JON KAMP and JENNIFER LEVITZ, Wall Street Journal
April 17, 2014
“For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids,” the agency said in a safety communication posted on its website Thursday. Myomectomy is the removal of just fibroids.
“In general, the procedure should not be performed,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said Thursday at a media briefing.
If doctors do perform such procedures, the FDA said, they should advise patients of the cancer-spreading risk.
The safety alert was addressed to doctors, medical associations, hospitals, women, device manufacturers and advocacy groups. The FDA’s alert follows a series of Wall Street Journal articles, starting in December, which documented the risk of spreading cancer and a campaign by two Boston-area physicians to halt the procedures.
Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, developed advanced uterine cancer shortly after a routine hysterectomy in October. The hospital where she was treated, Brigham and Women’s Hospital, acknowledge that use of morcellation worsened her cancer.
The FDA began its review in December, “when some high-profile cases covered in the media came to our attention,” Dr. Maisel said.
The FDA’s alert triggered immediate action on Thursday. Dr. Isaac Schiff, the chief of the Department of Obstetrics & Gynecology at Massachusetts General Hospital, said, “I have asked our doctors to stop the procedure immediately until we have more information.”
The FDA’s move could change the way many women are treated for symptomatic fibroids, which are common but often painful growths that spur about 40% of the roughly half-million hysterectomies performed in the U.S. each year, by some estimates.
Morcellators, first introduced in the 1990s, have helped gynecologists perform about 50,000 of these procedures each year through tiny holes, rather than longer incisions that can lead to bigger scars and a longer recovery.
Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, and an advocate for stiffer medical device regulations, said the FDA’s statement should have a major impact. Going against the FDA’s recommendation could increase doctor’s liability if there are mishaps, she said.
“What surgeon is going to take the chance of using this device if they FDA has made such a strong warning?” she said. The FDA’s action “is going to save a lot of lives.”
Dr. Maisel said the clinical community has been aware of the risk of cancer since the advent of the procedure, although he said the rate of that risk is only now coming into focus. He also said it’s conceivable that some patients may believe the risks of alternative procedures outweigh the risks of laparoscopic surgery with morcellation. They should be explicitly told of the risks, he said.
With the issue gaining steam since December, gynecological societies had already been doing their own reviews of power morcellation. Commenting on the FDA move on Thursday, the American College of Obstetricians and Gynecologists said its own review, which includes an assessment of risks for various groups of patients, is ongoing. “We greatly appreciate the urgency behind the issue,” the group said.
Dr. Maisel said older women have a higher risk of having a hidden sarcoma than younger women.
Many gynecologists have argued there are other ways to perform these procedures without cutting up tissue in the open abdomen, including performing vaginal procedures or cutting tissue manually and inside protective bags.
Gynecologists have acknowledged they seldom used these bags during hysterectomies and fibroid procedures previously. But a number of top hospitals, including Brigham and Women’s and Massachusetts General, have recently told their doctors to only morcellate inside such bags for added protection.
The FDA noted these changes, although Dr. Maisel also said bags have some downside, including obscuring surgeons’ view during procedures, and are “not a panacea.”
The FDA on Thursday said it will convene a public advisory committee meeting this summer to discuss whether such bags can enhance the effective use of morcellators, amid other issues. The agency instructed manufacturers “to review their current product labeling for accurate risk information for patients and providers.”
The FDA recommended “routine follow-up” with physicians for women who have already had hysterectomies or myomectomies, don’t have symptoms and were told post-surgery tests were normal. Tissue is commonly checked for cancer afterward. But women with “persistent or recurrent symptoms or questions should consult their health-care provider,” the agency said.