How a medical device spread cancer in women
April 28, 2016 | Medical Malpractice
In the United States, doctors perform approximately 600,000 hysterectomies each year. A medical procedure, called morcellation, was developed to reduce the size of an enlarged uterus so it could be removed through a minimally invasive procedure known as laparoscopic surgery. The introduction of power morcellation made the procedure easier for physicians and was used extensively to remove fibroid tumors in the uterus. Uterine fibroids, or non-cancerous tumors, which occur in as many as 80 percent of women by age 50, are the most common cause of an enlarged uterus and account for about 40 percent of hysterectomy cases. The problem is that power morcellators used to remove these fibroids can also spread undiagnosed cancer cells throughout the abdominal cavity of patients. In fact, a study released by the Journal of the American Medical Association determined that 1 in 386 women undergoing a procedure for presumed benign fibroids in fact had undiagnosed cancer tissue.
“Who would choose a big incision across your abdomen?” said Anita Austin, who unknowingly had tumor cells spread throughout her abdominal cavity by a morcellator. “Not one of my medical providers mentioned the word cancer. For me, it was a no brainer. I said, ‘Let’s do it laparoscopically.’”
But in 2014, more than two decades after the surgical tools were cleared for use, the U.S. Food and Drug Administration (FDA) cited evidence that the morcellators could spread cancer through the process of cutting up tissue, and issued a strong caution against the device, leading to a fallout that continues today. The issue went mainstream in December 2013 with the well-publicized case involving Amy Reed, a then-40-year-old anesthesiologist who joined her doctor husband in calling attention to the problem. In Reed’s case the use of morcellation resulted in a rare cancer known as a leiomyosarcoma being spread in her uterine wall. The power morcellator minced up the fibroid and tossed bits and pieces of the cancer throughout.
“Basically,” says Reed’s husband, also a doctor, “they created a man-made stage four cancer.” Doctors perform 100,000 to 200,000 operations like the one on his wife each year. “So I’m thinking,” he says, “even if it is one in 10,000, that’s still 10 or 20 women” with sarcomas that were spread.
Long before the FDA warned doctors of the dangers of using a power morcellator, a medical paper reported that “uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher” than originally presumed. The report went on to confirm the high rate of morcellation-related cancer, stating, “that the use of power morcellation can be associated with the undesired outcome of disseminating such lesions a high fraction of the time.”
Despite the eventual FDA warning that discouraged the use of morcellators for fibroid surgery, and the agency’s own review showing the risk for undetected uterine cancer was only one in 350, for women like Anita Austin and Amy Reed this warning came too late. “Say you have one woman in 350 over 20 years subject to an avoidable procedure. Their cancers get upstaged, and their lifetimes are shortened. That’s thousands of women,” says Dr. Hooman Noorchashm, Reed’s husband.
If you or someone you love was injured as a result of a defective or harmful medical device, please contact an experienced Colorado defective device lawyer who can evaluate your case and help you get the justice you deserve.