J&J Stops Selling Device Used in Fibroid Surgery Due to Cancer RiskMay 1, 2014
Johnson & Johnson has halted sales of a device used in fibroid surgery due to concerns that it could spread a rare but deadly cancer, the Wall Street Journal reported. World-wide sale, distribution and promotion of the tools, called power morcellators, will be halted. WSJ reported that in a letter to customers, J&J said it was waiting for the U.S. Food and Drug Administration (FDA) and the medical community to further determine the role of the devices in fibroid surgery.
Power morcellators use long, tube-shaped blades to cut away at tissue by dividing it into smaller pieces. These devices are often used in laparoscopic, or minimally invasive, procedures to remove tissue through small incisions.
The FDA recently advised against using power morcellators to remove fibroids due to a risk of spreading an often-hidden cancer. In an April 17th Safety Alert, the agency stated that "When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus." While the agency did not remove the devices from the market, it said that health care providers and patients should consider other methods of treating symptomatic uterine fibroids.
According to the FDA, uterine fibroids are noncancerous growths in the muscular tissue of the uterus. While the majority of women who develop fibroids exhibit few or no symptoms, others will experience symptoms such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination. In these cases, a number of women undergo hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids).
The FDA has emphasized that an estimated 1 in 350 women undergoing hysterectomy or myomectomy to treat fibroids has an undetected uterine sarcoma. The agency stated that "If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival."
According to Law360, Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, pointed out that there is “no reliable way to determine if a uterine fibroid is cancerous prior to removal,” and that is why the agency is discouraging the use of power morcellators for laparoscopic hysterectomy and myomectomy.
Women should discuss all the available options for treating fibroids and weigh the pros and cons of each, the FDA said. The agency said that if a laparoscopic hysterectomy or myomectomy is advised, then women should ask if power morcellation will be used.
The FDA asked manufacturers to review the labeling on power morcellators used during laparoscopic hysterectomy or myomectomy to ensure that it accurately reflects the risks. An Obstetrics and Gynecological Medical Device Advisory Committee public meeting will be held to discuss the issue, including whether or not there should be a "boxed warning" related to the risk of spreading cancer.