By Chuck Seegert, Ph.D.
The FDA has issued immediately in effect (IIE) guidance for labeling of power morcellators and continues to discourage their use for MIS hysterectomy or myomectomy in the majority of cases, based on the risk of spreading unsuspected uterine cancer.
Power morcellators are devices used in laparoscopic surgery to divide, or mince, a tissue into small fragments or pieces. This facilitates removal of large tissue volumes through very small incisions, as small amounts of tissue can be removed at a time. This procedure has been used in uterine fibroid surgery that includes removal of the uterus (hysterectomy), as well as in the removal of the fibroids themselves (myomectomy).
In April 2014, the FDA released a safety communication stating that up to one of every 350 women treated for fibroids by hysterectomy or myomectomy may have unsuspected uterine sarcoma, according to an article on Med Device Online. Performance of a morcellation procedure and the mincing of cancerous tissues increase the risk of spreading the cancer through the abdomen and pelvis, since small particles of cancer tissue can seed metastases throughout these areas.
In a new IIE guidance document, the FDA now recommends that manufacturers of power morcellators for laparoscopic use include specific safety statements consisting of a boxed warning and two contraindications in their product labeling. The suggested language from the safety statement is reproduced below.
The FDA recommends that a boxed warning inform health care providers and patients that:
- 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. This information should be shared with patients when considering surgery with the use of these devices.
The two contraindications advise of the following:
- Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are:
- peri- or post-menopausal, or
- candidates for en bloc tissue removal [removing tissue intact], for example, through the vagina or via mini-laparotomy incision. [Editor’s note: These groups represent the majority of women with fibroids who undergo hysterectomy and myomectomy.]
- Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.