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Coloplast controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2019

    Transvaginal surgical mesh regulatory and litigation controversy

    Coloplast was among medical-device companies involved in litigation concerning transvaginal surgical mesh implants. In 2019, the U.S. FDA ordered Coloplast and Boston Scientific to stop selling and distributing certain mesh products for pelvic-organ-prolapse repair because the companies had not demonstrated that the products were safe and effective for that use. The episode followed earlier multimillion-dollar settlements and broader scrutiny of transvaginal mesh safety.

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