FDA halts sale of all transvaginal mesh devices because they do not meet safety requirements - after years of protests from tens of thousands of women left crippled and in agony In 2016, the agency had reclassified the mesh as class III or high risk That required makers to submit and obtain approval from the FDA's most stringent device review pathway in order to continue marketing the products The move came after years of protests from women who'd been injured by the devices On Tuesday the FDA concluded there was not enough evidence to prove safety of meshes
By Reuters
Published: 18:41 BST, 16 April 2019 | Updated: 18:42 BST, 16 April 2019
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The US Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop sale and distribution of the products in the United States.
The FDA said makers of the products such as Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications.
The devices, made of synthetic or biological material, are
