FDA Issues Safety Warning Against Hysterectomy and Fibroid Surgical Technique That May Spread Cancer

The FDA is warning surgeons against using power morcellators to remove the uterus or uterine fibroids due to the risk of spreading undetected cancer cells outside the uterus during the procedure.

Uterine fibroids are non-cancerous tissue growths within the uterus. They are common in most women and usually cause no problems. But for some women, their fibroids can cause excessive menstrual bleeding, pain, and problems with urination. Surgery is frequently recommended to remove either the uterus (hysterectomy) and/or the uterine fibroids (myomectomy) and one popular surgical technique involves using a power morcellator.

A power morcellator is a bladed, shredding device used to cut up tissue like fibroids or the uterus into smaller pieces for easier removal during laparoscopic procedures. Laparoscopic procedures are done through small incisions that are minimally invasive with less risk of infection and a quicker recovery time.

Although laparoscopic power morcellation sounds like the preferable alternative to more invasive abdominal surgery, the FDA estimates that 1 in 350 women have a type of cancer called uterine sarcoma that cannot be fully detected prior to surgery and that can spread outside the uterus if a power morcellator is used to remove the uterus or uterine fibroids. Although the risk is low for most women, use of the morcellator for those with unknown cancer creates a deadly risk that may not be survivable.

In addition to discouraging the use of power morcellation, the FDA is also advising doctors to warn patients of the risks and benefits when choosing power morcellation and to discuss alternative treatments.

Because of the FDA warning, many hospitals now require that power morcellation for uterine procedures must be done using protective surgical bags to reduce the risk of spreading unknown cancer but using protective bags does not guarantee the unintended spread of unknown cancers throughout the body.

What should you do if Power Morcellation is recommended?

• Don’t be afraid to ask questions. If your doctor recommends a hysterectomy or surgical removal of your uterine fibroids, ask how the procedure will be done and whether a power morcellator will be used.
• Do your research and be informed before agreeing to any medical or surgical procedure.
• Consider getting a second opinion to help decide what is the best course of action for you.
• Discuss and consider all alternative treatments with your doctor, and all known benefits and risks of those treatments. There are both medical and surgical ways to treat uterine fibroids that do not involve morcellation and, therefore, do not carry the risk of spreading unknown cancer cells. Drug therapy or regular vaginal hysterectomy without morcellation are just two possible treatment alternatives.

Only you can decide what is right for you, and what risks you are willing to take, and an informed medical decision can only be made if you know all the facts, the risks and benefits of all possible treatments and potential outcomes.

The FDA monitors adverse events related to the use of laparoscopic power morcellation so please report any problems, complications or injuries you may have suffered following treatment for uterine fibroids with power morcellation at MedWatch: The FDA Safety Information and Adverse Event Reporting Program at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.