your loved ones from the risk of defective medical devices:
1. Consider the alternatives – If your doctor suggests an implant, simply ask what will happen if you don’t get it. Sometimes patients aren’t adequately informed about the options. For example, women who received transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice.
2. Research the device – The Food and Drug Administration’s website, FDA.gov, contains information on device safety warnings, complaints, and recalls, which are all accessible by searching the name of the device. Also, search for patient forums and other information about the device online.
3. Write down the details – Ask for your device’s brand name, model, and serial number (if applicable) so that if you learn of a warning or safety recall, you’ll know whether yours is one of the problem models.
4. Don’t panic – If you discover problems with your device, don’t assume it has to be removed. Contact your doctor and learn to recognize possible adverse side effects in your case.