ICIJ Report Shows More Women Injured by Medical Devices

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Medical devices harm twice the number of women as men, a recent analysis of federal safety data by the International Consortium of Investigative Journalists (ICIJ) found.

Women accounted for 67 percent of 340,000 injured patients included in a database of device-related injury reports maintained by the U.S. Food and Drug Administration. Male reports, in contrast, made up just 33 percent of reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

The MAUDE database houses reports of adverse events involving medical devices, without disclosing whether an injured patient is male or female. Interested in assessing whether men or women bore the brunt of device-related injuries, the ICIJ wrote an algorithm to comb the database for gendered adjectives and pronouns, such as female, male, he and she. The algorithm then mapped those terms against thousands of adverse event reports to find that women accounted for the majority of injury reports.

An FDA spokesperson, acknowledging the gender imbalance in device-related injury reports, said the agency is working on policies to better understand how medical devices perform in women versus men.

“Providing women with access to safe medical devices on the market that meet their health care needs is a top priority,” the spokesperson told MassDevice.

Madris Tomes, a former FDA manager and founder and CEO of Device Events, suggested a good first step by the FDA would be to unredact FDA data to show a patient’s gender. Revealing a patient’s gender would help patients, doctors and hospitals to more thoroughly evaluate the safety of devices, Tomes added.

“It has long been unclear why the FDA’s device division redacts data elements that are so vital to scientific study…age, sex, and even the outcome of the adverse event are redacted by the device division but not the drug division,” Tomes told MassDevice.

Originally published December 12, 2019

By Nicole Knight

Nicole Knight is a freelance writer based in Southern California. A former reporter for the Orange County Register, she most recently covered issues related to women’s health and economic justice for the nonprofit site Rewire.News. Her bylines have appeared in outlets ranging from Pacific Standard to Parents.com, reflecting her varied interests. She is a member of the Association of Health Care Journalists and the American Society of Journalists and Authors. Follow her on Twitter @nicolekshine.

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