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Fibroid Treatment May Spread Hidden Cancer

Posted in Drug & Medical Devices on April 23, 2014

The FDA has issued a warning that certain surgical procedures used to treat uterine fibroids can cause the spread of undetected cancer.

What are Fibroids?

A uterine fibroid is a tumor that grows in the wall of the uterus. While many women who develop fibroids experience no symptoms, those who do may require surgery to remove them. Fibroids can grow as a single tumor or in clusters and are usually not cancerous. However, according to the FDA, as many as 1 in 350 women who undergo myomectomy (removal of uterine fibroids) or hysterectomy (removal of the uterus) for symptomatic fibroids has an undiagnosed type of cancer called uterine sarcoma.

Uterine Power Morcellation in Hysterectomy and Myomectomy

If fibroid removal is necessary, many women opt for a minimally invasive or robotic procedure such as a laparoscopic hysterectomy or myomectomy, in which the surgeon accesses and removes the fibroids or the uterus through several small abdominal incisions. To remove the tissue, the surgeon may use a power tool, to chop up, or morcellate, the fibroids and/or uterus.

Cancer Seeding

If power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue to other parts of the abdomen and pelvis. This “cancer seeding,” or spread of cancer cells, puts women at risk for cancer in other organs.

Since there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. The agency is considering requiring a “black box warning” – the strongest warning it can mandate – for laparoscopic power morcellators.

The New York Times reports:

Sarcomas are a particular concern, because they are aggressive and almost never detectable with imaging or other tests before surgery. The diagnosis is usually made only after surgery, when the tissue is biopsied. By then, if a morcellator was used, it is too late to prevent the spread of the cancer, and the woman’s chances of long-term survival are significantly worsened, the agency said.

Morcellator Cancer Lawsuits

A growing number of lawsuits have been filed against the manufacturers of power morcellators, including Ethicon Inc., Blue Endo, Lina Medical, and others. Plaintiffs in these lawsuits claim that they were never warned that morcellation has the potential to “seed” undiagnosed uterine sarcoma (leiomyosarcoma), leading to the spread of the cancer.

FDA Recommendations

For women with fibroids and other gynecological health problems that may require surgery, it’s important to talk to your doctor. The FDA has released the following recommendations:

  • Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
  • If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
  • If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these 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.

UPDATE:

7/24/14 – According to The Washington Post, “A study by doctors at Columbia University, published Tuesday in the Journal of the American Medical Association, found that nearly 1 in 370 women who undergoes a hysterectomy using a surgical device called a power morcellator is found to have previously undetected uterine cancers.”

Sources:

“Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy” FDA Safety Communication, Issued April 17, 2014.

“F.D.A. Discourages Procedure in Uterine Surgery” by Denise Grady, The New York Times, April 17, 2014.

“Research supports FDA warning about a medical device that could spread cancer” by Caelainn Hogan, The Washington Post, July 22, 2014.