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FDA Advisory Panel Says Cancer Risk From Surgery Device Cannot Be Minimized

FDA Advisory Panel Says Cancer Risk From Surgery Device Cannot Be Minimized

July 14, 2014 — An FDA advisory panel on Friday said that there are no proven ways to use a common technique for hysterectomies and fibroid removal without risking the spread of malignant cancers to other parts of the body, the AP/Modern Healthcare reports.

FDA asked its advisory panel of obstetrics and gynecology experts to review the technique, called laparoscopic power morcellation, after concluding that it might present a higher risk of spreading undetected cancer than previously thought. The agency takes its panelists' recommendations into account when making regulatory decisions, but it has not announced a timeline for making a determination about the use of morcellation (AP/Modern Healthcare, 7/12).

Background

Laparoscopic power morcellation was developed as an alternative to invasive surgery for women with symptomatic uterine fibroids, which are responsible for about 40% of the 500,000 hysterectomies performed each year in the U.S. It uses a power device to grind uterine tissue so it can be removed through a tiny incision.

The technique has come under fire for its potential to spread a type of cancer -- known as a uterine sarcoma -- within the body.

In April, FDA issued a safety communication notice discouraging the use of the procedure. FDA in the notice said that uterine sarcoma affects about one in 350 women undergoing fibroid removal procedures and that laparoscopic power morcellation could significantly worsen the chances of long-term survival (Women's Health Policy Report, 5/12). The technique is used in about 50,000 procedures annually in the U.S. (Kamp, Wall Street Journal, 7/11).

Panel's Findings

FDA asked the advisory panel to evaluate whether there are ways to minimize the risk of spreading cancer during morcellation, such as using plastic specimen bags to collect tissue.

Although some surgeons are already using the bag technique, the panelists said it is unproven. "There's no evidence that the bags or any containment devices prevent the outcome we are trying to prevent," Craig Shriver, a surgical oncologist at Walter Reed Medical Center, said (AP/Modern Healthcare, 7/12).

The panel also said there is no reliable method for determining whether a woman has the cancer before the morcellation procedure (Wall Street Journal, 7/11).

The panel recommended that women who undergo laparoscopic power morcellation should have to sign a written consent form acknowledging that they understand the procedure's risks (AP/Modern Healthcare, 7/12).

According to the Wall Street Journal, some panelists seemed to support also requiring FDA's strongest warning -- known as a black box warning -- for morcellators, while others called for a complete ban (Wall Street Journal, 7/11). Cancer patients and their family members who spoke at the meeting also urged FDA to ban the device (Weintraub, USA Today, 7/11).

However, others said the procedure could still be useful. According to panelist and gynecologist Keith Isaacson, the tool may help young women who want to remain fertile. Meanwhile, a doctor providing testimony on behalf of the main trade group for minimally invasive gynecologists told the panel that prohibiting morcellators likely would lead more women to have more-invasive open surgery (Wall Street Journal, 7/11).