The U.S. Food and Drug Administration has updated its safety recommendations for a device used in fibroid removal surgeries. Aimed at health care providers and patients alike, the latest recommendations are intended to minimize the risk of undetected uterine cancer being spread to the patient’s pelvis and abdomen during minimally invasive fibroid removal procedures.
The safety recommendations for laparoscopic power morcellators (LPM) were released at the end of 2020 for inclusion on the morcellator package insert. In particular, the FDA recommended a black box warning, its most serious type of alert, stating that uterine tissue may contain unsuspected cancer and that the use of LPMs may spread such cancer and decrease long-term survival rates. Compliance with the safety recommendations, however, is entirely voluntary and up to the manufacturer.
Fibroids are benign uterine growths which can be removed individually in a procedure known as myomectomy, or through removal of the entire uterus, which is known as hysterectomy.
Minimally invasive, or laparoscopic, surgeries are associated with lower levels of discomfort, shorter recovery times and lower infection rates compared with traditional open abdominal surgeries. Laparoscopic procedures rely on the use of a tiny lighted camera inserted through a small incision. Laparoscopic morcellators are electrically-powered devices used to mince the uterine tissue into tiny pieces, enabling removal through incisions which are typically 2 centimeters or less in length.
According to the FDA, uterine fibroids and uterine sarcomas, a type of cancer, can present similar symptoms. Unfortunately, medical science currently has no reliable way of diagnosing uterine sarcomas in women with fibroids before surgery. Prior to 2014 the incidence of hidden sarcomas in women undergoing fibroid surgery was estimated to be extremely rare, about 1 in 10,000 women. The agency’s current estimates, however, are much higher, somewhere between 1-in-225 to 1-in-580 women.
Several studies indicate lower long-term survival rates for women with hidden sarcomas whose fibroids were removed by a laparoscopic power morcellator.
FDA Laparoscopic Fibroid Surgery Recommendations
For Health Care Providers
Power laparoscopic morcellators should never be used surgically with:
- Patients who are past menopause and/or over age 50, due to increased cancer risk
- Patients with suspected or confirmed cancer
- Patients who are candidates for “en bloc” (intact) removal of uterine tissues vaginally or through an incision less than 5 centimeters (mini-laparotomy)
With appropriate patients, laparoscopic morcellation should only be used in conjunction with a compatible “tissue containment system” to isolate benign tissue. The FDA notes, however, that cancerous uterine tissues may be spread through tissue manipulation that occurs before the tissue is placed in the containment system.
Currently only one tissue containment system for gynecologic surgery is available in the U.S., although the FDA encourages further innovation.
When used without tissue containment, power laparoscopic morcellators are also associated with the spread of benign uterine tissues such as parasitic myomas and disseminated peritoneal leiomyomatosis. Although not cancerous, such tissues can cause abdominal pain and distention and their spread may necessitate additional removal surgeries.
Health care providers should discuss the risks and benefits of all relevant treatment options with patients, including specifically the cancer risks associated with power laparoscopic morcellators.
For Patients
Discuss the risks and benefits of various treatments with your health care provider.
If laparoscopic fibroid removal or hysterectomy is recommended, ask your provider the following questions:
- Will a power morcellator be used?
- If so, why is power morcellation appropriate in your case?
- Will a tissue containment system be used?
- Which of the following other treatment options are appropriate?
- Traditional vaginal or abdominal surgery
- Laparoscopic surgery without morcellation
- Abdominal surgery using a smaller incision (laparotomy)
Be aware that tissues removed during fibroid surgery are usually tested for cancer.
- Continue routine follow-up care with your provider
- Alert your provider about any concerning symptoms.