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No Morcellation Adverse Events Brought to FDA’s Attention for Eight Years

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Although federal law requires the reporting of adverse events, no reports concerning power morcellators had been received by the U.S. Food and Drug Administration (FDA) prior to December 2013, according to The Cancer Letter.

Prior to December 2013, the FDA had received no Medical Device Reports (MDRs) concerning cancer and upstaging associated with morcellation, but since then, the agency became aware of about two dozen such cases as of November 2014. All the reports concerned morcellation procedures that took place prior to December 2013.

The Dangers of Morcellation

The laparoscopic power morcellator was first approved for gynecology in the 1990s, and enjoyed a rise in popularity in recent years because of the popularity of minimally invasive and robotic surgery. On November 24, 2014, the FDA issued a warning that the morcellator shouldn’t be used on most women during hysterectomies, a decision made after nearly a decade of debate regarding the safety of the procedure.

According to the FDA, approximately one in 350 women undergoing hysterectomy is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma that is spread throughout the pelvis and abdomen during the morcellation process. Two such women, Erica Kaitz and Dr. Amy Reed, underwent power morcellation in 2012 and 2013, respectively. Kaitz died on Dec. 7, 2013 from metastatic leiomyosarcoma, and Reed recently underwent surgery for a third recurrence.

Since then, Dr. Reed’s husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, has led a campaign calling for a ban on morcellation, twice petitioning the U.S. Food and Drug Administration (FDA) and meeting numerous times with members of Congress and the Senate. On April 17, 2015, the FDA announced that it discourages the use of laparoscopic power morcellators in most hysterectomy and myomectomy procedures because of the risk of spreading unsuspected cancerous tissue.

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    […] Although federal law requires the reporting of adverse events, no reports concerning power morcellators had been received by the U.S. Food and Drug Administration (FDA) prior to December 2013, according to The Cancer Letter. Prior to December 2013, the FDA […] Injury Board […]