Usually when one thinks of medical malpractice, he or she thinks of an error by a doctor or nurse that leads to a serious medical complication. Sometimes, however, the problem is not with the medical staff. Instead it is with the medical device. One such medical device has been making news ever since the FDA warned the public about it last year. This device is used for a treatment called laparoscopic power morcellation and the problem with it is that it appears to be causing cancer to spread throughout the body. Called a ¨power morcellator,” this device has been made by companies like Johnson & Johnson. The FDA warned doctors about the dangers of the device last year, but the FBI is investigating whether Johnson & Johnson knew about the problem long before that warning.
FDA Warned Doctors About the Device Last Year
Over a year ago, in April 2014, the Food and Drug Administration (FDA) issued a warning about laparoscopic power morcellation. The procedure involves using a power tool to chop up the tissue of fibroids or, in the case of a hysterectomy, to chop up the uterus itself. Tissue fragments are then removed from the body using tiny incisions. The problem is that roughly one out of every 350 women undergoing fibroid removal or a hysterectomy has a type of cancer called uterine sarcoma.
Using this device on these women can spread cancerous tissue throughout the woman’s abdomen and pelvis. The FDA approved the first power tool used for these procedures back in 1995. After issuing the warning, the agency began to review the warnings given to patients undergoing these procedures. In November the agency ordered that a strong new warning about this problem be given to patients considering the procedure. Meanwhile one manufacturer, Johnson & Johnson, pulled their power morcellator from the market. Models manufactured by other companies are still available.
Now a Doctor With Cancer is Speaking Out Saying the FDA is not Doing Enough
CBS News reports that a doctor who now has cancer is speaking out saying that the FDA is not doing enough about this problem device. Dr. Amy Reed was diagnosed with cancer in 2013. Her cancer was discovered after she had an operation to remove uterine fibroid tumors and doctors used a power morcellator on her to shred the fibroid tissue. That shredding spread cancer that had not yet been detected.
Dr. Noorchashm went to the FBI over the issue. The FBI is currently investigating what Johnson & Johnson knew about the device’s risks before the FDA warning issued. There are allegations that the company knew about this problem as far back as 2006. If something had been done about this problem earlier, Dr. Reed and others like her may not have had cancer spread throughout their bodies. As a result of the cancer, Dr. Reed has had multiple surgeries, chemotherapy, and radiation. Her cancer recently recurred with a tumor in her spine.
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