New York City Morcellation Lawyer
If you have undergone a power morcellator laparoscopic hysterectomy, and were diagnosed with cancer, you may be entitled to bring a lawsuit. A laparoscopic power morcellator is a medical device used during a minimally invasive surgery to remove uterine fibroids (myomectomy) or to remove the uterus (hysterectomy). A morcellator is a device which cuts tissue into small pieces or fragments and then sucks it out of the uterine cavity. A small percentage of women undergoing these procedures may actually have an undiagnosed sarcoma, which doctors are unable to detect prior to the uterine fibroid or hysterectomy procedure. The problem with the device is that it can cause potentially cancerous tissue to spray, drop or spread beyond the uterus, and increase the staging of a women’s cancer. Women who have uterine sarcomas and Leiomyosarcoma (LMS), a deadly type of cancer, have had the staging of their cancer uplifted or increased substantially. The risk that the morcellator can cause an uplifting or increase in an undiagnosed cancer has not been disclosed to women undergoing the procedure.
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On April 17, 2014, the FDA issued an advisory where they estimated that 1 in 350 women undergoing a hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
According to the FDA, there are a number of treatment options available to women for uterine fibroids including traditional surgical hysterectomies (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision, deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high intensity focused ultrasound, and drug therapy. These are options that women should thoroughly discuss with their gynecological surgeons.
There is a discussion in the industry of using morcellation specimen bags to prevent the spread of potentially cancerous tissue. Unfortunately, no bags have been approved by the FDA for such use, and none have been tested and proven to date to prevent the spread of cancerous tissue in the abdominal cavity.
JOHNSON & JOHNSON’S ETHICON SUSPENDS SALES
Soon after the April 17, 2014 FDA advisory warning, Ethicon suspended its global sales, distribution, and promotion of its power morcellation devices. This suspension includes Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator, all sold by the company’s Ethicon division. However, the company has not issued a recall of its devices, and the morcellators previously sold can continue to be used by gyn surgeons.
The controversy around the use of morcellators became prominent when Amy Reed, MD, an anesthesiologist at Beth Israel Hospital in Boston underwent a hysterectomy with morcellation. As reported by the Wall Street Journal, minimally invasive approach should have meant less recovery time for the mother of 6 children. Dr. Reed learned a few days after the surgery which was performed at Brigham and Women’s Hospital that she had a uterine leiomyosarcoma and the morcellation may have worsened her prognosis by spreading the cancer around her abdomen. Since then, Dr. Reed’s husband, cardiothoracic surgeon Hooman Noorchashm, MD, PhD, has led a campaign calling for a ban on morcellation. The medical community has responded in various ways, culminating with the US Food and Drug Administration (FDA) announcing on April 17 that it discourages the use of laparoscopic power morcellators in most hysterectomy and myomectomy procedures because of the risk of spreading unsuspected cancerous tissue.
If you have undergone a laparoscopic myomectomy (removal of uterine fibroid procedure), or a hysterectomy (removal of your uterus), and developed uterine cancer, leiomyosarcoma, or another cancer that has spread throughout your body, contact us immediately. We would like to speak to you and help you with your case.
