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FDA says more decisions on morcellation coming

from Outpatient Surgery

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. more


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