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Morcellation Media Monitoring 10/26/2015
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How Does Laparoscopic Hysterectomy Spread Cancer in Women?
Oct 28, 2015 | The Legal Examiner
By Shezad Malik MD JD
Short answer by causing the spread of undiagnosed malignant uterine cancer. In American women who are of reproductive age, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically. -
Hysterectomy Device Spread Cancer, Man Says
Oct 27, 2015 | Courthouse News Service
By Julie Baker-Dennis
After his wife died last month of occult cancer, a North Carolina man has filed a federal lawsuit against the makers of a medical device that he says spread tumors in her body. Jerry Woodell notes that his wife Bethann underwent a total laparoscopic hysterectomy to remove her uterine fibroids in March 2012. -
Power Morcellator Lawsuit Plaintiffs Hope Ethicon Will Keep Device Off The Market
Oct 27, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has commented on Ethicon’s decision to remove all of their power morcellator devices from the market. “Our clients are very pleased,” Sean Tracey, Esq noted. “They feel as though their voices are being heard.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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How Does Laparoscopic Hysterectomy Spread Cancer in Women?
Oct 28, 2015 | The Legal Examiner
By Shezad Malik MD JD
Short answer by causing the spread of undiagnosed malignant uterine cancer. In American women who are of reproductive age, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically.
According to the Centers for Disease Control and Prevention (CDC), from 2006-2010, 11.7 percent of women between the ages of 40-44 had a hysterectomy.
Approximately 600,000 hysterectomies are performed annually in the United States, and approximately 20 million American women have had a hysterectomy.
By the age of 60, more than one third of all women have had a hysterectomy. According to the National Women’s Health Network (NWHN) unnecessary hysterectomies have put women at risk, and that doctors should search for hysterectomy alternatives before performing life-changing operations.
What is Laparoscopic Hysterectomy?
Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.
Recently, many product liability and personal injury lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
Morcellator Causes Uterine Cancer spread
According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die within a few years of diagnosis and there are no curative treatments.
There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices to grind up the uterus. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.
Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors have stopped the use of power morcellators over the past year.
Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer, earlier last year. J&J, acknowledged that the devices pose an unreasonable risk of disseminating uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device. Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices.
Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Power Morcellators Under the Gun
Power morcellators have been under under fire since the well-publicized case of anesthesiologist Amy Reed, who underwent a hysterectomy, for fibroid removal in October 2013. Dr Reed, then discovered that power morcellation had spread an undiagnosed uterine leiomyosarcoma.
The FDA’s warnings last year triggered a widescale retreat from tissue morcellation. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer “uncertainty.”
Power Morcellator Litigation Centralized
Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.
Earlier this year an application was made to centralize and consolidate all of the federal power morcellator lawsuits. In October, the Judicial Panel on Multidistrict Litigation agreed and transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, for centralization in the multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon.
This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.
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Hysterectomy Device Spread Cancer, Man Says
Oct 27, 2015 | Courthouse News Service
By Julie Baker-Dennis
After his wife died last month of occult cancer, a North Carolina man has filed a federal lawsuit against the makers of a medical device that he says spread tumors in her body.
Jerry Woodell notes that his wife Bethann underwent a total laparoscopic hysterectomy to remove her uterine fibroids in March 2012.
Her surgeon used a laparoscopic power morcellator, which the complaint filed on Oct. 22 in New Jersey defines as an electric-powered medical tool "with spinning blades that shred, grind, and core tissue into smaller pieces or fragments so the tissue can be removed through small incisions in the abdomen."
"During tissue morcellation, fragments can be left in the abdomino-pelvic cavity, or attach to surrounding organs, and cancerous cells can travel to remote areas of the body," the complaint states.
Within six months of that surgery, Bethann was in a hospital emergency room complaining of fatigue, migraines and symptoms often associated with a urinary tract infection.
Woodell says testing over the next few weeks revealed Bethann had large masses in her pelvis. Doctors originally thought the masses were benign but surgical pathology soon revealed high-grade leiomyosarcoma, according to the complaint.
Bethann underwent extensive chemotherapy and numerous surgeries over the next year and the half, but the masses only spread and increased in size, her husband says. She died on Sept. 9.
Woodell says the makers of the morcellator devices have long known the risk they pose to spreading "occult (i.e. hidden) cancer," but that they have refused to address the design flaws or to respond to the numerous studies and reports.
Despite this evidence, no one warned Bethann that the device used in her 2012 surgery had the potential to spread any hidden cancer, the complaint states.
With 650,000 women undergoing a surgical myomectomy or hysterectomy every year to manage uterine fibroids, Woodell says laparoscopic procedures to remove uterine fibroids "have increasingly replaced traditional open abdominal surgical hysterectomies, myomectomies, and laparotomies."
"Long before [Bethann] underwent surgery in 2012, defendants knew or should have known that their laparoscopic power morcellators could cause occult malignant tissue fragments to be disseminated and implanted in the body, which, in turn, upstages any cancer present and significantly worsens a woman's chance of survival," the complaint states.
The U.S. Food and Drug Administration announced last year that it now "warns against using laparoscopic power morcellators to treat uterine fibroids."
"The FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma," a statement on the FDA's safety communication says.
"If laparoscopic power morcellation is performed in 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."
Woodell's complaint takes aim at Ethicon, Johnson & Johnson, Olympus and more than a dozen other medical-device manufacturers and their affiliates.
He seeks punitive damages for negligence, wrongful death and several other claims. Woodell is represented by Ellen Relkin with Weitz & Luxenberg in Cherry Hill, N.J. Neither Relkin nor representatives for Johnson & Johnson have returned requests for comment.
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Power Morcellator Lawsuit Plaintiffs Hope Ethicon Will Keep Device Off The Market
Oct 27, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has commented on Ethicon’s decision to remove all of their power morcellator devices from the market. “Our clients are very pleased,” Sean Tracey, Esq noted. “They feel as though their voices are being heard.”
In a move that surprised the medical community, Ethicon, a subdivision of Johnson & Johnson, announced on July 30th, 2014, that they had decided to voluntarily withdraw all of their power morcellators from the market. Hospitals around the country received notice of this in a letter from the company.
In their letter Ethicon stated, “We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.” They then insisted that all morcellators be returned to them, indicating that they would happily give prorated credit for used devices and full credit for unopened devices.
Until this withdrawal, Ethicon commanded almost 70% of the power morcellator market in the U.S. This surgical instrument, which has been used since 1991, was frequently favored by surgeons performing minimally invasive procedures. The initial belief was that the morcellator was safe for use in any surgery, where it is used to cut and remove unwanted tissues. Recently, however, the U.S. Food and Drug Administration reported that they believed the tool was dangerous when used in hysterectomies and myomectomies.
In a safety warning published about a month prior to Ethicon’s announcement, the FDA wrote: “When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
More than 30 women have filed lawsuits against several morcellator manufacturing companies including Ethicon, Gyrus ACMI, Richard Wolf GmbH, and Karl Storz GmbH. In each case, the plaintiff alleges that a power morcellator spread undetected uterine cancer to other areas of the abdomen resulting in an upstaging of the cancer.
At this time, only the first lawsuit filed has reached a settlement agreement. The remaining complaints have been consolidated and will be tried in the U.S. District Court for the District of Kansas. There is currently no word on when trials will begin.
For more information regarding this press release contact Sean Tracey at (713) 322-5375.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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