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FDA discourages certain procedure to treat uterine fibroids

Friday April 18, 2014
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In a safety communication notice, the Food and Drug Administration discouraged the use of laparoscopic power morcellation for hysterectomy or myomectomy in women.

Based on an analysis of available data, the procedure poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus, according to the FDA.

Laparoscopic power morcellation is one of several available treatments for fibroids. It uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.

According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms — such as heavy or prolonged menstrual bleeding, pelvic pressure or pain and frequent urination — that might require medical or surgical therapy.

Based on an analysis of available data, the FDA has determined that approximately 1 in 350 women undergoing hysterectomy or myomectomy for fibroids has an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a news release. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal.

“Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their healthcare professionals.”

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy and myomectomy and laparoscopic hysterectomy and myomectomy without morcellation, and other nonsurgical options.

The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.

“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” Maisel said. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and healthcare professionals are adequately informed of the risks.”

In the interim, the agency has instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their product labeling for accurate risk information for patients and healthcare professionals.

How to proceed

The FDA’s recommendations for healthcare professionals include:

• Be aware that the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.

• Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.

• Carefully consider all the available treatment options for women with symptomatic uterine fibroids.

• Discuss the benefits and risks of all treatments with patients.

After carefully weighing the risks and benefits of the procedure, if a healthcare professional nonetheless determines that laparoscopic power morcellation is the best therapeutic option for his or her patient, the professional should:

• Inform patients that their fibroids might contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.

• Be aware that some clinicians and medical institutions advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of cancer spread in the abdomen and pelvis.

Full notice on laparoscopic uterine power morcellation in hysterectomy and myomectomy: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm


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