FDA Cites Lack Of Power Morcellation Adverse Event Reporting Despite Federal Law Requirement

November 30, 2015 – – Tracey & Fox reports on a recent announcement by the United States Food and Drug Administration which noted that Federal Law requires the reporting of adverse events, though none concerning power morcellation have been reported to the agency for 8 years. Prior to December of 2013, according to FDA officials, the agency had not received any reports of adverse outcomes due to laparoscopic power morcellation.

A statement by the agency to The Cancer Letter explained: “Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination.” In addition, they shared: “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”

Power morcellators are commonly used in gynecological surgeries such as hysterectomies and myomectomies. They provide a less invasive option to open surgery for the removal of troublesome uterine tissue and fibroids. Power morcellators work much like a drill. They are inserted into the abdomen through a small incision. Once inside, they whip around small blades designed to shred tissue into small pieces, so that it is able to be removed from the body. According to many recent lawsuits, however, as the device shreds the tissue, it can allegedly uncover previously hidden cancer cells and spread them throughout the body, accelerating the cancer and negatively impacting the life expectancy of the patient.

In 2014, the U.S. Food and Drug Administration announced a safety advisory warning and estimated that approximately 1 in every 350 women who undergo laparoscopic power morcellation to treat uterine fibroids may have previously undetected uterine sarcomas, including leiomyosarcoma. The FDA warned that most women should refrain from using power morcellation during surgeries to avoid the risk of spreading these undetected cancers.

Cases against power morcellators manufactured by Ethicon, (a division of Johnson & Johnson), have been consolidated under one court. This consolidation will help litigation to move more efficiently and will conserve resources for all involved. As these cases await trial, it is expected that additional suits will be filed.

The attorneys at Tracey and Fox are working to ensure that everyone who has undergone power morcellation and who was subsequently diagnosed with cancer has the opportunity to explore their legal rights. These individuals and their families may be entitled to substantial compensation.

For more information regarding power morcellator lawsuits or to ask questions, contact Tracey & Fox by calling (713) 322-5375.

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Contact Tracey & Fox:

Sean Tracey
713-495-2333
440 Louisiana Street , Suite 1901
Houston, TX 77002

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