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Morcellation Media Monitoring 2/9/2015
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Power Morcellators Under Fire in Canada and U.S.
Feb 6, 2015 | Top Class Actions
By Robert J. Boumis
Facing pressure from legal action and regulators in the United States, power morcellators are now facing new troubles in Canada. -
Michigan Woman Files Morcellator Cancer Lawsuit
Feb 6, 2015 | Surgical Watch
By Laura Woods
A Michigan woman has filed a morcellator cancerlawsuit against a medical supply company. Denise Whitfield claims the use of a power morcellator sold by Karl Storz Endoscopy caused her to suffer serious injuries, including metastasized Stage 4 bone and breast cancer. -
Risk of Disseminated Cancer After Laparoscopic Hysterectomy Assessed in Report
Feb 6, 2015 | About Lawsuits
By Irvin Jackson
A new study calls for more specific guidelines for use of power morcellators during laparoscopic hysterectomy surgeries, amid concerns that the devices can spread and disseminate cancer that is hidden in the uterus. -
OncoBriefs: Myeloma Frailty Score, Pancreatic Ca Survival
Feb 5, 2015 | MedPage Today
By Charles Bankhead
Women 60 or older had more than a 10-fold greater prevalence of uterine sarcoma as compared with women younger than 50, adding more data to inform use of power morcellation to treat uterine fibroids, a review of a government database showed.
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Power Morcellators Under Fire in Canada and U.S.
Feb 6, 2015 | Top Class Actions
By Robert J. Boumis
Facing pressure from legal action and regulators in the United States, power morcellators are now facing new troubles in Canada.
Power morcellators are a type of surgical tool used in some types of laparoscopic surgery and the removal of uterine fibroids. Laparoscopic surgery is a surgical procedure where surgeons use tiny cameras and specialized tools—like power morcellators—to perform the bulk of the surgery within the body of the patient. This allows surgeons to work inside a person while cutting through a minimal amount of healthy tissue.
But when surgeons have to remove something during surgery, like they do when performing a hysterectomy or removing uterine fibroids, surgeons have a very simple technical problem: the tissue they have to remove from the body is far too large to remove from the tiny incisions used in laparoscopic surgery. To solve this, surgeons use a tool called a power morcellator to cut the material into more manageable bits. However, many medical professionals within the United States and abroad have raised concerns that morcellation of uterine fibroids could have serious health consequences.
A major use of power morcellators is a group of procedures to remove uterine fibroids, a type of benign tumor in the uterus. Uterine fibroids are non-cancerous growths on the uterus, which may cause no symptoms or may cause a patient great pain. In some cases, surgeons can remove uterine fibroids directly, or in other cases they may perform a full hysterectomy to remove them. However, medical data has demonstrated that many women with uterine fibroids also have undiagnosed cancers in the tissues of their uterus, including a type of uterine cancer called leiomyosarcoma.
Some U.S. Food and Drug Administration (FDA) numbers indicate that as many as 1 in 300 women who have laparoscopic surgery may also have cancers like leiomyosarcoma (also known as uterine sarcoma). Additionally, medical research strongly suggests that the physical action of power morcellation may throw bits of cancerous tissue around in the abdomen, quickly spreading uterine cancer during a hysterectomy. One of the biggest factors that determines how serious and treatable a cancer depends how widespread the cancer is within the body. If the allegations about power morcellators are true, this could mean the surgical tool could give uterine cancer a “jump start.”Morcellation Cancer Warnings
In December of 2014, Health Canada made an announcement regarding the safety of power morcellators. Health Canada is a government agency responsible for public health in Canada and fills the same roles that the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and FDA play in the American government. In their announcement, Health Canada echoed many of the same concerns the FDA had raised about power morcellators during 2014.
South of the border, the FDA also made a major announcement about power morcellators in December of 2014, just days before Health Canada’s announcements. In a Safety Communication, the FDA announced that power morcellators would now carry a “black box” warning informing consumers and physicians of the the risk of spreading uterine cancer. A black box warning is the highest level of censure the FDA can issue short of a full-on recall. This came as a culmination of FDA announcements that date back to April of last year.
Additionally, in April of 2014, Johnson & Johnson’s Ethicon unit, the market leader of power morcellators, voluntarily suspended sales of their power morcellators over concerns of spreading uterine cancer. J&J and many other power morcellator manufacturers are currently facing several morcellation cancer lawsuits in federal courts across the United States.
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Michigan Woman Files Morcellator Cancer Lawsuit
Feb 6, 2015 | Surgical Watch
By Laura Woods
A Michigan woman has filed a morcellator cancerlawsuit against a medical supply company. Denise Whitfield claims the use of a power morcellator sold by Karl Storz Endoscopy caused her to suffer serious injuries, including metastasized Stage 4 bone and breast cancer.
“She must undergo extensive and difficult treatments for her advanced-stage cancer, including daily medications, regular injections and multiple rounds of radiation therapy,” states the claim. “Plaintiff has experienced the ill-effects of both her cancer and cancer treatments including, but not limited to, fatigue, body pain, joint pain, stiffness, inflammation, swelling, insomnia and gastrointestinal distress.”
Power morcellators are medical devices used in a variety of laparoscopic surgeries, including those to treat uterine fibroids. They are used to cut and shred tissue to enable the removal of the tissue through small incisions.Plaintiff alleges power morcellator gave her cancer
On June 14, 2011, Whitfield underwent a laparoscopic supracervical hysterectomy and a bilateral salpingectomy for the treatment of uterine fibroids. Her surgeon used the Rotocut G1 power morcellator for tissue morcellation. The surgeon used the device to cut, shred and remove her fibroid and uterus. Consequently, this procedure caused her to develop cancer outside the uterus.
In 2013, the plaintiff underwent a mammogram that did not reveal any signs of cancer. However, she was admitted to the hospital on July 17, 2014 through the emergency room for spinal surgery. During this stay, it was discovered that she was diagnosed with Stage 4 metastasized bone and breast cancer. The plaintiff alleges that she developed Stage 4 bone and breast cancer as a result of the use of the Rotocut G1 power morcellator.
Since her diagnosis, she has been forced to undergo extensive and intensive therapies to treat and manage her advanced-stage cancer. This includes daily hormone medications, regular injections of medications by her physicians and multiple ten-week rounds of radiation therapy. Consequently, fibroid removal surgery without the use of a morcellator typically poses nearly no danger of dissemination of cancerous cells, subsequent development of cancer outside the uterus and/or upstaging of cancer.
The side effects of her cancer and subsequent cancer treatments have caused Whitfield to suffer fatigue, body pain, joint pain, stiffness, inflammation, swelling, insomnia and gastrointestinal distress. She claims she would not have developed Stage 4 bone and breast cancer without the use of the Rotocut G1 power morcellator.
“The plaintiff, as a result of having to undergo this radiation treatment, has incurred out of pocket expenses for treatment,” states the claim. “Not only does plaintiff now face a shortened life-expectancy, but she must also regularly visit her oncologist and physicians to undergo a battery of treatment and tests for the remainder of her life. Had plaintiff known that she would develop Stage 4, metastasized breast and bone cancer, she would not have chosen to undergo morcellation.”Power morcellator cancer lawsuit
In her power morcellator lawsuit, Whitfield is suing the defendants on nine counts, including:Failure to Warn, Negligence, Breach of Express Warranty, Manufacturing Defect, Breach of Implied Warranty, Fraudulent Misrepresentation and OmissionDesign Defect, Strict Liability, Negligent Misrepresentation
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Risk of Disseminated Cancer After Laparoscopic Hysterectomy Assessed in Report
Feb 6, 2015 | About Lawsuits
By Irvin Jackson
A new study calls for more specific guidelines for use of power morcellators during laparoscopic hysterectomy surgeries, amid concerns that the devices can spread and disseminate cancer that is hidden in the uterus.
In a report published in the American Journal of Obstetrics & Gynecology (ACOG) on February 5, researchers from the Irvine Medical Center at the University of California indicated that preoperative evaluation before uterine fibroid surgery should be used to determine whether a woman is eligible for a laparoscopic hysterectomy with morcellation.
Power morcellators are medical devices increasingly used in recent years during minimally invasive hysterectomy and myomectomy procedures for uterine fibroids, allowing doctors to cut up the tissue and remove it through a small incision in the abdomen. This is designed to reduce recovery time, minimize scarring and avoid the risk of infections or other complications associated with traditional hysterectomy procedures.
This new call for more specific guidelines seems to contradict other reports that have suggested there is no way to make power morcellators safer and reliably evaluate the risk of disseminating cancer during laparoscopic hysterectomy procedures, given an inability to diagnose whether uterine fibroids are cancerous before they are removed.
Researchers looked at data used in a number of studies involving morcellation during a laparoscopic hysterectomy for uterine fibroid removal, and determined that the overall quality of data is low, even in studies that helped the FDA determine that doctors should avoid using power morcellators for uterine fibroid removal in April 2014.
Ultimately, the agency required new black box warnings on all power morcellators to alert doctors and patients of the risk of upstaging undiagnosed uterine sarcoma and leiomyosarcoma. The agency also contraindicated the use of power morcellators for most women.
This latest study from researchers at Irvine Medical Center challenges those conclusions to some degree, and called for new, specific recommendations that would help doctors screen patients more effectively for power morcellation procedures.
“There are limited data on the prevalence of sarcoma in morcellated specimens and even fewer cases and studies on the incidence of disseminated disease in patients who underwent minimally invasive surgical techniques with the use of power morcellation,” the study’s authors state. “Without reliable data, any recommendation on the safety of power morcellation is premature, given the known benefits of minimally invasive surgery on patient recovery and quality of life.”
During FDA advisory panel meetings this summer, a panel of independent experts convened to evaluate the cancer dissemination risk with laparoscopic hysterectomies concluded that there is no way to make power morcellators safe, given the estimation that about one in 350 women who undergo uterine fibroid removal have undiagnosed uterine cancer. The panel could not decide whether power morcellators should all be recalled or whether they should all include a black box warning, which is what the FDA ultimately decided to do.
“Specific guidelines for the use of power morcellation may be of benefit while awaiting advances in preoperative diagnosis of sarcomas. If preoperative evaluation raises suspicion for malignancy, morcellation clearly should be avoided,” the new study concludes. “Surgeons should review surgical alternatives that include laparotomy, mini-laparotomy, and colpotomy with possible manual morcellation vaginally or within an endoscopic bag.”
In another study published by ACOG in December, researchers from Kaiser Permanente indicated that there were no risk factors which helped determine which women may be at risk of power morcellation cancer, and said no such guidelines are currently reliable.
“There was no association between any of the factors analyzed and uterine sarcoma,” that study determined. “Uterine sarcoma was found in 0.6% of patients who underwent power morcellation but was not found to be significantly associated with any preoperative factors.”Laparoscopic Hysterectomy Cancer Lawsuits
In recent months, many health experts called for power morcellator recalls to be issued and have recommended that doctors stop performing the minimally invasive, laparoscopic hysterectomy procedures involving morcellation.
The Johnson & Johnson subsidiary Ethicon, which was previously responsible for manufacturing 70% of all power morcellators on the market, announced a that it will no longer manufacture morcellators, indicating that there is currently no way to make the devices safe.
A number of hospital systems, doctors and health insurance companies have turned away from the procedures entirely, deeming power morcellation too risky for women.
As more women and families learn about the link between the spread of cancer and hysterectomy procedures, a growing number of laparoscopic hysterectomy lawsuits over disseminated cancer have been filed against various manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
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OncoBriefs: Myeloma Frailty Score, Pancreatic Ca Survival
Feb 5, 2015 | MedPage Today
By Charles Bankhead
The combination of comorbidities, cognitive function, and physical status better characterized frail patients with myeloma as compared with conventional variables, according to theInternational Myeloma Working Group (IMWG).
Application of the IMWG frailty score to 869 older patients stratified the group into three categories of fitness: fit, intermediate fitness, and frail. The fitness categories correlated significantly with 3-year survival, Anthony Palumbo, MD, of the University of Torino in Italy, and co-authors reported online in Blood.ADVERTISEMENT
The findings lead off this edition of OncoBriefs.
Frailty and Survival in Older Patients With Myeloma
Traditionally, definitions of frailty in myeloma have centered on patient age, performance status, and the clinician assessment and judgment. To determine whether other characteristics might better define frailty, Palumbo and colleagues analyzed pooled data from three randomized clinical trials. All of the study participants underwent a baseline evaluation that included comorbid conditions, cognitive function, and physical status. The authors added chronologic age to the mix to arrive at a frailty score.
The results showed that fit patients (score of 0) accounted for 39% of the patients, followed by intermediate fitness (1, 31%), and frail (≥2, 30%). After a median follow-up of 18 months, the 3-year overall survival was 84% in fit patients, 76% in those with intermediate fitness scores (HR 1.61,P=0.042), and 57% in frail patients (HR 3.57, P<0.001).
The frequency of grade ≥3 nonhematologic adverse events also correlated with the frailty score, though less robustly than did survival. The fit patients had a 22.2% incidence of nonhematologic adverse events at 1 year, increasing to 26.4% in the intermediate group (HR 1.23, P=0.217) and 34.0% in the frail patients (HR 1.74, P<0.001). The rate of treatment discontinuation at 1 year increased from 16.5% in fit patients to 20.8% in those with intermediate fitness (HR 1.41, P=0.052) to 31.2% in the frail patients (HR 2.21,P<0.001).
"Chronologic age, performance status, and physician's clinical judgment are not sufficient to characterize the frail population," the authors concluded. "The geriatric assessment is a more sensitive predictor of clinical outcomes, and the proposed score may be adopted as a valid new standard to evaluate patients' frailty."
"The International Myeloma Working Group proposes this score for the measurement of frailty in designing future clinical trials," Palumbo and colleagues added.
Pancreatic Cancer Survival Doubles With Vaccine Duo
Treatment with two immunity-boosting vaccines led to a significant increase in overall survival in patients with advanced pancreatic cancer, including a twofold increase among patients who received at least three doses of therapy, as reported online in the Journal of Clinical Oncology.
Median overall survival was 6.1 months in patients who received the combination of a vaccine of GM-CSF secreting allogeneic pancreatic tumor cells and a bacteria-based vaccine that expressed mesothelin, a tumor-associated antigen targeted by the first vaccine. In contrast, patients who received only the tumor-cell derived vaccine had a median overall survival of 3.9 months.
In a prespecified analysis, patients who received at least two doses of the GM-CSF secreting vaccine and one of the antigen-expressing vaccine had a median overall survival of 9.7 months versus 4.6 months for those who received at least three doses of the single vaccine. The findings confirm those originally reported at the 2014 Gastrointestinal Cancers Symposium.
"This 56% improvement (2.2 months) is significant in a disease where effective first-line therapy -- gemcitabine plus nab-paclitaxel -- showed a 27% improvement over gemcitabine alone," Dung T. Le, MD, of Johns Hopkins, and colleagues concluded. "The stable disease rate of 31%, 1-year survival rate of 24%, and changes in CA19-9 levels that correlated with survival for the combination arm are encouraging."
A follow-up trial has already begun, comparing the vaccine combination and the mesothelin-expressing vaccine in patients with previously treated pancreatic cancer.
The trial evaluated the combination of GVAX pancreas (GM-CSF secreting pancreatic tumor cells) and CRS-207 (live-attenuated Listeria monocytogenes-expressing mesothelin). Investigators at 10 sites in the U.S. randomized and treated 90 patients 2:1 to receive two doses of GVAX pancreas administered with cyclophosphamide followed by four doses of CRS-207 or to receive six doses of GVAX plus cyclophosphamide.
The rationale for using the combination came from the complementary mechanisms of action: GVAX pancreas induces T-cell immunity to cancer antigens, including mesothelin. CRS-207 induces innate and adaptive immunity. Each vaccine had been evaluated separately in pancreatic ductal adenocarcinoma.
Age-Related Differences in Uterine Sarcoma Risk
Women 60 or older had more than a 10-fold greater prevalence of uterine sarcoma as compared with women younger than 50, adding more data to inform use of power morcellation to treat uterine fibroids, a review of a government database showed.
The 60+ group had a sarcoma prevalence of 1.53% compared with 0.13% for women younger than 50. Women 50 to 59 had an intermediate prevalence of 0.58%. The findings translated into uterine sarcoma rates of one in 769 in the youngest women and one in 65 in women ≥60.
"The wide, patient-centered variability in the estimates of the prevalence of uterine sarcoma requires that stakeholders reflect on this and come up with more patient-centered recommendations," Art Sedrakyan, MD, PhD, of Weill Cornell Medical College in New York City, and co-authors reported online in JAMA Surgery.
The analysis by Sedrakyan and colleagues included all women with newly diagnosed uterine sarcoma during 2008 through 2011 in the California registries of the NCISurveillance, Epidemiology, and End Results program. The prevalence estimates further refined previously published overall estimates of one in 352 and one in 368 women undergoing uterine morcellation procedures.
In 2014 the FDA issued two cautionary statements about the use of power morcellators to treat benign uterine fibroids. In April the agency expressed concern that treating benign conditions with the devices could lead to the disruption and dispersal of cells from undiagnosed uterine sarcoma and formally discouraged use of power morcellators during hysterectomy or removal of uterine fibroids. Subsequently, an FDA advisory committeeconcluded that information was insufficient to determine the magnitude of the cancer risk.
Late last year, the FDA issued a more strongly worded warning to avoid use of power morcellators in treating benign gynecologic conditions, introduced more contraindications, and ordered the addition of a black-box warning for the devices' packaging and labeling.
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