FDA will weigh safety of sur­gi­cal morcellators

Modern Healthcare - - THE WEEK AHEAD - —Jaimy Lee

Pub­lic com­ments are due this week on whether de­vices known as power morcellators should con­tinue to be used in min­i­mally in­va­sive hys­terec­tomies and sur­gi­cal re­moval of uter­ine fi­broids. The Food and Drug Ad­min­is­tra­tion will re­view the com­ments and de­cide whether to take reg­u­la­tory ac­tion.

While the de­vices have been around for decades, there are new ques­tions about whether their use in­creases the risk of spread­ing un­di­ag­nosed and un­sus­pected can­cer in pa­tients. It’s un­clear what per­cent­age of pa­tients are at risk. Es­ti­mates range from 1 in 350 to 1 in 7,400. “It’s dif­fi­cult for the FDA to make a def­i­nite rec­om­men­da­tion with in­com­plete data,” said Dr. Ju­bilee Brown, a gy­ne­co­log­i­cal on­col­o­gist at the Univer­sity of Texas MD An­der­son Can­cer Cen­ter.

Morcellators cut fi­broid or uter­ine tis­sue into smaller pieces to al­low re­moval of the tis­sue dur­ing surgery. Com­plaints by two physi­cians, one of whom un­der­went mor­cel­la­tion and saw her can­cer spread, helped drive the cur­rent de­bate.

In a com­ment posted on­line, the So­ci­ety for Gyne­co­logic On­col­ogy said it does not sup­port re­stric­tions on power mor­cel­la­tion be­cause the tool has en­abled women to re­ceive min­i­mally in­va­sive pro­ce­dures rather than open pro­ce­dures. “Ban­ning mor­cel­la­tion may cause more harm to more women,” the so­ci­ety said.

John­son & John­son, which is es­ti­mated to have about two-thirds of the power mor­cel­la­tor mar­ket in the U.S., said July 31 that it would with­draw its mor­cel­la­tion de­vices glob­ally. A hand­ful of smaller man­u­fac­tur­ers have not said whether they will re­call the de­vices.

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