Power Morcellator Lawsuit Update: GAO To Investigate Morcellation Risks

September 16, 2015 – – Tracey & Fox have commented on the U.S. Government Accountability Office’s decision to move forward with an investigation into the controversy stemming from the use of power morcellators during hysterectomies and myomectomies. Mr. Tracey has stated, “I welcome this investigation by the U.S. Government Accountability Office. It is tragic that so many women have lost their lives as a result of the use of this device. If the U.S. Food and Drug Administration’s approval process is improved because of continued scrutiny, only good things will come as a result.”

Mr. Gene Dodaro, the Comptroller General and the head of the GAO, received a letter on August 7th, 2015 from the United States Congress. The letter was a request for the GAO to begin an investigation into the manner through which the U.S. Food and Drug Administration granted approval for the medical device known as a power morcellator. It was signed by twelve members of Congress.

The letter stated that “hundreds, if not thousands, of women in America are dead” because of the use of power morcellators during gynecological surgeries.

The morcellator has been used by surgeons for decades in a wide variety of laparoscopic surgeries. It was first approved by the FDA under a 501(k), which allows the approval of a surgical device without safety testing, if the device can be shown to be “substantially equivalent” to a previously approved device. But on April 17th, 2014, the FDA released a safety communication which warned that “When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”

In an updated safety communication issued on November 24th, 2014, the FDA required all power morcellators to have a “black box” label, warning of the risks associated with its use.

On September 1st, 2015, the GAO responded to the lead member of the Congressional group, U.S. Rep. Mike Fitzpatrick, agreeing to accept the request. Katherine Siggerud, the managing director for congressional relations at the GAO, has indicated the investigation will begin in several months after the necessary staff are made available.

This announcement comes after speculation that the Federal Bureau of Investigations had begun their own investigation into the risks of the power morcellator, and numerous lawsuits have been filed by women and the families of women who all allege that undiagnosed uterine cancer was spread by a morcellator resulting in metastasis to other areas of the body.

For more information regarding this press release, call Tracey & Fox at (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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