FDA Warns Uterine Morcellation in Hysterectomy and Myomectoy May Spread Undetected Cancer
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Laparoscopic power morcellators are medical devices that are used to for a number of laparoscopic surgeries, including surgeries to treat uterine fibroids. Uterine fibroid tumors are benign tumors that develop on the walls of the uterus. They are very common and most women will develop them at some point in their lives although many women will have no symptoms. For those women that do experience symptoms, uterine fibroids may cause pain, discomfort, a heavy or prolonged menstrual cycle and/or frequent urination.
To treat uterine fibroids doctors can remove the uterus (hysterectomy) or remove the uterine fibroids (myomectomy). Many doctors elect to perform these surgeries using a uterine morcellator. The morecellator is basically a power tool that grinds up the uterus and/or fibroids into small pieces that can be removed through small incisions in the abdomen. The purported benefit of the morcellator over traditional hysterectomy surgery is a faster recovery time and reduced risk of infection.
On April 17, 2014, the FDA issued a Safety Communication regarding the use of uterine morcellators in hysterectomy and myomectomy. The FDA found that based on its analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for treatment of uterine fibroid is found to have an unsuspected or hidden uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma, the deadliest form uterine sarcoma. When a uterine morcellator is used to perform these surgeries in women that have a hidden uterine sarcoma, the cancerous tissue in the uterus can spread within the abdominal area and the pelvic region leading to advanced stage uterine cancer and pre-mature death. The FDA concluded “based on currently available data, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
More than a year and a half before the FDA released its Safety Communication, a study conducted by doctors from Brigham & Women’s Hospital in Boston examined this issue. The authors concluded that the data suggests uterine morcellation carries a risk of disseminating cancerous tissue from the uterus leading to a much higher mortality rate than appreciated as of November 2012. In fact, the risk was far greater than the risk that was cited. This study was followed by other studies that provide further support for the FDA’s conclusion, including a study by researchers at Columbia University’s College of Physicians and Surgeons and researchers at the Dana Farber Cancer Institute.
Johnson & Johnson’s Ethicon division, the largest manufacturer of uterine morcellators, announced in April 2014 that it was suspending sales of the devices. This was followed by a recall of the devices by Johnson & Johnson in July 2014. On August 19, 2014, two New York Senators, Kristen Gillibrand and Charles E. Schumer, sent a letter to the FDA asking the FDA to request other manufacturers of uterine morcellation devices withdraw their devices from the market until additional risk assessments and patient and clinician education can be performed.
Numerous hospitals around the country have suspended the use of power morcellators in gynecologic surgeries. In Rochester, Rochester General Hospital suspended the use of uterine morcellators as did Unity Hospital. According to a March 23, 2014 article in the Democrat & Chronicle, the University of Rochester Medical Center has not suspended the use, but will require use of a containment bag when surgeons perform gynecologic surgeries using a morcellator.