FDA Recommendations on Fibroid Surgical Tool Are 'Irresponsible,' Leading Physicians Say

Surgeons make an incision while performing laparoscopic surgery. Lucy Nicholson/Reuters

A group of physicians in gynecology and related specialties are calling on the U.S. Food and Drug Administration (FDA) to reverse its stance severely limiting the use of a device for minimally invasive surgery to treat uterine fibroids for nearly all women.

On Monday, 48 physicians in the fields of gynecology, oncology and surgical oncology, along with women's health advocates, sent an open letter to the FDA, urging officials to rescind its ruling that prevents the use of power morcellators, which have been linked to leiomyosarcoma (LMS), a rare form of female cancer.

Additionally, the journal Obstetrics & Gynecology on Tuesday published a related article online by members of the expert group, self-identified as the Leiomyoma Morcellation Study Group.

In September 2014, The Wall Street Journal began to investigate the device's safety in a series of articles, prompted by the story of Amy Reed, a woman who underwent minimally invasive surgery to remove fibroids. Reed's surgeon used a power morcellator in the procedure, which caused the malignant tissue from her fibroids to spread elsewhere and develop into LMS. She launched a campaign to end the use of the device, and the story set off a firestorm of reaction and prompted federal officials at the FBI and FDA to conduct an investigation into the device's safety, while Johnson & Johnson, the device's largest manufacturer, halted sales of the device.

Some health insurance companies began refusing to pay for use of the device, and physicians were left with no other option than to stop using power morcellators in the surgical procedure. By November, the FDA had issued a high-level official warning that the tool shouldn't be used on most women.

The Leiomyoma Morcellation Study Group argues that the FDA's decision was based on an inaccurate analysis of research and clinical data on the risks associated with the device. The analysis led the agency to conclude that 1 in every 458 women who undergo fibroid surgery with power morcellation develops LMS. But the group says the calculations were highly inaccurate since the FDA didn't include research with findings that power morcellators are not associated with cancer risk.

In addition, the FDA included cases of LMS that do not meet the clinical criteria for the disease. The group says that when you add in that missing research and take out the inaccurately categorized cases, the risk for LMS related to power morcellation would be approximately 1 in 1,550, or 0.064 percent. Additionally, the group says some newer research shows the risk is even smaller: around 0.051 percent, or 1 in 1,960.

"The FDA did a really bad job of analyzing this data. The recommendations are irresponsible, and it's really a disservice to women," says Dr. William Parker, lead author on the journal article and director of minimally invasive gynecology surgery at the University of California, Los Angeles, Medical Center in Santa Monica. "Every procedure has risk and benefits. Our feeling is we need to know the right risks."

The American College of Obstetrics and Gynecology issued a statement on Tuesday in support of the group's efforts: "Without question, morcellation of an undiagnosed sarcoma can disseminate malignant tissue. However, by allowing some women to avoid the higher morbidity and mortality associated with open abdominal surgery, morcellation can also save lives."

Uterine fibroids are growths that can develop in the muscle tissue of the uterus. The condition is very common; estimates from the National Institutes of Health suggest 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids at some point in their lifetime. Most are benign and don't cause any symptoms. However, for some women fibroids can cause extreme discomfort, with symptoms including heavy bleeding, pelvic pressure and urinary problems. In these cases physicians recommend removing fibroids.

Uterine fibroids can grow as large as a grapefruit, which makes them difficult to remove. A power morcellator helps solve the problem and makes minimally invasive surgery possible by allowing a physician to cut up the fibroids into pieces so they can be removed laparoscopically through much smaller incisions.

Each year in the U.S., approximately 210,000 women undergo hysterectomies as a result of the condition, and 50,000 receive myomectomies, or surgical fibroid removal. Surgeons perform the procedure laparoscopically to reduce the risk for potential complications—such as hemorrhaging and infection—and speed up the recovery time.

"I would say it should not be a banned procedure but [should] still be allowed in select cases, [on] patients that have had a thorough preoperative evaluation," says Dr. Leslie Bradford, an assistant professor of obstetrics and gynecology at the University of Massachusetts Medical School. Bradford was not involved in the physician group's efforts to petition the FDA. "It's like any other tool when used by experienced physicians," she says.

Bradford adds that the FDA's decision has forced some of her colleagues to suggest patients undergo a more invasive hysterectomy through the abdomen—which has a higher risk for complications than laparoscopic surgery and, of course, means that a woman cannot become pregnant.

Rather than ban the device outright, the group of physicians recommends the FDA create stringent guidelines that help determine which patients are good candidates for laparoscopic surgery in which a power morcellator is used. This includes limiting the device's use in older post-menopausal women who have a greater risk for LMS. Though not 100 percent reliable, presurgery screening measures can also improve safety, including an endometrial biopsy, which can detect LMS before surgery, or an MRI to detect certain fibroid abnormalities.

Additionally, more care should be taken to ensure that fibroid tissue fragments are not left in the pelvis or abdominal cavities that could potentially implant and grow as cancerous cells. The group also urges the FDA to fund additional research on the safety and proper use of the device.