Laparoscopic Power Morcellators Get Safety Labeling Update
The Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in hysterectomy or myomectomy procedures for the majority of women.
Further, the FDA is also recommending in an Immediately in Effect (IIE) guidance that laparoscopic power morcellators manufacturers include specific boxed warning and two contraindications in their product labeling. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, procedure may spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival.
The boxed warning states: "Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients." The contraindications state: "Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal through the vagina or mini-laparotomy incision" and "Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous."
The new guidance impacts new and currently available laparascopic power morcellators for general and specific gynecological conditions. The FDA is considering other strategies to further reduce the risk of unsuspected cancer spread by laparoscopic power morcellation, including new ways to improve uterine cancer detection and to contain possible cancerous tissue.
For more information visit FDA.gov.