FDA mulls upping risk classification of vaginal mesh as lawsuits mount up for big mesh makers
This article was originally published in Clinica
Executive Summary
Transvaginal meshes to treat pelvic organ prolapse may soon be classified as "high-risk" devices requiring premarket approval, pending the outcome of a two-day US FDA panel meeting to discuss the safety and efficacy of the products. These meshes, made by the likes of Johnson & Johnson and CR Bard, were previously regulated under the less-stringent 510(k) procedures. However, growing concern over serious complications arising in patients implanted with the devices have prompted calls for stricter regulation.
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