In a shocking report just released by Kaiser Health News it was revealed that the Food and Drug administration has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.
According to KHN, since 2016 at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.
Also indicated in the report is how the FDA database includedes serious injury and malfunction reports for about 100 medical devices. Many of these devices, such as surgical staplers, balloon pumps inserted into blood vessels to improve circulation, and mechanical breathing machines, are widely used in routine surgeries.
The FDA revealed the hidden database after months of questions from KHN reporters. Within those databases were thousands of never-before-acknowledged instances of malfunctions or harm which all existed in reporting-exemption programs the FDA had created. The regulatory agency attempted to claim that that the databases in part were part of a new voluntary summary-reporting program and intended for issues that are “well-known and well-documented with the FDA.” Yet a former director of the agency has stated that he knew nothing about the program and it was also unknown to doctors and engineers involved in improving device safety.
As a result of the investigation the FDA was forced to officially confirm the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.
These reporting exemptions have been widely used by device makers to conceal injuries and deaths caused by some of the industry’s most controversial and risky products including pelvic mesh and devices implanted in the heart. In 2011 the FDA issued strong warnings about pelvic mesh, reclassified the device, and ordered safety studies that drove many manufacturers to pull the device from the market. But since then, according to the FDA and mesh makers who were asked about the practices, behind closed doors the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public.
Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.
In their report KHN outlines how under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single placeholder “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.
A spokeswoman for the FDA confirmed to KHN that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” Further inquiries uncovered agency records showing that, in 2017 alone, more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program.
In the course of my legal career I have defended patients injured or killed my a myriad of defective and dangerous medical devices such as pelvic mesh, hip and knee implants, IVC filters, and many others. One constant in every lawsuit was that the FDA had at one time certified each of these products safe for use. Only after untold suffering was it uncovered that in each and every instance that the FDA had failed in its oversight. Often science based standards and research was ignored and the FDA made decisions influenced by device manufacturers rather than the patients who were being harmed. It comes now as no shock that the regulatory agency charged with protecting the public from defective medical devices has been actively hiding damaging information about device-related injuries and malfunctions. At Saunders & Walker we have a long history of successfully representing victims harmed by drugs and medical devices. If you or someone you know have been injured after the having a medical device implanted please call Saunders & Walker at 1-800-748-7115 to discuss your legal options. All legal discussions will be strictly confidential.