FDA Warns of Morcellation Cancer Risk with Hysterectomy, Myomectomy
Federal health regulators are discouraging doctors from using power morcellation in hysterectomy or myomectomy procedures, due to the risk that the laparoscopic uterine fibroid procedure may cause the spread of aggressive cancer in women.
Amid mounting concerns in the medical community about the risk of aggressive cancer from hysterectomy morcellation surgery, the FDA warned this week that doctors should avoid performing the popular, minimally invasive uterine surgery, which an estimated 50,000 women have undergone each year.
In a safety communication issued on April 17, the FDA indicated that laparoscopic power morcellation used during surgery to remove the uterus (hysterectomy) or remove uterine fibroids (myomectomy) may cause the spread of cancerous tissue within the abdomen and pelvis, reducing a woman’s likelihood of long-term survival.
The FDA also released a summary and key findings (PDF) of an investigation it has conducted into power morcellation, which suggested that about 1 out of every 350 women undergoing the procedures may have unsuspected uterine sarcoma, which is a type of uterine cancer that may remain contained without the procedure.
Morcellation during a laparoscopic hysterectomy or myomectomy involves the use of an electric tissue-cutting device to allow the doctor to remove uterine tissue through a small incision.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA warned. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy and myomectomy for uterine fibroids.”
The FDA reviewed 18 studies, both published and unpublished, in scientific literature and looked at data on patients operated on from 1980 to 2011. The agency determined that 1 out of every 352 women who underwent hysterectomy or myomectomy for presumed benign leiomyoma had an undiagnosed case of uterine sarcoma. One out of every 498 women who underwent the procedures had undiagnosed leiomyosarcoma (LMS), both of which are forms of uterine cancer.
The agency says it will convene an outside panel of experts in obstetrics and gynecology to look at data and collected information on power morcellation during a public meeting. The agency has not released a date or location for that meeting as of yet.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.”
Recommendations to Doctors, Women
In the meantime, the FDA warns health care providers that they should never use laparoscopic uterine power morcellation in women with suspected or known uterine cancer. The agency also urges them to carefully consider all available treatment options for women with symptomatic uterine fibroids and to thoroughly discuss all the benefits and risks of the various procedures with their patients.
The agency notes that if even after that the health care provider and patient feel that power morcellation is still the best option they should inform the patient of the risks of spreading cancer and decreasing their chance of surviving uterine cancer. They should also be aware that some experts and medical institutions call for the use of a specimen bag during the procedure to keep uterine tissue contained and potentially prevent the spread of cancerous cells.
For women, the agency recommends they discuss all of their treatment options and specifically ask if power morcellation will be used during a laparoscopic hysterectomy or myomectomy. The FDA advised women that if they have already undergone the procedure, their tissue is usually tested for signs of cancer, and they should follow up with their physician, and ask questions if they have persistent or recurring symptoms.
About 500,000 women in the U.S. undergo hysterectomies each year, according to the FDA. The National Institute of Health (NIH) says that more than 200,000 of those are to remove uterine fibroids. About 50,000 of those operations involving power morcellation to remove fibroid tumors, according to FDA estimates.
“Most American women will develop fibroids at some point in their lives,” according to the NIH’s report on uterine fibroids. “One study found that, by age 50, 70 percent of whites and 80 percent of African Americans had fibroids. In many cases, fibroids are believed not to cause symptoms, and in such cases women may be unaware they have them.”
In cases where they do cause symptoms, they can lead to infertility, miscarriage, and early onset of labor, NIH reports.
Doctors’ Concerns Launch Investigation
The FDA’s determination came after a number of doctors, including one who underwent the procedure, pushed for a closer look at the use of power morcellators and whether women were being properly warned of the risks.
Concern began coming to a head over hysterectomy morcellation in December, when noted anesthesiologist Amy Reed found out that her own surgery increased the risk of spreading her case of leiomyoscarcoma. She was informed after the surgery that there was a 70% to 80% chance of the cancer spreading because of the morcellation surgery, leading Reed and her husband begin campaigning against the device. Reed became known for having treated the alleged Boston Marathon bomber at Beth Israel Deaconess Medical Center after he was injured during his capture last year.
Following concerns raised by Reed and her husband, Dr. Hoornan Noorchashm, a number of doctors wrote to the New England Journal of Medicine calling for a moratorium on the use of morcellation. Dr. Noorchashm is a surgeon at Brigham and Women’s Hospital. Since then, his hospital and a number of others have begun halting morcellator use during hysterectomies to review their health risks.
Dr. Noorchashm is leading a charge for a nationwide morcellator moratorium, including online petitions and letter-writing campaigns. He has stated that he is glad the FDA acted, but wished the agency had gone further to protect women, including forcing a power morcellator recall.
Last month, a hysterectomy morcellation cancer lawsuit was against the makers of power morcellators following the death of Donna Burkart, who died in February 2013 of metastatic LMS following a procedure at Reading Hospital. The complaint names Ethicon, Blue Endo and LiNA Medical as defendants, which are all manufacturers of power morcellators.
Following the FDA warnings, a number of women diagnosed with cancer following laparoscopic hysterectomy or uterine fibroid removal may now consider contacting lawyers to review whether they may be eligible for a lawsuit.