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FDA orders medical device companies to stop selling pelvic mesh

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The FDA said it couldn’t assure women that these devices were safe and effective longterm.

The CMO in Ireland said there is an evidence base to support the use of some mesh devices. Image: Michelle Hennessy/TheJournal.ie The CMO in Ireland said there is an evidence base to support the use of some mesh devices. Image: Michelle Hennessy/TheJournal.ie THE US FOOD and Drug Administration has ordered medical device companies to stop all sales and distribution of surgical mesh used in surgeries to repair pelvic organ prolapse.

A report from the Chief Medical Officer in Ireland last year found devices known as transvaginal mesh implants , used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment. As part of a 2016 reclassification of the devices as high risk, manufacturers were required to submit and obtain approval of premarket approval applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the US.

However the use of other vaginal mesh devices is likely to recommence – including for treatment of prolapse.

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