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PMAs loom for pelvic organ prolapse mesh devices; J and J stops morcellator sales

This article was originally published in Clinica

Executive Summary

The US FDA says that surgical meshes used for transvaginal repair of pelvic organ prolapse should be regulated under tougher standards based on health risks associated with the devices. The decision will affect companies including CR Bard, Covidien, Boston Scientific, Coloplast and Endo Pharmaceuticals (through its American Medical Systems unit). Johnson & Johnson was in the sector, but discontinued several of its vaginal meshes in 2012.

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