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As women fighting life-changing autoimmune disease, allergies and more - one life threatening, two with illnesses and injuries caused by different FDA-approved medical and dental devices, and one a former FDA employee fighting chronic autoimmune disease of not yet known cause – we call for Congress to do more than pass a 21st Century Cures Act. Congress must also pass a 21st Century Medical Device Safety Act.
The House of Representatives passed the 21st Century Cures Act 392-26. It is on to the Senate for a vote. Its bipartisan leaders smartly loaded it up with some benefits for almost everyone – a total of $4.8 billion in research funding for the Brain Initiative, Precision Medicine Initiative, Cancer Moonshot, and provisions for mental health, opioid abuse, Lyme disease, and more. Representatives from Pharma, Biotech, and Chronic Disease Groups have stormed the halls of Congress to ensure this bipartisan bill is enacted. On the surface, it is a slam dunk. But look beneath the surface, and we have work to do.
Sen. Elizabeth Warren, D-Mass. made a strong speech to stop the bill and fix it, launching a MoveOn petition, “Tell Congress: Don't let Big Pharma hijack the 21st Century Cures Act,” which has gathered over 166,000 signatures in days. Sen. Bernie Sanders, I-Vt, called to rewrite the bill to lower prescription drug costs. A courageous band led by Rep. Mike Fitzpatrick, R-Pa., and Rep. Louise Slaughter, D-NY, have been pressing to address medical device safety, through calls for the passage of Ariel Grace’s Law, the Medical Device Guardians Act, and a reboot of FDA’s device regulations to ensure patient safety first.
Why are we concerned? The Hippocratic Oath - First, do no harm - should apply to all health agencies. The rules governing medical devices at the FDA are focused on cost-benefit. Receiving half of its funding from industry user fees, the FDA’s Center for Devices and Radiological Health (CDRH) has a track record of weighing industry benefits more heavily than patient risks.
FDA’s CDRH uses a dated, mid-20th Century framework to assess device safety. If a new device is tested in a relatively small number of people, with some benefits and without major side effects for a relatively short period of time - as measured and reported by research sponsored by the company - it can be approved as a Class III device. Moreover, the device receives pre-market approval – a get-out-of-liability-free card – so patients have no recourse if harmed.
If a device is “substantially equivalent” to an already approved device, or was “grandfathered,” it can get the go-ahead as a Class II device following a less extensive review process. Facing extraordinary industry pressure for approval, even 19th century devices like mercury-containing dental amalgam are given the benefit of the doubt. There are no patient labels, warnings, or written informed consent for patients or parents, overriding the concerns raised by FDA’s expert Dental Products Panels in 2006 and 2010. Patients also lack recourse. With no medical necessity in dental insurance, insurers deny appeals to replace with biocompatible materials.
Fast forward to today. We know that people vary greatly by gene type, allergies, autoimmune responses, and other metabolic pathways. We know that infants, children, teens, adults and older adults vary greatly over the lifespan. We know that not everyone can eat peanut butter, or wear latex gloves, or get the same blood type transfusion. But we consider a medical or dental device that is safe for the majority, as safe for all. There is no prescreening to determine tolerance vs. toxicity, yet FDA recommends a patch test before using hair color!
What is the scale of harm that results from an outdated framework for FDA device approvals? According to the FDA, for Class III devices:
| Device | Deaths | Injuries |
| Defibrillators | 16,206 | 164,936 |
| Pacemakers | 11,869 | 160,936 |
| Infusion pumps | 2,561 | 92,253 |
| Nerve stimulators | 2,883 | 122,701 |
| Coronary stents | 9,600 | 53,293 |
| Breast implants | 92 | 18,340 |
| Essure | 36 | 12,763 |
| Penile implants | 7 | 10,201 |
In Class II, 127,000 injuries and illnesses have been reported for various forms of Mesh, both a Class II and Class III medical device. Over 100,000 patients have called patient support groups for information and referral to biologic dentists and physicians to overcome mercury toxicity and illnesses resulting from Class II dental amalgam, as people with certain gene types do not clear mercury well, and it builds up over time. A risk assessment shows 65+ million Americans are at risk. Together, FDA’s MAUDE and old DENS system have 1,230 reports - remarkable given the website and forms do not mention or give examples of dental products being covered. Fortunately, there is a new MedWatcher mobile application patients can use to report harm. Download the app at www.Medwatcher.org, register, click Device tab, and click Device name.
Congress - and the new Trump Administration - your job is not done. The Senate should press for inclusion of Ariel Grace's Law, the Medical Device Guardians Act, for immediate release of the FDA’s draft 2012 Patient Safety Communication on Dental Amalgam, and investigate the history of problems in the dental and gynecological device units.
Begin working on a comprehensive 21st Century Medical Device Safety Act. Make patient health and safety top priority. Reboot FDA’s Device Center. Ensure medical and dental devices are "right for us" before installation. Prevent medical harm, heartache, chronic diseases, disability, and rising health care costs from FDA-approved devices. Make America Healthy Again.
Laura Henze Russell is the Principal of Precision Research and Communications: Precision Health. Melanie Goshgarian is a Patient Navigator and member of Essure Problems and USA Patient Network. Madris Tomes is a former FDA employee, concerned citizen, and founder of Device Events. To join the effort to Make America Healthy Again and prevent medical device harm, please contact us at laurarussell2@comcast.net, melaniegosh27@gmail.com, and madris@deviceevents.com.
