David Randolph Smith & Associates is currently investigating legal claims involving women who have received a diagnosis for cancer after undergoing a hysterectomy or fibroid removal surgery.
Power morcellators, first approved in the mid-1990s, are widely used in minimally invasive (laparoscopic) hysterectomies and uterine fibroid removal procedures. These small bladed devices allow surgeons to cut the uterus or fibroid tissues into small parts, for easy removal through a laparoscopic tube inserted through a small incision in the patient’s abdomen.
For women who may have previously undiagnosed cancer or sarcoma, there is a serious risk of the device spreading cancerous cells inside the body. Recent medical studies published in the Journal of the American Medical Association in March 2014, and the much publicized story of 40 year old Boston doctor Amy Reed, (see video below) who herself has developed cancer after undergoing a hysterectomy using a power morcellation procedure, has prompted the medical community, federal regulators and lawyers to question whether or not these devices pose a serious health risk to women.
Power Morcellator devices include:
Gynecare Morcellex Tissue Morcellator
Morcellex Sigma Tissue Morcellator System
Gynecare X-Tract Tissue Morcellator
Power morcellators may also be used in spleen (splenectomy) or in laparoscopic renal (nephrectomy) surgery.
On April 17, 2014 the FDA issued a safety communication, warning doctors and women that laparoscopic robotic hysterectomies, and fibroid removal surgeries conducted with the use of a power morcellation device, could cause the spread of aggressive uterine cancers. The FDA stated, “Based on an analysis of currently available data, the FDA has determined that approximately one in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma (leiomyosarcoma). If laparoscopic power morcellation is performed in these women, 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.” Today there are more than a dozen power morcellator devices on the market, but shortly after the FDA issued its warning in April, Ethicon360, a division of Johnson & Johnson and the largest manufacturer of power morcellators, took the decision to suspend sales of its device.
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