PHOENIX, AZ (3TV/CBS 5) - Hundreds of thousands of reports of problems with breast implants have been hidden from the public.
The data was revealed as the FDA looks into whether breast implants need stronger regulations.
A former IT worker with the FDA was one of the first to realize that crucial information was not accessible to the public.
Madrise Tomes is the founder of Device Events, a company that specialize in finding information in the FDA's database that tracks problems with medical devices.
[SPECIAL SECTION: Breast Implant Illness Investigation]
An attorney hired Tomes to track down several cases involving problems with breast implants he knew had been reported, but were not showing up in the database.
Tomes says she knew something was wrong when she could not find a report on a ruptured implant. "That was how I found out. They are not submitting these reports the way they should be," says Tomes.
The FDA's database is a manufacturer and user facility device experience, or MAUDE.
The FDA's website explains how the agency uses MAUDE:
"Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
It's important to note, information put into this database is searchable and public, but implant manufactures were also allowed to use a different process to report problems. Something called Alternative Summary Reporting (ASR's)."
The FDA says to streamline its review process, device manufactures were allowed to combine multiple, sometimes thousands of reports of problems, into a single ASR.
The information in the ASR is not made available to the public.
Until recently, searches of MAUDE showed less than 350 problems with breast implants reported every year.
That number shoots up to 350,000 reports over the last decade when the reports from implant manufactures are included.
Tomes says for women and doctors searching for information on the risks of breast implants, the use of ASRs hide potential problems.
"We have millions of patients getting a device they thought was safe," said Tomes.
The data was revealed by the FDA as the agency reviews whether breast implants need stronger regulations following pressure from thousands of women who say breast implants made them sick.
Hidden reports are not limited to just breast implants. ASR's have been used for multiple medical devices.
A Kaiser Health News investigation found that since 2016 more than 1 million incidents with medical devices have been put in ASRs instead of the FDA's database, where the information would be available to the public.
In March, prior to stepping down, the FDA's Chief tweeted "it's imperative that all safety information be available to the public. We're now prioritizing making ALL of this data available."
However, the information in the ASRs had not been made public when Dr. Scott Gottlieb stepped down as the Commission of the Food and Drug Administration in April 2019.
CBS 5 Investigates contacted the FDA who sent us a statement explaining the use of ASRs and that the practice of using them ended for most devices in 2017.
At this point, the specifics on what is contained in the ASRs are unknown, but the FDA maintains it will make the information available to the public in the coming months.
The FDA's full statement reads:
"Summary reports about breast implants were previously allowed only in specific situations as part of summary reporting programs and were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE). The method of reporting did not change the FDA’s review of these reports. The FDA monitors all reports to identify signals and other important information.
The agency had established these summary reporting programs to more efficiently review adverse events for well-established risks, such as seroma (pocket of fluid) and hematoma (bruise), so that we could monitor the number of reports and details related and take action if new information warranted.
These reports were only allowed for specific known risks, they were not allowed in patient deaths and unusual, unique or uncommon adverse events, which included BIA-ALCL. Those have always required individual medical device reports that were made publicly available in MAUDE. Moreover, MDRs cannot be used to determine the frequency of adverse events which is why we use a variety of information sources to assess risks to patients from medical devices.
We appreciate the value to the public in assuring this information from medical device reports is readily available to them and we are looking at ways to make information the FDA reviewed in summary reports publicly available in the coming months.
It’s important to note that generally the number of reports received cannot be used to determine the frequency with which a particular adverse event occurs. The information in medical device reports is important, but they are only one tool that contributes to our understanding of breast implants. Further, it is important that people understand that the reports are just that – a report by an outside party. The agency has not verified that they are accurate, nor that the issue was in fact caused by the device. For this reason, among others, these reports cannot be used alone to determine an incidence rate, causation or associations as many reports can be duplicative or incomplete.
Because of the limitations of medical device reports, the FDA uses several tools to continue to evaluate breast implants after we have approved a breast implant product and they are marketed to women. These include evaluating the FDA’s medical device reports of adverse events that women, providers and manufacturers send to the FDA; analyzing data from FDA-mandated post-approval studies conducted by breast implant manufacturers; reviewing scientific literature; and participating in registries, which often are databases that collect information such as patient reoperations, directly from the doctors treating patients, which helps the FDA understand what led to the reoperation.
In an effort to promote greater public transparency, the FDA has taken action to end alternative summary reporting, which was established in 1997 and for which a guidance document was issued in 2000 after considering public feedback, was already revoked in 2017 for most medical devices, including breast implants."