Kaiser Health News reported on June 27, 2019 that its investigation found that “[medical] device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database [alternative summary reporting database], bypassing the public FDA database [MAUDE] that’s pored over by doctors, researchers and patients. Millions of reports, related to everything from breast implants to surgical staplers, were sent to the agency as “alternative summary” reports instead.”
Kaiser Health News reported that “[s]ince 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. Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.”
Kaiser Health News reported “the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time.” In 2016, there were nearly 500,000 such alternative summary reports submitted to the FDA. From 2006 through 2017, the average number of alternative summary reports exceeded 400,000 (just under 400,000 in 2017).
Kaiser Health News’ review of the newly available reports highlighted the following five findings:
1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, with 2.4 million reports over the past 20 years. Almost all the products were made by LifeScan, which had been a Johnson & Johnson company until it was sold to a private equity firm in 2018. Common problems included displaying incorrect messages, losing power, or being damaged before customers started using them.
2. There were 2.1 million reports for bad dental implants (114,200 were reported in 2018). Many of the reports were for problems with connections between the device and the bone.
3. There were 176 deaths reported through the alternative summary reporting system even though alternative summary reports are not supposed to include deaths, except for cardiac arrest potentially caused by certain kinds of heart valves that were implanted at least five years beforehand, which accounted for two-thirds of the deaths in the hidden database. Deaths reported to the database also included fatalities associated with two kinds of pacemakers, a breast implant, an intra-aortic balloon pump, and a ventilator. Of the 59 ineligible deaths, Kaiser Health News found that only eight appeared to have been revised in updated alternative summary reports.
4. Surgical stapler-related malfunctions accounted for more than 66,000 incidents in the hidden database since 2001. The FDA received only 84 reports for stapler-related harm in the public database but acknowledged that it had received nearly 10,000 reports through alternative summary reporting. The most common problems were staplers that failed to fire or fired malformed staples. Nearly 4,700 stapler problems were reported through the hidden database in 2017 alone. If a stapler fails to seal tissue properly during surgery, it can lead to serious bleeding or infection.
5. Breast implant injuries and malfunctions accounted for nearly half a million unique reports over two decades, including implants that leaked, deflated, or migrated. More than 6,600 incidents have been reported in 2019 by three companies: Allergan, Mentor and Sientra. The most common problem was rupture.
Kaiser Health News reported that thousands of medical device types are still eligible for reporting outside the FDA’s public database.
The FDA stated on June 21, 2019: “In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions. The FDA is now making all reports received under ASR exemptions from 1999 to 2019 available in the data files linked below.”
If you or a loved one suffered harm due to a medical device or implant in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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