Aetna Inc. has announced that it will no longer cover routine use of the laparoscopic power morcellator, a surgical tool commonly used in fibroid surgery and hysterectomy.
Regulators have determined that the morcellator can spread hidden cancer in women. Aetna is the nation’s third largest health insurer, with 23 million members, and loss of their coverage is significant, the Wall Street Journal reports. An Aetna spokeswoman said the company will implement the new policy beginning May 15. Power morcellation will not be covered under most circumstances, the spokeswoman said.
Power morcellation is used in minimally invasive surgeries to cut bulky growths or the uterus into pieces so they can be removed through tiny incisions. But dangerous cancers can masquerade as benign fibroids and can be spread in the abdomen by a morcellator’s rapidly spinning blade, significantly lowering a woman’s long-term chance of survival, according to the WSJ.
According to Food and Drug Administration (FDA) estimates, one in 350 women having fibroid surgery has an undetected sarcoma. Until recently, the risk of hidden sarcomas was thought to be much smaller, somewhere between one in 500 and one in 10,000. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said there is “no reliable way” to determine if a uterine fibroid is cancerous prior to removal.
Last year the FDA warned of the power morcellator risk, using a new type of directive called “immediately in effect guidance.” The agency skipped the usual procedure of issuing a draft of the guidance and allowing time for public comments before the guidance becomes final, the New York Times reported. The April 2014 safety alert discouraged the use of morcellators in most circumstances and as a result, some manufacturers, including the Ethicon division of Johnson & Johnson, took their power morcellators off the market. But some hospitals and doctors continue to use the device. Proponents of the tool call for an approach that balances the risks and benefits. Gynecology groups plan to argue to the FDA that when appropriate patients are carefully selected, the morcellator remains a valuable tool, allowing for a less invasive surgery.
The FDA stopped short of a ban on power morcellators, as some have called for, but advised doctors against using them in most hysterectomies and fibroid surgery, according to the Times. The FDA also recommended label changes to warn of the cancer risk and of two specific instances in which morcellators should not be used. The agency said morcellators should be avoided in women who are at or near menopause or in patients whose tissue can be removed intact through the vagina or via a small abdominal incision. Morcellators should never be used, the FDA said, when the tissue is known or suspected to be cancerous.
Opponents say the risk of spreading cancer makes the device too dangerous, especially for elective fibroid procedures for which there are alternatives, according to the WSJ.
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