Hundreds of thousands of incidents related to breast implants had been kept out of public sight may be revealed under new "Program"

Records of millions of cases of patient harm and product malfunctions previously kept hidden from the public could soon be released following a major policy change by the key United States regulator.

In a major advance for medical device transparency, the U. S. Food and Drug Administration has pledged to disclose information kept buried for nearly two decades under a program known as “alternative summary reporting.”
FDA Commissioner Scott Gottlieb announced the policy change on Twitter two days after the International Consortium of Investigative Journalists reported that hundreds of thousands of incidents related to breast implants had been kept out of public sight under the summary reporting program.
A March 7 report by Kaiser Health News revealed that more than 1.1 million incidents since 2016 had been kept from public view because of summary reporting.

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.
Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.
“I don’t want to sound over dramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

Via ICIJ