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Getting Answers From The FDA About Power Morcellators: The U.S. House Gets Involved.

On November 17, 2015, the House Committee on Energy and Commerce held a hearing entitled "Examining the Regulation of Diagnostic Tests and Laboratory Operations." In this hearing, various members of Congress questioned Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH), which is part of the Food and Drug Administration (FDA).

This hearing discussed many women's' health issues, including the use of power morcellators in hysterectomies. Power morcellators are devices that shred body tissue into tiny pieces, allowing for their easy removal. For years, manufacturers of power morcellators were aware that when women with undiagnosed uterine cancer underwent morcellation, the morcellator would cause the cancer to spread throughout the body cavity. As a result, hundreds of women have needlessly died due to upstaged cancer. While the manufacturers of morcellators have known about these risks for years, the FDA only admitted it was aware of these issues in December of 2013.

Pennsylvania Congressman Tim Murphy, the House Chairman of Oversight and Investigations, asked Dr. Shuren a number of questions about when the FDA was aware of the risks associated with power morcellators. He referenced a study from 2006, in which Dr. Robert Lamperter, a pathologist from Pennsylvania, tested a number of samples of morcellated uterine tissue. He found that 1 in 300 samples of morcellated tissue contained cancer.

Dr. Shuren indicated that at the time, the FDA did not believe the risk of cancer was as high as Dr. Lamperter's study, although upon revisiting the issue, the FDA found that using morcellators increased the risk of upstaged cancer. In November of 2014, the FDA warned against using power morcellators in hysterectomies or the removal of fibroids from the uterus, known as myomectomies.

Congressman Murphy followed up by referencing Brigham and Women's Hospital, a Boston hospital that became aware of these risks in 2012, due to the death of a patient in its care. He asked whether Brigham and Women's Hospital reported this death to the FDA. Dr. Shuren indicated that he was not aware.

This hearing is part of a Congressional effort to fully understand why so many women were needlessly exposed to these risks. Currently, there is litigation against Ethicon, a subsidiary of Johnson & Johnson, for its failure to warn women of the risks associated with power morcellators. This case involves at least 28 families, and is being heard in the United States District Court for the District of Kansas before Judge Kathryn Vratil.

Contact Fay Law Group, P.A.

Based in Washington D.C., we at Fay Law Group represent women across the United States whose cancer has been upstaged due to power morcellation, as well as surviving family members. Call 800-522-2715 to schedule a free initial consultation.

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