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Coloplast responds to FDA’s decision to remove Surgical Transvaginal Mesh as Treatment Option for Pelvic Organ Prolapse

05:09 EDT 17 Apr 2019 | Biotech 365

Coloplast was informed yesterday by the FDA that the PMA for Restorelle DirectFix Anterior is not approved and the company must cease marketing and distribution immediately. As a result, FDA regulations require that all anterior transvaginal synthetic mesh products, including … Continue reading

Original Article: Coloplast responds to FDA’s decision to remove Surgical Transvaginal Mesh as Treatment Option for Pelvic Organ Prolapse

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