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FDA Warns that Laparoscopic Uterine Power Morcellation May Spread Unsuspected Uterine Cancer

Every year, approximately 600,000 hysterectomies are performed in the United States. One of the most common ways this surgery has been performed in recent years has been via laparoscopic power morcellator—a surgical instrument used to divide large masses of tissue in order to remove them through relatively small incision points.

On November 24, 2014, the U.S. Food and Drug Administration (FDA) updated safety communications from April 17, 2014 regarding this form of minimally-invasive hysterectomy and myomectomy. The FDA now warns against morcellators, stating that power morcellation significantly increases the risk of spreading uterine cancer.

In the updated FDA safety communication, it is stated that nearly all women develop growths known as "uterine fibroids" on the muscle tissue of the uterus. These fibroids are often harmless and cause no symptoms, but sometimes they require surgical therapy. Many women choose to have a myomectomy or hysterectomy—the first being the surgical removal of the fibroid together with uterine reconstruction, and the second being the removal of the uterus altogether.

The problem is that some women who choose laparoscopic power morcellation for their myomectomy / hysterectomy may have unsuspected uterine cancer. Currently, there is no reliable method to predict or test women for a uterine sarcoma (cancer).

Morcellation significantly increases the possibility of spreading unsuspected cancerous tissue in the abdomen and pelvis. This in turn significantly decreases the chances of long-term cancer survival.

As a result, the FDA warns against power morcellation for the removal of uterine fibroids or of the uterus. The FDA also requires physicians and health care providers to warn patients of these risks and to explain any alternative options available to their patients who are considering myomectomies or hysterectomies.

What is required of health care providers?

  • Physicians and health care providers should be aware of these FDA safety warnings
  • Physicians and health care providers should inform their patients of these risks and warnings
  • Physicians should be aware of other possible forms of treatment for women with uterine fibroids and should explain those options to their patients

I had a myomectomy or hysterectomy and was never warned about this. What should I do now?

If you believe that you have suffered an adverse reaction after laparoscopic surgery using a power morcellator, you can file a voluntary report through MedWatch to help the FDA with further research and statistics. You also should not hesitate to speak with a Washington, D.C. medical malpractice attorney.

The Law Offices of Dr. Michael M. Wilson, M.D., J.D. & Associates can help you fight for compensation if you were not warned of the risks of using a power morcellator for a myomectomy or hysterectomy. This is especially true if cancerous tissue was spread in your abdomen as a result. Call (202) 684-2889 today for a free initial consultation with doctor and attorney Michael M. Wilson!

Categories: Medical Malpractice