Morcellators or power morcellators are used during surgery to chop up chunks of tissue to make them easier to remove from the patient’s body during hysterectromy and myomectomy procedures. A vacuum is used to remove the pulverized tissue from the body, creating a surgical procedure that is minimally invasive for the patient.
Surgery utilizing a morcellator is performed through a two-centimeter incision, reducing the risk for surgical complications, cutting healing time, and making the procedure less painful because there are no cuts through the muscles of the abdomen.
Unfortunately, despite the decrease in risk associated with morcellator use, there is still a great deal of potential complications – many of which were unpredicted when the device became popular for gynecological surgeries.
Hystorectomies & Morcellators
Some women undergoing hysteretctomies or myomectomies with morcellators were later been diagnosed with aggressive late-stage cancer as a result of the procedure. This is because morcellation can cause cancerous tissue to spread into the abdomen. In most cases, morcellator surgery is used to treat fibroids, which may or may not be cancerous, but cannot be diagnosed with any certainty until after they are removed from the body, even with a pre-op cancer screening.
Women of all ages can develop uterine fibroids, but as much as 80 percent have them by middle age. Fibroids are the most common reason for hysterectomies. If cancer cells are present anywhere in a fibroid or the uterus when it is pulverized during the procedure, it’s easy for those cells to spread throughout the body during surgery.
It is the type of cancer that makes the diagnosis so difficult. A woman can have leiomyosarcoma or uterine sarcoma, which tends to mimic the appearance of benign fibroids, making them nearly impossible to prior to removal. If contained, the five-year survival rate is about 50 percent, but once these cancer cells spread, that rate drops to as low as four percent.
Safe Alternatives to Procedures Using Morcellators
In the United States, surgeons perform approximately 600,000 hysterectomies per year, half of which are done using minimally invasive techniques. Until recently the use of morcellation in these minimally invasive procedures was on the rise and at one time, approximately 10 to 12 percent of minimally invasive hysterectomies utilized a morcellator.
The remaining women underwent hysterectomies that were not performed with a morcellator device, which means there are still a good deal of surgeries performed safely, even minimally invasively, without morcellation.
Morcellator procedures were approved by the FDA in 1991 and reached the market through the 510(k) process. This means manufacturers, including Cook Medical, were not required to perform formal clinical trials for using morcellators in hysterectomies because they were similar to products on the market already.
FDA Issues Safety Notification Regarding Morcellators
The concern surrounding morcellator procedures intensified so much that the FDA finally intervened in the spring of 2014. The agency issued a safety communication discouraging surgeons from using power morcellators in the removal of uterine fibroids or complete hysterectomies due to the risk for spreading cancer cells.
According to the FDA, there was about a one in 350 chance of women undergoing surgery for uterine fibroids to have uterine sarcoma, but since there is no reliable way to know in advance of the procedure, the risk of using a morcellator is not considered worth the risk by many. Some hospitals have stopped using morcellator devices and Johnson & Johnson, one of the leading manufacturers of morcellators, suspended worldwide sales of their device.
There are still some surgeons who believe morcellators offer value and unless a ban is put in place by the FDA, they plan to continue using them. They believe in certain circumstances, there is little to no risk for the spread of cancer, or the risk is outweighed by the benefits of morcellation for that particular patient.