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Morcellation Media Monitoring 4/20/2015
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Medical devices are facing tougher scrutiny – from regulators, and insurers too
Apr 16, 2015 | MedCity News
By Meghana Keshavan
Medical devices are coming under closer regulatory scrutiny, with U.S. health insurers calling for more stringent control over how reusable devices are approved, monitored and maintained. The most recent waves come from a Wall Street Journal series detailing the demise of the morcellator, a laparoscopic device used in hysterectomies. It has been found to spread uterine cancer within a patient – worsening the prognosis. As the morcellator gets withdrawn from general use, it’s serving as grounds for insurers and other stakeholders to call for toughening regulations. -
Insurance companies advocate for tougher FDA clearance — 8 things to know
Apr 16, 2015 | Becker's Spine Review
By Laura Dyrda
Healthcare insurance companies in the United States are hoping there will be tougher rules for approving and tracking medical devices, according to a Wall Street Journal report. The Health Insurance Plans trade group penned a letter to U.S. Senator Bob Casey earlier this week about the dangers associated with laparoscopic power morcellators, highlighting the "weakness" of the medical device clearance process and medical device monitoring system. -
Insurers want better FDA rules on medical devices
Apr 16, 2015 | Fierce Health Payer
By Dori Zweig
Health insurers are making their voices heard when it comes to approving and tracking medical devices. America's Health Insurance Plans sent a letter to Sen. Bob Casey (D-Pa.) this week warning about the danger of premature FDA approval for devices and lax oversight after they hit the market, according to the Wall Street Journal, which reviewed the letter. The letter cited regulatory gaps exposed last year when the tool used in hysterectomies, the laparoscopic power morcellator, was later found to spread cancer. -
Doctors and Hospitals Wary of Power Morcellators – With Good Reason
Apr 16, 2015 | The Legal Examiner
By Steven Davis
The American Congress of Obstetricians and Gynecologists recommends that each woman who is considering a minimally invasive hysterectomy or myomectomy that involves power morcellation discuss alternative treatment options as well as risks and benefits with their physician. According to the U.S. Food and Drug Administration, about one of every 350 women undergoing a laparoscopic hysterectomy with power morcellation may have undetected cancer that is spread throughout the pelvis and abdomen during the morcellation process. -
Insurance Companies Not Covering Power Morcellators Due to Cancer Risks
Apr 16, 2015 | Top Class Actions
By Melissa LaFreniere
Some of the largest heath insurance companies in the nation are choosing not to cover the use of a power morcellator for hysterectomy procedures due to the serious cancer risk warnings issued by the FDA. Companies like Aetna Inc., Cigna, UnitedHealth Group Inc. and various others are changing the way power morcellators are classified, making it extremely difficult to obtain insurance coverage to use the medical tool.
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Morcellation
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Medical devices are facing tougher scrutiny – from regulators, and insurers too
Apr 16, 2015 | MedCity News
By Meghana Keshavan
Medical devices are coming under closer regulatory scrutiny, with U.S. health insurers calling for more stringent control over how reusable devices are approved, monitored and maintained.
The most recent waves come from a Wall Street Journal series detailing the demise of the morcellator, a laparoscopic device used in hysterectomies. It has been found to spread uterine cancer within a patient – worsening the prognosis. As the morcellator gets withdrawn from general use, it’s serving as grounds for insurers and other stakeholders to call for toughening regulations.
But this comes on top of that UCLA superbug scare – in which a reusable duodenoscope that was difficult to clean wound up being the root cause of a CRE outbreak. As a result, the Food and Drug Administration recently issued guidance that calls for makers of reusable medical devices to thoroughly test and label their devices, and outline appropriate methods to clean them.
As far as the morcellator goes, the FDA said in November that it shouldn’t be used in the vast majority of women. Trade group America’s Health Insurance Plans wrote to Sen. Bob Casey (D-Penn) that the dangers of the morcellator are indicative of the many weaknesses in how devices are approved and regulated once they’re on the market, the WSJ reports:
America’s Health Insurance Plans called for strengthening the 510(k) system and efforts to track devices.
The 510(k) system has drawn criticism over the years, including a 2011 report from a panel at the influential Institute of Medicine, which called for scrapping the process. But the medical-device industry and FDA have defended it.
Steve Ubl, president and chief executive of the Advanced Medical Technology Association, a device trade group, called the 510(k) system “overwhelmingly safe.”
“FDA’s 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements,” Mr. Ubl said in a statement responding to the letter from America’s Health Insurance Plans.
The FDA, which has said the device-approval process balances innovation and safety, declined to comment on the letter.
Despite these concerns, the FDA is launching a new, expedited market access program for certain high-risk devices that treat life-threatening disease, Mass Device points out. It’s an ROI thing, perhaps – what’s the risk of disease spread versus lives saved?
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Insurance companies advocate for tougher FDA clearance — 8 things to know
Apr 16, 2015 | Becker's Spine Review
By Laura Dyrda
Healthcare insurance companies in the United States are hoping there will be tougher rules for approving and tracking medical devices, according to a Wall Street Journal report.
The Health Insurance Plans trade group penned a letter to U.S. Senator Bob Casey earlier this week about the dangers associated with laparoscopic power morcellators, highlighting the "weakness" of the medical device clearance process and medical device monitoring system.
The letter comes after the FDA warned physicians that the tool shouldn't be used in most women after a series of journal articles focused on the device's risks. Here are eight key concepts from the report:
1. Medical devices similar to ones already on the market can go through the FDA 510(k) clearance process.
2. Devices deemed high-risk receive more stringent FDA reviews, which can include clinical trials.
3. Advanced Medical Technology Association's president and chief executive Steve Ubl said the clearance system is "overwhelmingly safe."
4. Hospitals and device makers are required to report serious problems with devices, logged in the Maude database.
5. The tools used in surgery aren't usually included in medical claims data, which means insurers have difficulty tracking that information.
6. There are current efforts to assign unique device identifiers that would track devices used and any issues patients have.
7. The FDA has not responded to the initial letter.
8. Insurance companies cover medical devices, and stricter regulations could mean less coverage for new innovations.
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Insurers want better FDA rules on medical devices
Apr 16, 2015 | Fierce Health Payer
By Dori Zweig
Health insurers are making their voices heard when it comes to approving and tracking medical devices.
America's Health Insurance Plans sent a letter to Sen. Bob Casey (D-Pa.) this week warning about the danger of premature FDA approval for devices and lax oversight after they hit the market, according to the Wall Street Journal, which reviewed the letter.
The letter cited regulatory gaps exposed last year when the tool used in hysterectomies, the laparoscopic power morcellator, was later found to spread cancer.
Casey wrote to AHIP on March 24 to follow up on the Food and Drug Administration's (FDA) announcement in November that advised restricting the tool in hysterectomies. Casey said he wanted to hear the insurance industry's reaction to the announcement and asked whether health plans track adverse events related to the device, reported the WSJ.
In the letter to Casey, AHIP President Karen Ignagni wrote that chief medical officers reported "a major reduction in the use of laparoscopic power morcellators in today's market." She also mentioned that tools such as morcellators aren't normally included in medical claims data, so it's difficult for insurers to know when they are used.
AHIP wants to improve the 510(k) system--the process the FDA uses to approve most medical devices--and efforts to track devices after they're approved. Identifiers would allow insurers to track the use of certain devices.
Insurers efforts to limit certain types of medical procedures isn't new. Recently,UnitedHealth began to require doctors get prior authorization before performing most inpatient hysterectomies. Anthem also requires it, while Aetna and Cigna do not, FierceHealthPayer previously reported.
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Doctors and Hospitals Wary of Power Morcellators – With Good Reason
Apr 16, 2015 | The Legal Examiner
By Steven Davis
The American Congress of Obstetricians and Gynecologists recommends that each woman who is considering a minimally invasive hysterectomy or myomectomy that involves power morcellationdiscuss alternative treatment options as well as risks and benefits with their physician.
According to the U.S. Food and Drug Administration, about one of every 350 women undergoing a laparoscopic hysterectomy with power morcellation may have undetected cancer that is spread throughout the pelvis and abdomen during the morcellation process.
What are Morcellators?
Morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. They basically allow surgeons to grind up the uterus or uterine fibroids into small pieces so that the tissue may be removed through a small abdominal incision.
But because there is no definitive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, the undetected cancer cells can be spread, leading to rapid upstaging of the disease. As this risk has become more apparent, more and more doctors have become wary of using power morcellators.
Morcellators and the FDA
In the past year, the FDA has made various announcements and issued warnings regarding the use of power morcellators, including:
In April 2014, the FDA began urging doctors to avoid morcellators for laparoscopic hysterectomies or myomectomy
On November 24, 2014, the FDA announced that it is adding a black box warning, the strongest warning that can be placed on a medical device, to uterine morcellator devices still on the market.
Also in November 2014, the FDA announced that power morcellators should not be used on women who are near menopause, who are post-menopausal, or who could have tissue removed through the vagina or via a small incision.Morcellator Litigation
A growing number of morcellator lawsuits are being filed filed across the nation, mainly by women who were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma, and other types of cancer following uterine fibroid surgery involving morcellation. Many women allege that they were never warned about the risks of power morcellation.
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Insurance Companies Not Covering Power Morcellators Due to Cancer Risks
Apr 16, 2015 | Top Class Actions
By Melissa LaFreniere
Some of the largest heath insurance companies in the nation are choosing not to cover the use of a power morcellator for hysterectomy procedures due to the serious cancer risk warnings issued by the FDA. Companies like Aetna Inc., Cigna, UnitedHealth Group Inc. and various others are changing the way power morcellators are classified, making it extremely difficult to obtain insurance coverage to use the medical tool.
This action comes as morcellation cancer risks prove too serious to ignore. Studies show that one in 350 women who use a power morcellator for a hysterectomy or myomectomy procedure are eventually diagnosed with uterine sarcoma.
The lack of insurance coverage may affect the estimated 50,000 women each year who undergo a hysterectomy or myomectomy procedure by choosing the less invasive laparoscopic incisions provided by a power morcellator.Power Morcellator
The use of a power morcellator in hysterectomies means a shorter post-operative recovery time for patients compared to a traditional abdominal hysterectomy. However, the FDA has issued warnings that despite the benefits of a less invasive procedure, use of a power morcellator on uterine tissue that contains unsuspected cancer may in fact spread the cancer throughout the abdomen.
Studies show there’s no real way to detect if uterine sarcoma exists prior to having surgery, making the risk of using a power morcellator for the laparoscopic procedure serious or even life-threatening. FDA Warnings
The FDA power morcellator warnings addressed in a recent report encourage health care providers, patients and manufacturers to take the following actions:Health care providers are asked to limit the number of laparoscopic incisions that use a power morcellator and to “carefully consider available alternative treatment options for the removal of symptomatic uterine fibroids.”Patients are encouraged to seek out different options available, but if a doctor still recommends a laparoscopic hysterectomy or myomectomy make sure to find out if he/she plans to use a power morcellator.Power morcellator manufacturers are strongly urged to include a “black box” warning on all new and existing power morcellators, which is the strongest caution issued by the FDA before taking the product off the shelves.
After the FDA issued its serious warnings, one of the leading manufacturers of the power morcellator, Johnson & Johnson, decided to stop selling the product until the connection between the medical tool and its potential role in spreading cancer was better understood. However, this action has not stopped patients from filing morcellator lawsuits against Johnson & Johnson, alleging the company should have known the serious risks involved with using the medical tool yet downplayed any concerns.Power Morcellator Lawsuits
The number of power morcellator lawsuits being filed continues to grow. Hundreds of women and families who have lost a loved one due to the spread of morcellation cancer are placing the blame on power morcellator manufacturers, including Johnson & Johnson’s Ethicon subsidiary. Many of the lawsuits already filed allege manufacturers of this product endangered patients by failing to warn medical professionals and patients of the life-threatening risks involved with using this medical tool.
If you have suffered injuries after a power morcellator procedure, you may have legal claim to one of the morcellation cancer class action lawsuits currently in the investigative process.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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