Two Harvard doctors are speaking out about the dangerous risks that power morcellation devices pose.
Dr. Amy R., a surgical ICU doctor and anesthesiologist, was diagnosed with a rare and aggressive cancer known as leiomyosarcoma shortly after she underwent a laparoscopic hysterectomy to remove uterine fibroids. After discussing her options with her doctor, she opted for this form a surgery, where a power morcellator would be used, instead of an abdominal hysterectomy due to the quicker recovery time.
However, it was during this surgery that the power morcellator disseminated undetected uterine sarcoma throughout her abdominal cavity, leaving her with a virtual death sentence.
In October 2013, Dr. Amy underwent several aggressive and expensive procedures to stop the spread of the leiomyosarcoma including having her insides soaked with chemo, removal of her gallbladder, appendix, ovaries and various membranes that held her organs in place. After the procedure, she suffered a blood clot in her lungs and was hospitalized for eight days.
Doctor Calls for Morcellation Ban
Dr. Amy’s husband, a Harvard cardiac surgeon, began to research medical databases and got a sense that the risk of power morcellation cancer was high. In his attempt to bring attention to these risks, however, he was met with red tape and little support from hospital administrators. Still, despite this red tape and being ostracized from the hospital community, he pursued his campaign against the use of power morcellators. He even took his plight to the FDA and a Change.org petition.
It was here that he learned that his wife was not the only victim of morcellation cancer. As his own wife was undergoing surgery, another patient, Erica K. was nearing death as an alleged result of morcellation surgery. In fact, just four days before Dr. Amy’s husband met with hospital administrators, Erica died.
Still, Dr. Amy’s husband continued his crusade and small changes began to happen – a handful of area hospitals began placing mandates on morcellation surgery and Senator Elizabeth Warren began taking an interest in his cause. In 2014, the FDA issued a safety communication “discouraging” the use of power morcellators for gynecological surgeries.
Yet, Dr. Amy’s husband feels, that while a small victory, it is not enough. He is adamant that the devices be banned due to their inherent risk of spreading cancer. And finally he was listened to.
FDA Addresses Morcellation Cancer Concerns
After the FDA announcement, the American College of Obstetricians and Gynecologists announced they would be thoroughly investigating use of the devices and many hospitals opted to ban the use of the devices. Then, Johnson & Johnson, a leading manufacturer of power morcellators, announced it would be suspending worldwide sales and distribution and marketing of the surgical tools.
However, this response came too late for many women who underwent a laparoscopic surgery and were diagnosed with cancer. In Spring 2015, Dr. Amy was told her leiomyosarcoma had returned an underwent additional surgery and started radiation treatment.
What is Power Morcellation?
Laparoscopic power morcellation is a procedure that uses a device called a morcellator to slice the affected tissue into small pieces and remove it through small incisions in the abdomen. This type of surgical treatment was found to decrease the recovery time, pain, blood loss, and scarring.
But, since doctors are unable to tell whether or not a fibroid contains cancerous tissue before removal, this procedure carries the risk of spreading any cancerous tissue into other parts of the body.
Several studies have found an increased risk in the spread of cancerous tissue after a woman undergoes a power morcellation procedure.
The Journal of the American Medical Association, JAMA, published a study in March 2014 that found 13 women between 1983 and 2010 unexpectedly developed uterine cancer after undergoing power morcellation.
An additional study published in March 2014 in PLOS One showed that women were nine times more likely to develop cancer after undergoing power morcellation to remove their uterus or uterine fibroids.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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