I want to update you on a story I published in May on the use of power morcellators to remove fibroid tumors and perform hysterectomies. Recently, the FDA held two days of hearings to gather evidence and opinion on the practice of using these surgical tools. The hearings featured experts, victims and FDA advisers, all weighing in on the use of morcellators, which can unintentionally spread undetected, potentially deadly cancer.
There were many opinions and unanswered questions, but the only conclusion was that more research is needed. The FDA has not indicated when it will rule, but it issued a warning in April, “urging doctors to stop performing the procedure in uterine surgeries.” It has suggested stronger guidelines for doctors on informing patients of the surgery and the risks involved.
One consideration is a “Black Box” warning, the most severe warning the FDA can issue, but some gynecologists, and victims, don’t consider that strong enough. Roughly 1 in 350 women who have a hysterectomy or fibroid removal have an undetected sarcoma—a deadly cancer that is spread throughout the body by the tiny blades contained in the morcellator. The question becomes how much risk is acceptable?
The power morcellator is used when the mass targeted for removal is too large to be safely removed without traditional surgery. It is a less invasive procedure and presents fewer health risks to women who may be obese or have other significant health issues. But, the resulting chance of developing cancer is too significant to dismiss.
“Some large physicians groups said that the device remains effective and beneficial for many women. The American Congress of Obstetricians and Gynecologists and the AAGL, an association of gynecologists specializing in minimally invasive surgery, argued that a ban would deny women minimally invasive treatment that reduces the risks of open surgery, particularly for obese patients. Jubilee Brown, a gynecological oncologist and an AAGL spokeswoman, said there is no ‘perfect scenario where you can exclude all risk,’ but that until there was “sufficient evidence” on the risks of power morcellation, there should be no ban.” (Wash. Post, 7/9/14)
Ben Fisher, FDA division director for reproductive, gastro-renal and urological devices in the office of device evaluation acknowledges the significant health risks. Yes, increased awareness of the risks will help women make an informed choice, but if the medical profession is unable to reach an appropriate conclusion there will still be women facing a surgical procedure that could result in a devastating cancer.
There are doctors who will continue to use the power morcellator. For the latter group, hopefully there will be more informed conversations with patients before performing these kinds of surgeries. Research is being conducted at a number of hospitals to determine whether an inflated bag, used to contain the uterus before cutting starts, will effectively keep cancer particles from being released into the body. The effectiveness of this procedure is yet to be verified. If you or a loved one is having one of these surgeries, ask a lot of questions about the risks and any safeguards employed.