Devices

FDA Increasing Scrutiny of CooperSurgical IUD: Report

FDA appears to be increasing scrutiny over CooperSurgical and its manufacturing facility in North Tonawanda, NY, where Paragard (intrauterine copper contraceptive) is made, according to a report by Spotlight on America, which describes itself as “a national award-winning investigative news franchise airing on 90+ ABC, CBS, NBC, FOX, CW and MyTV stations across the country.” Over the past three years, the group has been raising concerns about the IUD Paragard as thousands of women have reported breakages with the device.

Spotlight says it recently became aware that FDA inspected the manufacturing facility in North Tonawanda in 2022, and it reinspected the plant in February. The FDA Form-483 from the 2022 inspection cited CooperSurgical for not adequately investigating breakage complaints, saying it failed to “implement adequate corrective action and preventive plans.” No records from the February inspection have been released by the agency, the group says.

According to a Spotlight on America analysis of FDA's Adverse Event Reporting System there were 1,231 reports of breakage in 2023, which it says is the most recorded in a single year since tracking began. “There have been more than 6,000 total complaints since tracking began, and 80% of them were deemed to be 'serious,’” Spotlight reports. As Spotlight on America noted last year, a 2022 analysis of all IUDs showed those made by Paragard broke at a rate of nearly double compared to all others.

Spotlight notes that Paragard's current warning label, issued in 2019, does acknowledge the possibility of breakage, but women the group interviewed said they were never warned by their doctors about the potential for breakages.

Additionally, Spotlight says CooperSurgical issued a recall for a batch of IUDs due to sterility issues just before the FDA inspection in 2022. The company also was issued a Warning Letter in 2021 for advertising issues, such as failing to adequately communicate risk information associated with the IUD’s use.

Spotlight on America says it repeatedly sought comment from CooperSurgical, but the company did not respond.

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