November 28th, 2018
Almost a billion people in the world have a medical device implanted inside them. How many of these devices are ineffective, malfunction, or cause harm? Alarmingly we don’t know, because even complex medical devices are not always tested on humans before approval, and product recalls and adverse events are often not reported or unavailable.
The International Consortium of Investigative Journalists has taken the matter into their own hands, by launching the Implant Files, a global investigation of medical device safety issues and the harm they have caused. This investigation is a massive, year-long effort involving more than 250 journalists and data specialists from 58 media outlets in 36 countries. As well as producing many in-depth articles, the ICIJ has also created an impressive searchable database of medical devices and related safety issues, using more than 70,000 recalls, alerts, and other records.
Earlier this year, The Bleeding Edge Netflix documentary highlighted issues with medical device approval in the US and the harm that metal-on-metal hips, sterilization devices, vaginal mesh, and other devices have caused to Americans. However, medical device safety is not only a problem in the US. In fact, device makers often sell their untested devices in Europe first, because the regulations there are more lax than in the US. Many countries have no regulatory bodies for medical devices, and instead rely on the US and European regulatory agencies to ensure safety and effectiveness, which can backfire; more than 4,500 devices are not approved by the US Food and Drug Administration but are still marketed and sold overseas.
You can read many in-depth articles about the problems with medical devices on the ICIJ website, on topics such as injuries from breast implants, the effect of industry lobbying on device safety in Europe, and the difficulty getting help for device injuries. More articles are being published every day on their website and by many other media outlets.
The ICIJ investigation has already prompted government agencies and medical societies to action. The UK’s Royal College of Surgeons is calling for “drastic changes” to the medical device approval process, including “compulsory registration of every new device and implant that goes into a patient in the UK.”
The US Food and Drug Administration just announced plans to overhaul the medical device approval process and create a more “robust medical device safety net.” These plans include moving to an active surveillance system for device safety issues and creating a system for gathering “real world evidence” called NEST. The FDA will also create advisory committees and registries focused specifically on devices that affect women’s health.
The FDA’s long list of proposed policies might look impressive, but in fact these changes are nothing more than “window dressing and damage control,” as journalist Jeanne Lenzer tweeted. For one, most of these policies were in process before the IJIC report, so they aren’t anything new. According to the FDA statement, the NEST system “will provide another source of information for medical device manufacturers to assess the safety and effectiveness of their devices and continue to develop innovative improvements.” Despite the FDA’s intention to be “first in safety,” it seems in part they are relying on industry to police themselves, which so far has not worked. Further, the NEST project is partly funded by device makers themselves, which may give the FDA less incentive to strictly regulate industry than if the project were funded entirely independently.
The FDA has promised new policies to address the 510(k) approval process (which currently allows devices to be approved based on their similarity to existing products, rather than their proven safety or effectiveness). We look forward to analyzing these policies and hope they will address the systemic problems with our lax device approval process. However, given the FDA’s attitude as expressed in their statement, we aren’t counting on revolutionary change. In the statement, FDA Commissioner Scott Gottlieb and Director of the Center for Devices and Radiological Health Jeff Shuren write:
“On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day…Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market. Even reasonably-sized premarket trials cannot be expected to reveal everything that could eventually become known about a novel medical device once it’s more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians.”
Essentially, Gottlieb and Shuren are saying, “We can’t solve all of the problems with regulation, so why even bother trying?” However, many of the problems the ICIJ team has written about over the past few days could have easily been prevented with basic oversight and reporting. The FDA needs to take more responsibility for the harms that medical devices have caused — it’s the least they could do.