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Has the FDA said anything about the safety of power morcellators?

Yes. In April 2014, the Federal Drug Administration (FDA) issued a safety notification discouraging the use of power morcellation to remove a woman’s uterus or uterine fibroids. The stated reason for the safety notification was because of concern that the use of a power morcellator in this type of procedure could risk spreading cancerous tissue to other parts of a woman’s body.

How Big Is the Risk?

Hysterectomies to remove the uterus and myomectomies to remove uterine fibroids are common. The FDA estimates that as many as 1 in 350 women who are undergoing one of these procedures has undetected cancer at the time of the procedure. When a power morcellator is used, it cuts the uterus or the fibroids into smaller pieces while it is still inside the body so that the pieces can be removed through a small incision. Since the tissue is cut while still in the body, there is a risk that any cancerous tissue could spread through the patient’s pelvis and abdomen and significantly impact her chances of survival.

While the FDA did not go as far as to recall power morcellators, it did discourage their use and encourage doctors and patients to consider other options. Additionally, in July 2014, Johnson & Johnson, the largest maker of power morcellators, voluntarily withdrew these medical devices from the market. Although Johnson & Johnson isn’t selling any new morcellators, those devices that were sold earlier may remain in use in hospitals and clinics across the United States.

What If You’ve Already Had Surgery?

If you were told that there was cancer in your uterus or in the fibroids on your uterus and you had a laparoscopic myomectomy or hysterectomy, then you should talk to your surgeon. If a power morcellator was used in your surgery, then it is important to know now whether the cancer spread.

To learn more about your rights, please read our FREE report, Power Morcellators: What You Need to Know About Them, and please start a live chat with us now.

Jason F. Abraham
Managing Partner, Hupy and Abraham