Morcellator LawyerJanuary 8, 2016 — U.S. Representative Michael G. Fitzpatrick has sent a letter asking the FDA to open a criminal investigation into why three hospitals failed to report deaths related to the use of morcellators during hysterectomies and fibroid surgery.

Federal law requires hospitals and manufacturers to report device-related deaths and injuries. The rules are essential for identifying safety issues and protecting public safety.

Rep. Fitzpatrick cited the following hospitals for failing to report four deaths linked to morcellators, including:

  • Brigham and Women’s Hospital in Boston: Erica Katz, a woman who had surgery in June 2012 and died the next year from leiomyosarcoma upstaged by a morcellator.
  • Rochester General: Barb Leary had surgery in 2009 her leiomyosarcoma was upstaged by a morcellator. She died in September 2013. Another victim, Linda Interlichia, died in October 2013 — one year after a morcellator upstaged undiagnosed leiomyosarcoma.
  • University of Rochester Medical Center: Brenda Leuzzi had surgery 2012 and had an undiagnosed leiomyosarcoma upstaged by a morcellator, which caused her death in October 2014.

Rep. Fitzpatrick asked whether the hospitals or Ethicon had ever been subject to enforcement action. He specifically questioned whether told the FDA about the risk after being warned by Dr. Robert Lamparter.

In 2006, Dr. Lamparter, a pathologist from Pennsylvania, contacted Ethicon to say that “In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery.”

Dr. Lamparter’s warnings prompted Ethicon to update the label on a morcellator to warn that it “may lead to dissemination of malignant tissue.” Dr. Fitzpatrick asked if the FDA was ever informed about the risk, and if not, to explain why:

“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.”

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