Warning Against Uterine Fibroid Treatment Is Strengthened

Last week, the FDA updated its warning from earlier this year about the cancer-spreading danger of a surgical procedure to treat uterine fibroids. For most women, the feds now say, power morcellation should not be performed.

Our blog, “FDA Warns of Cancer Risk with Uterine Procedure,” described morcellation, which involves a tool that cuts or grinds tissue into tiny pieces so they can be extracted through a small incision. It can spray bits of uterine tissue or fibroids around the surgical cavity.

The main concern now is that morcellation can spread cancer cells, turning a small hidden cancer from totally treatable and survivable into a killer spread throughout the lower abdomen.

The FDA’s order expanded the contraindications for power morcellation to gynecologic surgery patients with known or suspected malignancy, and to peri- and postmenopausal women seeking treatment for fibroids. It also imposed a so-called “black box” warning on the devices’ labels.

The warning, the most extreme type the FDA issues, states that “uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”

It’s stronger than the earlier advisory that the FDA “discourages the use of the devices during treatment for uterine fibroids.” Since April, when it was issued, many hospitals have stopped doing morcellation procedures, and many insurers won’t cover it.

Although it still might be appropriate for some women, the FDA recommends that women requiring a uterine procedure:

  • Discuss with your health-care provider all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.
  • If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him or her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.
  • If you have undergone a hysterectomy or myomectomy for fibroids, the tissue removed generally is tested for the presence of cancer. If your tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health-care provider.
  • Consider other surgical options, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy (smaller incision than open surgery) and myomectomy without morcellation. All treatments carry risk, and you should discuss them thoroughly with your health care provider.

To read the whole alert, link here. To report an adverse event with morcellation (or any other medical procedure), link to the FDA’s MedWatch program here.

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