The US Food and Drug Administration issued stringent new warnings Monday against the use of a medical power tool to pulverize uteruses or fibroid growths amid concerns the device could spread hidden cancers.
But the agency stopped short of banning the tool, known as a morcellator, prompting criticism from a prominent Boston surgeon who first sounded the alarm about the device’s dangers last year after his wife was diagnosed with end-stage uterine cancer following morcellation at Brigham and Women’s Hospital.
While manufacturers must now include a boxed warning on the device stating that morcellators “may spread cancer and decrease the long-term survival of patients,” the surgeon, Dr. Hooman Noorchashm, who recently left the Brigham for Thomas Jefferson University Hospital in Philadelphia, said his wife’s cancer “would still have been morcellated under the new guidelines.”
The FDA recommended against using the device in “the majority of women with fibroids,” including those who are at or past the point of menopause, and those who are able to have their uterus removed vaginally or through a small incision.
The new guidance will probably result in further curtailing of the procedure, which has fallen out of favor over the past year. Many Boston-area hospitals, including the Brigham, Boston Medical Center, and Tufts Medical Center, banned surgeons from using morcellators after the FDA issued a safety advisory in April.
Massachusetts General Hospital and the Brigham had been allowing the procedure sparingly in a research setting, using a new technique in which the uterus is placed in an inflated bag before it is morcellated. But that research has been halted after Monday’s FDA announcement.
“Essentially, we’re stopping it until we get more information,” said Dr. Isaac Schiff, chief of obstetrics-gynecology at Mass. General. “We need to digest the new guidelines and share them with patients to provide proper informed consent if they wish to be part of a study.”
The FDA estimates that 1 in 350 women who have fibroids removed through any surgical procedure will be found to have a previously undetected uterine cancer, and the risk of these cancers rises with age.
More than two dozen reports of cancer spread by the morcellator device have been filed with the FDA since last December.
In deciding not to remove the device from the market, the agency said it wanted to preserve its use in the small percentage of cases in which benefits outweigh risks. Younger women with large fibroids who wish to remain fertile, for example, might need to have those fibroids morcellated.
But doctors need to inform women about the risk that the device could spread undiagnosed cancers, the FDA guidance stated.
“The FDA’s decision today is based on what we believe is best for patients,’’ Dr. William Maisel, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health, said during a media briefing.
Until recently, the power morcellator was used on an estimated 50,000 American women each year to grind up and remove giant fibroids or an enlarged uterus through tiny incisions. Studies suggest this leads to fewer infections, shorter hospital stays, and faster recuperation than traditional hysterectomies, which involve a much larger incision.
For those reasons, the American College of Obstetricians and Gynecologists has lobbied to keep morcellators on the market to be used in women deemed at “low-risk” for a hidden cancer.
“We are pleased that the FDA’s action takes steps to enhance patient safety while allowing the appropriate use of power morcellation in gynecologic surgery for select women,” said Dr. Hal Lawrence, executive vice president of the confederation of obstetrician-gynecologists.
Johnson & Johnson, the biggest manufacturer of morcellators, decided to pull its device from the market a few months ago, though other makers remain.
During an FDA hearing in the summer, Noorchashm; his wife, Amy Reed; and other affected patients and family members called for a ban. Reed, a 41-year-old anesthesiologist and mother of six, criticized gynecologists for seeing cases similar to hers without reporting them to the FDA.
Reed’s stage 4 cancer is in remission, and she plans to take a position at the Hospital of the University of Pennsylvania in January. Noorchashm said the couple has not decided whether to file a lawsuit against the Brigham.
He called the FDA’s new guidance a “massive failure” of the federal government. “They’re leaving the door open for someone’s wife or someone’s daughter to get killed from an avoidable technique,” he said.