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FDA Pushes for Warning on Power Morcellators, Informed Consent

Two male doctors operating on patient

Members of a specially formed Food and Drug Administration panel say there is not enough evidence to prove using power morcellators to remove uterine fibroids does not increase the risk of spreading undetected cancer – a risk that may be more common than previously thought. During a recent two-day meeting, the FDA health advisors concluded that doctors should make their patients more aware of the risk of accidentally spreading uterine cancer when power morcellators grind up tissue during surgeries. The meeting followed the FDA's April safety communication discouraging the use of the devices. While the panel of obstetrics and gynecology experts did not take a formal vote, it suggested adding a serious warning to power morcellators’ product packaging or reclassifying the tools as high risk, class III devices. If the products are reclassified, manufacturers would have to test devices for safety and effectiveness and provide proof to the FDA before selling them. Surgeons use the electric devices to grind up tissue and remove it through a small incision, a minimally invasive procedure that means less blood loss and quicker recovery time for patients. Now there are concerns that the cancer risks outweigh the benefits. In shredding fibroids and other tissue, morcellation spreads bits of the tissue to other organs and parts of the abdomen. If an undetected cancer is present, the morcellators can spread cancer cells to other parts of the pelvic and abdominal area. Research suggests that 1 in 500 women may also carry a particularly deadly uterine cancer called leiomyosarcoma. Women who want to have fibroids removed undergo pre-surgical testing for cancer. They must be cancer-free to be eligible for a procedure that involves power morcellators. Sometimes, however, cancer can be present but not detected by pre-operative tests. Cancerous tissues and normal fibroids can at times be impossible to differentiate from one another. An estimated 50,000 women a year in the United States undergo surgery for fibroids or hysterectomies in which doctors use power morcellators. Colleen Daley lost her sister Patricia to leiomyosarcoma that spread after morcellation treatment. She was at the panel meeting along with other cancer patients and family members, reported ABC News. They urged the FDA to ban the devices for fibroid removal. "Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?" Daley asked. The agency made no promises but said it may consider a ban. The cancer risk has led to a growing number of women or surviving family members to seek restitution in court.

Reducing the Risk

Experts had estimated that 1 in 7,000 women may be at risk of developing cancer. Now researchers say the risk is closer to 1 in 350. The FDA panel also asked experts for suggestions on how to lessen the risk. Some doctors use small bags attached to the device to gather up the shredded tissue so it does not spread in the body. According to the panel, there is no proof that this technique prevents the spread of tissue – or cancer. At this point, the FDA doesn’t really have enough information to take proper action. "I think there was consensus in that we have so many questions and incomplete answers," Dr. Michael Neuman of Michigan Technological University Center told The Boston Globe. Neuman was one of the doctors on the panel. Some hospitals and doctors are taking matters into their own hands. For instance, some well-known medical centers in the Boston area decided to ban the devices after the FDA's safety communication in April. These include Brigham and Women's Hospital, Boston Medical Center, Tufts Medical Center and Massachusetts General Hospital.

Informed Consent

The only thing the panel agreed on was that women should provide informed consent before the surgery. The FDA said in a statement that women "should sign a written consent form stating they understand the serious risks of laparoscopic power morcellation." But many of the women and families who attended FDA panel meeting said doctors never discussed the possibility of new or upstaged cancer because of the procedure because it was rare. In addition, some doctors still advocate for the use of these devices. “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,” Dr. Hal Lawrence told the Boston Globe. Lawrence is executive vice president and chief executive officer of the American College of Obstetricians and Gynecologists. With a lack of proper data and doctors on both sides of the issue, any status change for morcellators by the FDA and any change in regulation is likely to take some time.