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News For ISRG From The Last 14 Days
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November 24, 2014
09:26 EDTISRGFDA updates warning on laparoscopic power morcellators to treat uterine fibroids
The FDA announced it is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April, the FDA warns against using laparoscopic power morcellators in the removal of the uterus or fibroids in the vast majority of women. In an Immediately in Effect guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. Johnson & Johnson (JNJ), the largest manufacturer of morcellators, stopped selling the gynecological surgical tool in April and in August told customers to return any devices in their inventory. Intuitive Surgical's (ISRG) da Vinci surgical system can be used with tissue morcellators in such surgical procedures.

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