Jamee Cook poses for a photo at Rayburn House Office Building after meeting with congressional leaders on Capitol Hill, Thursday, Sept. 6, 2018, in Washington. Cook had breast implants that ruptured and which she believes caused her medical problems. She now is lobbying the FDA and congressional leaders to do a better job of tracking and regulating medical devices. (AP Photo/Jose Luis Magana)

Breast implant injuries hidden as patients' questions mount

November 26, 2018 - 11:02 am

WASHINGTON (AP) — Breast implant recipients say that for years data on ruptures and other problems was kept hidden by the U.S. government and manufacturers, making it hard to know whether the medical devices are safe.

A joint investigation by The Associated Press and the International Consortium of Investigative Journalists found that the U.S. Food and Drug Administration allowed breast implant manufacturers to report problems in bulk, rather than individually, effectively suppressing the actual number of complaints about injuries and malfunctions.

The breast implant reporting issue is just one of the problems caused by the FDA's current tracking system for medical device problems. Agency officials say they have requested millions to overhaul the system to help the agency become the first among world regulators to identify and act on medical device safety problems.

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