The use of power morcellators, devices that dice up and vacuum out tissue to ease removal through laparoscopic incisions, has become commonplace during laparoscopic hysterectomy and myomectomy (removal of fibroid tumors) since their approval in 1995. But once in a while such patients will have an unsuspected malignant tumor, a leiomyosarcoma, hidden in the abdominal cavity. Some experts have said that power morcellation has the potential of turning early-stage disease into a stage IV cancer; when a leiomyosarcoma is accidentally morcellated, malignant tissue can be sprayed around the cavity, greatly facilitating metastasis and decreasing the chances of survival.
Since late last fall, a very public campaign against uterine power morcellation has been waged by Amy Reed, an anesthesiologist, and her husband, Hooman Noorchashm, a cardiothoracic surgeon, spurring an investigation by the Food and Drug Administration (FDA). According to media reports and the couple's online petition, Reed had uterine fibroids and underwent a hysterectomy involving power morcellation in October 2013. After the procedure, a biopsy revealed a previously unsuspected sarcoma. She has since undergone the removal of several organs, as well as aggressive chemotherapy for stage IV cancer, and the couple blames the procedure for the spread of her disease.
Leiomyosarcomas were once thought to be rare, affecting about one out of 10,000 women undergoing hysterectomy or myomectomy, but that rate has recently been revised to about one in 350. On April 17, the FDA issued a safety communication regarding the use of laparoscopic uterine power morcellation in hysterectomy and myomectomy, warning health care professionals, medical facilities, and patients-as well as manufacturers of laparoscopic surgery equipment-of the potential danger of power morcellation. Some critics, including Noorchashm, have said the FDA's warning doesn't go far enough and that power morcellation should be banned altogether.
Power morcellation has been favored because laparoscopic procedures, with their smaller incisions, are associated with much shorter postoperative recovery times and fewer complications such as infection. Although the risk that cancer can be spread through morcellation has been discussed for years, many experts believed the benefits of the procedure outweighed the risks. In light of the revised frequency data, that is no longer the case.
A major problem is that uterine sarcoma is difficult to detect in preoperative screenings. "There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," said William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in an April 17 news release (http://1.usa.gov/QrUIg4).
In light of the risks, some medical institutions have required surgeons to use a specimen bag to contain the tissue during power morcellation. The FDA has stated that the effectiveness and safety of the specimen bag requires further investigation, and are among the matters to be discussed in a planned public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee.
In the meantime, health care providers are urged to consider all available treatment options for women with uterine fibroids and to thoroughly discuss the benefits and risks of all treatments with patients-including the risk of spreading an unsuspected cancer and significantly worsening their prognosis in the event of a malignancy.-Laura Wallis