The U.S. Food and Drug Administration recently issued stringent warnings about morcellators, medical power tools used to pulverize fibroid growths, as there are concerns that the devices could be causing cancers to spread in patients. The agency, however, stopped short of banning the devices, which has triggered some harsh criticism.
Thought to be a less invasive approach that offers faster recovery times, doctors use a laparoscopic morcellator with a blade to cut into and remove fibroids in a myomectomy, or to remove the uterus in pieces through tiny incisions, via the morcellator’s hollow tube. Sometimes though, pieces of tissue get left behind. If they’re malignant pieces of cancerous fibroids, morcellation causes the cancer to then spread.
Since last December, over two dozen reports of cancer spread as a result of morcellation have been filed with the FDA.
“We believe that in the vast majority of women, the procedure should not be performed,” said Dr. William Maisel, the chief scientist and deputy director for science of the FDA’s Center for Devices and Radiological Health.
Now, manufacturers must include a boxed warning on the device saying that they “may spread cancer and decrease the long-term survival of patients.”
However, prominent Boston-based surgeon Dr. Hooman Noorchashm said that his wife’s cancer would still have been morecellated under the new guidelines that have been set. Last year, his wife was diagnosed with end-stage uterine cancer after she underwent morcellation.
The FDA said that it did not entirely ban morcellators because it wanted to preserve its use in the small percentage of cases in which the benefits of morcellation outweighed the risks. For example, younger women with large fibroids, who have a lower risk of having such cancers, and who wish to remain fertile, might need to have their fibroids morcellated. They just need to be informed of the risk that the device could inadvertently spread undiagnosed cancers.
According to Dr. Maisel, “The FDA’s decision today is based on what we believe is best for patients.”