Johnson & Johnson and other makers of laparoscopic power morcellators are facing growing criticism over the potentially defective surgical devices, which may inadvertently spread cancer in women undergoing hysterectomy or myomectomy procedures. In women diagnosed with metastatic leiomyosarcoma following surgery with power morcellation, the likelihood of long-term survival is significantly worsened, dropping from 50% to between 4% and 16%. If you believe you have been adversely affected by a hysterectomy or myomectomy surgery with power morcellation, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medical devices, and can help put you in touch with a qualified attorney, who can help you pursue compensation through a morcellation cancer lawsuit.
Women undergoing hysterectomy or myomectomy procedures are routinely screened for uterine cancer prior to undergoing surgery, in order to reduce the risk of cancerous tissue being spread throughout the body with the use of power morcellation. However, while most cancers can be diagnosed prior to surgery, a rare type of cancer called leiomyosarcoma, or uterine sarcoma, is often undetectable in medical imaging and preoperative testing. In most cases, this aggressive cancer is diagnosed after surgery, when the tissues are examined by a pathologist. However, if power morcellation is used to extract the cancerous tissue, the undiagnosed cancer may have been spread throughout the body. For this reason, women undergoing hysterectomy or myomectomy procedures are searching for alternative treatment options, including the following:
April 2014 – The FDA issues a safety announcement advising against the use of laparoscopic power morcellation during hysterectomy and myomectomy procedures, citing a risk of unsuspected sarcoma being spread throughout the body.
July 2014 – The FDA convenes the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the alleged safety risks of power morcellation.
July 2014 – Johnson & Johnson suspends worldwide sales of its Gynecare Morcellex, Morcellex Sigma Tissue Morcellator System, and Gynecare X-Tract Tissue Morcellator laparoscopic power morcellator devices.
November 2014 – An updated safety communication issued by the FDA warns against “the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
May 2015 – The FBI launches an investigation into what exactly Johnson & Johnson knew about the health risks of power morcellators before pulling its devices off the market in 2014.
November 2015 – On the heels of several power morcellation lawsuits, the U.S. Government Accountability Office announces that it will be investigating the safety of power morcellator devices.
December 2013 – The Society of Gynecologic Oncology (SGO) advises physicians and patients to discuss the risks and benefits of power morcellators before reaching a decision about using the medical devices for hysterectomy or myomectomy procedures.
January 2014 – An editorial published in The Lancet Oncology highlights the case of a woman diagnosed with stage-four leiomyosarcoma following morcellation of presumed benign uterine fibroids.
September 2014 – Research published in the Journal of the American Medical Association finds that one of every 368 women who undergo surgery with power morcellation had unsuspected uterine cancer identified during or after their procedures.
December 2014 – A retrospective review published in the American Journal of Obstetrics & Gynecology indicates that 0.6% of women who underwent laparoscopic hysterectomy with power morcellation were diagnosed with uterine sarcoma.
April 2015 – Researchers from the University of Michigan find that one in 368 women undergoing a hysterectomy or uterine fibroid removal surgery have undetected uterine sarcoma, which can spread throughout the abdomen during power morcellation.
April 2015 – Women who undergo power morcellation for hysterectomies face a greater risk of undetected cancer being spread throughout the body than women who undergo morcellation for myomectomies, according to research published in JAMA Oncology.
August 2015 – An American Journal of Obstetrics & Gynecology study conducted by researchers at the University of Michigan analyzes hysterectomies performed during a 16-month period following the 2014 FDA warning, and finds that the use of power morcellator devices dropped by 4.1%.
November 2015 – Research conducted by the Boston University Medical Center indicates that “the risk of morcellating cancer is much higher than previously understood.”
According to estimates by the FDA, power morcellators are used in approximately 60,000 hysterectomy and myomectomy procedures every year, and new information suggests that the manufacturers of power morcellators like Johnson & Johnson’s Gynecare Morcellex knew or should have known about the unreasonable risk of cancer associated with morcellation during a hysterectomy or uterine fibroid surgery, yet failed to provide consumers and the medical community with adequate warnings about the potential side effects. As a result, women and their families across the country filing legal claims against the makers of power morcellation devices allege the following:
According to the latest reports regarding the risks associated with power morcellators, the removal of broken up fibroids and tissues may not be 100% effective, and if any of the tissues left behind contain cancer, the cancerous tissue can be spread to other areas of the body, leading to the development of potentially life-threatening tumors. If you have been diagnosed with leiomyosarcoma (LMS) uterine sarcoma, or another type of cancer you believe was spread during surgery by a power morcellator device, contact an experienced morcellation cancer lawyer today for legal help. You may have grounds to file a product liability lawsuit against the maker of the allegedly defective medical device, in order to pursue financial compensation for your injuries and medical expenses.