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Morcellation Media Monitoring 01/21/2016
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PA Congressman Calls For FDA Investigation Into Morcellator Cancer Deaths
Jan 20, 2016 | Top Class Actions
By Ashley Vanover
Republican Rep. Michael Fitzpatrick of Pennsylvania is seeking a criminal inquiry into deaths associated with the use of power morcellation devices, a surgical tool that can allegedly spread cancer in women when uterine fibroids are removed or hysterectomies are performed. -
Plaintiffs Note Potential Overuse Of Power Morcellator Tools And Suggest Link To Spreading Of Uterine Cancer
Jan 20, 2016 | Press Release
By Banville Law
Banville Law reports on recent data designed to evaluate whether laparoscopic hysterectomies are performed too frequently in the United States, which was spurred by a 2014 U.S. Food and Drug Administration safety warning issued regarding the use of this procedure to remove uterine fibroids, indicating that the surgical tool could spread previously undetected uterine sarcomas.
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PA Congressman Calls For FDA Investigation Into Morcellator Cancer Deaths
Jan 20, 2016 | Top Class Actions
By Ashley Vanover
Republican Rep. Michael Fitzpatrick of Pennsylvania is seeking a criminal inquiry into deaths associated with the use of power morcellation devices, a surgical tool that can allegedly spread cancer in women when uterine fibroids are removed or hysterectomies are performed.
On Dec. 18, 2015, Fitzpatrick sent a letter to George Karavetsos, head of the Office of Criminal Investigations at the Food and Drug Administration (FDA), requesting that the federal agency investigate alleged power morcellator cancer deaths at Brigham and Women’s Hospital, Rochester General Hospital, and University of Rochester Medical Center.
Fitzpatrick’s letter raises concerns about deaths of four women who underwent minimally invasive gynecological surgery including the removal of fibroids. In each case, there was undiagnosed cancer that was “upstaged and spread” by the morcellation procedure, which led to each woman’s death.
The lawmaker also questioned whether the power morcellator cancer deaths were properly reported to the FDA, noting that under Medical Device Reporting Regulations, hospitals must report to the FDA within 10 days information that “reasonably suggests that a device has or may have caused or contributed to the death of a patient in …[a given] … facility.”
Additionally, Fitzpatrick is asking for an investigation of the most prominent maker of morcellation devices, Ethicon, a subsidiary of Johnson & Johnson.
The hospitals named in the letter have released statements that they did not violate FDA regulations.
FDA: Morcellators Could Spread Cancer
A power morcellator uses small rotating blades to cut up uterine fibroid tumors into small pieces, allowing the growths to be removed laparoscopically through small incisions in the abdomen. Unfortunately, many women undergoing surgery via power morcellation were unaware that the medical device could spray undetected cancer cells throughout their bodies.
Because of the substantial risk of harm to female patients, the FDA has cautioned that power morcellators should not be used in most hysterectomy and myomectomy procedures.
The federal agency now believes that power morcellators could spread cancer in as many as one-in-352 cases. However, some gynecologists apparently disagree, insisting that the devices are safe when proper patient selection criteria is followed.
Still, the devices have become so controversial that the chief morcellator manufacturer Ethicon announced that they were halting all sales of their morcellator devices in 2014.
Power Morcellator Lawsuits
As the link between power morcellator use and advanced stage cancer becomes better understood, victims are coming forward.
All morcellator lawsuits related to the spread of cancer have been centralized in a Kansas federal court under U.S. District Judge Kathryn H. Vratil as part of a multidistrict litigation (MDL). More power morcellator cancer lawsuits are expected to be filed against Ethicon and a half dozen other manufacturers.
If you or a loved one developed cancer after undergoing morcellation surgery, you may be eligible to file a power morcellator lawsuit or a wrongful death lawsuit against the device manufacturer.
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Jan 20, 2016 | Press Release
By Banville Law
Banville Law reports on recent data designed to evaluate whether laparoscopic hysterectomies are performed too frequently in the United States, which was spurred by a 2014 U.S. Food and Drug Administration safety warning issued regarding the use of this procedure to remove uterine fibroids, indicating that the surgical tool could spread previously undetected uterine sarcomas.
The FDA’s warning also estimated that 1 out of every 350 women who currently undergo laparoscopic power morcellation during gynecological surgeries may have uterine cancer cells that they are completely unaware of. When cancer cells are encapsulated within a uterine fibroid, they are virtually impossible to detect without surgery.
The Centers for Disease Control and Prevention (CDC) released information noting that between the years of 2006 through 2010, about 11.7 percent of women ages 40-44 had undergone a hysterectomy. This is the equivalent of approximately 1 in 8 women. Across the nation, an estimated 650,000 hysterectomies are performed each year, and about 20 million women overall have had the procedure completed at one time in their life.
These numbers only grow as women increase in age. By 60 years of age, in fact, over one third of women have undergone hysterectomy procedures. Many of these are completed via laparoscopic power morcellation, which allows the surgery to be a minimally invasive one and offers the patient shorter recovery times. The National Women’s Health Network has warned that unnecessary hysterectomies have put many women at unnecessary risk, and that physicians should research alternative procedure possibilities before looking at these surgeries as the only option, due to their potentially life-altering side effects.
Plaintiffs involved in power morcellator lawsuits claim that uterine cancer cells are spread through the whipping, tissue-shredding motion of the morcellator device, which then accelerates the cancer cells and significantly impairs the patient’s chances of survival.
Recently, lawsuits filed against various power morcellator manufacturers have reached an all-time high, and continue to increase in number. Plaintiffs involved commonly claim that the devices can spread uterine sarcomas. Because of their common claims, those lawsuits filed against morcellator manufacturer Ethicon have been consolidated to form MDL No. 2652 in the U.S. District of Kansas. These cases will be overseen by Judge Kathryn H. Vratil.
The attorneys at Banville Law are attempting to help ensure that all women who have undergone power morcellation to remove uterine fibroids and who subsequently received cancer diagnoses will have the opportunity to fully explore their legal rights. These women are currently offered free legal consultations through Banville Law, and may be entitled to legal action and significant compensation.
To request additional information on power morcellation lawsuits, or to ask questions, please contact the attorneys at Banville Law by calling (888) 997-3792.
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