(CBS 5 INVESTIGATES) -- For the first time, we are getting to see what's in the millions of reports of problems with medical devices that until now had been hidden from the public. 

When considering the use of a medical device like an implant or monitor, patients should be informed of the risks.

[WATCH: Which medical devices have the most hidden problems?]

The Food and Drug Administration recently released nearly 6 million reports of problems with various medical devices that were not available to the public. Even doctors did not know about these records.

The data dump came in the form of zip files with information labeled by complex codes. While that's a standard format for government purposes, it can be difficult for the average person or medical professional to use.

FDA data dump

Madris Tomes and her company started with pages and pages or data that looked like this -- millions of lines of indecipherable codes.

Madris Tomes runs Device Events, a company that specializes in searching FDA databases for information.

Tomes has now developed software to put the millions of newly released reports into a usable form.

Tomes says that while some of the medical devices -- like breast implants -- have been getting a lot of attention, other devices have not.

[SPECIAL SECTION: Breast Implant Illness Investigation]

CBS 5 Investigates asked Tomes to look at which devices had the most reports of problems. The top three are blood glucose tests, dental implants, and breast implants.

Tomes' in-depth searches show not only how many reports were hidden, but also the types of problems with the devices.

The lists are long and varied.

Blood glucose tests

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Dental implants

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Breast implants

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Turning raw data and complex codes into readable information

Tomes is a former FDA data analyst who helped expose the FDA's use of a secret reporting process that allowed device manufacturers to hide information from the public.

The public is allowed to see problems reported to the FDA's database, the Manufacturer and User Facility Device Experience (MAUDE).

FDA's database, the Manufacturer and User Facility Device Experience (MAUDE)

Device manufacturers, however, had another process to report problems called Alternative Summary Reporting (ASR). That information did not go into MAUDE. Instead, manufacturers were allowed to put tens of thousands of reports of problems into the ASRs. Until now, the public had no way of knowing about those problems documented in those reports.

[RELATED: Reports of problems with breast implants hidden from public]

Stephanie Caccomo, a spokeswoman for the FDA, says the ASRs were released as part of the agency's efforts to be more transparent.

"The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks," she said. "Our goal is to make medical device reports data more usable and easier to find, furthering our efforts to increase transparency in medical device reporting. Important details about the content and format of the ASR data were made available in June on the MDR Data Files page."

FDA

The FDA says its ASR program ran from 1997 through June 2019 -- more than 20 years.

A spokeswoman for the FDA tells CBS 5 Investigates they have always monitored the information in the ASRs.

What happens now?

Currently, the agency is reviewing and looking at updating regulations and warnings for breast implants, dental implants, and blood glucose tests.

The FDA held public meetings on the safety of breast implants and is exploring stronger warnings about the risks.

CBS 5 Investigates reached out to the FDA, the American Academy of Implant Dentistry and The American Dental Association.

Dental implants

The number of problems with dental implants may still be underreported because dentists are not required to report issues.

No one could answer the question of how many dental implants are used annually.

The number of problems may still be underreported because dentists are not required to report problems.

Dental implants will be part of an upcoming meeting looking at the safety of materials in medical devices and why some patients have a reaction.

The FDA is also in the process of updating the guidelines for manufacturers to make future blood glucose tests more reliable.

 


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