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Morcellation Media Monitoring 06/11/2015
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Hysterectomy Device Will Be Covered by Insurer Despite Danger of Uterine Cancer’s Spread
Jun 9, 2015 | Wall Street Journal
By Jon Kamp
Health Care Service Corp., the nation’s fourth-largest health insurer, will continue to cover laparoscopic power morcellators after considering a policy that would have curbed the surgical tools used in hysterectomies, a spokeswoman said Tuesday. -
Cutting the power on morcellation
Jun 8, 2015 | Rochester Democrat & Chronicle
By Patti Singer
A report in late May that the FBI is investigating the use of power morcellators during minimally invasive surgery for hysterectomy has renewed interest in what arguably was the biggest women's health issue last year. Considering Rochester played a large role in the controversy over the device, an update is in order. -
Pathologist Warned J&J of Morcellator Cancer Risks 9 Years Ago, Report Tracey & Fox Lawyers
Jun 11, 2015 | Digital Journal
Attorneys at Tracey & Fox have reported that a doctor from Pennsylvania notified Johnson & Johnson of concerns that power morcellators present a risk of spreading undetected uterine cancer more than nine years ago. -
Health Care Service Corp. to continue controversial morcellator coverage
Jun 10, 2015 | FierceHealthPayer
By Dori Zweig
After some debate, Health Care Service Corp. (HCSC) has decided to continue covering procedures that use laparoscopic power morcellators, reported the Wall Street Journal.
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Hysterectomy Device Will Be Covered by Insurer Despite Danger of Uterine Cancer’s Spread
Jun 9, 2015 | Wall Street Journal
By Jon Kamp
Health Care Service Corp., the nation’s fourth-largest health insurer, will continue to cover laparoscopic power morcellators after considering a policy that would have curbed the surgical tools used in hysterectomies, a spokeswoman said Tuesday.
It is the latest insurer to take a closer look at the device since last year, when the U.S. Food and Drug Administration warned that the morcellators can spread and worsen undetected uterine cancer. The FDA estimated 1 in 350 women undergoing surgery for common benign growths called fibroids actually have cancers called sarcomas, a significantly higher risk than many doctors realized. The agency said the tool shouldn’t be used on the vast majority of women.
Last month Aetna Inc., the third-biggest U.S. insurer, stopped covering routine use of morcellators. The country’s biggest health plan, UnitedHealth Group Inc., imposed tighter controls on its hysterectomy coverage in April, steering patients toward procedures that don’t require morcellators.
HCSC considered labeling morcellation “not medically necessary” in a draft policy that could have gone into effect June 1. But after gathering opinions, the insurer decided against such a policy, spokeswoman Lauren Perlstein said. The devices cut tissue into smaller pieces for removal through small incisions, most often in minimally invasive hysterectomies.
“Based on the thoughtful input we’ve gathered from industry experts during the draft policy review process, we believe the use of the power morcellator tool is best determined through dialogue between the provider and patient,” Ms. Perlstein said. HCSC has more than 15 million members in five Blue Cross and Blue Shield units in Texas, Illinois, Montana, New Mexico and Oklahoma.
HCSC based its decision on many factors, including a recommendation from the main gynecology association—the American College of Obstetricians and Gynecologists—that doctors should tell patients upfront about the risks, benefits and alternatives of these procedures, Ms. Perlstein said. ACOG has expressed concern that doctors would be left without the option to use a morcellator in select cases.
The FDA called for a “black-box” warning on morcellators to limit their use, but many insurers and hospitals have gone further. Johnson & Johnson, formerly the biggest morcellator maker, left the market last year, although versions from other companies remain on sale.
HCSC also raised a practical concern for policing morcellator use: The device isn’t covered by a specific code used in the industry to track procedures. Aetna requires doctors to obtain prior approval for any procedure involving the device.
“We will continue to monitor this issue, maintain our dialogue with the health-care industry, and make further adjustments, as necessary,” Ms. Perlstein said.
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Cutting the power on morcellation
Jun 8, 2015 | Rochester Democrat & Chronicle
By Patti Singer
A report in late May that the FBI is investigating the use of power morcellators during minimally invasive surgery for hysterectomy has renewed interest in what arguably was the biggest women's health issue last year. Considering Rochester played a large role in the controversy over the device, an update is in order.
Hysterectomy is the second-most common surgical procedure for women of reproductive age, according to the National Women's Health Network. Citing data from the Centers for Disease Control and Prevention, it reported that from 2006-2010, nearly 12 percent of women between ages 40 and 44 underwent hysterectomy. By age 60, one in three women have had the procedure. Chances are good that you know someone who had a hysterectomy.
Even without power morcellation in minimally invasive procedures, the NWHN has said many hysterectomies may be unnecessary and symptoms could be managed in other ways.
Whether or not a hysterectomy is appropriate for an individual woman is a decision between her and her doctor.
Once they agree on the need, the discussion can turn to the method. Options can depend on a woman's symptoms and how she envisions her body at the outcome. A power morcellator, a device with high-speed blades that cut tissue and can spread it through centrifugal force, was used in certain types of procedures.
A grassroots effort started by the husband of a woman who underwent the procedure and subsequently was found to have cancer made the rest of us understand that those blades can spread tissue in the abdomen. If that tissue is cancerous,tumors can be spread.
To recap: The Food and Drug Administration issued warnings about the apparatus and the leading manufacturer, Johnson & Johnson, recalled the device. Hospitals in Rochester were among the first in the nation to restrict and then ban use of power morcellators.
However, the move was too late for some. At least three Rochester-area women who underwent minimally invasive gynecologic surgery with power morcellation learned after the fact that what were presumed to be benign fibroids actually were cancerous tissue. Months after their cancers were spread by the procedure, they died from the disease.
At the same time some hospitals were banning power morcellators, others were looking at how to use the device within a cut-resistant bag
A YouTube video (with graphic images of a procedure) explains how power morcellation could be used with such a containment system.
But that is not being done in Rochester as part of minimally invasive procedures.
At UR Medicine, Dr. Adrienne Bonham explained the process:
"I extend one of my incisions, port sites, to about 3 centimeters. Which is not very big. In order to prevent pieces of the uterus from falling into the abdomen, I put the uterus inside a bag. There are laparoscopic plastic bags we use to take organs out. So you put the uterus inside the bag and then you bring the bag back up through the incision and actually cut it in pieces while it's still in the bag."
Bonham said the surgeon uses a scalpel to cut by hand and tissue is extracted. Sometimes scissors are used and sometimes the incision is a little larger. Once the entire organ is small enough, the bag is removed.
At Rochester Regional Health, Dr. Eugene Toy wrote that all cutting of the tissue is done outside the body and the bags that others have used for that technique are not used at the system's hospitals.
As for the size of the incision and whether fibroid or hysterectomy procedures are minimally invasive, he responded to email questions by writing, "if (the incision) is 2 inches or less, it remains a minimally invasive procedure, otherwise it is considered a laparotomy in order to extract it intact."
The lessons of power morcellators should be that doctors and health care consumers need an earnest conversation before an elective procedure takes place. Unfortunately, many consumers don't know what to ask and therefore rely on their doctor for the best advice. They may be able to start the conversation with, "please explain all steps of the procedure you are suggesting" and "what complications have arisen when you've performed this procedure before?" and take your cue from the responses.
With new technology and new techniques and the desire for the best outcomes in the shortest time, both consumers and doctors have to work as a team with their slogan being "first, do no harm."
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Pathologist Warned J&J of Morcellator Cancer Risks 9 Years Ago, Report Tracey & Fox Lawyers
Jun 11, 2015 | Digital Journal
Attorneys at Tracey & Fox have reported that a doctor from Pennsylvania notified Johnson & Johnson of concerns that power morcellators present a risk of spreading undetected uterine cancer more than nine years ago.
At the time, Johnson & Johnson was the world’s largest manufacturer of power morcellators, a medical device frequently used in minimally invasive hysterectomies and myomectomies. Through its Ethicon subsidiary, Johnson & Johnson would go on to capture an estimated 72% of the laparoscopic morcellator market by 2011. But Ethicon stopped selling its devices, and then asked physicians worldwide to return them to the company, after a 2014 FDA safety advisory warned physicians to avoid morcellation in the majority of gynecological procedures.
For many public health advocates, including Dr. Robert Lamparter, Johnson & Johnson’s response may be too little, too late. Lamparter, a former pathologist, contacted Ethicon director David Robinson in February of 2006, asking Johnson & Johnson to “reconsider [the power morcellator’s] risk to the patient.” Morcellators are used to grind fibroid and uterine tissue into small pieces for easier removal. The devices promise patients shorter recovery times and less trauma, but come at a serious risk.
As Lamparter noted in his email to Robinson, while the majority of uterine fibroids are assumed to be benign, or noncancerous, preoperative “screening [...] misses a certain number of malignancies.” According to the US Food & Drug Administration, as many as 1 in every 350 women who undergo a morcellation procedure are in fact harboring unsuspected uterine sarcomas, a rare and aggressive form of soft tissue cancer. Under the morcellator’s spinning blade, undiagnosed cancer cells can be spread throughout a patient’s abdomen and pelvis, “upstaging” the disease and significantly worsening prognosis.
Lamparter became alerted to the risks of morcellation at the Pennsylvania hospital where he worked for 28 years. As a pathologist, he inspected body tissues after surgical removal for signs of malignancy and other medical conditions. And even at his small hospital, where only around 300 hysterectomies were performed every year, Lamparter was finding at least one unsuspected cancer in morcellated fibroid tissue every year. In his email, Lamparter presented his own conclusion clearly: “if a morcellation is done, the patient’s survival is jeopardized.”
Robinson responded quickly, saying he had submitted Lamparter’s concerns to Ethicon’s World Wide Customer Quality department as a complaint. But in May, 2006, the complaint was dismissed and Lamparter’s subsequent attempts at correspondence went unanswered.
Lamparter would have to wait nine years before public outcry brought his early warnings into the spotlight. In an interview with the Wall Street Journal, Lamparter now says that he has been approached by the Federal Bureau of Investigation (FBI). According to the WSJ, the FBI has begun investigating the risks of power morcellation, with a focus on what manufacturers, including Johnson & Johnson, knew about those risks years before public pressure forced Ethicon to recall its devices and drove many insurance companies to stop covering routine gynecological procedures in which power morcellators are employed.
Several public health advocates have also been contacted. Doctors Hooman Noorchashm and Amy Reed say they were approached by federal investigators as well. After a hysterectomy for what her doctors had concluded were “clearly benign” fibroids in 2013, Reed was diagnosed with leiomyosarcoma, a form of uterine cancer. Along with husband Noorchashm, Reed has become one of the most vocal proponents of a complete ban on the use of power morcellators in fibroid removal procedures. A Change.org petition that she started has received more than 88,000 signatures in support.
Meanwhile, patients who were diagnosed with metastatic uterine cancer after morcellation procedures have begun to file legal claims against the manufacturers of these devices. In as many as a dozen complaints, plaintiffs claim that power morcellators are defective in design and that companies failed to adequately warn patients and surgeons of the risks of morcellation. Several wrongful death lawsuits have been filed by widowers who survive their loved ones.
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Health Care Service Corp. to continue controversial morcellator coverage
Jun 10, 2015 | FierceHealthPayer
By Dori Zweig
After some debate, Health Care Service Corp. (HCSC) has decided to continue covering procedures that use laparoscopic power morcellators, reported the Wall Street Journal.
The nation's fourth-largest insurer considered deeming the morcellator "not medically necessary" but decided against the policy, which would have taken effect June 1, HCSC spokeswoman Lauren Perlstein told the WSJ.
"Based on the thoughtful input we've gathered from industry experts during the draft policy review process, we believe the use of the power morcellator tool is best determined through dialogue between the provider and patient," said Perlstein.
In November, the Food and Drug Administration warned against the use of morcellators on woman. 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,FierceHealthPayer previously reported.
Despite the industry's hesitation, HCSC based its decision on recommendations from the American College of Obstetricians and Gynecologists, which told the insurer that providers need to be up front with patients regarding the risks of such devices as well as the benefits of the procedures, noted the WSJ.
Because there's no specific code to track morcellator use--another growing concern throughout the industry--Perlstein told the WSJ that HCSC "will continue to monitor this issue, maintain our dialogue with the health-care industry, and make further adjustments, as necessary."
Elsewhere, Aetna decided last month to stop covering the routine use of morcellators, the WSJ reported, as has Highmark. Meanwhile, Anthem and UnitedHealth Group recently required doctors to get prior authorization before performing most inpatient hysterectomies.
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