All of us have read about safety and reliability issues of medical devices ranging from implantable mesh for pelvic support, pacemaker defects, and breast implants,
Silicone Breast Implant
Intravaginal Pelvic support Meshwork
Frequently these device failures do not become publicly known until a number of occurrences, which is brought to the attention of the FDA by users (surgeons, or medical professionals.) It often takes a number of providers to connect the dots. In some cases such as academic institutions, or very large integrated health systems which have their own internal checks by surgical committees detects the device failure.
Some patients experienced serious neurologic problems, including memory loss, tremors, and even dementia. Patients with MOM hip replacements had Cobalt levels elevated in blood and urine. During replacement of the metal on a metal hip prosthesis, severe tissue damage was found, with Cobalt ions leached into the tissue causing necrosis and entering the circulatory system. The question arises, is Cobalt poisoning be the next Mercury poisoning?
Failing metal hip implants could be releasing genotoxic material
In any case, the FDA has its own reporting mechanism FDA WATCH. There is no online reporting form. Form FDA3500 (pdf)(form fill) can be downloaded by providers and consumers to report individual incidents
The KHN report exposes a redundant, confusing and largely unknown file of device incidents. The situation was so confusing that even a former FDA Commissioner was unaware of the database.
The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. 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.
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.
An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.
Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.
Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone. The FDA alternative summary reporting program was established in 2000, perhaps as a method to reduce reporting administration by the overworked FDA. The devil in the details is described at the link above.
Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a summary report to be filed publicly.
More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years. The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.
The KHN investigation had to perform a careful dissection of FDA databases, exceptions and who had access to the relatively unknown information. There was certainly a lack of transparency even within the FDA.
To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields. “The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database.
Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.
To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields. “The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database.
"The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices. "
Madris Tomes, former FDA manager
Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.
Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not. The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.
"I don’t want to sound overdramatic here, but it seemed like a cover-up."
Dr. Douglas Kwazneski, surgeon
FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices | California Healthline:
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