FDA takes lid off secret database, exposes top 3 problem devices

The FDA recently ended a program that allowed devicemakers to conceal nearly 6 million reports of device-related harm and malfunctions from the public and physicians. Under the program, the reports were hidden in a database, but they are now accessible to the public. 

CBS 5 asked Madris Tomes, who founded and runs a company that specializes in decoding and searching FDA databases for information, to help analyze the newly released data.

After analyzing the data, Ms. Tomes found that blood glucose tests, dental implants and breast implants had the most problems reported in the hidden database.

In particular, blood glucose tests had more than 2.4 million additional manufacturer reports.  Among the most-reported problems were defective components, incorrect message display and loss of power. 

Dental implants had nearly 2.2 million additional manufacturer reports. The most reported problems included failure to osseointegrate, an adverse event or fractures. 

Breast implants had more than 446,000 additional manufacturer reports.  Among the most-reported problems were deflation, fluid leaks and implant ruptures.

Access the full CBS 5 report here. 

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