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Morcellation Media Monitoring 4/2/2015
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Morcellation risk outweighed by risks of laparotomy
Apr 1, 2015 | Modern Medicine Network
By Judith M. Orvos ELS, Miranda Hester
A new study that modeled outcomes for treatment of fibroids with laparoscopic plus morcellation versus an abdominal procedure indicates that risks of an open procedure outweigh those associated with potentially morcellating a leiomyosarcoma. The findings, for a hypothetical cohort of 100,000 premenopausal women with a 5-year time horizon, could help better inform decision-making about morcellation. -
Studies: Increased Risk Of Uterine Cancer Post Morcellation Surgeries
Mar 31, 2015 | Top Class Actions
By Ashley Vanover
Two new studies are adding to mounting evidence that surgery tools known as power morcellators can spread hidden uterine cancer. The medical devices already face scrutiny from the U.S. Food and Drug Administration (FDA), which has warned about the cancer risk and has imposed restrictions on their use. -
Woman Who Fought To Ban Power Morcellator Faces Cancer Recurrence
Apr 1, 2015 | Fighting Injustice
By Jennifer Walker-Journey
*Note this article is sponsored by Beasley Allen Law Firm. The doctor who launched a campaign to ban a commonly used gynecology surgical tool called a power morcellator because it can spread undetecteduterine cancer and worsen a woman’s odds of survival, announced she has suffered a recurrence of the deadly disease. -
Power Morcellator Lawsuit Filed by Southern Med Law Alleges Wife’s Death Resulted from Cancer Spread via Uterine Morcellation
Mar 31, 2015 | PR Web
By Southern Med Law
The complaint, which was filed by her husband and is currently pending in the U.S. District Court, Eastern District of Pennsylvania, alleges that the power morcellator used during her March 2012 hysterectomy was responsible for spreading the undiagnosed malignancy. The Morcellator lawsuit names LiNA Medical US d/b/a LiNA Medical, Blue Endo and Ethicon Inc. as defendants. The original power morcellator cancer lawsuit was originally filed the women was still living. The complaint has recently been amended and refiled to reflect the women's passing.
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Morcellation risk outweighed by risks of laparotomy
Apr 1, 2015 | Modern Medicine Network
By Judith M. Orvos ELS, Miranda Hester
A new study that modeled outcomes for treatment of fibroids with laparoscopic plus morcellation versus an abdominal procedure indicates that risks of an open procedure outweigh those associated with potentially morcellating a leiomyosarcoma. The findings, for a hypothetical cohort of 100,000 premenopausal women with a 5-year time horizon, could help better inform decision-making about morcellation.
Published in the American Journal of Obstetrics & Gynecology, the decision-tree analysis predicted fewer overall deaths with laparoscopic hysterectomy than with an abdominal procedure (98 vs 103 per 100,000). Risk of leiomyosarcoma-related deaths was higher with laparoscopy (86 vs 71 per 100,000) but risk of hysterectomy-related death was higher with an abdominal procedure (32 vs 12 per 100,000). The authors chose the study design because of the challenge inherent in doing a prospective study in this area but noted that data are lacking on the incidence of occult leiomyosarcoma associated with uterine procedures for “benign” fibroids and on how morcellation impacts those masses.
For the study, researchers from the University of North Carolina School of Medicine focused on a cohort of 100,000 because an estimated 200,000 hysterectomies are performed annually in the United States. Existing published data—largely from high-quality studies and more recent publications—were analyzed and morbidity and mortality outcomes were evaluated extending out 5 years. In arriving at the conclusion about risks, the model took into account the reality that women can experience multiple adverse events simultaneously.
Transfusion, abdominal wound infection, vaginal cuff dehiscence, venous thromboembolism (VTE), incisional hernia, leiomyosarcoma and death from leiomyosarcoma or hysterectomy were the surgical outcomes assessed. For laparoscopic surgery, rates of transfusion, VTE, and incisional hernia were lower for laparoscopic surgery than for abdominal hysterectomy (2400 vs 4700, 1500 vs 6300, and 710 vs 8800, respectively, all per 100,000), whereas rates of vaginal cuff dehiscence were higher (640 vs 290 per 100,000).
Estimates of death from leiomyosarcoma were based on data from Surveillance, Epidemiology and End Results reports and incidence of leiomysarcoma in women undergoing hysterectomy for presumed fibroids was based on data from 10 studies.
“On average,” the authors stated, “women who undergo laparoscopic hysterectomy experience an additional 0.85 quality-adjusted life years over 5 years (1.02 months), compared with women who undergo abdominal hysterectomy.” In concluding, they acknowledged a need for further researcher on morcellation, calling for “new diagnostics to preoperatively distinguish benign from malignant myomata” and “enhanced methods of tissue extraction.”
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Studies: Increased Risk Of Uterine Cancer Post Morcellation Surgeries
Mar 31, 2015 | Top Class Actions
By Ashley Vanover
Two new studies are adding to mounting evidence that surgery tools known as power morcellators can spread hidden uterine cancer. The medical devices already face scrutiny from the U.S. Food and Drug Administration (FDA), which has warned about the cancer risk and has imposed restrictions on their use.
A University of Michigan study published last month in Obstetrics & Gynecology found that one in 368 women undergoing a hysterectomy or uterine fibroid surgery had undetected uterine sarcoma. Cells from these cancers, including a deadly type called leiomyosarcoma, could be spread throughout the abdomen when a morcellator is used during the surgery. The effect can upstage the cancer, making it more difficult to treat.
Researchers gathered information from nearly 7,500 women who had hysterectomies to conduct their study.
“No reliable predictors of uterine sarcoma exist and caution is warranted in preoperative planning for hysterectomy,” study authors concluded.
In the second study, researchers from Columbia University found lower rates of uterine cancer in women who underwent myomectomy procedures, which involve the removal of uterine fibroids while keeping the uterus intact, with the intent to preserve a woman’s ability to have children.
In their study, uterine cancer was found in one of 528 women who underwent myomectomy procedures without the use of power morcellators, and in one in 1,073 who did undergo a myomectomy with morcellation. They found that the rate of any pathologic finding, such as cancer in women who did not have morcellation surgery was one in 150 and 1 in 230 for women who have a morcellator used during surgery.
The researchers said that while the risk of uterine cancer for women who underwent uterine fibroid surgery, usually performed in younger women, is rare, that risk appears to increase with age.
Risks and Side Effects of Power Morcellators
Power morcellators can allow surgeons to perform minimally invasive surgery of large tissue that otherwise could not be pulled through small incisions. However, power morcellation is currently under critical review by the FDA as it considers banning the device due to the potentially life-threatening risks associated with its use, especially during laparoscopic surgery.
One of the most alarming risks associated with power morcellators is the potential for the device to spread and upstage undetected malignant uterine cancer during a laparoscopic hysterectomy or myomectomy, significantly worsening a patient’s cancer prognosis.
While this risk is difficult to calculate, the FDA has concluded that there is no reliable method for preoperatively predicting whether a woman with uterine fibroids may have a uterine sarcoma.
Based on a quantitative assessment of power morcellation released in April, the FDA states that one in 350 women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids has an undetected uterine cancer, such as leiomyosarcoma, a particularly aggressive uterine sarcoma with an already poor prognosis.
Power Morcellator Lawsuits
Women who have been harmed by power morcellators are beginning to file power morcellator cancer lawsuits against the manufacturers of power morcellators for their allegedly dangerous products. Some women died from their upstaged cancers, and their families also filed morcellation cancer lawsuits against the device manufacturers.
If you have been diagnosed with a uterine sarcoma after a surgery involving a power morcellator, or had fibroids or uterine tissue removed from other organs after such a surgery, you should consult an attorney to assess your legal options.
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Woman Who Fought To Ban Power Morcellator Faces Cancer Recurrence
Apr 1, 2015 | Fighting Injustice
By Jennifer Walker-Journey
The doctor who launched a campaign to ban a commonly used gynecology surgical tool called a power morcellator because it can spread undetecteduterine cancer and worsen a woman’s odds of survival, announced she has suffered a recurrence of the deadly disease.
Amy Reed, 41, did not set out to be an advocate for women’s health issues. The issue sort of fell into her lap. Reed, an anesthesiologist, and her husband, a heart surgeon, live in Pennsylvania with their six children.
In October 2013, Reed underwent a hysterectomy to remove what doctors thought were benign uterine fibroids. Doctors removed her uterus using alaparoscopic power morcellator, a surgical tool fitted with a blade that minces the uterus or uterine fibroids inside the body and removes them through a small incision in the abdomen.
Power morcellation is used in about 50,000 hysterectomies or myomectomies (removal of uterine fibroids) each year in the United States. The procedures are often favored over open surgeries because they are less invasive, leave less scar tissue, and offer shorter recovery time.
What doctors didn’t realize was that Reed actually had a type of uterine cancer known as uterine sarcoma, orleiomyosarcoma. There are no reliable methods to diagnose this rare type of uterine cancer without first removing the tissue. The process of power morcellation scattered bits of cancerous tissue throughout Reed’s abdomen, seeding new cancer growth and making the disease more difficult to treat.
Reed was diagnosed with uterine sarcoma shortly after undergoing power morcellation surgery and was in remission. During that time she and her husband launched a campaign to ban the devices. Their efforts led the Food and Drug Administration (FDA) to launch a review that resulted in the agency strongly discouraging use of power morcellation in most women. Several hospitals vowed to drastically cut back on procedures using the surgical tools, and some insurance companies announced they would no longer cover the cost of the procedures.
The victory is bittersweet for Reed, however. In February, she learned her cancer had returned. She had surgery to remove a small tumor in the bony part of her spinal column and will receive radiation.
“There are some days when I feel, yeah, we’ve won,” she told Philly.com. “But most of the time, it’s completely frustrating that these devices are still out there and there are doctors – albeit not many – using them. Morcellation makes cancer worse.”
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Mar 31, 2015 | PR Web
By Southern Med Law
Dr. François Blaudeau, the founder of Southern Med Law, is serving as Lead Counsel in a power morcellator lawsuit filed on behalf of a Pennsylvania woman who died as a result of metastatic leiomyosarcoma, a rare and aggressive form of uterine cancer, in February 2013. The complaint, which was filed by her husband and is currently pending in the U.S. District Court, Eastern District of Pennsylvania, alleges that the power morcellator used during her March 2012 hysterectomy was responsible for spreading the undiagnosed malignancy. The Morcellator lawsuit names LiNA Medical US d/b/a LiNA Medical, Blue Endo and Ethicon Inc. as defendants. The original power morcellator cancer lawsuit was originally filed the women was still living. The complaint has recently been amended and refiled to reflect the women's passing.(No. 5:14-cv-1557)
As both an attorney and practicing obstetrician/ gynecologist with a specialization in advanced gynecological surgery, Dr. Blaudeau possesses a unique understanding of the issues at the center of this complaint.
According to the complaint, the Decedent underwent a minimally invasive hysterectomy in March 2012, just nine days before she was diagnosed with leiomyosarcoma. Her husband charges that the device, which shreds uterine tissue into small pieces so that it may be removed via a small incision in the abdomen, “seeded” undetected cancer cells into her peritoneal cavity. The lawsuit further alleges that the manufacturers of power morcellators knew of this risk, but concealed the danger from U.S. health regulators and the medical community.
Court documents indicate the potential for the spread of cancer through power morcellation, and that In April 2014, the U.S. Food & Drug Administration (FDA) expressly discouraged surgeons from using power morcellators to perform hysterectomies or myomectomies because of their potential to spread undetected cancer cells beyond the uterus. The FDA’s warning pointed out that uterine cancer is difficult to detect prior to surgery, and that spread of such a malignancy via a power morcellator greatly reduces a woman’s chances for long-term survival. And In November 2014, the FDA again warned against the use of power morcellators, stating that the devices should be avoided in the vast majority of women who require hysterectomy or myomectomy. According to the agency, this patient population includes women who are in menopause, about to enter menopause, or those who are good candidates for minimally invasive procedures that don’t require their use.
Dr. Blaudeau and the staff at Southern Med Law continue to offer free legal evaluations to those whose cancer was allegedly spread via uterine morcellation. If you or a woman you loved were diagnosed with uterine cancer following such a procedure, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation power morcellator lawsuit review by visiting http://www.southernmedlaw.com, or by calling the office directly at 205-547-5525.
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