The New Yorker April 20, 2020 pp73-76 Books “The Cutting Edge” “As surgeons implant more and more devices in us, who is looking after our safety” “Unlike drugs, medical implants are not required to be tested in clinical trials” A review by Jerome Groopman of “The Invention of Surgery, A History of Modern Medicine: From the Renaissance to the Implant Revolution” by David Schneider, March 3, 2020 384 Pages Pegasus
Unless you’re a medical doctor or a medical historian you probably wouldn’t know that prior to modern anesthesia, sterilization, antibiotics and imaging surgeons were not highly regarded and surgery was principally performed in a “life or death” situation. In recent times, elective surgeries are common and less invasive using laparoscope and even laser knifes. No longer just life or death, “surgeons became so trusted that patients with conditions that were merely ‘inconvenient, annoying, or even just aesthetically unpleasing” ‘felt secure enough to go under the knife’. So secure that, in 2014 1.4 million implant surgeries were performed for knees (783,000), hips (522,800), shoulders (90,000), finger joints (16,000), elbows (15,000), toe joints (12,000), angles (2,000) and wrists (2,000). By 2030, this “Implant Revolution” will 4 million surgeries. Besides skeletal surgeries, other devices like cardiac stents, cardiac pacemakers and biological transplants of kidney, heart and liver are common. These surgical procedures are life-saving-in a cardiac emergency and -organ failure or joint extending for skeletal implants.
As you might not know, implants are weakly regulated when compared to the FDA oversight of traditional pharmaceutical and biologic agents which require safety and efficacy clinical trials before being approved for use. The lowest risk implants, Class II devices like hips, knees etc. require just registration with the FDA but no clinical trials and the devices are marked as cleared rather than approved. Riskier devices, Class III like pacemakers, require only a 90-day notice to FDA prior to marketing and pre-market approval provided the manufacturer gives assurance of safety and efficacy. As of 2006, of 1,000 high risk devices only about 160 had undergone rigorous testing. Between 2008-2012 nearly 400 stents, hips, surgical mesh and IVC filters were approved without testing.
When you consider Bluetooth and WIFI connectivity, allowing physicians to monitor from afar pacemakers, deep brain stimulators, implanted cardiac defibrillators, gastric stimulators, insulin pumps and cochlear implants, you reasonably might worry about failures and even hacking. “FDA does not require encryption” of these devices.
In 2015, 16,000 deaths were associated with medical devices. It is believed that 99% of such events are not reported so such failures could be ten- or hundred-fold higher making these “one of the leading causes of death in the U.S.” Example of failures. Depuy Articular Surface Replacement (ASR) was recalled in 2010 after 90,000 implants. Metal particles resulted in “intense inflammation” around the hip “damaging tendons, ligaments, muscle and bone” and creating pain and suffering. 2015, Medtronic was fined $2.8M for selling a Spinal Cord Stimulator without approval and failed to report 1,000 adverse events. 2004, 96,000 cardiac stents were recalled for causing perforations, heart attack and death. A 2012 study of 7,000 cases found no benefit in a stent preventing heart attack or death when placed in an elective rather than emergency setting. 2007, FDA recalled the Spring Fidelis Defibrillator implanted in 250,000. Some breast implants are associated with an aggressive form of lymphoma. In all the FDA recalls 1,100 devices annually.
Not surprisingly, the root cause of many of these issues is money. Medical progress today is driven by innovation fueled by market analysis, research and product development by physicians, engineers, biologists and consulting physicians. Without the need for clinical trials, devices generate operating financial margins of 25% or better for the $136Bn industry (2014). As always, financial incentives and lack of sufficient regulatory oversight can “blind better judgement”. Making matters worse patients have little recourse as federal law limits judgements of wrongdoing. The device lobby spends heavily to ensure the status quo by limiting the adoption of new regulations.
Unlike Australia, Canada, Japan, New Zealand and some EU countries, America does not even require registration of each implanted device-an action that would provide objective data on performance and failures.
What's needed to ensure public safety?
1) Federal registry of all implanted devices
2) Two or more randomized clinical trials
3) Judicial changes allowing patients more recourse
Without improvements in the “Best of light patients are part of a large uncontrolled experiment”. “When we submit to being cut, and to having something implanted in our body, we have a right to feel some level of confidence that it has been shown to be safe and beneficial, meaning that it has a chance to cure”.
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