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FDA Issues Warning That Power Morcellator Procedures Can Spread Undetected Uterine Cancers

  Alan Fuchsberg  |  April 23, 2014  |  

The FDA has just released a warning that the treatments for removing uterine fibroids through certain laparoscopic surgical procedures may actually spread hidden cancers.

Many women develop uterine fibroids at some point in their lives. In most cases, they are benign and cause no symptoms. But, for some, the fibroids cause pain, excessive bleeding, and other difficulties. As a treatment, some women undergo removal of their uterus (called a hysterectomy) or removal of the fibroids (called myomectomy) through minimally invasive procedures called laparoscopic surgeries.

These types of procedures reduce recovery time and get patients back to their daily life activities more quickly than invasive procedures. But this week, the FDA warned doctors and patients that these low impact surgeries may have potentially deadly consequences.

How Power Morcellators Spread Uterine Cancer

Specifically, the FDA warned that power morcellators, devices used during these fibroid-related surgeries, which break up tissue rapidly into smaller pieces or fragments, can spread undetected cancer cells and advance the progression of certain types of cancers.

The FDA’s concerns, reported in an FDA Safety Communication, stem from data which estimated that 1 in 350 women undergoing a hysterectomy or myomectomy to treat fibroids has unsuspected uterine sarcoma. Since there is no reliable method for predicting whether a woman with fibroids has a uterine sarcoma, these procedures can kick-start a rapid progression of this cancer.

Doctors in the field should have been aware of this issue since this problem was described in a joint Harvard/John Hopkins study published in November 2012. It follows that anyone who has had this procedure performed on them in recent years and now has uterine cancer might wonder whether their illness is due to professional negligence.

If you would like to learn more about medical malpractice and doctor errors or have questions about FDA Safety Communication, we invite you to contact us.

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