FDA Says More Decisions on Morcellation Coming
The agency will hold a public meeting in July.
Published: June 12, 2014
Will morcellation devices used to laparoscopically remove uterine fibroids be recalled or banned? The FDA is convening a meeting next month to take up the topic.
The agency issued an advisory in April, discouraging their use because the devices can spread cancerous tissue in women with undetected uterine sarcomas, a condition the agency says may affect as many as 1 in every 350 women.
However, proponents of morcellation say the proportion of women with undetected sarcomas is likely closer to 1 in 1,000; that the prognosis is already bleak for those women; and that for everyone else, the alternatives are typically much more dangerous and invasive.
The FDA's Medical Devices Advisory Committee will hold a public meeting on July 10 and 11 and plans to "make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations" for morcellators.
One stock analyst, Greg Chodaaczek of Sterne Agee, says the meeting is likely to result in a so-called black-box warning, saying he doesn't think there's enough data to warrant a recall or ban.
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