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Congressman Calls for Federal Morcellator Investigation

court houseA congressman has called for the FDA to investigate several hospitals on grounds that they failed to report deaths believed to have been brought on by power morcellators.

Mike Fitzpatrick, a Representative from Pennsylvania, has taken up the mission of constituents who were left widowed and now blame the device.

The FDA approved power morcellators two decades ago to remove tissue during keyhole, or laparascopic, surgeries. A surgeon uses the morcellator to blast the tissues into small, easily removable particles that are small enough to fit through the keyhole opening.

Power morcellators linked to risk of advanced cancer

The devices have become popular for use in gynecological procedures like fibroid removal and hysterectomies; more than 200,000 women undergo surgeries via power morcellators each year.

However, a striking number of those women have soon afterward developed highly aggressive ovarian cancer.

FDA warns morcellators spread undetectable cancer

According to an FDA warning from 2014, morcellators are so risky because one out of every 350 women who undergoes a laparascopic uterine procedure has an undetectable type of cancer. The morcellator’s blasting of the uterine tissues can disseminate the cancer cells throughout the abdomen. The cancer that follows is quickly-advancing and difficult to treat. The morcellator’s spreading of the cancer cells greatly decreases the patient’s chances of survival.

The FDA has not banned the device but many hospitals have voluntarily quit using the procedure due to the risk.

FDA investigation into hospitals’ response

On December 18, 2015, Representative Fitzpatrick sent a letter to George Karavetsos, head of FDA Office of Criminal Investigations, requesting that the FDA investigate Brigham and Women’s Hospital, Rochester General Hospital, and University of Rochester Medical Center. The letter claims that the hospitals failed to disclose when women died of uterine cancer that was likely spread by power morcellators.

Representative Fitzpatrick’s letter raises questions about deaths of Erica Kaitz, Barbara Leary, Linda Interlichia, and Brenda Leuzzi. The women underwent minimally invasive gynecological surgery including removal of fibroids. In each case, the woman had undiagnosed cancer that was “upstaged and spread” by the procedures and led to her death.

Under federal regulations, hospitals have 10 days to report to the FDA from the time they receive information that a device has or may have contributed to the death of their patient. The representative’s request asks the FDA to examine whether each hospital complied with this duty to report. According to letter, the FDA’s Medical Device Reporting regulations missed the serious dangers that morcellation poses to women’s health; the first report did not come from a medical facility or the device manufacturer but from the family of cancer victim.

The hospitals named in the letter have released statements that they did not violate FDA regulations. According to the hospitals, the incidents did not fit the categories of reportable event because they did not involve serious injury caused by a device failure. Rather, the device operated as expected, even though with tragic results.

As the link between power morcellator use and advanced stage cancer becomes better understood, victims are coming forward. More than two dozen lawsuits against Ethicon, the largest of the morcellator manufacturers, have been filed and consolidated in the federal court in Kansas. More lawsuits are expected to be filed against Ethicon and a half dozen other manufacturers.