Medical devices, which range from heart valves to prosthetic joints to insulin pumps, are a huge business, estimated at $400 billion world-wide in 2018. As the elderly population grows, this market will only expand. A major problem world-wide is that the safety and reliability of these devices is not always guaranteed. In the United States there is a fairly robust system for approving new drugs for marketing that grew in large part out of the thalidomide disaster. Thalidomide was marketed in the late 1950s and early 1960s for morning sickness in pregnant women, and resulted in the birth of thousands of babies with major birth defects. Stiff new regulations followed, and pharmaceutical manufacturers are now expected to show both efficacy and safety of their products before they can be sold. As regular readers of these posts or Prescription for Bankruptcy know, I am concerned that in too many cases the medical experts helping evaluate new drugs are beholden to the pharmaceutical industry, but the system generally does work to maximize the cost/benefit ratio of new drugs that come to market. Drug firms must usually perform three trials of their product before it is approved.
The system for approving devices is much looser. There is often only a single trial, and these are rarely if ever randomized or blinded as drug trials are expected to be. In many cases a new device is approved based on it being similar to an existing device. Regulators routinely allow device manufacturers to make major changes to existing products without any formal evaluation.
This loose approach to regulation has resulted in a few but serious problems. The most obvious is the metal-on-metal hip prostheses, which resulted in an unacceptably high failure rate and in some cases led to metallic ions or particles being released into the bloodstream. Johnson and Johnson pulled one of their hip replacement products from the market in 2010 and Smith and Nephew pulled one of theirs in 2012. The lawyers are still having a field day. Essure, a coil-shaped metal device intended to provide permanent birth control, was implanted in the fallopian tubes of over 1,000,000 women. Even though it was designed and sold as a lifetime permanent solution, it was approved for marketing after only short-term (1-2 year) studies with very limited data (25%) going out even as far as two years. Though it seemed safe and successful in the small early studies, thousands of women suffered major complications, including severe bleeding and ruptured tubes. The manufacturer, Bayer, wrote to European doctors in 2017 asking them to stop using the product, but kept selling it in the United States; it was finally taken off the U.S. market at the end of 2018 “for business reasons.” Medtronic marketed an updated version of the wire (Sprint Fidelis) used to connect the control unit to its implantable heart defibrillator in 2004, and it was only pulled from the market 3 years later when a cardiologist published a study showing that it was failing at a much higher rate than other similar products and was either not working when needed or shocking patients (quite painfully!) when the shock was not needed.
The FDA was aware of these problems in its system but was slow to act. An Institute of Medicine panel in 2011 recommended that the FDA replace its flawed approval system that did not really establish either efficacy or safety before marketing. At the time, the FDA disagreed with this recommendation and did nothing. Only when an international group of investigative journalists published a scathing review of the medical device industry in late 2018 did the FDA finally announce that it was going to adopt new measures, and many of these will not take effect for years.
Let me be clear about one important fact. The vast majority of medical devices are both effective and safe. My two hip replacements have allowed me to remain physically active. Properly chosen heart failure patients live longer with an implanted defibrillator. However, despite the fact that most of us are law-abiding, we still need a police force. Even though most devices are safe and effective, we need meaningful oversight. If your prescription medicine proves harmful, you can stop taking it. If a device implanted in your body is harmful, you can either live with it and hope or have an invasive procedure to remove or change it. The FDA must place patients’ interests over manufacturers’ profits.
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