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Medical Devices / Regulatory Affairs

CooperSurgical Cited for IUD’s DTC TV Ad

Aug. 2, 2019
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The FDA slapped Connecticut devicemaker CooperSurgical with an untitled letter over a direct-to-consumer TV ad for its ParaGard T380A copper contraceptive, an intrauterine device.

The agency said that while the TV ad warned the device shouldn’t be used by patients with certain cancers, it misled customers by not informing them about other important risk information.

The advertisement failed to mention contraindications for the product, including acute pelvic inflammatory disease or current behavior suggesting a high risk of pelvic inflammatory disease.

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