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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  • Linda, thank you for your clarification, and your excellent comment and recommendations. The standards for Class III and full testing need to go even further than invasive surgery, however. I am thinking of both IUDs and Essure, which can be installed in “non-invasive” office procedures, and dental fillings and devices. Dental fillings are technically considered prosthetic devices. Fillings, crowns and bridges are not invasive like dental implants, but can have systemic impacts on health – especially in genetically susceptible, allergic, immune reactive, and other vulnerable subgroups such children, pregnant and nursing mothers, and people with kidney, liver and neurological problems. The criteria of long-term installation should be considered.

    • I agree with you completely, Laura! However, part of the issue with these considerations is the poor quality of the clinical trials being conducted. Usually the trial size is too small to encompass the full demographic slate that will eventually be using these devices and treatments. Then too, the studies do not extend over a long enough period of time for adequate analysis of potential harm down the road. Those two concerns have been directly discounted by the 21st Century Cures Act and FDA Guidance issued over the last year. It is unacceptable to place all of the risk on patients by allowing devices on the market without adequate assurances of safety and effectiveness while planning to “catch” the harm in clinical settings. The post market surveillance system is defunct and the new system relies on real world evidence – in other words, documentation of harm after the fact. We are about to witness a tragic tide of medical harm be unleashed on the American people, and by ignorance and in trust, the public is unaware and unprepared. This is sheer treachery!

  • The article lists joint replacements as an example of a Class III medical device, but the truth is that 95% of medical devices are cleared for market through the fast track 510(k) process and are therefore classified as Class II devices. This is also true of the majority of joint replacement devices. The only joint replacement devices which are in Class III are those that were required to go through the PMA (Premarket Assessment) process to receive approval. the 510(k) pathway was established in 1976 legislation directing the FDA to finish classifying a large number of devices already on the market. It was a way to grandfather in those devices. since that time, the FDA has insisted upon using the 510(k) as a pathway to market for new devices, despite being told that this was not justified by the boundaries of the legislation establishing the process. (IOM report to the FDA in 2011). Please note that approval and clearance are not interchangeable terms. Approval is based on clinical trial evidence, however small the trial size or length of study may be. Cleared devices are placed on the market based upon substantial equivalency (SE) with a predicate device already on the market – no testing required. PMA devices utilize at least some testing for safety and effectiveness while cleared devices use none! I believe both the use of the 510(k) and classification of a joint replacement as Class II is wrong. Any device which requires invasive surgery to implant and explant should be a Class III device. No devices should be allowed on the market based upon established SE with a previous device, especially since it does not matter if the predicate has harmed patients, fails or is recalled. In the end, the classification of a device has more to do with whether or not the device was required to go through clinical trial than being life-sustaining or consideration of risk. This is a significant weakness in the FDA oversight process and needs to be changed.

  • I helped champion the Needlestick Safety and Prevention Act signed into law in November, 2000. I led the acquisition and introduction of many sharps safety devices that protected healthcare workers worldwide. I began this initiative in 1988.

    • Ken, thanks for your exceptionally helpful reply, and for your leadership.

      For permanently implanted/installed devices, which this piece focuses on, there is an overlooked, systemic, cross-cutting medical safety issue of immune reactivity, or biocompatibility, which varies by individual and is not in the current framework for approval and monitoring of device safety. In other words, there is no “Precision Device” framework to accompany Precision Medicine.

      Selecting the right materials for each individual seems basic from an engineering and medical standpoint. Yet as you point out, government laws and regulations are “sticky” – there is a lot of inertia and it takes years to build a movement strong enough to change them, by which time the field has often advanced and the new regulations are already outdated. That is what happened when Congress added Unique Device Indicators to strengthen monitoring and surveillance but didn’t address biocompatibility at the front end. It enabled a better watch on damage being done.

      The other problem with a company by company, device by device strategy, is that it just doesn’t work in some parts of FDA’s CDRH, such as the Dental Products Unit. For decades, there have been repeated concerns expressed about the safety of dental amalgam from biologic dental associations – especially for susceptible subpopulations. The FDA overrode the concerns of its own expert Dental Product Panels in 2006 and 2010, and does not require patients to get the same or similar warnings about toxicity, side effects, and contraindications that it requires manufacturers to give to dentists. There have been numerous petitions for reconsideration, and lawsuits which have compelled FDA to act, but it has not acted safely, wisely, or in the patients’ and public’s interest.

      There is a fundamental problem when a professional association has commercial/trade functions, and affiliates holding patents, as the ADA has – in contrast to the AMA (read the ADA Code of Ethics). There is a fundamental problem when physicians do not look at a part of the body with a systemic impact on health, or have access to dental records – in contrast to every other specialty. There is a fundamental problem when routine medical visits update patients’ prescription drugs and OTCs – but not dental and medical device materials. There is a fundamental problem when EHRs do not include dental records, so they can be analyzed by Big Data. There is a fundamental problem when health insurance, omitting dental, enables dental insurance to steer patients to the cheapest and least safe material – with patients and their families, employers, health plans and government picking up the tab for the health impacts that result.

  • Thank you for the voice of clarity in a world of so much deception. This is a much needed public service because there are so many of us whose lives have been damaged by cosmetic and biomedical implants. An added problem is that the general public, including doctors, have been indoctrinated to believe that implants are “100% safe”. Doctors will see their sickly patients and deny, misdiagnose, and treat the auto immune symptoms with toxic narcotics, that cure nothing. The lucrative Pharmaceutical industry has a long historical precedence of fraud and misconduct that have resulted in illness and loss of many lives. The Rx opiate epidemic causes more deaths every year than cancer and even auto accidents. The Medical Associations who dictate medical protocol and medical training, are directly controlled by Pharma industry who are the biggest benefactors of their Medical Association foundations. The conflict of industry is ridiculous by any standards. The reputation of the entire medical industry has been tarnished by this corruption, and the millions of people affected aren’t given a voice. The majority share holders of the Pharma giants such as Vaguard etc, also own the Media Conglomerates, as well as the Health Insurance providers. That is why it seems like we are living in a fake Truman Show sometimes, and keeping people sick is good business. Victims who are compensated, are placed under a Gag Order and the crimes against humanity continue. Until the corruption ends, Functional or Hollistic Medicine is our only safe choice.

    • Laura – Since there are a multitude of medical devices, each with their own and often unique safety related challenges, each device should be addressed with respect to improving its safety profile.

      Along with that, there is the need for users to be alerted to the specific problem, cost and impact on both healthcare workers and patients. This is an educational task that took us quite a while at BD for sharps safety devices, despite our brand name, 50_ person sales force and a landmark study documenting the problem in the New England Journal of Medicine. As I posted above, we began the sharps safety initiative to eliminate needlesticks in 1988 and the Needlestick Prevention and Safety Act wasn’t signed into law until 12 years later.

      Today needle safety devices continue to see improvement as thy transition from “activated” modes of action requiring the healthcare worker to active the safety device to “passive” modes of action that automatically deploy the safety device and eliminate the need for the healthcare worker to activate it.

      This is a very long and complex area that is best addressed on a company to company and device by device basis. This takes time, company commitment, user education and many more factors.

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