Medical Device Perils — Are You in Danger?

Millions of Americans live with artificial joints, surgical mesh, heart defibrillators, and other medical devices. Although most people assume they've been tested for safety, the unsettling truth is that in most cases, they haven't. Are they safe? Recent headlines have questioned the safety of metal hip devices, and the FDA is currently conducting a safety review of all metal-on-metal hip implants. Its Orthopaedic and Rehabilitation Devices Panel will meet later this month to discuss the risks and benefits of the devices and make recommendations for their use. The FDA requires safety and effectiveness studies before new drugs are approved, but doesn't hold medical devices to the same strict standards. Should they be held to the same safety standards as drugs? "Actually, they should have higher standards," Dr. Erika Schwartz, a leading national wellness expert, tells Newsmax Health. I see patients in my office every day with problems secondary to implanted devices like the mesh." Unfortunately, says Schwartz, the FDA has no rules that require rigorous testing. Medical devices, such as pacemakers, were "grandfathered" in. "Indeed, they save lives, but they may also hurt." It's the same with the mesh and hip replacements, she says: They do not have to undergo any special testing or have any special safety requirements. "We're really kind of on our own to figure out what's best for us," she warns. If you need a device, such as a hip replacement, where do you go for accurate information? The first place most people goes is the Internet, says Dr. Schwartz, but that's a double-edged sword. On one hand, she says, you'll get information that promotes the device, but that information may come straight from the manufacturer. "You have to look at who is sponsoring the particular information," she says. If it's from a consumer advocate group, the information is likely to be unbiased and from a group that just wants to get accurate information to the public. "Look at the FDA and know that they're not really watching out for you," she says. "Because of that, you need to work with the right doctors and the right hospitals." Schwartz and other experts are trying to put together a national registry, so that people will know the manufacturer and the exact model number of the particular instrument that was implanted into their bodies — the type of hip replacement, type of mesh, etc. "People need that kind of information," she says. "Before you allow anyone to put anything in you, make sure you know where it came from, and who made it," along with other identifying information. "Also," she adds, "make sure your doctor is on your side and not the side of the manufacturer." It's not difficult for doctors to keep up with information about implanted devices, but many don't, she says, because they don't care enough. "Unfortunately, most doctors don't care about you," says Dr. Schwartz. "They get busy, and they forget to stay on top of what's going on. "If you go to the cutting-edge doctors who really work for you, then you're going to get the right information. Otherwise, you're best off not getting the device — you're best off not having the device than having one that will malfunction. "On the other hand," she says, "if you need the device, find the doctors who are the ones who will represent your best interests."