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The U.S. Food and Drug Administration 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 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
In an Immediately in Effect (IIE) 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. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.
FDA recommends manufacturers updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.
FDA recommends the following warnings to be shared with patients when considering surgery with these devices
– The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.
– Laparoscopic power morcellator should not be usedf or removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removalt hrough the vagina or mini-laparotomy incision
– Should not be used in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
Source: Nov 24, 2014 FDA Government