November 24, 2014 – The Food and Drug Administration warned against using laparoscopic power morcellators in either myomectomy or hysterectomy for the treatment of uterine fibroids. The warning is based on an FDA analysis of medical literature, from which it concludes that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids has unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.
Because there is currently no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma, the FDA has warned against the use of morcellators—which can spread undetected cancer throughout the abdomen—in hysterectomy or myomectomy surgeries.
Further, the FDA warning advocates (1) limiting the patients for whom laparoscopic morcellators are indicated; (2) providing strong warning to patients of the risk of spreading undetected cancer; and (3) urging doctors to share this information directly with their patients. The FDA’s most recent guidance on the use of power morcellators “strongly urges” manufacturers to add important safety information to product labels.
FDA has recommended two new contraindications for the use of power morcellators:
- Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
- Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
Further, the FDA strongly urges that this information should be contained in a new boxed warning on power Morcellator labeling:
- Uterine tissue may contain unsuspected cancer
- The use of laparoscopic power morcellators could cause any undetected cancer to spread, decreasing long-term survival for patients.
- Patients should be told of these risks when considering surgery with the use of these devices.
Read the full advisory statement from the FDA here.
Burg Simpson Eldredge Hersh & Jardine, P.C is currently investigating legal claims against leading manufacturers of power morcellators, including the Gynecare Morcellex™ manufactured by Ethicon. Women who have received a diagnosis for cancer after undergoing a hysterectomy or fibroid removal surgery may be entitled to compensation. To find out more information and to contact us to see if you should file a claim, click here.