For decades, the U.S. Food and Drug Administration’s medical-device approval system has allowed defective implants to spill onto the market, like contaminated water from a broken pipe. Many of those products have remained on hospital shelves, and in patient bodies, long after problems were known.
On Sunday, November 25, 2018, the International Consortium of Investigative Journalists, NBC News Investigative Unit and the Associated Press published a year-long investigation that shows regulators bowing to industry pressure to rush approvals, lower safety standards and cloak critical information, and the consequences: a string of grisly accidents that have left hundreds of thousands disfigured, disabled or dead. Our groundbreaking data collection and analysis allowed us to quantify more than 83,000 deaths and 1.7 million injuries in the past decade linked to problem devices. Among other things, we uncovered more than 2,100 deaths wrongly reported as something else.
The project required an unprecedented global effort to gather millions of medical-device records from public data and more than 1,500 freedom of information requests. We deployed machine learning and other data analysis to place stories of individual suffering in a global, systemic context. We found artificial hips that corrode flesh and poison blood, spinal-cord stimulators that shock and permanently injure and surgical mesh that cuts into tissue, causing chronic pain and bleeding – all cleared through a U.S. approval pathway, known as 510(k), that okays new devices based not on human testing, but on their similarity to older products.
Implant Files sparked a global response from patients and the public, as well as immediate reforms in the U.S. and abroad. The FDA announced “the most significant modernization” in a generation of 510(k), issued an alert about defective pain pumps, strengthened oversight of surgical mesh, declared an “ambitious new goal” to be “first among the world’s regulatory agencies” to identify harmful devices, among other measures. Denmark, Spain, Canada, Italy, India and elsewhere announced major overhauls of device oversight.
In a major advance for medical device transparency, the FDA in March 2019 pledged to disclose injuries kept buried for nearly two decades under a program known as “alternative summary reporting,” another issue highlighted in our series. In April 2019, French health authorities imposed a sweeping and historic ban on two categories of breast implants associated with an elevated risk of a rare form of cancer. Advocates had pushed for such a measure for years. Canadian authorities followed with a plan to suspend the sale of so-called textured breast implants, while plastic surgeons in The Netherlands did so voluntarily after a request from the government there. The UK, Netherlands, Germany and Italy announced they are separately considering mandatory registers of implants, a huge step in tracking post-approval problems. We built the International Medical Devices Database – a reform unto itself – to allow the public for the first time to search 109,000 records from 26 countries (and counting) to find whether their device has been flagged for official safety concern.
