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US regulator bans sale of transvaginal surgical mesh

April 17, 2019

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The order was issued following the FDA’s review of premarket approval (PMA) applications submitted by Boston Scientific and Danish medical device maker Coloplast. Boston Scientific submitted PMAs for Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, while Coloplast sought approval for its Restorelle DirectFix Anterior device.

The regulator said that the companies’ products did not show an adequate assurance of long-term safety and effectiveness when compared to surgical tissue repair without using mesh.

Read More on medicaldevice-network.com