Risks of the Power Morcellator and FDA’s Safety Update

Recently, last month, the FDA announced an update to their April 17, 2014 Safety Communication .

Current available data estimates that 1 in 350 women undergoing treatment of uterine fibroids (myomectomy/hysterectomy) find that they have unsuspected uterine sarcoma.

As of now, it is said there isn’t a reliable method to test or predict uterine sarcoma.

The power morcellator is a device that assists in minimally invasive surgery and the particular medical device being used risks the spread of cancerous tissue within the abdomen and pelvis.

“The FDA believes that the risk is higher than previously understood.”

The FDA findings from their own research shows estimates that are higher than previously understood by the clinical community.

Benign fibroids are found 1 in 352 and cancerous fibroids (leiomyosarcoma) are found 1 in 498 women.

In result of the updated findings the FDA is enforcing a new boxed warning stating,

“The FDA warns 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.”…

The FDA has made recommendation to the manufactures, health care providers and women who had surgery using this device and those researching their options.

Below is the recommendation to Health Care Providers.

“… the following new contraindications recommended by the FDA;

1. Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
2. Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.”

The FDA suggests that manufacturers and health care providers explain options and risks to the women that need to remove symptomatic uterine fibroids.

Be sure to fully discuss your treatment options and their risks with your physician.

If laparoscopic myomectomy or hysterectomy is recommended, ask if power morcellation will be used during the procedure.

If so, ask if why this is an appropriate treatment option.  Additional treatment options can include traditional (vaginal or abdominal) surgery and laparoscopic myomectomy or hysterectomy without morcellation.

The FDA says, “All treatments carry risk, and you should discuss them thoroughly with your health care provider.”

Tissue is typically tested for cancer if you had a myomectomy or hysterectomy.

If the tests came back normal and you don’t have symptoms the FDA suggests you follow up with your physician on a routine basis.

Of course, if you have persistent or recurrent symptoms you should consult with your health care provider.

Our law firm, Zoll & Kranz., is currently investigating this dangerous medical device.

If you have questions about the power morcellator or even if you believe you might have a potential claim, we are here to listen and take action, if applicable.

Please contact us by leaving a comment or call us toll-free at (419) 827-3194.

We also have a free case evaluation form available on this page.