Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed in damage control mode in an attempt to polish its tarnished reputation.
“I want to set the record straight so patients can have confidence in the safety and effectiveness of the medical devices they depend on to live longer, healthier, more productive lives,” Advanced Medical Technology (AdvaMed) President and CEO Scott Whitaker wrote in a Jan. 18 web blog. “America’s medical technology industry is dedicated to providing patients worldwide with safe, innovative treatments and cures to solve some of our most pressing health care challenges, including cancer, heart disease, and diabetes. No regulatory system is perfect, and industry is willing to engage with all stakeholders on ways to make the process better. But to completely ignore the incredible benefits that medical devices and diagnostics have brought to millions of people worldwide—thanks to the diligence of manufacturers and the oversight of FDA—is irresponsible and a disservice to the patients we serve.”
Whitaker crafted the 739-word blog to refute a scathing Washington Post editorial two weeks earlier that linked the industry to defective medical devices and more than 80,000 patient deaths. The newspaper places much of the blame for these deaths on the U.S. Food and Drug Administration (FDA), contending its “laissez faire” approach to product approval enables most devices to be marketed without clinical studies.
The editorial also took issue with the FDA’s 510(k) pathway, a process by which products are cleared for market upon proving comparable safety and efficacy to existing devices. The agency estimated last fall that nearly 20 percent of 510(k)-cleared products are based on predicate devices authorized more than a decade ago.
That gap is about to narrow, though. In November, the agency outlined plans to “modernize” its 510(k) clearance program, promising to sunset older predicates and encourage use of newer ones. It also pledged to publish on the Center for Devices and Radiological Health website a list of cleared devices based on substantial equivalence dating back more than 10 years. “We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices,” FDA Commissioner Scott Gottlieb, M.D., said in a Nov. 27 statement. “We believe that encouraging product developers to use more recent predicates will advance health technology and lead to more competition in the marketplace.”
The FDA’s 510(k) revamp announcement came on the heels of an unflattering media report on the alleged harmful effects of medical device industry regulation. The account, which eventually inspired the Washington Post editorial, came from the International Consortium of Investigative Journalists (ICIJ); the group based its findings on more than 8 million device-related health records, the majority of which were derived from FDA adverse event reports filed over the last decade. ICIJ reporters also examined whistleblower claims in federal lawsuits, studied academic papers, and scrutinized device trial outcomes in determining that “medical implants sicken, maim, and sometimes kill the very people they were destined to help...”
AdvaMed immediately criticized the ICIJ report, claiming it failed to examine the industry’s challenges and achievements. “We should never discount any patient’s experience,” an agency statement read. “But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate patient risk, we always strive to improve our technologies and delivery.”
The statement also could have applied to an NBC News investigation about dangers with medical devices released in other countries (AdvaMed did not specifically address this report). The investigation was part of a global project organized by the ICIJ.
Like others before it, the NBC News investigation painted a captious picture of the medtech industry, though it focused specifically on “export only” devices. The probe spotlighted nearly a half-dozen examples of patient injuries/product malfunctions from items that either were recalled, lost marketing approval, or missing from adverse event reports.
One such item was Integra LifeSciences, a Plainsboro, N.J.-based developer of solutions in extremity, neuro, and reconstructive/general surgeries. The company’s PyroTITAN implant was designed for shoulder resurfacing procedures (a more conservative alternative to shoulder replacement surgery).
NBC News claims PyroTITAN was used overseas despite its reported troubles. Integra alerted clinicians in 2012 to the possibility the implant could break; the following year, Australian authorities warned of first-year breakage with the implant, and a 2016 recall notice said the device needed so much friction to snap into place that it could burn the arm bone when implanted. Ultimately, 19 PyroTITAN patients needed the device removed.
Integra did not explain the absence of the PryoTITAN on adverse event reports, but released a statement to NBC News that read, “Today, the PryoTITAN devices meets all regulatory, safety, and performance requirements and has enabled many patients to regain the mobility of their shoulders.” The company did not say whether the device had been modified.