FDA discouraging use of power morcellation

A safety communication discouraging use of power morcellation during hysterectomy or myomectomy for fibroids has been issued by the Food and Drug Administration (FDA) because of concern about risk of inadvertent spread of unsuspected cancer to abdominal and pelvic cavities. The FDA’s recommendations to health care providers include not using the technology in women with suspected or known uterine cancer. Recommendations to women undergoing laparoscopic hysterectomy or myomectomy include asking your health care provider if power morcellation will be performed and if so, why it is considered the best treatment option for you.

Perspective from Deputy Editor Jon I. Einarsson, MD, PhD, MPH

“The FDA safety communication discourages use of laparoscopic power morcellation and indicates that the practice will be further evaluated by the Obstetrics and Gynecological Medical Devices Panel. Physicians are encouraged to consider all available treatment options and to discuss the risks and benefits of all options with their patients. Several institutions have already stopped or significantly restricted the use of open power morcellation due to concerns about the spread of undiagnosed malignancy.

In our experience, in-bag morcellation is a feasible approach to laparoscopic specimen retrieval which may significantly limit potential spread of occult malignancy during laparoscopy. In-bag morcellation is being actively investigated by several centers at the present time because more information is needed about the safety and efficacy of this approach. Alternative methods of tissue extraction that do not involve traditional morcellators are also being developed. I suspect that this field will continue to evolve very rapidly during the next few months.”

For more coverage from Contemporary OB/GYN on morcellation, read our March cover story.