FDA panel to dis­cuss risks of la­paro­scopic de­vice

Modern Healthcare - - THE WEEK AHEAD - —Jaimy Lee

A Food and Drug Ad­min­is­tra­tion ad­vi­sory com­mit­tee will meet this week to dis­cuss whether la­paro­scopic power mor­cel­la­tor de­vices, which are used to re­move uter­ine fi­broids or a pa­tient’s uterus, should be re­clas­si­fied as high-risk med­i­cal de­vices.

If mor­cel­la­tor de­vices were re­clas­si­fied as high-risk, they would be sub­ject to a pre­mar­ket ap­proval ap­pli­ca­tion. Power mor­cel­la­tion de­vices, made by a few com­pa­nies in­clud­ing John­son & John­son and Karl Storz, have been in use since the early 1990s, but there has been a re­cent spate of safety con­cerns about whether the de­vices can cause the spread of can­cer­ous tis­sue in a pa­tient’s body.

The FDA in April be­gan to dis­cour­age mor­cel­la­tion for hys­terec­tomies or the re­moval of uter­ine fi­broids be­cause of the risk of spread­ing un­sus­pected uter­ine sar­coma.

Dur­ing surgery, mor­cel­la­tors are used to cut the tis­sue to al­low for the re­moval of the fi­broids or uterus in pieces. Mar­ket an­a­lysts say about 50,000 of the 600,000 hys­terec­tomies per­formed each year are as­so­ci­ated with mor­cel­la­tion de­vices.

Other risks can in­clude in­jury to or­gans, es­pe­cially in cases where the physi­cians are not ad­e­quately ex­pe­ri­enced users of the tech­nol­ogy.

Us­ing a mor­cel­la­tor de­vice also can mean the pro­ce­dure it­self takes longer, said Dr. Natalya Danilyants, a gy­ne­co­logic sur­geon who prac­tices in Mary­land.

The meet­ing is sched­uled for July 10 and 11.

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