FDA Issues High Risk Warning for Transvaginal Mesh

http://www.medpagetoday.com/OBGYN/GeneralOBGYN/55503?xid=nl_mpt_DHE_2016-01-05&eun=g875301d0r

As part of the premarket approval application process, manufacturers will be required to address concerns about severe pelvic pain and organ perforation through a “rigorous PMA pathway.” …

In March 2015, Johnson & Johnson’s Ethicon unit was ordered to pay out a $5.7 million settlement to a woman who sued the manufacturer over a transvaginal mesh implant (the judgement is currently under appeal). In August, an investigative report found several medical lenders linked to profit schemes and litigation over removal of transvaginal mesh.

The agency notes that these orders are not applicable to surgical mesh used for other indications, such as stress urinary incontinence or open (abdominal) repair of pelvic organ prolapse.

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