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Morcellation Media Monitoring 05/26/2015
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2 Local Doctors Want FDA To Do More To Make Sure Medical Devices Are Safe [Video]
May 21, 2015 | CBS 3 Philadelphia
By Stephanie Stahl
Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They’re fighting to prevent more tragedies, while living through their own. -
Aetna Stops Coverage of Morcellation
May 21, 2015 | Legal Examiner
By Steven Davis
Aetna, Inc. has announced that the company officially stopped covering routine use of the laparoscopic power morcellator on May 15, according to a report in the Wall Street Journal.
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2 Local Doctors Want FDA To Do More To Make Sure Medical Devices Are Safe [Video]
May 21, 2015 | CBS 3 Philadelphia
By Stephanie Stahl
Is the FDA doing enough to protect patients from potentially dangerous medical devices? Two Philadelphia area doctors say no. They’re fighting to prevent more tragedies, while living through their own.
Amy Reed is on a mission, trying to save other families, from the agony hers is enduring. The 42-year-old has six children and a deadly cancer. She says her prognosis is not good.
Amy and her husband Hooman Noorchashm are both doctors who feel patients’ lives are in danger. They fear what happened to Amy, as a patient, will happen to others.
Dr. Noorchashm says, “I’m worried every day, it’s like having a gun to your head.”
Back in 2013 Amy had what was supposed to be a routine operation. A device called a morcellator was used to shred fibroid tumors, so they could be easily removed.
Doctors didn’t know before the operation that the fibroids were cancerous. The shredding ended up inadvertently spreading the cancer. Dr. Reed says, “This type of cancer it’s like ink, once you spill it you can’t just go back and undo it.. I had no idea that they used this type of technique.”
Just recently Aetna the country’s third largest insurer said it’s ending coverage for most procedures using morcellators, and many surgeons have stopped using the device.
A year ago, when morcellators were first investigated, Amy had been through multiple surgeries and rounds of radiation and chemotherapy. She recently had a recurrence, a tumor in her spine. When asked what she tells her children, Amy said, “Having kids forces you to be very forthcoming. You say cancer and they say well will it kill you and you say I don’t know.”
While hoping to find a way to keep Amy alive, the Bucks County doctors and others want the FDA to do more to make sure medical devices are safe.
They were horrified last year, when the FDA issued a safety communication discouraging the use of power morcellation, but said it could be appropriate for a small number of women. Dr. Noorchashm says, “The FDA is not doing a good job of ensuring and maintaining public health by making sure there are certain fundamental safety standards applied to medical devices.”
The FDA says, “The vast majority of devices perform well .. in some cases unanticipated adverse events are identified.. when this occurs the FDA carefully assesses the issue and takes action to protect the public health based on scientific data.”
For now, Amy and her husband are spending as much time as they can with their children, the youngest is only two. Dr. Reed says, “You don’t know what the future holds and you remain optimistic and you know, do want you can today.” Amy says she’s fighting for her family and others.
Link to clip: http://philadelphia.cbslocal.com/2015/05/21/health-2-local-doctors-want-fda-to-do-more-to-make-sure-medical-devices-are-safe/
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Aetna Stops Coverage of Morcellation
May 21, 2015 | Legal Examiner
By Steven Davis
Aetna, Inc. has announced that the company officially stopped covering routine use of the laparoscopic power morcellator on May 15, according to a report in the Wall Street Journal.
What are Power Morcellators?
Power morcellators are minimally invasive tools used to remove common uterine growths known as fibroids during procedures such as hysterectomies. The devices can cut the sometimes large, bulky growths into smaller pieces so that they can be removed through small incisions.
However, because deadly cancers can appear as benign tumors and there is no conclusive way to diagnose uterine cancer before using morcellator devices, when the tissue is ground up, any undetected uterine cancer cells can be spread, leading to rapid upstaging of the disease. As a result, power morcellation has come under growing scrutiny and prompted numerous power morcellator lawsuits.
Morcellation Use Restricted
In 2014, the U.S. Food and Drug Administration (FDA) warned that patients undergoing hysterectomies or fibroid removal surgery have an estimated 1 in 350 risk of harboring dangerous cancers known as sarcomas, a significantly higher rate than was previously known. In November, the FDA recommended that power morcellators not be used on most female patients, and asked device companies to add a black box warning concerning the risks.
Hartford, Connecticut-based Aetna is the third-largest health insurance provider in the U.S. with about 23 million members. The company plans to require doctors to obtain prior approval for any procedure that would involve morcellation. Doctors will be able to request exemptions for premenopausal women who want to preserve fertility and have no other effective surgical option.
Although many clinics and hospitals have discontinued or limited the use of morcellators and Johnson & Johnson, the largest former manufacturer of power morcellators, left the market in 2014, the devices remain available through other companies. The FDA decided not to completely ban morcellators, but doctors are understandably moving away from their use as other health insurers are starting to follow Aetna’s lead.
Link to clip: http://chicago-land.legalexaminer.com/defective-dangerous-products/aetna-stops-coverage-of-morcellation/
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