Laparoscopic Power Morcellation Creates Caution, FDA Cites Cancer Risks

In April 2014, the Federal Drug Administration (FDA) called for caution when using a laparoscopic power morcellation to aid in a hysterectomy or myomectomy in women. The FDA noted that the use of laparoscopic power morcellation in hysterectomy or myomectomy increased cancer risk in women. Just over six months later, the FDA issued an “Immediately in Effect” guidance to the public and health professionals, requiring the manufacturer of laparoscopic power morcellators to update warnings on the box.

How it Works

Laparoscopic power morcellation is commonly used in hysterectomy—removal of the uterus —and myomectomy—removal of uterine fibroids. Laparoscopic power morcellation is one of several options to remove fibroids, but offers a few benefits like reduced risk of infection and quicker post-operation recovery time. These devices breakdown uterine fibroids into fragments so they can be removed from the body.

Where the Danger Lies

Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institute of Health, most women will develop uterine fibroids at some point in their lives.

However, current data estimates that 1 in every 350 women undergoing a hysterectomy or myomectomy is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

Insurers Have Taken Notice

Given the danger of performing laparoscopic power morcellation in women to remove fibroids, Aetna Inc—the nation’s third-largest health plan—will stop covering routine use of laparoscopic power morcellation. Citing the FDA’s concerns with the increased risk of cancer, Aetna’s new policy will take effect on May 15^th, 2015, and will require prior approval from the insurer.

Getting Help

If you, or a loved one, has recently had a hysterectomy or myomectomy where laparoscopic power morcellation was used, consequently spreading cancerous tissue, it is important to call an attorney immediately. The Law Offices of Michael Cordova has attorneys who are experienced in wrongful death, medical malpractice, and products liability, and will vigorously fight for your justice.