After issuing safety warnings, the FDA may revoke its approvals of transvaginal mesh devices made by Boston Scientific and Johnson & Johnson, according to a Mass Device report.
The devices, used to treat pelvic organ prolapse, face rising concerns that they could expose patients to unnecessary risk without offering greater clinical benefits than safer options.
In the meantime, the FDA has asked surgeons to carefully consider all other treatment options and fully inform patients of potential complications from the surgical mesh.
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