Did you know September is National Gynecological Cancer Awareness month? In recent months, a common gynecological procedure has come under scrutiny from the FDA. This minimally invasive procedure uses a device called a ‘power morcellator’, which unknowingly accelerates hidden cancers that may be present in the uterus. In April 2014, the FDA released a safety warning, labeling power morcellators to be dangerous. The FDA’s safety alert was distributed to across the U.S. medical community including cancer advocacy groups, medical facilities, hospitals and medical device manufacturers. In response, Johnson & Johnson has voluntarily asked customers to discontinue the use of power morcellators and to return the devices to the company.
The Device
A power morcellator is a medical device used in numerous types of laparoscopic surgeries. Among the most common are hysterectomies (removal of the uterus) and myomectomies (removal of uterine fibroids). The rotating blades of the tubular-shaped surgical device are designed to cut or divide tissue into fragments. These tiny fragments can then be suctioned away through a small abdominal incision.
The Problem
This procedure creates a substantial and hidden risk to the patient. Women with undetected cancers, especially leiomyosarcoma (LMS), a rare, predominately fatal disease, are at the greatest risk. The rotating blades on the device can spread the sarcoma cells throughout the abdomen and pelvis region, exacerbating the risk of upstaging the cancer.
In result of this dangerous reoccurrence, the FDA held a hearing in July to discuss the dangers, potential risks and future use of power morcellation. For now, the FDA is recommending that doctors carefully consider every option available when determining the appropriate procedure.
FDA Recommendations
The FDA recommends that patients considering a hysterectomy or myomectomy, to discuss their options with their doctor. If a laparoscopic is the only available choice, it is important to ask your doctor if a power morcellator will be used in the procedure. For women who have already had a procedure where a power morcellator was used, it is crucial to follow up with your doctor, especially if there are persistent or recurring symptoms.
Sources:
http://recallcenter.com/power-morcellator/lawsuit/
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm393689.htm
