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:
Power morcellators are medical devices commonly used in hysterectomy procedures and uterine fibroid (myomectomy) surgery, because they allow surgeons to cut up the uterus or fibroids and remove the tissue through a small incision in the abdomen, thereby reducing recovery time and the risk of surgical complications. However, a large percentage of women undergoing a hysterectomy or uterine fibroid removal surgery with a power morcellator may have undiagnosed sarcoma, a type of malignant cancer, and use of the morcellator may actually result in the devastating spread of cancerous tissue throughout the pelvis and abdomen. Power morcellators may be used during the following procedures:
The first power morcellator was approved by the U.S. Food and Drug Administration (FDA) in 1995, and the surgical devices have grown in popularity in recent years for hysterectomy or uterine fibroid removal procedures among women with uterine fibroids. However, mounting research has questioned the safety of surgery using power morcellators, and reports indicate that one out of every 350 women who undergo a hysterectomy or myomectomy with morcellation may have an undiagnosed sarcoma. This may result in the spread of an aggressive type of cancer known as leiomyosarcoma (LMS) uterine sarcoma, which may have been contained had morcellation not been used during surgery.
Johnson & Johnson’s Ethicon unit was the largest seller of power morcellators in the past, until the FDA issued a public health advisory in April 2014, warning that power morcellators used during hysterectomy and myomectomy procedures may cause cancerous tissue to spread throughout the pelvis and abdomen. In response to this alleged risk of the dissemination of deadly uterine cancer, Johnson & Johnson announced in July 2014 its plans to ask doctors to return the company’s power morcellators, in what J&J called a “worldwide market withdrawal” of all Ethicon morcellation devices that remained on the market in the United States.
The FDA issued the first warning about the alleged morcellation cancer risk in April 2014, when the agency advised the medical community to avoid using morcellators during surgery for uterine fibroid removal. Power morcellators used in recent years may include Ethicon Gynecare Morcellex, Blue Endo MoreSolution Tissue Morcellator and Karl Storz Rotocut G1 Morcellator, among others. Compensation may be available for women diagnosed with leiomyosarcoma (LMS) uterine sarcoma or other types of cancer that may have been spread by morcellation during one of the following procedures:
March 2014 – A high-profile lawsuit is filed in a Philadelphia federal court on behalf of a woman who died from metastatic leiomyosarcoma, despite having no evidence of metastatic cancer before undergoing a hysterectomy with power morcellation.
May 2014 – Karl Storz Endoscopy America, the maker of the Karl Storz Rotocut Morcellator, faces a product liability lawsuit brought on behalf of a Florida woman who underwent a hysterectomy in 2013, and soon after, was diagnosed with disseminated endometrial stromal sarcoma.
May 2014 – A New York woman files a power morcellation lawsuit against Ethicon, after being diagnosed with acute uterine leiomyosarcoma following her hysterectomy procedure.
January 2015 – Karl Storz faces another product liability lawsuit filed on behalf of a woman who underwent a hysterectomy with power morcellation, and was subsequently diagnosed with a stage-four cancer that had spread to her bones and breasts.
June 2015 – A power morcellation lawsuit is filed against Brigham & Women’s Hospital on behalf of a woman who died in December 2013 from leiomyosarcoma after undergoing a hysterectomy at the Boston, Massachusetts hospital.
July 2015 – A product liability complaint is filed in New Jersey court on behalf of a 43-year-old woman who died from leiomyosarcoma cancer following the use of power morcellation during her hysterectomy procedure.
July 2015 – One of the first power morcellator lawsuits filed in federal court is settled for an undisclosed amount.
October 2015 – A power morcellation lawsuit is brought in Philadelphia against the manufacturer of the PKS PlasmaSORD Bipolar Morcellator, alleging that use of the medical device caused the spread of cancer cells throughout the plaintiff’s abdomen.
October 2015 – The Judicial Panel on Multidistrict Litigation centralizes all power morcellation lawsuits before U.S. District Judge Kathryn H. Vratil in the District of Kansas, for coordinated pretrial proceedings as part of an MDL.
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.