Even though the U.S. Food and Drug Administration have warned that the use of laparoscopic morcellators can spread undetected cancer, specifically leiomyosarcoma, some doctors continue to use the device.
Morcellators are small blades that can be used in laparoscopic surgery to remove a uterus (hysterectomy) or fibroids (myomectomy). The device had become very popular because it breaks apart tissue so it can be removed from a small incision, offering a less invasive procedure with shorter recovery times and lower risk of infection compared to traditional abdominal surgeries.
The problem is that deadly sarcomas can masquerade as fibroids, and go undetected until they are removed and examined. Evidence is surfacing that when the morcellators are used on the sarcomas, it spreads the cancer and can worsen a patient’s long-term prognosis.
In mid-April, the U.S. Food and Drug Administration issued the following safety warning:
“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. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
A controversy now brews within the medical community about what the actual risks are and what alternatives might be safe. This also shows that while the FDA can regulate medical devices, it has no authority over how doctors practice medicine. At this point, unless the FDA chooses to ban the power morcellator, doctors are free to continue to choose to use it.
The Wall Street Journal reports that a segment of the gynecological professional community is defending the morcellator’s benefits. Most agree that in the past, its risks were not sufficiently acknowledged or explained to patients. However, now proponents argue that so long as patients are fully informed and doctors are aware of some adaptations that might lower risks even further, it should remain an option.
One director of a hospital obstetrics unit in New Jersey said he first thought the FDA had overreached, but he has since changed his mind. He now agrees that doctors should stop using the device until we know it can be used safely. He said what you do about it is – you stop. People want to fight back, but it’s not putting patients’ safety first. It’s not worth playing Russian roulette with the patient.