No agreement on whether FDA should ban hysterectomy tool
SILVER SPRING, Md. — A panel of experts reviewing the safety of a controversial cutting device used to perform minimally invasive hysterectomies could not agree Friday on whether the government should withdraw the device from the market.
The group of advisers to the US Food and Drug Administration did agree that surgeons could not eliminate the chance that in rare cases, use of the power morcellator device could spread hidden cancers. And they said women who have surgery using the device should be informed of the risk and sign a form acknowledging that they understand that risk.
But while some said the morcellator should not be banned because it provided benefits for certain women, others stated that they wanted it scrapped.
The FDA has already discouraged surgeons from using the device, in a safety advisory issued in April. The agency will now weigh the panel’s advice and could decide to force morcellators off the market or allow them to remain, possibly with a warning label spelling out the risks and whether doctors should avoid using the device in certain women.
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 laparoscopically through tiny incisions. Studies suggest this leads to fewer infections, shorter hospital stays, and a faster recuperation time than traditional hysterectomies, which involve a much larger incision.
The procedure is not performed on women with diagnosed cancers, but in a small number of cases, women have undetected tumors, which can be scattered by the device. This risk was thought be minuscule until the last few years, when several studies suggested that undiagnosed cancers might be more common in women undergoing morcellation.
“I think there was consensus in that we have so many questions and incomplete answers” about the safety of the device, panel member Dr. Michael Neuman of Michigan Technological University Center said in an interview after the meeting.
The issue drew increased scrutiny late last year after a Brigham and Women’s hospital surgeon launched an online petition and letter-writing campaign about his wife Amy Reed’s undetected cancer being spread by morcellation during a routine hysterectomy at the hospital. It was the second such case in short succession at the Brigham.
Many Boston-area hospitals, including the Brigham, Boston Medical Center, Tufts Medical Center, and Massachusetts General Hospital, banned the use of morcellators after the FDA issued its safety advisory.
Use of the device during hysterectomies has fallen sharply since then.
After reviewing the latest research, the FDA estimated that as many as 1 in 350 women undergoing hysterectomies have hidden uterine cancers and that 1 in 500 have a particularly deadly kind called leiomyosarcoma, the same kind Reed has. Patients who had such cancers morcellated wound up with a worse prognosis 25 to 65 percent of the time, the FDA estimated.
Before weighing in with their opinions, the panel listened to two days of testimony by FDA experts, cancer specialists, and industry groups, as well as emotional testimony from more than a dozen women and family members of those who died from cancers after undergoing morcellation.
Many of these patients and relatives said their doctors never discussed the possibility — rare as it was — that the use of a morcellator could cause hidden tumors to spread.
Reed, a 41-year-old anesthesiologist and mother of six, criticized gynecologists for seeing cases similar to hers without reporting them to the FDA. In his testimony, her husband, Dr. Hooman Noorchashm, demanded a ban on morcellators, saying their use leaves too many women with early-stage cancers vulnerable to developing stage 4 disease.
Some gynecological leaders, however, fear that women with large benign fibroids — a far larger group than those with hidden cancers — may be forced to undergo a more invasive hysterectomy if their uterus or fibroids are too large to be removed with other minimally-invasive procedures, such as through the vagina.
“Patients who are obese, have diabetes, or vascular diseases like lupus have underlying issues that would make a major abdominal surgery much riskier for them,” said Dr. Hal Lawrence, executive vice president and chief executive of the American College of Obstetricians and Gynecologists. They may be more likely to experience blood clots, internal bleeding, or life-threatening infections.
The college, a medical society that represents obstetricians-gynecologists, recommended in May that doctors still offer morcellation as an option for women deemed to be at low-risk of cancer while fully explaining the potential risks of spreading a hidden cancer. “We’re trying to say don’t abandon morcellation, but let’s be more selective about who gets it,” Lawrence said.
While no imaging test or biopsy procedure can tell doctors for certain whether cancer is present before a hysterectomy, certain woman are at higher risk — such as those taking the breast cancer drug tamoxifen and those who are post-menopausal with symptomatic fibroids. They should avoid morcellation, according to Lawrence.
Dr. Isaac Schiff, chief of obstetrics-gynecology at Massachusetts General Hospital, said in a phone interview he was also against an “outright ban” but preferred a moratorium on the procedure “until we have a safer way of doing it.”
Dr. Keith Isaacson, a gynecologist at Newton Wellesley Hospital who served on the panel, said surgeons there recently launched a study to perform morcellation in a research setting using a new technique in which the uterus is placed in an inflated bag before it is morcellated. Inflating the bag keeps the power tool from cutting the bag and also from injuring vital organs — both problems seen when the bags aren’t inflated.
Mass. General also plans to participate in the study.
Some of the FDA advisory panel expressed concerns about the bag being technically difficult for surgeons to use and questioned whether the new inflated bag was better than the older version.
Dr. Tony Shibley, a Minnesota surgeon who developed the technique using the inflatable bag in 2011, testified that more than 200 patients had morcellation using the inflatable bag with no complications.