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Power morcellators are typically used in minimally invasive, or laparoscopic, surgeries such as hysterectomy (removal of the uterus) and myomectomy (removal of fibroids in the uterus). The instrument resembles a drill and the end can be fitted with sharp edges, scissor-like jaws, or graspers for tissue removal.
Power morcellators were initially considered a safer option than more intensive surgeries to remove the uterus or uterine fibroids. Due to the way that they work, however, morcellators can spread cancer tumors and cells throughout the body, if any cancer is present.
Purpose of Power Morcellators
Power morcellators can be used in a number of laparoscopic surgeries, with the purpose of breaking tissue into small pieces via small incision sites, to maintain a minimally-invasive surgery with faster recovery time. Morcellation is defined as dividing, or mincing.
Power morcellators have been approved by the FDA for use in hysterectomies and myomectomies since the mid-1990s. Women often opt for laparoscopic hysterectomies and myomectomies because of shorter recovery time and reduced risk of infection.
Power Morcellators Safety Concerns
When power morcellators are used on women that have uterine fibroids, the device creates a risk of spreading unknown cancerous tissue beyond the uterus.
Power Morcellation Can Spread Cancerous Tissue
Most women will develop uterine fibroids, or leiomyomas, at some point in their lives. Most uterine fibroids, however, cause no symptoms. When the fibroids are symptomatic, they can show as heavy or prolonged menstruation, pelvic pressure or pain, and/or frequent urination. These symptoms can lead to surgery.
Based on data the FDA released in April 2014, 1 in 350 women who undergo a hysterectomy or a myomectomy to treat uterine fibroids has an unsuspected uterine sarcoma, a type of uterine cancer. When a power morcellator is used on this tissue the procedure could potentially spread cancerous cells throughout the abdomen and pelvis. This significantly decreases the patient’s likelihood for long-term survival.
FDA Warnings Against Use of Power Morcellators
In April 2014, the FDA cautioned against their prior approval for using power morcellators in uterine surgeries.
Then, in November 2014, the FDA further updated this warning, announcing an Immediately in Effect (IIE) guidance. The IIE guidance included a boxed warning on power morcellators’ link to spreading cancer, and that this risk must be shared with patients considering surgery using these devices. The IIE guidance also included two scenarios for which power morcellators should not be used:
- The removal of uterine tissue suspected of fibroids in patients who are peri- or postmenopausal, or candidates for removing tissue intact via the vagina or mini-laparotomy incision, and
- Gynecologic surgery in which the tissue to be morcellated is known or suspected of being cancerous.
Other Adverse Effects of Morcellation
In addition to the possibility of spreading cancer, power morcellators can cause a number of side affects and adverse reactions. Many of these effects may come as a result of any type of surgery, even ones that are described as “minimally invasive,” as morcellation often is.
Power Morcellator Lawsuits
Several individual lawsuits and a multi-district litigation (MDL) have been brought against manufacturers of power morcellators.
Power Morcellator Manufacturers
Several American and international companies manufacture power morcellators. In response to the April 2014 FDA warnings, Johnson & Johnson immediately suspended sales for their power morcellators worldwide.
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