Why are Physicians Still Using a Dangerous Medical Device for Hysterectomies?
In July 2014, the largest manufacturer of a surgical tool identified as having the potential to spread cancer in women pulled it from the market. Unfortunately, many physicians are still using the device, called a laparoscopic morcellator.
It's used in a type of hysterectomy known as power morcellation, performed on about 60,000 women each year. The physician removes the uterus or fibroid tumors by cutting the tissue into small pieces and taking them out through small incisions. Designed to be minimally invasive, it's now thought to pose potential dangers by spreading undetected cancers in the women.
Power Morcellation May Spread Cancer
The Food and Drug Administration (FDA) approved the morcellator in 1995.
In April 2014, the FDA warned physicians about using the surgical tool and the procedure. It estimated one in 352 women undergoing a hysterectomy or fibroid removal has a type of undetected cancer called uterine sarcoma. This cancer is particularly aggressive. The nature of the procedure, the FDA warned, could cut the undiagnosed cancerous tumors and spread them within the abdomen and pelvis, thereby endangering the patient's life. In response, one maker of the device stopped selling it.
One in 360 Women Found to Have Uterine Sarcoma
A study published a few months later in the Journal of the American Medical Association found that about one in 368 women had uterine sarcoma and concluded that power morcellation risked spreading this cancer, particularly in older women. Previous estimates as to the number of women who may have undetected sarcoma tumors were as high as one in 10,000.
Subsequently, the leading maker not only stopped selling the device but asked physicians to return it. But the morcellator is made by other companies and there are gynecologists still using the device, as reported by the Wall Street Journal. (Since the FDA has yet to ban the morcellator, physicians may still use it.) The FDA recently dictated that a new warning be printed on the packaging of the morcellators; a warning that patients most likely will never see.
While minimally invasive, the surgery is known to pose significant risks. So when a woman undergoing the procedure is harmed - especially if the doctor did not communicate those risks - it might be viewed as an avoidable surgical error.
When physicians and hospitals make mistakes, patients can suffer grave consequences. Such cases can be complicated, so those who have lost a loved one due to a physician's error or negligence may want to consult an attorney experienced in conducting medical malpractice investigations.
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