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Rep. Asks FDA for Criminal Probe Into Morcellator Deaths

Rep. Asks FDA for Criminal Probe Into Morcellator Deaths

January 8, 2016 — U.S. Representative Mike Fitzpatrick (R-Pa.) is demanding answers from the FDA after Ethicon and three hospitals failed to report deaths linked to morcellators.

Rep. Fitzpatrick sent the letter to George Karavetsos, the FDA’s director of the Office of Criminal Investigations. He questioned why it took the FDA so long to identify safety issues:

“It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations worked as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation.”

Rep. Fitzpatrick also asked whether Ethicon ever told the FDA about the risk after being warned nearly a decade ago. In 2006, a pathologist from Pennsylvania named Dr. Robert Lamparter contacted Ethicon to report that 1/300 women at his hospital undergoing hysterectomies had undiagnosed cancer.

Dr. Lamparter’s warnings prompted Ethicon to update the device label to say its use “may lead to dissemination of malignant tissue.”

Hospitals and manufacturers are required by law to tell the FDA when they have reasonable evidence that a device caused a serious injury or death. However, four deaths at the following hospitals were not reported until recently:

  • Brigham and Women’s Hospital (Boston): Erica Katz died one year after a morcellator upstaged undiagnosed leiomyosarcoma.
  • Rochester General: Barb Leary had leiomyosarcoma upstaged by a morcellator and died in September 2013. Linda Interlicka died one year after a morcellator upstaged her leiomyosarcoma.
  • University of Rochester Medical Center: Brenda Leuzzi had leiomyosarcoma upstaged by a morcellator in died two years later.

Although morcellators have been on the market for decades, it was not until 2013 that the FDA says it received the first report of a morcellator upstaging undiagnosed uterine cancer after gynecological surgery. Since then, the downfall of the device has been rapid.

In 2014, the FDA put a “Black Box” on the devices and warned that 1/350 women undergoing hysterectomy or fibroid surgery has undiagnosed uterine cancer. The agency has not recalled morcellators, but warns they should not be used in the “vast majority” of women.

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