For two decades, the regulator charged with overseeing medical device safety in the United States allowed manufacturers to conceal from public view serious injuries and other malfunctions associated with implants and other medical products, from breast implants to surgical staplers.
No longer.
On Friday, in a major advance for medical device transparency, the U.S. Food and Drug Administration released more than 6 million previously hidden medical device “incident” reports, filed in secret from 1999 through 2019 by device makers using a controversial and now-ended program known as “alternative summary reporting.”
The release comes seven months after publication of the Implant Files, an investigation by the International Consortium of Investigative Journalists and media partners. Among other revelations, ICIJ showed that breast implant makers had concealed thousands of apparent injuries through use of summary reporting — a number that swelled to more than 350,000 after subsequent disclosures by the FDA.
A March 7 report by Kaiser Health News revealed that more than 1.1 million incidents since 2016 had been kept from public view because of summary reporting.
The newly-released reports describe harm inflicted on countless patients by a host of products, from breast implants to surgical staplers and pediatric breathing machines. Devices made by more than 100 manufacturers are included.
“Although there were hints at what the reports contained in the last few years, the sheer number of reports that were withheld from public view shows that the FDA was not committed to transparency,” said Madris Tomes, a former FDA data analyst and the founder of Device Events, a database that tracks medical device adverse events data.
The FDA has long made some medical device incident reports available to patients and health care providers through its public MAUDE database. These reports come from doctors, manufacturers, patients and even lawyers, and describe cases where a device is suspected to have caused or contributed to a serious injury or death, or has experienced a malfunction that would likely lead to harm if it were to recur.
An analysis by ICIJ of 5.4 million reports filed to MAUDE over a decade identified more than 1.7 million injuries and nearly 83,000 deaths linked to a problematic medical device.
The new release, though it covers more years than covered by ICIJ’s earlier analysis, roughly doubles the number of incident reports available for public view. Though the reports have limitations — they may include incomplete or inaccurate information — they offer patients, advocates and health care providers the best available portal into medical device safety.
The alternative summary reporting program, championed by the industry, was an initiative meant to reduce paperwork and save time, the FDA had said. Instead of filing an individual report with each injury or malfunction or other issue, the FDA permitted manufacturers to submit quarterly spreadsheets summarizing reports of common problems of approved devices. This program was specifically intended to exclude severe or unexpected events — for example, those requiring a broader remedial action than a correction to a single device.
But experts have long been skeptical of this claim.
“My concern has always been that these reports contain serious injuries and in reviewing the reports for the last few days, my concerns were well-founded,” Tomes said.
Tomes said she had already identified incident reports describing medical implants that migrated around inside patients’ bodies, implants that were rejected by a patient’s body, ruptures and other dangerous problems.
Concerns about summary reporting date at least as far back as 2016, when the Minneapolis Star-Tribune reported that medical device goliath Medtronic had used summary reports to bury problems with Infuse, a bone growth product. Medtronic was also a focus of ICIJ’s Implant Files investigation.
The FDA has been winding down the alternative summary reporting for months. In a press release, the agency said it was ending the program “in the spirit of public transparency,” and that it had issued revocation letters to the 13 manufacturers with remaining exemptions, which covered dental implants, implantable cardiac defibrillators and pacemaker electrodes.
The agency, which has acknowledged weaknesses in its ability to rapidly identify dangerous medical devices, is also rolling out new programs meant to boost its early warning capabilities, the FDA said.
