The results of a massive, nearly year-long investigation have exposed glaring failures in medical device safety and governmental regulations intended to protect patients around the globe.
Upwards of one million patients were sickened or maimed and 83,000 were killed by the very medical devices that were supposed to improve their health, according to joint reporting by news outlets including NBC News and Associated Press, and led by the International Consortium of Investigative Journalists (ICIJ). Dubbed the Implant Files, the in-depth reporting project represents the first examination of the medical device industry and its watchdogs worldwide.
Among the key takeaways: health authorities worldwide failed to protect patients from poorly tested devices, even as the medical device industry raked in profits.
In response, the Food and Drug Administration has vowed to provide “a more robust medical device safety net for patients.” The medical safety regulator said a specific focus would be transvaginal mesh implants — devices linked to three deaths, as MedTruth reported.
Reporting by the ICIJ found:
Doctors, health authorities and device manufacturers withheld vital medical information from patients. Some 2,000 patients told ICIJ their doctors didn’t inform them of the health risks of their medical device before the devices were implanted.
The metal contraceptive Essure is linked to thousands of painful injuries, including uterine perforations. An ICIJ analysis of U.S. adverse event data found nearly 8,500 events over the last decade that required Essure to be removed from patients.
Breast implant manufacturers buried injury evidence for years, aided by lax FDA reporting rules. Before the FDA instituted more rigorous reporting rules, the average number of suspected breast implant injuries was fewer than 200 a year through 2016. With the more rigorous rules, the number of injury reports soared to 4,567 events in 2017, and at least 8,242 in the first six months of 2018.
How are medical devices approved?
Medical devices must only demonstrate a “reasonable assurance” of safety in the United States before they’re sold to patients. This low bar, according to the ICIJ, typically means devices undergo a single study and no randomized, controlled trials — a rigorous form of testing which compares how patients fare while undergoing different treatments. In contrast, drug makers must show “substantial evidence” of a new product’s safety and effectiveness — which usually requires three randomized, controlled trials.
As the ICIJ reported, “In 2017, the FDA approved more than three times as many devices as it did in 2010, while its warnings to device manufacturers about product safety fell by nearly 80 percent.”
The FDA openly acknowledges it approves one dozen new or modified medical devices every business day.
Medical Device Lobbying in Washington, D.C.
The medical device industry spent more than $335 million between 2007 and 2017 to influence legislation in its favor, according to the Center for Responsive Politics.
Millions of industry dollars flow to the FDA — the country’s device-safety watchdog — in the form of fees. More than one-third of these fees come from the device industry, per the ICIJ.
On top of this, the nation’s 10 largest medical device corporations paid nearly $600 million to doctors or their hospitals last year.
In one egregious case, Johnson & Johnson paid a Los Angeles orthopedic surgeon nearly $30 million in payments and royalties after the surgeon helped design a two metal-on-metal hip replacement devices. One device was later pulled from markets worldwide, amid fears it shed “dangerous levels of metal ions” inside patients.