FDA sat on hundreds of thousands of breast implant incident reports

Posted on March 29, 2019 by UNITED PHOTO PRESS MAGAZINE


If you don’t have a personal experience with breast implants, you might have missed ICIJ’s ongoing Implant Files coverage of the popular, but controversial, medical devices.

But a story from my colleague Sasha Chavkin this week about how the FDA sat on hundreds of thousands of breast implant incident reports — followed by a major announcement from the agency’s outgoing commissioner — offer prime examples of why our reporting matters to everybody.

More than 10 million people around the world have breast implants, but questions about durability and safety have never been fully resolved.

The U.S. Food and Drug Administration warns that as many as one in five people who receive breast implants will get them removed within a decade.

The safety risks, the agency says on its website, “are sufficiently well understood for women to make informed decisions.”

But our reporting has raised serious doubts about that argument.

In November, we revealed that regulators have been slow to acknowledge growing concerns about auto-immune disorders and a rare form of cancer linked to breast implants.

Huge numbers of patients have told us that their doctors never informed them of these risks.

We also found that the FDA had allowed breast implant manufacturers to bury malfunction and injury reports. When those companies were forced to submit these incidents separately, the number surged from a few hundred a year to more than 8,000 in the first half of 2018.

Here’s where we come back to Sasha’s new reporting.

In advance of a hearing on breast implant safety, the FDA circulated a report. On page 13, Sasha discovered what at first he assumed was a mistake: a chart that showed the FDA was actually aware of more than 20 times as many incident reports than the agency had previously made available.

Madris Tomes, a former FDA data expert, knew the agency had failed to disclose the true number of reported problems — but even she was stunned to learn the volume of hidden reports. The agency has “no regard” for patients and physicians, she told us.

Sunlight, as we say in investigative reporting, is the best disinfectant. Exposing how the FDA and other regulators have hidden vital safety information from patients has put pressure on those agencies to share more.

Later in the week, Commissioner Scott Gotlieb vowed in a tweet to do just that. “We're now prioritizing making ALL of this data available,” he wrote.