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Morcellation Media Monitoring 12/07/2015
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Incidence of Undetected Cancer in Patients Undergoing Gynecologic Surgery for a Benign Condition Higher Than Estimated
Dec 4, 2015 | Onclology Nurse Advisor
By Kathy Boltz
At the time of gynecologic surgery for disease, an unsuspected cancer that was thought to be benign was found in 1 in 352 women. This study was published in the journal Women's Health Issues -
Federal Panel Sets Up Morcellator Cancer MDL
Dec 3, 2015 | Top Class Actions
By Paul Tassin
Fifteen morcellator cancer lawsuits have been consolidated into a single multidistrict litigation in a federal court in Kansas. -
Power Morcellator Lawsuits Consolidated In Kansas Before Judge Kathryn H. Vratil
Dec 5, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on details of laparoscopic power morcellation lawsuits included in multidistrict litigation number 2652. These cases were consolidated to form the MDL by the Judicial Panel on Multidistrict Litigation on October 15th, of 2015. The cases are being overseen by the Honorable Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas. It is expected that the number of cases involved in the MDL will continue to increase as additional women are diagnosed with cancer after undergoing laparoscopic power morcellation procedures on uterine fibroids.
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Dec 4, 2015 | Onclology Nurse Advisor
By Kathy Boltz
At the time of gynecologic surgery for disease, an unsuspected cancer that was thought to be benign was found in 1 in 352 women. This study was published in the journal Women's Health Issues(doi:10.1016/j.whi.2015.09.008).
Minimally invasive gynecologic surgeries have advantages for patients, including shorter hospital stays, quicker recoveries, and less pain. However, power morcellation, a technique that cuts the uterus or fibroid into small pieces for extraction from the abdomen through a small incision, may worsen a woman's prognosis if the morcellated tissue is a cancer.
Using a national insurance database of 55 million women, Boston Medical Center (BMC) researchers in Massachusetts looked at cases from 19 500 women who underwent laparoscopic hysterectomies or myomectomies, procedures that typically incorporate power morcellation. They sought to determine how frequently cancer is diagnosed in women after undergoing gynecologic surgery for a problem believed to be benign.
"Our findings show that the risk for morcellating cancer is much higher than previously understood," said senior author Michael Paasche-Orlow, MD, MPH, general internal medicine physician at BMC and associate professor of medicine at Boston University School of Medicine (BUSM). "It makes sense to avoid morcellation for women with cancerous or precancerous lesions. As it is difficult to ascertain in advance, safer alternatives are needed."
The study also determined that more than half of the patients who received a diagnosis of uterine cancer or endometrial hyperplasia, a precancerous condition of the lining of the uterus, did not undergo endometrial testing prior to surgery. Thus, researchers suggest improving how physicians evaluate patients undergoing hysterectomies or myomectomies before they reach the operating room.
"We are continually seeking opportunities to move gynecologic surgery forward," said lead author Rebecca Perkins, MD, a practicing gynecologist at BMC and associate professor of obstetrics and gynecology at BUSM. "Because minimally invasive surgery has many advantages, future research should seek to improve techniques to create safer procedures for women."
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Federal Panel Sets Up Morcellator Cancer MDL
Dec 3, 2015 | Top Class Actions
By Paul Tassin
Fifteen morcellator cancer lawsuits have been consolidated into a single multidistrict litigation in a federal court in Kansas.
In an order filed on Oct. 15, the federal Judicial Panel on Multidistrict Litigation (JPML) established a multidistrict litigation consisting of claims against Ethicon Inc., the manufacturer of power morcellators used in laparoscopic gynecological surgery.
Plaintiffs in these morcellator cancer lawsuits generally allege that the power morcellator used during their hysterectomy or uterine fibroid surgery caused an aggravation of previously undetected cancer.
The MDL will be overseen by Judge Kathryn H. Vratil of the U.S. District Court for the District of Kansas. Future morcellator cancer lawsuits against Ethicon will be transferred into this MDL.
Ethicon is a subsidiary of Johnson & Johnson, who is also named as a defendant in some of the transferred morcellator cancer lawsuits.
Morcellation Cancer
Power morcellators are surgical devices used to remove larger masses of tissue through smaller incisions used during laparoscopic surgery. It lets patients undergoing hysterectomy or myomectomy enjoy the advantages that laparoscopic surgery has over open abdominal surgery: shorter recovery time, smaller scars, less pain, less loss of blood, and reduced risk of infection.
The problem with power morcellators that has created so much recent controversy is the possibility that morcellation can inadvertently spread previously undetected cancerous tissue throughout the body, causing the cancer to progress and upstage.
The risk is a particular problem for patients undergoing laparoscopic gynecological surgery. By one estimate, about one out of 350 women undergoing uterine fibroid surgery has a uterine sarcoma. Uterine sarcomas themselves are difficult to diagnose – a uterine biopsy may only detect about 30 percent of sarcomas, and magnetic resonance imaging may also fail to reveal the cancer.
In April 2014, the FDA issued a warning about the risk of morcellator cancer. The agency recommended that doctors and patients take that risk into consideration before deciding to use a power morcellator. The FDA followed up that warning a few months later with a new and stronger warning to be included in the labeling for power morcellators.
Ethicon has since taken its morcellators off the market and encouraged doctors to stop using them. Other companies are still making and selling their own models, however.
One patient whose cancer was aggravated after morcellation has become an advocate for stronger protection against morcellation cancer. Amy R., herself a doctor, was diagnosed with cancer after undergoing uterine fibroid surgery using a power morcellator. She has since had to undergo several rounds of surgery, chemotherapy and radiation therapy. Recently her cancer was discovered to have recurred in her spine.
Amy says that more action taken sooner could have prevented her own situation and that of hundreds of other women. She and her husband say they have spoken with FBI investigators about the device. Amy’s husband, who is also a doctor, says they began contacting the FBI in late 2013 and eventually got a response from agents in New Jersey. The FBI is reportedly now investigating what Johnson & Johnson knew about the risks involved in power morcellation.
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Power Morcellator Lawsuits Consolidated In Kansas Before Judge Kathryn H. Vratil
Dec 5, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on details of laparoscopic power morcellation lawsuits included in multidistrict litigation number 2652. These cases were consolidated to form the MDL by the Judicial Panel on Multidistrict Litigation on October 15th, of 2015. The cases are being overseen by the Honorable Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas. It is expected that the number of cases involved in the MDL will continue to increase as additional women are diagnosed with cancer after undergoing laparoscopic power morcellation procedures on uterine fibroids.
Current lawsuits are made up of power morcellator victims or family members filing suit for these victims who have since passed away due to high-grade cancer. These plaintiffs requested the MDL in order to allow them to maintain their individual lawsuits, yet fast-track the initial litigation process. MDL consolidation helps to avoid duplicate discovery and different rulings from multiple judges while saving time and money for all involved. Although the defendant was opposed to this consolidation, the JPML moved ahead with it.
Power morcellation was the subject of an April, 2014 safety warning issued by the U.S. Food and Drug Administration which announced that women should refrain from undergoing procedures involving the tool during hysterectomies and myomectomies for uterine fibroids due to the risk of spreading previously undetected cancer cells throughout the body. The FDA additionally announced that an estimated 1 in every 350 women who undergo these gynecological procedures have unsuspected uterine cancer cells. If these cells are encapsulated within a uterine fibroid, they become virtually impossible to detect prior to surgery.
When these women undergo power morcellation on their uterine fibroids, the tool enters their abdomen through a small incision where it spins tiny blades designed to shred the uterine fibroid tissue. In doing so, however, plaintiffs allege that the tool exposes and spreads cancer cells, accelerating the cancer and significantly decreasing the likelihood of long-term survival.
The attorneys at Tracey & Fox believe that anyone who has undergone laparoscopic power morcellation and who was subsequently diagnosed with cancer should have the opportunity to explore their legal rights. They are working to ensure this, and therefore offer anyone involved free legal consultations. The women affected may be entitled to significant compensation.
To request additional information regarding power morcellation lawsuits, or to ask questions, feel free to contact the attorneys at Tracey & Fox by calling (713) 322-5375.
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