Two Philadelphia doctors say the U.S. Food and Drug Administration (FDA) is not doing enough to protect women against cancer that can spread during a morcellation hysterectomy, CBS News reported.
Dr. Amy Reed was diagnosed with cancer in 2013 after undergoing a minimally invasive hysterectomy with a laparoscopic power morcellator- a bladed tool that chops the uterus into tiny pieces to be removed through a small laparoscopic incision. However, according to the FDA ,one in 350 women has undetected sarcoma that can spread throughout the body during the procedure and worsen the cancer and the patient’s prognosis.
Reed and her husband, Dr. Hooman Noorchashm, have been fighting to raise awareness about the risks of morcellator hysterectomy and cancer since her diagnosis.
In May 2015, the Wall Street Journal reported that the Federal Bureau of Investigation (FBI) is examining the safety of power morcellators and what Johnson & Johnson (J&J) -the leading manufacturer- knew about the risk of spreading undetected cancer when a power morcellator is used in gynecological surgeries. J&J issued a worldwide withdrawal of its morcellators in July 2014 after the Journal of the American Medical Association (JAMA) study suggested that one in 368 women who undergo a morcellation hysterectomy have an undetected uterine cancer that could spread during the procedure. The FDA discouraged the use of power morcellators due to cancer risks in April 2014 and issued a black box warning in November 2014.
This is not the first time the Wall Street Journal reported about the hidden dangers of morcellators. According to an April 11, 2014 article, doctors who trained on early morcellators in the 1990s noticed that tissue fragments were sometimes left behind and suggested that if malignant, the fragments could spread the cancerous cells throughout the body.
Pittsburgh pathologist Dr. Robert Lamparter contacted J&J in 2006 about the potential risk of cancer spreading during a morcellation procedure and asked that they “reconsider the risk to the patient,” according to a Pittsburgh Business Times.
Dr. Reed told CBS that if action had been taken earlier, her situation may have been prevented–“not only mine but hundreds of other women. That’s what’s so maddening.”
Women who were diagnosed with cancer after undergoing a morcellation procedure are urged to contact a morcellator lawyer to preserve their legal rights.