Proponents of a surgical tool used for a common uterine procedure will argue at a hearing next month that the device's benefits—facilitating a less-invasive operation—make it too important to take it off the market.
But opponents say the device's cancer-spreading risks make it too dangerous, especially for an elective procedure for which there are clear alternatives.
The debate about the tool will come to a head at the Washington-area hearing, where a Food and Drug Administration advisory panel will weigh whether to ban the device—a drastic move the agency has made only once before.
In April, the FDA discouraged gynecologists from using the tool, called a power morcellator, estimating that 1 in 350 women undergoing the procedure have a hidden cancer that can be spread by the instrument.
Morcellators are used in an estimated 50,000 minimally invasive hysterectomies a year in the U.S. to remove often-painful growths called fibroids. The tools slice up the tissue so it can be extracted through tiny incisions.
"There is a real person attached to that number, that 1 in 350 number, and we don't want other women to meet the same fate," said Margaret Jacobson, a doctor and hospice director in Bellingham, Wash., who plans to argue for a ban at the FDA meeting.
Her sister, lawyer Elizabeth Jacobson, died in January 2013 at age 55 after a morcellator was used during her hysterectomy, records show. She had been diagnosed with fibroids but turned out to have cancer.
Others are calling for a more nuanced approach, highlighting the balancing act the FDA faces.
Gynecology groups plan to argue that with more stringent patient selection by doctors, the instrument remains a valuable tool. For instance, women under 35 have an extremely low chance of having uterine sarcoma masquerading as a fibroid, said Hal Lawrence, executive vice president of the American College of Obstetricians and Gynecologists, which puts the overall risk of hidden sarcoma at 1 in 500 women undergoing surgery to remove fibroids.
"It's critical that we not severely restrict treatment options for women who would benefit from minimally invasive gynecology surgery while minimizing the risk for the small number of women who may have an occult or hidden cancer," he said.
Banning an approved medical device involves a protracted regulatory process and is considered a radical move, said lawyers for device makers. The FDA has done it only once, for artificial hair implants.
Nearly all recalls are voluntarily done by manufacturers, though often in response to behind-the-scenes pressure from the agency.
The FDA cleared power morcellators for sale in the 1990s through an expedited process that allows devices similar to ones already on the market to be approved without clinical trials to show safety and effectiveness.
In addition to removing morcellators from the market, as some want, the FDA could take other steps. It said it also will consider reclassifying morcellators as high risk instead of moderate risk, a rare move that would require makers of existing devices to conduct trials to keep their products on the market.
"It could easily just kill the device," said Jeffrey K. Shapiro, a director at Hyman, Phelps & McNamara PC, a Washington, D.C., law firm that represents device manufacturers. Some of these companies wouldn't find it economically worthwhile to do trials, he said.
Johnson & Johnson, JNJ -0.51% by far the largest U.S. manufacturer of power morcellators, halted sales of the device globally in April and says it is awaiting further guidance from the FDA.
The FDA's Obstetrics and Gynecology Devices Panel, which is scheduled to hold the hearing July 10-11, also will explore whether containment bags—used in the body to prevent the spread of harmful tissue—would reduce the risk of spreading cancer and whether to require enhanced warning labels on morcellators.
The FDA isn't obligated to follow the advice of the panel but gives heavy weight to its guidance. "The FDA's primary concern as it considers the continued use of these devices is the safety and well-being of patients," said agency spokeswoman Jennifer Rodriguez.
Underscoring the debate are questions about whether the device is necessary.
Morcellators are most often used in a procedure that spares the cervix, a technique that has been touted as offering sexual and urinary-function benefits. Although that theory has been largely dismissed, the technique is still easier for most physicians to perform than other minimally invasive approaches.
Doctors say that removing the cervix so the uterus can be brought through the vagina—which the main gynecology group considers the preferred method—is particularly challenging.
There are alternatives for fibroid removal, including traditional open surgery—still the most common type of hysterectomy—and other less-invasive techniques, including vaginal surgery and the mini-laparotomy, in which the tissue typically is removed through a small incision above the pubic bone. There also are nonsurgical options.
Some in the gynecological field worry that without morcellators, doctors who lack experience with other less-invasive techniques will turn to open abdominal surgeries, which are linked to bigger scars, longer recoveries and more complications, said Ray Wertheim, director of minimally invasive gynecology at Inova Fair Oaks Hospital in Fairfax, Va.
Dr. Wertheim, who was on a task force to write morcellator guidelines for his specialty's medical society, said the solution is more training for gynecologists. "That's the fine line we're walking here," said Dr. Wertheim, who doesn't use a morcellator. He supports its use only in a containment bag and said he wasn't speaking on behalf of the society.
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