FDA concludes study of Coloplast's transvaginal mesh, upholds ban
The US health authority brings its follow-up study of a discontinued Coloplast product to an end, restating that benefits do not outweigh the risks of the treatment for pelvic organ prolapse.
by albert rønning-andersson, translated by daniel pedersen
A transvaginal mesh for the treatment of pelvic organ prolapse, POP, made by Coloplast will continue to be commercially unavailable for US patients, a post-market surveillance study conducted by the US Food and Drug Administration (FDA) concludes.
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