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Morcellation Media Monitoring 3/16/2015
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Cancer risk low in women with fibroids removed using morcellator
Mar 15, 2015 | Chicago Daily Herald
By Anna Edney
Women who had uterine fibroids removed with or without a medical device that chops up the growths had a low prevalence of cancer, a study found, adding new data to debate over risks from the technique. Known as power morcellators, the devices have come under scrutiny from regulators as potentially raising the risk of cancer, since fragments of undetected tumors could be spread during the procedure. A study published recently in the journal JAMA Oncology analyzed data on 41,777 women who had fibroids removed, 7.7 percent of whom underwent morcellation. -
Johns Hopkins Releases New Restrictions on Morcellation
Mar 13, 2015 | The Legal Examiner
By Eric T. Chaffin
Amidst concerns that power morcellators used during certain gynecological surgeries could potentially lead to serious cancer diagnoses, Johns Hopkins University has announced that they will no longer used the power tools or certain surgeries in postmenopausal women. -
SC Widower Files Power Morcellation Lawsuit Against Ethicon
Mar 13, 2015 | Top Class Actions
By Ashley Vanover
The husband of a South Carolina woman has filed a wrongful death lawsuit, just one of a growing number uterine cancer lawsuits involving power morcellators. Plaintiff John O. alleges that a device manufactured by Johnson & Johnson’s Ethicon subsidiary caused his wife’s cancer to be disseminated during a robotic partial hysterectomy. The complaint was filed on Feb. 3, following the death of Mrs. Cynthia O. due to the spread of a rare, malignant cancer called leiomyosarcoma. -
Presence of unexpected uterine sarcoma during myomectomy increases with age
Mar 12, 2015 | Healio
By Cameron Kelsall
The risk for unexpected uterine sarcoma in women undergoing myomectomy for presumed benign leiomyoma varied greatly across age groups, according to study results.
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Cancer risk low in women with fibroids removed using morcellator
Mar 15, 2015 | Chicago Daily Herald
By Anna Edney
Women who had uterine fibroids removed with or without a medical device that chops up the growths had a low prevalence of cancer, a study found, adding new data to debate over risks from the technique.
Known as power morcellators, the devices have come under scrutiny from regulators as potentially raising the risk of cancer, since fragments of undetected tumors could be spread during the procedure. A study published recently in the journal JAMA Oncology analyzed data on 41,777 women who had fibroids removed, 7.7 percent of whom underwent morcellation.
The study found that among women who had morcellation, 1 in 1,073 developed uterine cancer. In women who didn't have morcellation, 1 in 528 did.
Power morcellators are used to help surgeons remove a woman's uterus or the fibroids by cutting tissue into pieces that can be taken out through a small incision in the abdomen.
The Food and Drug Administration last year warned that most women shouldn't use the devices because of a risk they could spread undetected cancer cells in the uterine tissue. In November, HCA Holdings Inc., which operates 280 hospitals and surgery centers in the U.S. and England, said it would stop use of the devices. Johnson & Johnson, based in New Brunswick, New Jersey, suspended sales of its power morcellators last year after an FDA warning.
The study's conclusion that the surgical approach should be used with caution in women older than 50 is in line with the FDA's recommendation that a young woman who wants to keep her uterus intact may still be a candidate for the technique. The devices had been widely used despite a lack of conclusive data on cancer risk, according to the researchers.
"These events highlight the difficulty of evaluating, using and marketing surgical devices," said the researchers, led by Jason Wright, a gynecologic oncologist at Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital. "From a public health perspective, these findings highlight the need for more rigorous comparative effectiveness research and heightened regulatory oversight for new devices and procedures."
Risk also differed by age. Of women younger than 40 who had fibroids removed without morcellation, 0.05 percent had uterine cancer, compared to 3.4 percent in women 60 or older.
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Johns Hopkins Releases New Restrictions on Morcellation
Mar 13, 2015 | The Legal Examiner
By Eric T. Chaffin
Amidst concerns that power morcellators used during certain gynecological surgeries could potentially lead to serious cancer diagnoses, Johns Hopkins University has announced that they will no longer used the power tools or certain surgeries in postmenopausal women.
According to Oncology Practice, the University made the announcement in December 2014, stating that they had developed a new safety protocol surrounding power morcellation, to protect women going through minimally invasive surgeries.
FDA Warns of Risks with Power Morcellation
Power morcellators are tools that surgeons use during some uterine fibroid removal and hysterectomy procedures. It used to be that a woman’s only option was to go through traditional surgery requiring a long incision in the abdomen. Laparoscopic surgery, in which the surgeon uses a mini camera to perform the surgery through much smaller incisions, creates less blood loss and allows for a faster recovery. It requires, however, that surgeons use something to cut up larger tissues like fibroids and the uterus for removal through a small incision. That tool is the power morcellator.
For years, thousands of women benefitted from minimally invasive gynecological surgeries. In recent years, however, studies have shown that in rare cases, the morcellator—which cuts up larger tissues into smaller ones—could potentially spread cancerous tissues into other areas of the abdomen and the rest of the body, where they could re-seed other cancers.
In April 2014, the FDA released a safety communication warning that about one in 350 women undergoing hysterectomy or myomectomy for fibroids has an unsuspected type of uterine cancer. If doctors use a power morcellator on 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.”
Hospitals Considering Other Options
Since the FDA’s statement, a number of hospitals and medical centers have considered changes in policy regarding power morcellators. While they offer increased convenience for many women, the risks for some seem to outweigh the benefits.
Johns Hopkins will no longer use morcellation for fibroids or hysterectomies in women over the age of 50. They have also stated that when morcellation is used, it is to be only by surgeons with a lot of experience with the procedure, and who also use an endoscopy bag to catch any tissues that may be spilled or would otherwise escape to migrate to other areas of the body. They add that a number of cancer screening tests, including endometrial sampling and MRIs, are to be used prior to surgery to try to detect any potential cancers.
Pre-surgical screening is still an inexact science, however. So far, we have no test that will rule out the possibility of cancerous cells in fibroids, the uterus, or surrounding tissues, which means that even if tests come back clean, women may still be at risk of malignancy. Johns Hopkins has noted that women must be warned of the risks before opting for morcellation.
Women who went through morcellation without receiving these warnings and were then diagnosed with cancer may be eligible to file a personal injury lawsuit in an attempt to recover damages.
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SC Widower Files Power Morcellation Lawsuit Against Ethicon
Mar 13, 2015 | Top Class Actions
By Ashley Vanover
The husband of a South Carolina woman has filed a wrongful death lawsuit, just one of a growing number uterine cancer lawsuits involving power morcellators.
Plaintiff John O. alleges that a device manufactured by Johnson & Johnson’s Ethicon subsidiary caused his wife’s cancer to be disseminated during a robotic partial hysterectomy. The complaint was filed on Feb. 3, following the death of Mrs. Cynthia O. due to the spread of a rare, malignant cancer called leiomyosarcoma.
Cynthia underwent a total laparoscopic robotic power morcellationhysterectomy and cystoscopy in October 2012. During this surgical procedure, a power morcellator made and sold by J&J’s Ethicon division was used to cut, shred, and remove three large uterine fibroid specimens and to partially morcellate her uterus. Prior to her surgery, there was no evidence that she suffered from any form of leiomyosarcoma cancer.
However, the morcellation device allegedly caused Cynthia’s undiagnosed leiomyosarcoma cancer to spread throughout her abdomen, increasing the cancer from its earliest (and most treatable) stage to its most deadly form. She subsequently died of leiomyosarcoma cancer in September 2014.
FDA Warning Against Power Morcellators
Laparoscopic surgery offer benefits for many patients being treated for benign uterine fibroid tumors (leiomyomas), such as allowing for shorter postoperative recovery time, reduced risk of infection, and less pain compared with more invasive abdominal hysterectomy and myomectomy. When laparoscopic hysterectomy and myomectomy procedures are performed with the assistance of a power morcellator, the morcellator cuts the tissue into small fragments that may then be extracted via a small incision.
The U.S. Food and Drug Administration (FDA) issued an updated safety communication warning against the use of laparoscopic power morcellators during hysterectomy and myomectomy procedures in most women. The warning, released on Nov. 24, 2014, cites concerns that power morcellators “may contribute to the spread of occult gynecologic cancer cells” in female patients.
The FDA estimates that 1 out of 350 women who undergo hysterectomy or myomectomy for presumed uterine fibroids actually have unsuspected leiomyosarcoma, a malignant, cancerous tumor. When power morcellation is used during surgery, these women are at increased risk for development of dispersed cancer growth within the abdomen and pelvis, reducing the likelihood of long-term survival.
Power Morcellation Lawsuits
The power morcellation lawsuit accuses Ethicon of negligence, breach of implied warranties, loss of consortium and is seeking both compensatory and punitive damages. A jury trial has been demanded. John’s wrongful death lawsuit joins a growing number of similar power morcellation lawsuits that are now being pursued on behalf of individuals nationwide diagnosed with disseminated uterine cancer or leiomyosarcoma following a minimally invasive, laparoscopic surgery.
The Power Morcellation Lawsuit is Case No: 6:15-cv-00516-MGL, in the U.S. District Court for the District of South Carolina, Greenville Division.
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Presence of unexpected uterine sarcoma during myomectomy increases with age
Mar 12, 2015 | Healio
By Cameron Kelsall
The risk for unexpected uterine sarcoma in women undergoing myomectomy for presumed benign leiomyoma varied greatly across age groups, according to study results.
These data may help inform researchers of the risk for using morcellators to remove masses that are presumed to be benign.
“Our study represents an advancement in the understanding of the risk of unexpected uterine sarcoma in the setting of surgery for presumed benign leiomyoma,” Andrew S. Brohl, MD, of the department of hematology and medical oncology at Icahn School of Medicine at Mount Sinai, said in a press release. “Importantly, our risk model is the first to take into account how much a patient’s age affects her risk and shows that some age groups are at a much higher risk for unexpected uterine sarcoma than previous estimates imply.”
The FDA recently issued guidance recommending manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during power morcellation, increasing risks for morbidity and mortality.
The guidance also recommends laparoscopic power morcellators be contraindicated for women who are peri- or postmenopausal, as well as those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision.
Brohl and colleagues conducted a retrospective cohort study to determine the incidence of unexpected uterine sarcoma in women who underwent surgery for presumed benign leiomyoma. They also stratified risk by age.
The researchers evaluated data from 2,075 patients (mean age, 38.3 years) who underwent myomectomy at Mount Sinai between 2005 and 2014. The analysis also included data from eight additional studies, resulting in an aggregate population of 10,120 women.
Eighteen women were diagnosed with leiomyosarcoma following surgery, equating to an aggregate risk of 1.78 per 1,000 women (95% CI, 1.1-2.8). Eight additional women were diagnosed with endometrial stromal sarcoma, equating to an aggregate risk of 1.16 per 1,000 women (95% CI, 0.5-4.9). These diagnoses combined translated to a total risk estimate of uterine sarcoma of 2.94 per 1,000 women (95% CI, 1.8-4.1).
The analysis also included data from 8,365 women with uterine sarcoma identified using the SEER 18 database. Researchers compared the age of women in the SEER cohort at the time of diagnosis of uterine sarcoma with the ages of women in the retrospective cohort at the time of myomectomy surgery. The analysis assumed age-stratified risk following myomectomy would parallel the age-stratified ratio of incidence of uterine sarcoma to incidence of uterine leiomyoma requiring surgery.
Results of these analyses indicated the highest estimated risk for uterine sarcoma occurred in women aged 75 to 79 years (10.1 cases per 1,000 surgical procedures, or 1 in 98). The lowest risk occurred in women aged younger than 30 years (˂1 in 500). The risks increased from approximately 1 in 400 among women aged 35 to 44 years, to 1 in 304 among women aged 45 to 49 years, to 1 in 216 among women aged 50 to 54 years.
“Clinicians and expert groups can use this risk-prediction model to inform practice guidelines and to provide more accurate and more individualized counseling to patients who require surgical intervention for uterine fibroids or myomas,” Brohl said.
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