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Morcellators Get “Black Box” Warning for Cancer Risk

December 1, 2014 — After nearly a year of debate, the FDA had decided against banning power morcellators in hysterectomies and fibroid surgeries, but they will strengthen warnings about the risk of spreading cancer.

The agency has published a Safety Communication to update warnings from April 2014.

The FDA will require its strongest warning, the so-called “Black Box,” which will state:

“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.”

Power morcellators will be contraindicated in gynecological surgery when the tissue is known or suspected to be cancerous. They will also be contraindicated for fibroid surgery in women who are menopausal or post-menopausal, or intact removal of fibroids through the vagina or mini-laparotomy incision.

The problem is that there is no way to know whether a fibroid is actually undiagnosed cancer before surgery. An estimated 1 in 350 women who has surgery for a suspected fibroid actually has uterine sarcoma, and 1 in 500 has leiomyosarcoma.

When the spinning blades of a power morcellator grind up tissue, they can leave behind bits of tissue and “seed” cancer throughout a woman’s abdomen and pelvis, greatly worsening her long-term chances of survival.

Although power morcellators have been in use since the 1990s, their popularity has boomed in recent years with the growing popularity of robotic surgery. From 2007-2010, the percentage of hysterectomies performed with a robot skyrocketed from 0.5% to 9.5%.

Do I have a Morcellator Injury Lawsuit?

The Schmidt Firm, PLLC is currently accepting power morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer after a hysterectomy or fibroid surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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