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Morcellation Media Monitoring 07/7/2016
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Tragedy, Trade-offs, and the Demise of Morcellation
Jun 30, 2016 | The New England Journal of Medecine
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
Rosenbaum’s article on morcellation (March 10 issue) contends that the practice receded from use in gynecology because of an “emotionally” publicized “N-of-1” complication at a prominent hospital. It is true that an N of 1 mobilized a large-scale focus on determining the actual risk of death from cancer upstaging owing to morcellation — on the order of 1 in 300, as now established by several notable studies. Until December 2013, most women had no idea that their fibroids were being morcellated or that they might be at risk for cancer upstaging — and this was a serious professional error in gynecology. -
Bill Aims to Crack down on Dangerous Medical Devices
Jul 4, 2016 | Ground Report
By Vladimir Zivanovic
After the movement of the bill through the house for strict action against faulty medical devices, this will be a moment to cherish for the advocates fighting for patient’s rights in this regard. When legalized by the house, this will help the FDA cut off faulty medical devices from the market as early as possible.
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Tragedy, Trade-offs, and the Demise of Morcellation
Jun 30, 2016 | The New England Journal of Medecine
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
To the Editor:
Rosenbaum’s article on morcellation (March 10 issue) contends that the practice receded from use in gynecology because of an “emotionally” publicized “N-of-1” complication at a prominent hospital. It is true that an N of 1 mobilized a large-scale focus on determining the actual risk of death from cancer upstaging owing to morcellation — on the order of 1 in 300, as now established by several notable studies. Until December 2013, most women had no idea that their fibroids were being morcellated or that they might be at risk for cancer upstaging — and this was a serious professional error in gynecology.
To suggest that eliminating avoidable risks of death, like that caused by morcellation of fibroid tumors, leads to being “ethically obligated never to do anything” is an absurd trivialization. But most troublesome is this article’s core idea that “trade-offs” with “majority benefit,” “choice,” and “economics” justify accepting a surgically incorrect practice, which causes avoidable risks of death to a minority subgroup of patients. This perspective violates the core medical ethical principles of beneficence and nonmaleficence, which we owe to every one of our patients.
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Bill Aims to Crack down on Dangerous Medical Devices
Jul 4, 2016 | Ground Report
By Vladimir Zivanovic
After the movement of the bill through the house for strict action against faulty medical devices, this will be a moment to cherish for the advocates fighting for patient’s rights in this regard. When legalized by the house, this will help the FDA cut off faulty medical devices from the market as early as possible.
Once these bills are ratified by the Senate, it will provide a law for the patients who want to sue the manufacturers of faulty medical devices.
As per the Medical Guardians Act of 2004, the passage of this bill would make sure that physicians inform the FDA when/if any of the medical devices, i.e. a Power Morcellator, result in an injury to the patient.
Looking at what they are intended to do, Power Morcellators are used to remove benign cancerous tumors from the uterus of the patients. However, in actual practice, the usage of Morcellators diced those tumors, resulting in their spread through the human body.
Consequently, as per the proponents of this bill, this particular characteristic of the Power Morcellator forced them to present this bill.
As ridiculous as it might sound, the FDA has given hospitals the authority to report whenever such medical devices misbehave. As a result, whenever such medical devices have actually misbehaved in the past, doctors were not given the permission to report it to the FDA. Rather, this matter was left at the discretion of the hospitals.
This part of the law is in stark contrast with that of the medical drugs. For example, if a medical drug causes damage to the patient, doctors have the full authority to report it to the FDA.
As a result, patients have complained about the loophole that is present in the law. Moreover, patients are of the opinion that the existing law – which holds Hospitals responsible for reporting medical devices – creates problems.
Two U.S Representatives, Louis Slaughter and Michal Fitzpatrick, are working as a team to introduce this legislation. Both of them decided to present this bill after they were informed by a group of patients of the dangers of these medical devices.
According to Slaughter, despite treating the original problem, these devices act as a catalyst in spreading the tumor. She has put forward her query in front of Govt. Accountability Office to investigate why the Food and Drug Administration approved this device in first place.
While this is the first time that Power Morcellators are being discussed in the house, they have been in the National Media for two years now. Johnson and Johnson were the first American Company that faced and later on settled lawsuits that were based on Power Morcellators.
As per the spokesperson of J&J, the company had to settle “more than 100” lawsuits with the plaintiffs. This presents a damning picture for Ethicon, which might face lawsuits of the same nature in the Courts over the next few months.
However, Ethicon has rubbished all such statements claiming that these settlements don’t have anything to do with the wrongdoing of Morcellators. According to a spokesperson of Ethicon, she refused to comment on the settlements while talking to the Wall Street Journal.
According to a person whose wife died after getting treated by the Morcellator:
‘’All of us share a similar sad story.’’
Talking about the other counsel involved in the introduction of this act, Fitzpatrick was called into this case by a physician husband and wife. After approaching the Representative, this couple then launched a complaint against Ethicon.
‘’While we all agree that the majority of medical devices can and should prove to be invaluable life-saving products we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.’’
Both the bills enjoy no sponsorship in the Senate as of yet. However, despite the odds stacked firmly against him, Senator FitzPatrick is confident that it will be considered by the end of 2016.
The first bill, Medical Device Guardians act, will take into account both the existing and the upcoming devices into the legislation. As for the second bill, which is concerned with Essure, a permanent birth control method, the manufacturers could be held liable.
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