Wednesday, August 13, 2014

Power Morcellation: What You Should Know

Morcellation has been in the news recently so we thought we would pass on some information provided by Judy Cohen, Outreach Coordinator, American Recall Center

Power Morcellation: What You Should Know
Practically everyone knows someone who has undergone a hysterectomy. Recently, however, a medical device commonly used for some hysterectomy procedures has come under scrutiny by the FDA. This device, a 'Power Morcellator', is used to cut fibroid tissue into smaller pieces for easier removal from the body. Power morcellators are deemed to be responsible for the spread of formerly undetected cancer cells throughout the abdominal cavity and pelvis of women. Shockingly, the mortality rate of women who have undergone accidental morcellation of a cancerous tumor is quite high with a life expectancy of only 24-36 months following the procedure.

The FDA has come to the conclusion that there is no known fully accurate and reliable method for preoperatively determining whether fibroids in the female may also contain a uterine sarcoma. Results of studies done on power morcellation were released in April. Based on those studies, the FDA states that approximately 1 in 350 women undergoing a hysterectomy or myomectomy for the treatment of fibroids likely has an undetected uterine cancer. Leiomyosarcoma (LMS), a particularly aggressive uterine sarcoma, has a poor prognosis which the power morcellator only exacerbates. If you or someone you know has had a procedure using this device, be sure to keep all follow-up appointments with your doctor!


On July 10th and 11th, the FDA met to discuss the inherent dangers and the possible future of morcellation procedures. A final decision is currently under discussion. Meanwhile, in late July, one of the largest manufacturers of power morcellators, Johnson & Johnson, issued a voluntary recall of the device. Determining the procedure to be too risky, they are in the process of removing all existing devices from the marketplace. The more awareness that can be raised about this dangerous device, the faster we can put an end to the spread of avoidable and deadly cancers in women.



Dee
Co-moderator #gyncsm chat 

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