W

ith the landmark 21st Century Cures Act now signed into law, Congress needs to turn its attention to another pressing health issue: the safety — or lack thereof — of medical devices.

Thousands of medical devices are on the market today, with a steady stream of new ones coming along. They include spinal and breast implants, pacemakers, TENS devices for pain, transvaginal mesh slings, tubal occlusion sterilization coils, dental amalgam, prosthetic joints, and more.

The Food and Drug Administration puts medical devices into three categories. Class I devices are simple and have little potential to cause harm, such as bandages. Class II devices are more complicated and present a greater risk or harm. These include motorized wheelchairs and simple implants such as radio frequency identification chips; they are often approved with special guidelines for control. Class III devices help support or sustain life or present a potentially significant risk of injury. Examples include pacemakers, artificial heart valves, and joint replacements.

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For all the good that medical devices do, they can also cause harm. I know this because my health was almost irreparably harmed by the mercury-based dental amalgam used over my lifetime to fill cavities — it turns out that genetic susceptibility is a factor. I have friends, relatives, and colleagues who have endured cancers and autoimmune diseases, allergies, rashes, pain, memory loss, and incredible emotional strain from problems caused by various medical devices.

Take a look at the numbers below for Class III devices, collected by Device Events, a company that helps businesses and organizations extract and understand reports on the millions of adverse event reports for medical devices submitted to the FDA. The numbers below are for the past 20 years.

 

Device Injuries Deaths
Implantable defibrillators 164,936 16,206
Pacemakers 160,839 11,869
Infusion pumps 92,253 2,561
Nerve stimulators 122,701 2,883
Coronary stents 53,293 9,600
Breast implants 18,340 92
Tubal sterilization devices 12,763 36
Penile implants 10,201 7

 

For various forms of mesh or sling, which are both Class II and Class III devices, 126,329 adverse event have been reported, along with 1,303 deaths and 49 recalls. Adverse event reports are far lower for Class II dental amalgam, with 328 reported illnesses and two deaths. In part that’s because few people think to submit event reports for adverse effects from dental devices, which aren’t even listed on the reporting form. And there is no requirement for doctors or dentists to submit such reports.

The rules governing medical devices, enacted 50 years ago, focus on cost and benefit. The FDA’s Center for Devices and Radiological Health, which oversees device approval and regulation, gets half of its funding from industry fees. The center uses a dated framework to assess device safety, although it is adding a system of unique identifiers to devices and strengthening surveillance to detect problems after devices are allowed into the market.

Surprisingly, a new Class III device needs to be tested only in a relatively small number of people for a relatively short period of time. If testing shows some benefits without major side effects, the FDA can approve it. Such devices get premarket approval, which the FDA says is “a private license granting the applicant (or owner) permission to market the device.”

If an individual is harmed by a Class III medical device, it can be difficult to sue the manufacturer. Under the Supreme Court’s decision in Riegel v. Medtronic, those attempting to file claims for defective Class III medical devices are generally preempted by federal law under the Medical Device Amendments of 1976.This protective shield for manufacturers, which derives from the supremacy clause in Article VI of the Constitution, gives federal laws precedence over state laws. It can be broken if fraud (such as concealing unfavorable data) or malfeasance (unlawful or wrongful action) is proven.

When it comes to food and medications, what works for one person may harm another. Some people can’t eat peanut butter or handle a latex balloon or take penicillin without developing a life-threatening reaction. Others can be harmed from the accumulation of heavy metals or other chemicals if they aren’t able to excrete them. In short, we are all different.

Yet the FDA considers medical or dental device materials to be safe for just about everyone. There is no required prescreening to determine if an individual has a contact allergy or an autoimmune response to the device. This can easily be done using a skin patch test and a biocompatibility blood test, which are offered by a handful of labs. That is ironic when you stop to think that the FDA recommends that consumers do a skin patch test before using hair coloring agents.

The FDA requires manufacturers to list materials composition and safety warnings for many medical devices, but not dental devices. If serious problems are reported, it may require a “black box” warning on the label. But this is closing the barn door when the horse is already out. Issuing a black box warning or a recall — the strongest step — doesn’t help those already harmed.

Patients with device-related illnesses are trapped in a web of difficult diagnoses, trouble finding care, and roadblocks to paying for treatment. Until knowledge of such problems becomes widespread, many doctors are skeptical that a device has caused harm. Far fewer physicians do procedures to remove and replace defective devices than install them. Health plans may deny coverage for such treatments, or require other treatments first, and force patients to turn to lengthy appeals even as they continue to be harmed by the device. Health insurance doesn’t cover dental work, and appeals are not granted for medical necessity in dental insurance. All of this is on top of rising copays and deductibles, and lost time from work.

If you or a loved one has been harmed by a medical or dental device, tell the FDA. To make this easier, the Boston startup Epidemico worked with the FDA to develop and release the MedWatcher mobile app. You can also file an adverse event by completing an FDA MedWatch form online. Such reports can help save others from being harmed by medical devices. It is also a good idea to join a support group for your device injuries and illnesses.

But we need more. Instead of resting on its laurels after passing the 21st Century Cures Act, Congress needs to begin working on a comprehensive 21st Century Medical Device Safety Act that makes patient health and safety a top priority. Such an act must provide for rebooting the FDA’s Center for Devices and Radiologic Health and giving it the tools and resources it needs.

It is time to make sure that medical and dental devices are “right for us” before they are used in our bodies, given the rich variation in our genes and immune systems. I call on all of our lawmakers to create and pass legislation to prevent medical harm, heartache, chronic diseases, disability, and rising health care costs from FDA-approved devices.

Laura Henze Russell is a patient activist for medical device safety and the principal of Precision Research & Communications: Precision Health.

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