How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
"...Noorchashm stayed up nights writing strongly worded letters, posting comments on every website remotely relevant to the cause, and having strategic conversations with anyone who would talk to him. The only resulting change he saw was in his own reputation. He'd gone from star surgeon to social leper, shut out of the operating room at his own hospital (though he can't prove it was because of the campaign) and avoided by colleagues and former friends. "They closed ranks on me," he says now, with sadness in his voice. "I broke the white code of silence; I hung out our dirty laundry."..."
Dr. Noorchashm asks: "When new technology makes
medicine cheaper and more convenient, how many
patients have to die to prove it's not worth it?"
Petition by Hooman Noorchashm, MD, PhD:
My wife [Dr. Amy Reed] had a surgical procedure that spread cancerous cells throughout her body. She now has stage 4 cancer. Please sign my petition demanding the FDA stop a procedure that has spread cancer in thousands of women.
My wife Amy is a mother of six, and an accomplished anesthesiologist who helped treat victims of the Boston Marathon bombing last year.
Now, because of a dangerous, but standard, gynecological
procedure her early stage cancer was spread -- causing stage 4 cancer.
Last Fall, Amy went in for a routine hysterectomy to treat what
we thought were benign fibroids, and had a minimally invasive “morcellation”
procedure to remove her uterus. Little did we know that this procedure would
end up spreading malignant cancer cells throughout Amy’s belly. What's more is
that “morcellation” is totally avoidable and it has devastated thousands of
women and families by spreading and upstaging dangerous cancers of the uterus
and ovaries.
Now we’re taking a stand in hopes of banning this surgery for
good, and saving the lives of countless women and mothers. And the momentum is
on our side.
Because of the momentum of this petition,
numerous hospitals around the country have stopped performing this type of
hysterectomy. Last week, a major health insurer -- Blue Cross Blue Shield --
announced that they would no longer cover the procedure. And Johnson &
Johnson, which manufactures some of the surgical tools used in this procedure,
issued a worldwide voluntary recall of the tools called "power
morcellators," saying that they couldn’t guarantee that the procedure was
safe for women to undergo.
The reason this surgical procedure is so controversial is that doctors
have no reliable way of testing whether patients are at risk of having
cancerous cells spread throughout their body during the surgery. That was
the case with Amy -- in the process of removing her uterus, undetected cancer
cells were spread throughout her abdomen region, and stage 4 cancer developed.
The same has happened to scores of other women, globally. Women who went in
thinking they were having a “minimally invasive” procedure, left the operating
room with an advanced stage of cancer.
Last month, the FDA held public hearings on this surgical
procedure. Amy and I traveled down to Washington, D.C., to talk about this
petition and to bring Amy’s story to the attention of FDA and congressional
regulators. They are currently debating whether to ban this procedure or not,
and that’s why I need your help today.
I cannot tell you what this means to my wife, to me, and to our
family. Together, we can help potentially save the lives of thousands of women
moving forward. No other woman should ever have her uterine cancer upstaged to
an advanced stage by a gynecologist practicing this totally avoidable procedure
they call "morcellation."
Thank you,
Hooman Noorchashm, MD, PhD
Boston, MA
Boston, MA
Health Alert: Many Women Have Died Unnecessarily Because Dangerous Cancers of the Uterus and Ovaries Are Being Spread using MORCELLATORS. Stop MORCELLATION in Minimally Invasive Gynecological Surgery.
Friends of the Public,
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
Many women have been harmed and have died prematurely or unnecessarily because of a routine but avoidable gynecological practice known as MORCELLATION. This world-wide practice has devastated many families for well over two decades now.
More than 600,000 hysterectomies are done in the US every year. By the age of 70, one out of every three American women will have had a hysterectomy. About 90% of these surgeries are done for what is presumed to be a benign condition called fibroids. More and more of these surgeries are done with minimally invasive techniques. Usually, to get the uterus out of the body using the "minimally invasive" technique, it is cut into small pieces with a machine called a morcellator. However, a devastating problem happens if in fact the woman did NOT have fibroids – but if she actually had cancer. Unfortunately, the tests that are done before a hysterectomy do not identify these cancers well. Many gynecologists don't even bother getting any tests. In fact, morcellating cancer spreads the cancer inside the woman’s body.
This is called ‘up staging’ the cancer.
It is important to understand:
1) The average life span following accidental morcellation of sarcoma is only 24-36 months.
2) Only 15% of woman who have leiomyosarcoma (LMS) that has spread (stage 4) will be alive after 5 years.
3) Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.
This is an avoidable disaster.
This problem has been recognized for more than two decades. A review of the literature reveals that 1 in 415 women who go for fibroid surgery actually has sarcoma. This means that everyday 2-5 women in the US – and more around the world will have a deadly cancer spread because of morcellation.
This catastrophic problem has happened in our own family and we are fighting to stop this dangerous activity called morcellation. A chance of 1 in 415 for such a devastating outcome is much too high to accept. Women should be told the truth and the practice should stop.
Please help us bring an end to spreading cancer with morcellation. There are alternatives. Some surgeons have begun using a special bag to avoid spreading cancer cells. Several of the reasons why this has not yet become commonplace are the fact that: a) bag morcellation takes more time – and time is money; b) lack of training; and c) lack of awareness. Other people opt for a traditional open hysterectomy. People need to understand their options – but – currently, most women never hear anything about morcellation or about the possibility of cancer upstaging. We need your help.
Please sign our petition so we can get the word out. We want the American Congress of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology to change this "standard of care" by ending the needless waste of life caused by spreading cancer with morcellation.
For more information and original references see: http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=188 ) (also see:http://www.ncbi.nlm.nih.gov/pubmed/23189178) (also see:http://www.ncbi.nlm.nih.gov/pubmed/21565389).
The attached video below shows an example of morcellation http://www.youtube.com/watch?v=fMnzQbRMWJ8
The following companies manufacture and distribute uterine morcellator devices:
1) ETHICON: Gynecare morcellator
2) Storz: Rotocut Morcellator
3) Richard Wolf Medical Instrumentation Company
4) LiNA: LiNA Xcise Cordless Laparoscopic Morcellator
5) Blue Endo MOREsolution Tissue Morcellator
Intuitive Surgical's Da Vinci Robot deserves special mention, as the frequency of robotic hysterectomies performed by minimally invasive gynecologists is currently on the rise across the United States. Note that Intuitive Surgical builds and markets the DaVinci robot, which is not itself a "morcellator". However, use of the DaVinci robot almost invariably appears to require that the uterus be minced up, or morcellated, into smaller pieces inside the woman's belly cavity in order to extract from the abdomen. A clear example is shown in the following YouTube video of DaVinci being used to perform a robotic hysterectomy and manually morcellating the uterus using the endo-wrist component of the robot (morcellation is being performed at minute 5:30 of the video).
https://www.youtube.com/watch?v=f6luiX6UQmg
Without morcellation using equipment manufactured by Intuitive Surgical, robotic hysterectomies would, likely, not be possible using the DaVinci Robot. It is noteworthy that the DaVinci robot does not appear to have a readily available warning label advising against its use to morcellate tumors with malignant potential inside the body. The company's Chief Medical Advisor, Dr. Myriam Curet, a surgeon herself, has been informed and advised of this severe hazard in the use of DaVinci for robotic hysterectomy and the absence of a readily available warning label.
No comments:
Post a Comment