The Food and Drug Administration strengthened its warnings Monday against the use of a controversial uterine surgical technique, recommending that doctors avoid using laparoscopic power morcellators to remove uterine growths in the vast majority of women because of the risk of spreading hidden cancers.
The agency said it will ask manufacturers to place "boxed" warnings on the devices — the strongest type of labeling a product can have while remaining on the market. The warnings, which come seven months after the FDA first recommended against the widespread use of the procedure, would inform patients that using power morcellators to remove uterine growths could unwittingly spread cancer inside their bodies and decrease the odds of long-term survival.
"The recommendations we're making today, we believe, are in the best interest of patients," William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, told reporters Monday. "We believe the recommendations are appropriate and put appropriate restrictions on the use of laparoscopic power morcellation. We believe in the vast majority of women, the procedure should not be performed."
Power morcellation involves inserting a small electric device into the abdomen and slicing up tissue in order to remove it through a small incision. It has long been used to remove fibroid tumors from the uterus, or to remove the uterus itself, and is far less invasive than traditional abdominal operations.
But a growing number of researchers and clinicians have abandoned the procedure as evidence has shown that it can scatter cancerous cells throughout the body, making the disease more lethal and harder to treat than it would have been otherwise.
Some physicians perform the procedure using an "isolation bag" in an attempt to prevent the spread of tissues, but that method presents its own challenges and also can fail.
An analysis by the FDA this year estimated that 1 in 350 women who undergo morcellation have an unsuspected form of uterine cancer called uterine sarcoma. In April, the agency issued initial warnings about the procedure but did not try to ban either the practice or the dozens of FDA-approved devices used to perform it.
Hooman Noorchashm, a Boston cardiothoracic surgeon whose wife developed stage-four cancer after a supposedly routine procedure spread undetected tumor fragments throughout her abdomen, called Monday's action inadequate and indefensible.
"This is a massive, massive failure of federal regulation," said Noorchashm, who along with his wife, Amy Reed, has led a national campaign to ban the devices and their use in uterine fibroid surgery. "The evidence of harm is there. ... If they can't regulate something as clear-cut as this, then what are they there to do? Are they just there to protect the industry's interest?"
Noorchashm acknowledged that the use of the devices — and the associated risks — likely will decline because of the FDA's latest warnings. But allowing any risk to remain by permitting the use of the devices to continue is unwise, given the consequences, he said. "What are they going to say to the family of the next woman who gets cancer [because of this procedure]?" Noorchashm said. "A federal agency's role is to protect the people. That's not what happened here."
Meanwhile, the American College of Obstetricians and Gynecologists praised the FDA's approach, which said uterine fibroid surgery by morcellation might still be appropriate for some younger women who have a lower risk for cancer and want to maintain their ability to have children, as long as they are aware of the risks.
"We continue to believe that power morcellation has a role in gynecologic surgery," the group's chief executive, Hal C. Lawrence, said in a statement. "Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure."
Maisel said Monday that FDA officials "certainly recognize there are differing views on the safety" of the devices. He said the agency will continue to monitor scientific research, adverse event reports and input from doctors and patients, and that it could take more forceful actions in the future.