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Morcellation Media Monitoring 4/9/2015
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U.S. health insurers consider new curbs on morcellators amid regulatory pushback
Apr 6, 2015 | Fierce Medical Devices
By Emily Wasserman
U.S. health insurers are joining a swelling chorus of discontent over power morcellators, limiting the products or considering new restrictions a year after the FDA warned against using the devices in certain gynecological procedures. -
More insurers restrict morcellator use following FDA warning
Apr 8, 2015 | Healthcare Dive
By Heather Caspi
Numerous insurance companies have begun to restrict the use of laparoscopic power morcellators during hysterectomies following the FDA's warning that it shouldn't be used on most women due to cancer risks. According to a Wall Street Journal review, insurers covering about 93 million Americans have curtailed use of the device or are considering restrictions.Those considering new policies include Health Care Service Corp. and Aetna Inc. Those that have already taken action against morcellator usage include UnitedHealth Group, Highmark Inc., UPMC Health Plan, Blue Shield of California, Blue Cross Blue Shield of Massachusetts and AmeriHealth Caritas. -
More insurers restrict morcellator use in hysterectomies
Apr 6, 2015 | Fierce Health Payer
By Brian Eastwood
A growing number of insurers plan to follow the advice of the Food and Drug Administration (FDA) and restrict the use of the laparoscopic power morcellator in hysterectomies, the Wall Street Journal reported. -
‘True Informed Consent’ is Vital for Women Considering Morcellation Surgery
Apr 9, 2015 | Top Class Actions
By Melissa Clyne
The key factor for women considering surgical options to remove uterine fibroids is to be a well-informed patient and have a well-informed physician, according to a decision-tree analysis constructed by medical researchers investigating morcellation surgery. -
FDA Issues Power Morcellation Cancer Warnings
Apr 7, 2015 | Top Class Actions
By Robert J. Boumis
In November of 2014, the U.S. Food and Drug Administration (FDA) issued an updated Safety Communication regarding power morcellation and its alleged link to uterine cancer. Power morcellation is a type of technique used in laparoscopic surgery. Laparoscopic surgery is a type of surgery wherein surgeons use small, specialized tools to perform the bulk of the procedure inside the patient’s body. This allows surgeons to cut through less healthy tissue, shortening recovery times and making surgery an option for many patients who would be too weak for regular invasive surgery. One of the few downsides to laparoscopic surgery is that in some procedures, like hysterectomies, surgeons must remove large tissue from the body through the small incisions, which has created the necessity for power morcellation. -
Hospitals Switch To Other Methods After Power Morcellation Ban
Apr 8, 2015 | Righting Injustice
By Jennifer Walker-Journey
*Note: This site is sponsored by Beasley Allen Law Firm. The Food and Drug Administration (FDA) issued a warning to physicians to usepower morcellation to remove uteruses or uterine fibroids in only rare cases because of the risk of spreading undetected cancer and worsening the odds of survival. The warning has prompted many gynecologists to seek out other minimally invasive ways to perform the same surgeries.
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Morcellation
Full Text of Stories Below
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U.S. health insurers consider new curbs on morcellators amid regulatory pushback
Apr 6, 2015 | Fierce Medical Devices
By Emily Wasserman
U.S. health insurers are joining a swelling chorus of discontent over power morcellators, limiting the products or considering new restrictions a year after the FDA warned against using the devices in certain gynecological procedures.
As The Wall Street Journal reports, insurers covering about 93 million Americans are rethinking their coverage of morcellators after regulators said last April that 1 in 350 women undergoing surgery for fibroids have uterine sarcomas and the device could spread cancer. The country's fourth-largest U.S. health insurer, Health Care Service Corp. (HCSC), recently proposed labeling power morcellation "not medically necessary," meaning the procedure most likely would not be eligible for coverage. HCSC, which covers nearly 14.7 million members in 5 states, is leaving its draft policy open to public comments before deciding whether to make its decision official on June 1.
The move comes on the heels of more pushback, as insurers such as Blue Shield of California, Highmark and UnitedHealth Group ($UNH) have already placed restrictions on power morcellator devices. In February, UnitedHealth--the country's largest insurer with 40 million customers--said that as of April it would require doctors to get prior authorization before performing most kinds of hysterectomies, including those performed with power morcellator tools. "We needed to do more on behalf of our members to ensure that they would get the safest and most effective method" of hysterectomy, Dr. Sam Ho, UnitedHealth's chief medical officer, said at the time.
But other insurers are taking a more measured approach. Cigna ($CI), which insures 13.2 million patients in the U.S., is monitoring the medical literature to determine whether a policy change is warranted, spokesman Mark Slitt told theWSJ. And Aetna, the nation's third-largest insurer with 23 million U.S. members, is looking into coverage changes for procedures using the device. Spokeswoman Cyntha Michener told the WSJ that Aetna expects to complete its review later this month and implement a new policy that is consistent with the FDA's most recent warning.
Meanwhile, regulators and the industry continue to respond to public outcry over the devices, which were used in an estimated 50,000 U.S. uterine surgeries each year before the FDA warning last April. In July 2014, Johnson & Johnson ($JNJ), the largest U.S. manufacturer of the devices, pulled its related product from the market. The company's Ethicon unit had already suspended sales for the devices following the FDA's advisory warning, which discouraged physicians from using the tools in surgical procedures.
In November, the FDA called for an immediate "black-box warning"--its strongest warning--on the devices, recommending against using power morcellators on the majority of women. The agency said manufacturers should add boxed warnings and two contraindications for the devices in their product labels, warning about morcellators' risks and restricting their use to certain procedures and patients.
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More insurers restrict morcellator use following FDA warning
Apr 8, 2015 | Healthcare Dive
By Heather Caspi
Dive Brief: Numerous insurance companies have begun to restrict the use of laparoscopic power morcellators during hysterectomies following the FDA's warning that it shouldn't be used on most women due to cancer risks. According to a Wall Street Journal review, insurers covering about 93 million Americans have curtailed use of the device or are considering restrictions.Those considering new policies include Health Care Service Corp. and Aetna Inc. Those that have already taken action against morcellator usage include UnitedHealth Group, Highmark Inc., UPMC Health Plan, Blue Shield of California, Blue Cross Blue Shield of Massachusetts and AmeriHealth Caritas.
Dive Insight:
The fact that insurers are driving change in the provision of hysterectomies has been controversial in the healthcare industry, as Healthcare Dive has previously reported.
"Plans are looking very seriously at this," Karen Ignagni, president and chief executive of America's Health Insurance Plans, told the Wall Street Journal. The group is collecting data on how insurers are handling the subject at the request of US Sen. Bob Casey of Pennsylvania.
Ignagni notes that some insurers are continuing to cover the use of morcellators while they weigh evidence and consider the positions of the FDA and the American College of Obstetricians and Gynecologists, which seeks to keep morcellators as an available option for some patients.
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More insurers restrict morcellator use in hysterectomies
Apr 6, 2015 | Fierce Health Payer
By Brian Eastwood
A growing number of insurers plan to follow the advice of the Food and Drug Administration (FDA) and restrict the use of the laparoscopic power morcellator in hysterectomies, the Wall Street Journal reported.
Health Care Service Corp. (HCSC) is considering whether to deem the power morcellation procedure "not medically necessary," which would mean it's no longer eligible for coverage. The decision is open to public comment and will be made by June 1, according to the Journal. Aetna and Cigna are also reviewing their policies, the article said.
If the insurers do restrict morcellator use, they will join UnitedHealth, whose decision to require doctors to get prior authorization before performing most inpatient hysterectomies goes into effect today, FierceHealthPayer previously reported.
That decision drew the ire of gynecologists, who said they felt the choice regarding what type of hysterectomy to perform, and what type of equipment to use, was best made by a patient and her doctor, not a third-party administrator.
However, the FDA warned in November that physicians shouldn't use morcellator devices on a vast majority of women, the Journal said. The device uses a fast-spinning blade to remove benign growths called fibriods--but in women who have uterine sarcoma, a procedure using a morcellator could disperse the cancer into the abdominal cavity.
Payer restrictions on morcellator use have emerged only in the months since the FDA aired its safety concerns, Karen Ignagni, president and chief executive of America's Health Insurance Plans, told the Journal. Payers now must consider whether to halt altogether or simply restrict morcellator use, recognizing that it remains a minimally invasive option for hysterectomies.
Among major insurers, UnitedHealth and Anthem require prior authorization for morcellator use. Highmark, Blue Cross Blue Shield of Massachusetts and AmeriHealth Caritas are among the payers who have ceased coverage of procedures that use a morcellator.
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‘True Informed Consent’ is Vital for Women Considering Morcellation Surgery
Apr 9, 2015 | Top Class Actions
By Melissa Clyne
The key factor for women considering surgical options to remove uterine fibroids is to be a well-informed patient and have a well-informed physician, according to a decision-tree analysis constructed by medical researchers investigating morcellation surgery.
The use of a power morcellator in hysterectomies or to remove uterine fibroids involves a medical device – the power morcellator – shredding the tumor into tiny pieces inside of the abdomen, enabling the surgeon to remove them laparoscopically. But gynecological morcellation has come under fire for the potential of spreading cancer throughout the abdomen, resulting in a more advanced stage of the disease.
Morcellation and Informed Consent
In constructing the decision tree, researchers relied on morbidity and mortality data from 26 earlier morcellation studies conducted over several decades. They found that women who underwent laparoscopic hysterectomy with morcellation experienced fewer surgical complications as well as an increased quality of life, compared with women who underwent abdominal hysterectomy for presumed uterine fibroids.
On the flip side, there were more deaths from leiomyosarcoma – a smooth muscle connective tissue tumor – following laparoscopic hysterectomy.
“Obstetrician-gynecologists understand that total abdominal hysterectomy has higher rates of morbidity and mortality than less-invasive alternatives, including those conducted with morcellation,” according to Georgetown University Hospital’s Dr. Hal Lawrence, who is also the executive vice president and CEO of the American College of Obstetricians and Gynecologists.
“Based on previous data, we continue to assert that vaginal hysterectomy offers patients fewer complications and better outcomes for patients, so is the preferred route of hysterectomy when possible. Of course, there is no one-size-fits-all solution for the treatment of fibroids. Not all women are indicated for vaginal hysterectomy, so it is essential that laparoscopic hysterectomy with morcellation and total abdominal hysterectomy continue to be available as treatment options.”
The ideal is “true informed consent,” Obstetrician/Gynecologist Dr. Diana Bitner told MedPage Today.
“I agree with the findings and think women deserve informed consent that, while cancer being spread is a risk of morcellation, most women do not have cancer to be spread and … so many other risks [are reduced] with laparoscopic surgery,” according to Dr. Bitner, who is director of Women’s Health Network at Spectrum Health in Grand Rapids, Mich.
“As a pelvic surgeon, it will kill me to go backwards and go back to open surgery when minimally invasive could be so much safer, reduce hospital time, time off work, pain, and need for narcotics, etc.”
Morcellation Safety Concerns
In 21014, the FDA issued a safety advisory after analyzing data that showed morcellation surgery might cause the spread of unsuspected cancerous tissue outside the uterus. The FDA ultimately decided not to ban morcellators but contraindicated the device for removal of uterine tissue in menopausal and post-menopausal women, and in women who are eligible for surgeries that remove uterine tissue intact i.e. through the vagina or mini-laparotor.
Morcellation cancer lawyers are looking for women diagnosed with leiomyosarcoma (LMS), uterine sarcoma or other cancer within two years after their initial morcellation surgery to remove fibroids, the uterus, ovaries or fallopian tubes.
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FDA Issues Power Morcellation Cancer Warnings
Apr 7, 2015 | Top Class Actions
By Robert J. Boumis
In November of 2014, the U.S. Food and Drug Administration (FDA) issued an updated Safety Communication regarding power morcellation and its alleged link to uterine cancer.
Power morcellation is a type of technique used in laparoscopic surgery. Laparoscopic surgery is a type of surgery wherein surgeons use small, specialized tools to perform the bulk of the procedure inside the patient’s body. This allows surgeons to cut through less healthy tissue, shortening recovery times and making surgery an option for many patients who would be too weak for regular invasive surgery. One of the few downsides to laparoscopic surgery is that in some procedures, like hysterectomies, surgeons must remove large tissue from the body through the small incisions, which has created the necessity for power morcellation.
Power morcellation is a type of laparoscopic procedure where surgeons use a power morcellator to cut tissue into pieces small enough to be removed from the body. But there are growing concerns regarding morcellation cancer, a dangerous side effect of using these convenient medical devices.
The FDA’s November morcellation cancer statement was an update to earlier safety communications from earlier in 2014 on the subject of power morcellation. In this statement, the FDA strongly recommended against the use of power morcellators for hysterectomies because of concerns regarding uterine cancer.
A common reason for the use of power morcellation in hysterectomies is due to the presence of uterine fibroids, a type of benign tumor. However, post-surgical reports have strongly suggested that the many women whom have uterine fibroids may also have malignant cancer cells bound up within the fibroids that have gone undetected. The process of power morcellation is alleged to liberate these cancer cells and spread them within the abdomen, a condition known as morcellation cancer. How far the cancer cells spread is a major predictor of how severe a case of cancer is.
The FDA has advised patients who have had robotic hysterectomies to be vigilant for signs of morcellation cancer and undergo follow-up testing. The FDA has also recommended strongly against the use of power morcellators in hysterectomies and related procedures since this discovery. The FDA, however, stopped short of a full ban on power morcellators, stating that further evidence was needed to justify a full ban. However, the FDA did issue new boxed warning that power morcellators shouldn’t be used to remove uterine fibroids
Power morcellation lawsuits have been filed by women who developed advanced uterine cancer after their uteruses were removed by power morcellation. Power morcellation lawsuits typically allege that the makers of power morcellators were aware—or reasonably should have been aware—of the risk of morcellation cancer associated with their medical devices. Morcellation cancer lawsuits typically seek to recoup the costs of medical care, lost wages, and other costs allegedly linked to morcellation cancer.
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Hospitals Switch To Other Methods After Power Morcellation Ban
Apr 8, 2015 | Righting Injustice
By Jennifer Walker-Journey
The Food and Drug Administration (FDA) issued a warning to physicians to usepower morcellation to remove uteruses or uterine fibroids in only rare cases because of the risk of spreading undetected cancer and worsening the odds of survival. The warning has prompted many gynecologists to seek out other minimally invasive ways to perform the same surgeries.
Power morcellators are surgical tools that are fitted with blades that mince uteruses or uterine growths inside the body and remove them through small incisions in the abdomen. The procedures were favored over open surgeries because they were less invasive, left less scaring and had a reduced risk of infection, and offered less recovery time.
About 50,0000 power morcellation procedures were done each year in the United States until last fall, when the FDA strengthened a warning it had given the previous April that an estimated 1 in 350 women who underwent power morcellation procedures for hysterectomies or myomectomies (uterine fibroid removal) had a rare form of uterine cancer, known as uterine sarcoma. The process of power morcellation could allow bits of cancerous tissue to spread within the uterine cavity, seeding new cancer growth and making the disease more difficult to treat. Because uterine sarcoma is difficult to diagnose until the uterus or tissue is removed, the FDA strongly advised against the procedure in the vast majority of women.
The FDA’s warning was followed by insurers, including UnitedHealth Group Inc.,the nation’s largest health insurer, requiring approval before the procedures are covered. Some hospitals also have vowed to honor the FDA’s recommendations to limit the number of power morcellation procedures they perform.
A group of Yale University researchers set out to quantify just how many gynecologists are limiting their use of power morcellation, and find out what type of procedures they are using instead. They found that among 43 high-volume gynecologists and fellowship faculty members at large teaching hospitals in the U.S., 78 percent had switched methods after the FDA warning. Instead, they are choosing a “mini-laparotomy” in which the uterus is removed through a small incision – about 1 ½ to 3 inches in length – above the pubic bone. While this procedure, with a larger incision than power morcellation, increases the risk for infection, it dramatically lowers the risk of cancer spread.
A handful of doctors said instead of power morcellation for myomectomies, they are opting to manually remove fibroids inside surgical bags so that the tissue can be removed through small incisions. The procedure is more time consuming but lowers the risk of cancer spread.
For patients, however, the changes are a welcome option. Amanda Varga, 54, sought advice from her doctor about the removal of her uterine fibroids. Her doctor explained the ban on power morcellation and suggested a laparoscopic mini-laparotomy. “I was on board right away,” she said. “If there is a possibility it could be cancer for some women, I don’t want to be that possibility.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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