San Francisco, CAJohnson & Johnson, the maker of a highly controversial surgical instrument known as a power morcellator, is under investigation by the FBI. Specifically, the Federal Bureau of Investigation is trying to determine if J&J kept selling the devices after it was discovered it could spread a type of cancer.
The US Food and Drug Administration (FDA) has issued a safety communication warning against the use of laparoscopic power morcellation for hysterectomy or myomectomy (uterine fibroid removal). Of concern are reports of the spread of unsuspected cancerous tissue, specifically, uterine sarcoma, during laparoscopic hysterectomy.Laparoscopic power morcellation lawsuits have now been filed by women alleging they were harmed by the use of a power morcellator during laparoscopic hysterectomy.
In an interview with ABC7 News in San Francisco, Boston doctor Amy Reed and her husband say she was harmed by the device. They want morellators banned. "At no point in time did anyone ever say, well you know because you had it morcellated, that worsens your prognosis. That's something we discovered on our own," explained Reed. "If you disrupt the mass it's like a bee's hive. If you start chopping it up the bees spread and you're in trouble," said Hooman Noorchashm, Reed's husband.
Laparoscopic power morcellation has been marketed as a non-invasive hysterectomy or myomectomy. The surgery is used in women who are undergoing a hysterectomy or myomectomy for uterine fibroids. Power morcellation is a procedure that uses a medical device to break the uterine tissue into smaller pieces so it can be removed through a small incision in the patient's abdomen. Uterine fibroids are typically non-cancerous growths in the uterus that do not generally cause health problems but can cause pelvic pressure, pain and prolonged menstrual bleeding.
According to the FBI investigation, J&J was first made aware of the risks associated with the power morcellator in 2006, but didn’t pull the device from the market until July 2014.
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