Power morcellation ban unlikely, but other FDA restrictions coming soon
The doc spearheading the antimorcellation campaign says FDA is divided, as are gynecologists
Showing posts with label Morcellators. Show all posts
Showing posts with label Morcellators. Show all posts
Sunday, November 9, 2014
Power morcellation ban unlikely, but other FDA restrictions coming soon
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| Johnson & Johnson's Ethicon division's power morcellation device, which has been recalled since the controversy errupted--Courtesy of Johnson & Johnson |
Cardiac surgeon Hooman Noorchashm and wife, Amy Reed, an anesthesiologist, have led the charge against the controversial surgical technique performed using the drill-like power morcellator. Power morcellation can upstage preexisting uterine cancers like uterine sarcoma to fatal levels.
Noorchashm and Reed have sparked public outcry, an FDA safety notice and a recall of power morcellators by former market leader Johnson & Johnson ($JNJ) via efforts like a petition on Change.org. Now they are aiming to take the campaign to its logical conclusion by securing an FDA ban of the device. That does not appear likely, according to information Noorchashm has received from a source within the FDA, who he wouldn't name during an interview.
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"The imminent plan that the CDRH has is to sugarcoat this thing using a probationary mechanism. That would deflect any sort of criticism away from 510(k). It would deflect public criticism of anyone who says FDA didn't do anything. CDRH can comes out and says, 'Well we did something. We put out an FDA advisory and we put the device under probation.' That basically will give industry a chance to recover from an absolute medical atrocity," he said.
It is unclear what a probation would entail. During the FDA's public hearing on power morcellation, the agency discussed solutions such as enhanced informed consent requirements, the use of a surgical bag during morcellation and the need for improved testing of uterine sarcoma prior to surgery. A ban of power morcellators was also on the table, although agency officials didn't seem too intent on that option.
Central to the debate is the prevalence ratio of uterine sarcoma prior to power morcellation. The FDA estimates that the ratio is one women in 350.
A well-publicized paper in the Journal of the American Medical Association estimated that the rate of uterine cancer in women who underwent morcellation was one in 370. However, uterine sarcoma is a rare subset of uterine cancer that is more difficult to detect prior to surgery than other cancers of the uterus. Uterine sarcoma specifically is the main cause of concern among the FDA and other public health experts.
The paper's author, Dr. Jason Wright of the Columbia University College of Physicians and Surgeons, said in an email to FierceMedicalDevices that he is unable to separate sarcomas or other subtypes of uterine cancer based on the insurance database. But he added, "I would assume that most cancers (in the sample) were not known preoperatively in women who underwent morcellation."
"Physicians who are defending this are saying the incidence (of uterine sarcoma in women undergoing morcellation) is one in 7,500," Noorchashm said, referring to research by obstetrician-gynecologist Elizabeth Pritts of the Wisconsin Fertility Institute.
Pritts spoke at the FDA public hearing and believes the agency is wildly overestimating the prevalence of uterine sarcoma because the agency used confirmation bias in its literature review used to arrive at its estimate of one in 350 women.
To add to the complexity, most experts assume that power morcellation poses a great chance of upstaging preexisting uterine sarcoma to fatal levels because it shreds and spreads the cancerous tissue to new parts of the body. However, in October Pritts and medical colleagues published a paper in the Journal of Minimally Invasive Gynecology concluding "there is no reliable evidence that morcellation (power or otherwise) significantly results in tumor upstaging."
"The new data by Dr. Pritts et al reveal that there is no proof that uterine morcellation upstages cancer. This is a critical discovery and changes the framework for discussion of how to care for the 31 million women with symptomatic fibroids," said gynecologic surgeon Antonio Pizarro in Shreveport, LA in an email. "Dr. Wright has issued a report of lapses in preoperative diagnosis for women with detectable cancers, not a report on sarcoma on women with fibroids."
Other members of the field favor strict action against power morcellators. "What you do about it is: you stop," said Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center in a prior article in The Wall Street Journal, adding "it's not worth playing Russian roulette with the patient."
So far the FDA has only banned one device. In 1983 it outlawed prosthetic hair fibers.
"The FDA is considering a great deal of information, including the panel's input, all comments from the public docket, and all relevant available data, in determining any future regulatory action. If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register," said an FDA spokeswoman in an email to FierceMedicalDevices.
Meanwhile, the Democrat & Chronicle reports that a third Rochester, NY, woman has recently died of an undetected cancer two years after undergoing power morcellation.
- here is the email
- here's the article in the Democrat & Chronicle
- here's Dr. Pritt's paper abstract
Related Articles:
Physicians defend power morcellator devices amid industry fallout
Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash
Upcoming study to dispute FDA's data on power morcellation risk
FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further
Power morcellator fallout continues after FDA advisory warning
Tuesday, October 28, 2014
The medical establishment values profits over patient lives, as seen in Morcellation procrastination
After
George Leuzzi pays final respects to his wife on Tuesday at her
funeral, he will turn his attention to caring for their young daughter
and bringing an end to a procedure that claimed 44-year-old Brenda.
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
Saturday, August 30, 2014
Many Women Have Died Unnecessarily Because of surgery with MORCELLATORS
Why does Morcellation surgery continue when we know it kills women? Why do doctors continue to do the surgery? The answer: profits for medical device companies, profits for doctors.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
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.
How Many People Have To Die To Show A New Surgery Technique Isn't Worth It?
By Harriet Brown
Prevention Magazine
May 2014
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.
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