WASHINGTON D.C. — Representative Michael Fitzpatrick (R-PA) wants to know why the Food and Drug Administration ignored warning signs and took no action against Ethicon Manufacturing and other power morcellator manufacturers.
Mr. Fitzpatrick stated that “hundreds, if not thousands, of women are dead” due to this dangerous medical device. He specifically asked the watchdog agency to investigate a December 2013 fatal incident at Brigham and Women’s Hospital in Massachusetts and was never reported, despite agency regulations to the contrary. Earlier, in 2012, that patient underwent a power morcellator procedure and was subsequently diagnosed with leiomyosarcoma. According to the letter, a similar event occurred in 2014 at Rochester General Hospital. The Congressman also asked the FDA to investigate Ethicon Manufacturing, quoting an internal email from 2006 that the device “’may be linked to dissemination of malignant tissue.’” “Had the regulations worked as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation,” he concluded.
In an emailed statement, an FDA spokesperson said that the agency was aware of the inquiry and would “respond to the Congressman via our usual process.”
A morcellator is used during a laparoscopic hysterectomy to mince a woman’s uterus into small bits that can be easily extracted from the abdomen. During this process, tissue that is possibly carcinogenic is distributed throughout the bladder, spleen, pancreas, and other organs in the area and cause serious complications. Some patients develop an unexpected leiomyosarcoma, one of the most fatal cancerous tumors known to medical science.
In November 2014 the FDA issued a warning that forbade doctors from using a power morcellator in certain procedures and required manufacturers to add additional warnings to the product label.
If you or a loved one suffered adverse side effects from use of a power morcellator, you may be entitled to significant cash compensation as a result of your economic and non-economic damages. Punitive damages are also available in most defective medical device lawsuits.
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Our dangerous medical device lawyers help if you or someone you care about was harmed while undergoing this procedure. Lawsuits have been filed against the manufacturer by both patients and their families seeking compensation for injuries caused by the dangerous device. You may be entitled to a cash settlement.
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