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FDA Finally Bans Devices That’s Been Hurting Women

Public Citizen News / May-June 2019

By Mike Stankiewicz

This article appeared in the May/June 2019 edition of Public Citizen News. Download the full edition here.

Surgical mesh products for pelvic repair that cause irreparable harm to women are finally off the market – but it took the U.S. Food and Drug Administration (FDA) eight years to act.

In April, the FDA ordered manufacturers of surgical mesh used to treat pelvic organ prolapse to immediately stop producing and selling the products. Pelvic organ prolapse afflicts many women and occurs when the muscles supporting the pelvic organs become weak, allowing the organs to drop or press into the vagina.

The FDA noted that it determined that the remaining makers of these devices, Boston Scientific and Coloplast, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

Public Citizen had urged the FDA for years to ban these devices because they are unsafe. The organization first petitioned for a ban in 2011, citing studies that found the use of surgical mesh for pelvic repair provided no clinically significant benefits compared to repair without mesh.

Surgical mesh also was found to cause serious complications that resulted in permanent life-altering harm to women. That same year, the FDA itself reported that from 2008 to 2010, the agency had received about 1,500 reports of serious complications that were associated with surgical mesh devices used for pelvic organ prolapse repair. Complications included urinary problems, injuries to organs and vaginal scarring.

However, the agency denied Public Citizen’s petition in 2014 and instead reclassified the products in 2016 as high-risk devices, putting them under the FDA’s most stringent regulatory oversight. The agency also required manufacturers to submit documentation that provided evidence of the devices’ effectiveness and safety. During the three-year document submission period, the devices remained on the market.

In February, Public Citizen testified before an FDA advisory committee and once again urged the agency to ban the products. Additionally, tens of thousands of woman have sued device makers, claiming injuries from the devices, which led to many manufactures withdrawing these devices from the market. At the time of the FDA’s ban, only Boston Scientific and Coloplast still sold the products.

Accounts from numerous women who experienced permanent injuries, and overwhelming scientific evidence, appeared to have finally moved the agency to take the toughest action possible.

“Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had not demonstrated a reasonable assurance of safety,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The agency’s reckless delay in removing these mesh products from the market belies the agency’s assertion that ‘patient safety is our highest priority.’ Had the agency granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm.”