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Item ID 14016916 in Category: Health & Beauty - Health Services

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FDA Asks Manufacturers to Keep Their Transvaginal Mesh for POP Off the Market
The FDA has advised against a transvaginal mesh by Coloplast, and the manufacturer is compelled to keep the product off the market for the time being. The decision is based on a surveillance study of about 36 months. The Coloplast transvaginal mesh was for use in Pelvic Organ Prolapse (POP) The agency has also made the data from the surveillance study public. Although the mesh is equally effective and safe compared to nature tissue repair, it comes with risks, according to the FDA. In 2019, the FDA convened an advisory committee that suggested transvaginal POP repair need to be more effective and safe compared to natural tissue repair at 36 months and requires a favorable risk-benefit profile. Unfortunately, months later, Coloplast failed to extend a reasonable guarantee of the effectiveness and safety of the transvaginal mesh. For more details please visit our website - https://www.medhealthreview.com/2025/05/21/fda-asks-manufacturers-to-keep-their-transvaginal-mesh-for-pop-off-the-market/
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Target State: New York Target City : New York City Last Update : Aug 19, 2025 1:57 AM Number of Views: 18	Item Owner : medhealthreview Contact Email: Contact Phone: +1 702-213-6364

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Hot-Web-Ads > Health & Beauty > Health Services > Item ID 14016916

2025-08-19 (0.333 sec)