FDA Safety Warning On Power Morcellation And Uterine Cancer Prompts University Study

December 15, 2015 – – Tracey & Fox reports on a study which has been conducted by the University of Michigan. The study was designed to evaluate the overall impact of the U.S. Food and Drug Administration’s 2014 warning regarding power morcellation use on uterine fibroids. The safety statement issued indicated that the devices should no longer be used during gynecological surgeries involving uterine fibroids due to the possibility of spreading previously undetected cancer cells.

This FDA warning is supported by decades of research, and estimates showing that approximately 1 in every 350 women who undergo these procedures may have uterine sarcomas they are unaware of. These statements and the research that supports them have led to changes in many prominent medical facilities. Even Ethicon, a large power morcellator manufacturer (and subsidiary of Johnson & Johnson) has completely stopped production of the devices, and recalled those currently on the market.

Researchers from the University of Michigan attempted to find out how surgeons had reacted to these FDA warnings, and to see how their reactions may be affecting patient outcomes. Their study evaluated women who had undergone laparoscopic hysterectomies via power morcellation at hospitals located in the statewide Michigan Surgical Quality Collaborative. Data analyzed was from 9,597 of the procedures which were performed over a 16-months following the initial FDA warning and another 5,775 which were performed up to 8 months after the warning was released.

As predicted, findings indicated that laparoscopic hysterectomies with the use of power morcellator devices had decreased by 4.1%. This caused an overall increase in abdominal and vaginal hysterectomies, without the use of power morcellation. Additionally, instances of abdominal hysteretomies increased by 1.7% and vagnial hysterectomies increased by 2.4%.

Although data seemed to highlight the decrease they assumed they would find, authors were surprised that the decrease was not greater. After further research, however, they noted that when observing strictly supracervical laparoscopic hysterectomies (which are specifically associated with power morcellation), they noted a decline of 59% in use, which seemed much more in line with their expectations.

Power morcellator devices and the likelihood that they may spread cancer cells are the subject of more than just FDA warnings and studies. They have become the topic of a growing number of lawsuits which have now been consolidated to form multidistrict litigation number 2652. Plaintiffs involved in these lawsuits all commonly allege that power morcellation on uterine fibroids can spread cancer in patients, causing these patients to be diagnosed with aggressive, widespread cancers post-surgery, and threatening their lives.

The attorneys at Tracey & Fox are currently working to ensure that anyone who has undergone laparoscopic power morcellation and who has subsequently been diagnosed with cancer will be able to explore their full legal rights. These individuals may be entitled to substantial compensation, and Tracey & Fox is offering free consultations to those affected.

To request additional information concerning power morcellation, or to ask questions, please 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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