Medical Forum / Diseases and Disorders / Breast Cancer / October 2004
NCI Spells Out Risks of Breast Implants: Increased Risks Of Death From Cancers and Suicide
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Ilena Rose - 04 Oct 2004 21:05 GMT http://biz.yahoo.com/prnews/041004/dcm055_1.html
Press Release Source: National Research Center for Women & Families
National Cancer Institute Spells Out Risks of Breast Implants Monday October 4, 3:15 pm ET Data Show Increased Risks Of Death From Cancers and Suicide
WASHINGTON, Oct. 4 /PRNewswire/ -- A new research summary by the National Cancer Institute (NCI) reveals its concerns about the health risks of silicone and saline breast implants, finding that "implant patients were three times more likely to die from respiratory tract cancer, two to three times more likely to die from brain cancer, and four to five times more likely to die from suicide" compared to other plastic surgery patients of the same age.(1) NCI researchers also found an increased risk of certain connective tissue diseases, such as a doubling in rheumatoid arthritis, and even greater increases in lupus and Sjogren's Syndrome.(2) However, increases in connective tissue diseases were not conclusive because of methodological issues, including the difficulty of studying increases in rare diseases and the lack of medical exams to confirm the accuracy of the diagnoses. "This very cautious summary provides essential information for women considering implants, and the almost two million American women who already have them," noted Dr. Diana Zuckerman, President of the National Research Center for Women & Families, a Washington-based nonprofit research and policy organization. "This is the latest of several red flags, warning women that the risks of breast implants have not been adequately studied. Women in the NCI studies had implants for at least 8 years -- longer than any other studies. But, women getting implants want them to be safe for the rest of their lives, and we still need research to find out what is happening to all the women who already have had breast implants for 20 years or more."
In addition to finding a higher risk of death from certain cancers and suicide, this study crystallizes the difficulties researchers face in studying the health risks of breast implants:
* More long-term data is needed on women with breast implants; * Large samples sizes are necessary to detect rare but debilitating diseases, such as scleroderma; * Safety studies need to be based on medical exams by independent doctors; * Studies are needed to evaluate the health of women with leaking silicone breast implants.
Most epidemiological research on implants has not satisfied these criteria. The studies by NCI and the Food and Drug Administration (FDA) are the best studies thus far, because patients in their studies had implants for a minimum of six years. Most epidemiological studies that have been widely quoted, including those in the Institute of Medicine report on implants, included women who had breast implants for only a month or more.
"This report confirms how difficult it is to measure disease risks when studying breast implants, because many diseases take at least 10-15 years to develop. After years in the human body, breast implants change dramatically, and even the sturdiest silicone implants tend to break and leak. The FDA should consider these long-term risks when they consider manufacturers' applications to sell silicone breast implants without restrictions," added Dr. Zuckerman, who served on the NCI scientific advisory panel for their studies on breast implants.
This is the first time NCI has summarized all their research data in one report. The review includes findings from four published studies. These studies were ordered by Congress in the early 1990s, after a federal investigation revealed that a regulatory loophole had enabled manufacturers to sell their products for nearly forty years without conducting safety studies.
The increase in diseases and suicide among women with implants are expected to be considered by the FDA as it reviews new data recently provided by implant manufacturers. In January 2004, the FDA announced its intention to keep restrictions on the sale of silicone breast implants due to safety concerns and the lack of long-term safety data. According to the FDA, and the manufacturers' own data, nearly all implants fail, many women require corrective surgery within a few years, and patients report an increase in joint and muscle pain and chronic fatigue.(3)
In addition, breast implants interfere with the detection of breast cancer. According to a recent study published in the Journal of the American Medical Association, mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.(4)
Concerns have mounted recently, after a study presented at the American Chemical Society's August 2004 meeting found higher than normal concentrations of platinum, which is highly toxic, in women with silicone breast implants, and in the children they breast-fed after getting implants.(5)
The National Research Center for Women & Families, formerly known as the National Center for Policy Research for Women & Families, provides consumer- friendly research-based information on a wide range of health issues affecting women, children, and families. See http://www.center4research.org and http://www.breastimplantinfo.org for more information.
(1) http://www.nci.nih.gov/newscenter/siliconefactsheet (2) Brinton, LA et al (2004). Risk of Connective Tissue Disorders among Breast Implant Patients, American Journal of Epidemiology, 160: 619-627. (3) www.fda.gov/ohrms/dockets/ac/cdrh03.html#GeneralandPlasticSurgery (4) Miglioretti DL, Rutter CM, Geller BM, et al. (2004). Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association, 291: 442-50. (5) "Platinum found in women with implants.'' The Associated Press, August 26, 2004.
-------------------------------------------------------------------------------- Source: National Research Center for Women & Families
Orac - 05 Oct 2004 01:55 GMT > http://biz.yahoo.com/prnews/041004/dcm055_1.html > > Press Release Source: National Research Center for Women & Families I'm confused. When I go to the NCI website under their news section, I find this:
http://www.nci.nih.gov/newscenter/pressreleases/BreastImplantsO1Oct04
"NCI Study Finds No Long-term Health Effects from Breast Implants"
This is a recent study showing no definite link to connective tissue disorders.
A little digging revealed the site you're referring to:
http://www.nci.nih.gov/newscenter/siliconefactsheet
It's actually a fairly nice summary of the available data. It's also somewhat less alarming than the press release you cite. It even includes the study above that found no long term risk of connective tissue disorders from implants. An excerpt of the key conclusions of the NCI summary:
<BEGIN EXCERPT>
Results/Publications
1. The authors showed that other plastic surgery patients are a more appropriate comparison group than women in the general population for studies of the health effects of breast implants.
In analyzing the data from the 7,447 breast implant patients and 2,203 patients with other types of plastic surgery, there were no differences between the two groups with respect to family income, number of pregnancies, alcohol consumption, cigarette smoking, histories of previous gynecologic operations, or operations for benign breast disease.
Reference: Brinton LA, Brown SL, Colton T, et al. Characteristics of a Population of Women with Breast Implants Compared with Women Seeking Other types of Plastic Surgery. Plastic and Reconstructive Surgery 2000;105(3):919-27.
2. The NCI researchers found no association between breast implants and the subsequent risk of breast cancer
In addition, they found no link between breast cancer risk and number of years of follow-up, nor with any particular type of implant. They did, however, see a shift toward somewhat later detection of breast cancers among the implant patients compared to the controls. Even though the differences were not statistically significant, there were consistently smaller percentages of in situ (early-stage) cancers among the implant patients. However, there was no significant difference in breast cancer mortality between the implant and comparison patients.
Reference:Brinton LA, Lubin JH, Burich MC, et al. Breast Cancer Following Augmentation Mammoplasty (United States). Cancer Causes & Control 2000; 11(9):819-827.
3. Women with implants were not at increased risk for most cancers with the exception of respiratory and brain cancers. The significance of the increased risks is not clear.
NCI researchers did not find increased risks for cancers of the stomach, large intestine, cervix, uterus, ovary, bladder or thyroid. Likewise, neither connective tissue nor immune system cancers such as soft tissue sarcomas, lymphoma, and multiple myeloma, developed at higher rates. These cancers were previously linked to implants in smaller studies. The cancer rates for brain and respiratory cancers, however, were two to three times greater in the implant patients compared to other plastic surgery patients; only the rates of respiratory cancers reached statistical significance. The significance of the findings is not clear. It is possible that the higher risks observed for respiratory and brain cancers are not related to exposure to silicone, but are due to either chance findings or to factors common to women who choose to have implants.
Reference: Brinton LA, Lubin JH, Burich MC, et al. Cancer Risk at Sites Other than Breast Following Augmentation Mammoplasty. Annals of Epidemiology May 2001; 11(4):248-256.
4. Women with implants were not at increased risk for most causes of death compared to the control group. The exceptions were deaths from suicide, and brain and respiratory cancers, but the significance of these increased risks is not clear.
The researchers found that nearly every cause of death, including all cancers, circulatory and digestive system diseases, and endocrine, nutritional, metabolic and immune diseases, was decreased among implant patients compared to the general population. However, implant patients were three times more likely to die from respiratory tract cancer, two to three times more likely to die from brain cancer, and four to five times more likely to die from suicide than the comparison group; only the rates for respiratory cancers reached statistical significance. It is possible that these higher risks are not related to exposure to silicone, but are due to either chance findings or to factors common to women who choose to have implants.
Reference: Brinton LA, Lubin JH, Burich MC, et al. Mortality Among Augmentation Mammoplasty Patients. Epidemiology May 2001;12(3):321-326.
5. Women with breast implants were not at an increased risk for connective tissue disorders when their records were reviewed by two independent rheumatologists who did not know if the women had an implant or not
According to initial reporting by an implant patient questionnaire, there appeared to be a two fold increased risk for developing rheumatoid arthritis, scleroderma, systemic lupus erythematosus, and Sjogren's syndrome in this population. NCI researchers were able to access only 34-40% of these patients' records who reported being diagnosed with a connective tissue disorder. When these records were reviewed by two independent, board-certified rheumatologists who did not know if the patient had an implant or not, the rheumatologists found between 17-30% of the diagnoses likely. As a result, the risk for developing a connective tissue disorder due to breast implants, while still somewhat elevated, became statistically non-significant. Further research including records linkage, standardized diagnostic criteria for rheumatoid disorders, and clinical exams, is needed to understand if a relationship exists.
Reference: Brinton LA, Buckley LM, Dvorkina O, et al. Risk of Connective Tissue Disorders among Breast Implant Patients. American Journal of Epidemiology; 2004;160; 619-627.
<END EXCERPT>
One notes that the discussion of the supposed increased cancer risk is virtually identical (albeit much shorter) to the same discussion I posted of that paper a year and a half ago, in which I explained that only the respiratory risk approached statistical significance and it was not clear if the researchers had adequately controlled for smoking behavior between the groups, which could certainly affect rates of respiratory cancers:
http://www.google.com/groups?selm=orac-1542AA.12281701022003%40news4.suck news.com&output=gplain
Similarly, the discussion of the other Brinton paper is very similar to my discussion as well, also posted a year and a half ago:
http://www.google.com/groups?selm=orac-A8114E.10410530012003%40news4.suck news.com&output=gplain
Bottom line: The NCI summary supports the conclusion that implants are not connected to connective tissue disorders. It suggests that there might be a link to respiratory cancers and brain cancer, although the link to brain cancer is very tenuous.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 05 Oct 2004 14:02 GMT >Bottom line: The NCI summary supports the conclusion that implants are >not connected to connective tissue disorders. It suggests that there >might be a link to respiratory cancers and brain cancer, although the >link to brain cancer is very tenuous. Wrong Bottom Line:
The authors say that they can't conclude whether or not implants cause CTD based on their study, because of these methodological problems.
Further ...
Ahttp://biz.yahoo.com/prnews/041004/dcm055_1.html
Press Release Source: National Research Center for Women & Families
National Cancer Institute Spells Out Risks of Breast Implants Monday October 4, 3:15 pm ET Data Show Increased Risks Of Death From Cancers and Suicide
WASHINGTON, Oct. 4 /PRNewswire/ -- A new research summary by the National Cancer Institute (NCI) reveals its concerns about the health risks of silicone and saline breast implants, finding that "implant patients were three times more likely to die from respiratory tract cancer, two to three times more likely to die from brain cancer, and four to five times more likely to die from suicide" compared to other plastic surgery patients of the same age.(1) NCI researchers also found an increased risk of certain connective tissue diseases, such as a doubling in rheumatoid arthritis, and even greater increases in lupus and Sjogren's Syndrome.(2) However, increases in connective tissue diseases were not conclusive because of methodological issues, including the difficulty of studying increases in rare diseases and the lack of medical exams to confirm the accuracy of the diagnoses. "This very cautious summary provides essential information for women considering implants, and the almost two million American women who already have them," noted Dr. Diana Zuckerman, President of the National Research Center for Women & Families, a Washington-based nonprofit research and policy organization. "This is the latest of several red flags, warning women that the risks of breast implants have not been adequately studied. Women in the NCI studies had implants for at least 8 years -- longer than any other studies. But, women getting implants want them to be safe for the rest of their lives, and we still need research to find out what is happening to all the women who already have had breast implants for 20 years or more."
In addition to finding a higher risk of death from certain cancers and suicide, this study crystallizes the difficulties researchers face in studying the health risks of breast implants:
* More long-term data is needed on women with breast implants; * Large samples sizes are necessary to detect rare but debilitating diseases, such as scleroderma; * Safety studies need to be based on medical exams by independent doctors; * Studies are needed to evaluate the health of women with leaking silicone breast implants.
Most epidemiological research on implants has not satisfied these criteria. The studies by NCI and the Food and Drug Administration (FDA) are the best studies thus far, because patients in their studies had implants for a minimum of six years. Most epidemiological studies that have been widely quoted, including those in the Institute of Medicine report on implants, included women who had breast implants for only a month or more.
"This report confirms how difficult it is to measure disease risks when studying breast implants, because many diseases take at least 10-15 years to develop. After years in the human body, breast implants change dramatically, and even the sturdiest silicone implants tend to break and leak. The FDA should consider these long-term risks when they consider manufacturers' applications to sell silicone breast implants without restrictions," added Dr. Zuckerman, who served on the NCI scientific advisory panel for their studies on breast implants.
This is the first time NCI has summarized all their research data in one report. The review includes findings from four published studies. These studies were ordered by Congress in the early 1990s, after a federal investigation revealed that a regulatory loophole had enabled manufacturers to sell their products for nearly forty years without conducting safety studies.
The increase in diseases and suicide among women with implants are expected to be considered by the FDA as it reviews new data recently provided by implant manufacturers. In January 2004, the FDA announced its intention to keep restrictions on the sale of silicone breast implants due to safety concerns and the lack of long-term safety data. According to the FDA, and the manufacturers' own data, nearly all implants fail, many women require corrective surgery within a few years, and patients report an increase in joint and muscle pain and chronic fatigue.(3)
In addition, breast implants interfere with the detection of breast cancer. According to a recent study published in the Journal of the American Medical Association, mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.(4)
Concerns have mounted recently, after a study presented at the American Chemical Society's August 2004 meeting found higher than normal concentrations of platinum, which is highly toxic, in women with silicone breast implants, and in the children they breast-fed after getting implants.(5)
The National Research Center for Women & Families, formerly known as the National Center for Policy Research for Women & Families, provides consumer- friendly research-based information on a wide range of health issues affecting women, children, and families. See http://www.center4research.org and http://www.breastimplantinfo.org for more information.
(1) http://www.nci.nih.gov/newscenter/siliconefactsheet (2) Brinton, LA et al (2004). Risk of Connective Tissue Disorders among Breast Implant Patients, American Journal of Epidemiology, 160: 619-627. (3) www.fda.gov/ohrms/dockets/ac/cdrh03.html#GeneralandPlasticSurgery (4) Miglioretti DL, Rutter CM, Geller BM, et al. (2004). Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association, 291: 442-50. (5) "Platinum found in women with implants.'' The Associated Press, August 26, 2004.
-------------------------------------------------------------------------------- Source: National Research Center for Women & Families
Orac - 06 Oct 2004 01:38 GMT > >Bottom line: The NCI summary supports the conclusion that implants are > >not connected to connective tissue disorders. It suggests that there [quoted text clipped - 5 lines] > The authors say that they can't conclude whether or not implants cause > CTD based on their study, because of these methodological problems. My statement is correct as stated. The study detected no statistically significant difference in relative risk for connective tissue disorders. Consequently, it supports the conclusion that implants are not connected to connective tissue disorders. You could quibble with that, but here's one thing you can't quibble with. It certainly it does NOT support support the conclusion that implants are associated with connective tissue disorders.
Oh, BTW, I've read the whole article--the original study. Have you?
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 06 Oct 2004 02:29 GMT >My statement is correct as stated. This isn't about you Dave Gorski ... it's about millions of women with aging breast implants.
Here is what the authors said ... what you say is just Quacking.
> The authors say that they can't conclude whether or not implants cause > CTD based on their study, because of these methodological problems. Orac - 07 Oct 2004 02:00 GMT > >My statement is correct as stated. > > This isn't about you Dave Gorski ... it's about millions of women with > aging breast implants. > > Here is what the authors said ... what you say is just Quacking. What's wrong Ilena? Annoyed that I didn't respond to you right away. I notice you posted this message at 9:29 PM EDST last night and then posted the identical response to me again 12 hours later, at 9:23 AM EDST this morning. Seems a little obsessive, but I've seen you do much worse to others as far as repetition goes. Unlike perhaps you, I don't have time to post during the day (and sometimes not even at night). I'm too busy helping patients and doing medical research.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Tim K. - 05 Oct 2004 13:12 GMT It's bad enough you cross-post this sh.t all over the place, but on top of that you can't even write your own post. Another C&P fuckwit. <flush>
M*a*r*k P*r*o*b*e*r*t-October 4, 2004 - 05 Oct 2004 14:05 GMT > It's bad enough you cross-post this sh.t all over the place, but on top of > that you can't even write your own post. Another C&P fuckwit. > <flush> That was far too good a treatment of her.
Ilena Rose - 05 Oct 2004 15:17 GMT >It's bad enough you cross-post this sh.t all over the place, but on top of >that you can't even write your own post. Another C&P fuckwit. ><flush> This posting is written by a highly qualified researcher and is on topic for every newsgroup to which it was posted.
Orac - 06 Oct 2004 01:43 GMT > It's bad enough you cross-post this sh.t all over the place, but on top of > that you can't even write your own post. Another C&P fuckwit. > <flush> Sadly, Ilena only very rarely posts anything original that she has written herself. The vast majority of what she does post that is her own writing usually consists of rants against her enemies, inquisitorial questioning designed to trap whomever she is attacking, or sarcastic little rejoinders in response to substantive posts with actual citations for evidence. I can't recall the last time I've seen her even try to post a reasoned argument, other than cut'n'paste jobs, as you put it.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 06 Oct 2004 02:23 GMT >Sadly, Ilena only very rarely posts anything original that she has >written herself. Sadly? I feel your pain ... and it's as real as Vera Teasdale's (the woman Terry Polevoy prances around here pretending to be) ovaries.
More Hogwash Dave Gorski ... if I posted my own work, then you Professional Quack Whiners would whine about that.
http://www.mercola.com/2001/jun/6/breast_implants.htm
Breast Implants: America's Silent Epidemic by Ilena Rosenthal
Daily my phone rings and my email overflows with urgent and painful calls from women just awakening from the ether of their breast implants. Although their first surgeries may have been decades ago, they are finally emerging from the web of deceit that their plastic surgeons and the silicone manufacturers have woven through the media for years in a brilliant, expensive public relations coup of enormous proportions.
Now reality has struck as they join scores of thousands of ill and disfigured women in learning the hidden truth - their cherished breast implants may cost them their insurance, their health, their beauty, their vitality, their families, their careers, and too often, even their lives.
Everything I have ever done or thought or studied for 47 years brought me to November, 1995 when I created a Newsgroup (alt.support.breast-implant) on the Internet to provide an International Forum to discuss this perplexing issue and create a place for the women to connect with each other. I had no idea of the depth, breadth, or width of the Pandora's Box I was opening.
Five years later, after unknown thousands of communications from women, doctors, loved ones, attorneys, supporters and tormentors alike, I admit I am no longer without bias. I now know that a huge fraud has and continues to be committed on women, and the background on this issue reads like a non-fiction espionage bestseller.
No stranger to plastic surgery (first nose bob during my Dallas high school years) I do not now, nor have I ever had implants. There, but for the grace of God go I. A few million of our sisters have made that choice for a variety of reasons.
However, two common denominators remain the same -- they were always assured they were "safe" and the "risks minimal," and eerily, they have come up against a medical establishment unwilling and unable to cure their illnesses.
In 1992, after 30 years of unimpeded marketing, the FDA finally banned silicone gel implants for most women. Because of the lobbying of the manufacturers and plastic surgeons -- who flew in around 400 women to lobby Washington DC on their behalf -- women post-mastectomy were and are still allowed to get these unproven, highly risky medical devices.
Even though early studies were resurrected, long hidden by the manufacturers, proving they knew that their implants would break, immune reactions would occur, the gel would migrate, and even more disturbing, could cross the placenta and affect the unborn fetuses, almost never did this information make it to the women it could have protected.
They also hired visible spokesdoctors to misled the public into believing that implant rupture -- a devastating medical event -- was "only 4-6%." They also claimed to examine and find "no association" between implants and a myriad of painful and debilitating autoimmune diseases suffered in disproportionate percentages.
In fact, the Executive Editor of the New England Journal of Medicine, Dr. Marcia Angell, chose to publish two very flawed, small and short studies funded by those who stood the most to gain by the results. She then promoted and defended these studies as if they were gospel in her pro-manufacturer book, Science on Trial, and flooded the media with this corporate science while branding a scarlet "Junk Scientist" on any doctor who dared to dispute the "experts."
This PR campaign includes labeling the women "crazies" and their leaders and supporters "fear mongers" and "wackos" so desperate are they to destroy the credibility of any of us who dared to speak out on the dangers. The result is that for years, women have been lulled into a false belief, that they had a 95% chance of being rupture free. The contrary is true.
Alarming, indisputable evidence was released in October 2000, when the FDA published a landmark study of implanted women, many still without symptoms. This objective work revealed that 69% of these women had at least one ruptured implant, most without any knowledge of it, although implanted a median time of less than 17 years.
Other studies had already revealed over a 90% chance of rupture within 20 years.
Hardly, the "lifetime" product they were promised.
The cover up continues to fall apart . . .
Dr. David Feigal, director of the Center for Devices and Radiological Health at the FDA, said it so clearly, "When it happens to you, the rupture rate is 100 percent." By January 2000, over 127,000 women had written the FDA about the serious complications from their silicone gel implants.
The tragedy is that still today, they are unable to get good medical care as the majority of doctors refuse to believe the connection. Even worse, doctors don't have a clue what to do to heal these assaulted immune systems and rid women's bodies of the dozens of dangerous ingredients found in implants such as platinum, silica, formaldehyde, plasticizers and organic solvents.
Implant formulations were frequently changed -- shells and gel thicker then thinner then thicker again -- and "new and improved" was marketed so often, it appears silicone merchants believed their own hype.
In the 80's, as "the" answer to capsular contracture, over 100,000 women received gel implants with polyurethane foam glued to them. Not only did the foam disintegrate, often within just weeks of implantation, but it broke down into TDA, a known carcinogen, decades ago removed from hair dyes.
These women are amongst the most ill, and even when these dangerous implants were hurriedly taken off the market in 1991, no recall or even courtesy call was made to warn the implanted women.
The most recent implant disaster was exported to Europe, where well over 5,000 women, mainly in Britain, were implanted with soy oil filled implants, unlovingly known as "tofu titties." The American protocol for this product required this new round of female "lab rats" to be past childbearing age, but somewhere on it's way across the Atlantic, this requirement was dropped.
Health advocates and cautious scientists were warning of the serious potential dangers but were ignored and the "experts" made fortunes implanting them even in very young women. Their bubble burst as shocking reports and the rancid soy oil leaked out in Spring of 2000, and all the women were advised to have them removed as quickly as possible.
The damage to many had already been done. Now, like the millions with failed gel implants, they are faced with yet another difficult decision, should they replace them with saline filled implants? Is Saline the Solution?
From her wheelchair, Jackie Strange, the former Deputy Postmaster General of the United States spoke of the destruction of her life at hearings by the Institute of Medicine at the National Academy of Sciences in Washington, DC.
Infections, peripheral neuropathy, and a myriad of autoimmune diseases struck in both rapid and slow succession following her implantation with saline filled, silicone implants. Concurrently, the manufacturers and plastic surgeons were creating a multi-media blitz touting saline implants from billboards, glossy magazines and TV. With ads reminiscent of "You've come a long way, baby," young women were featured praising their implants and plastic surgeons did the Talk Show circuit assuring women that saline was "natural" and leakage benign.
In Spring, 2000, in spite of over 50,000 reports of serious adverse reactions from water-filled implants, the FDA made the fateful decision to give their highly valued stamp of "safety approval" on two brands of saline implants, declaring them "safe enough." How can this be?
The manufacturers own studies show that within just the first 3 years, nearly 40% of post-mastectomy patients had to have additional surgeries with these implants.
The complication rate for these women is around 80% in just 4 years time. After cancer, invasive surgery to remove the tumors, often radiation and / or chemotherapy, the body is simply not strong enough to handle this foreign invader.
Even for women wanting implants just for augmentation to boost their self-esteem, the complication rates are staggering. Glamour Magazine, in their November 2000 issue published a full page photo revealing a saline filled implant, entirely black with aspergillus niger and other fungi.
Breast Cancer and Implants - No Easy Answers
Nearly 200,000 American women -- our sisters, mothers, teachers, lovers, daughters, friends -- will be diagnosed with breast cancer this year. Cancer and implant survivor, retired Professor of Health Education, Henrietta Farber, recently summarized the feelings of many who know, "The cancer was challenging.
The implants almost killed me." While the manufacturers press releases rage "The Case Against Implants Collapses," and try to close this ugly chapter in medical history, the women, now united, have a plan of their own. With the health of women and their offspring at stake, Martha Murdock, Co-Founder of the National Silicone Implant Foundation in Dallas, with four generations of her family affected by silicone toxicity, says it best, "It's not over 'til we win."
Risks of Breast Implants
1. Implants can rupture during mammography.
2. Implants make routine self exams and mammography more difficult. More views are necessary, meaning additional radiation each time.
3. Implant rupture can go undetected for years and silicone is known to migrate through the lymph system and has been found in the brains, spinal fluid, ovaries, livers, and other organs of implanted women.
4. Implants are not lifetime devices, and may need to be replaced (even without systemic problems) more than once a decade.
5. At any time infections are possible, including fungal and antibiotic resistant bacterial infestations.
6. Loss of breast sensation, especially around the nipple area is reported, as well as hyper-senstivity to touch.
7. Capsular contracture can be very uncomfortable, to the point of severe pain and deformation.
8. Many women have experienced severe necrosis and other forms of breast tissue loss.
9. Many women have experienced serious autoimmune diseases post implantation including: rheumatoid arthritis, scleroderma, multiple sclerosis, Sjøgrens Syndrome (severe dry mouth, eyes, etc.), and lupus. Those women with pre-existing compromised immune systems are now warned to avoid implants.
10. Disproportional numbers of implanted women have reported neurological and cognitive complications, as well as endocrine disruption including hysterectomies, miscarriage.
11. Children born of implanted women have experienced the same autoimmune conditions and have been seriously inadequately studied.
12. Breast implants often negatively affect the ability to produce milk for breast-feeding.
13. Health insurance carriers are routinely denying coverage for implanted (and explanted) women.
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Orac - 07 Oct 2004 02:04 GMT > >Sadly, Ilena only very rarely posts anything original that she has > >written herself. > > Sadly? I feel your pain ... and it's as real as Vera Teasdale's (the > woman Terry Polevoy prances around here pretending to be) ovaries. Pain? You really give yourself too much credit if you think you cause me any signficant distress. Perhaps a long time ago, but that was before I knew your M.O.
> More Hogwash Dave Gorski ... if I posted my own work, then you > Professional Quack Whiners would whine about that. > > http://www.mercola.com/2001/jun/6/breast_implants.htm A cut and paste job of something you wrote over three years ago.
As I said, you don't bother to write anything original for Usenet, other than rants against your enemies, inquisitorial questioning designed to trap whomever you are attacking, or sarcastic little rejoinders in response to some one else's substantive posts with actual citations for evidence.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 06 Oct 2004 14:16 GMT >My statement is correct as stated. This isn't about you Dave Gorski ... it's about millions of women with aging breast implants.
Here is what the authors said ... what you say is just Quacking.
> The authors say that they can't conclude whether or not implants cause > CTD based on their study, because of these methodological problems. Orac - 07 Oct 2004 01:57 GMT > >My statement is correct as stated. > > This isn't about you Dave Gorski ... it's about millions of women with > aging breast implants. > > Here is what the authors said ... what you say is just Quacking. Not "quacking," merely drawing conclusions from what the authors themselves say. I'm sure the authors would agree that their study fails to support the contention that implants cause connective tissue disorders. Indeed, by admitting that it would likely require a very large study to demonstrate a link, they are inherently admitting that their present study does not do so.
> > The authors say that they can't conclude whether or not implants cause > > CTD based on their study, because of these methodological problems. Which means that their study does NOT support the conclusion that implants cause connective tissue disorders. Clearly, you don't understand basic study methodology and how to interpret conclusions.
But, don't believe me, believe the authors themselves, cut and pasted straight from the PDF file of the paper:
"These results indicate that self-reports of connective tissue disorders are influenced by reporting and surveillance biases. Given the diagnostic complexities of these diseases, excess risks, if they exist, may be beyond detection even in a study of this size."
Translation: We didn't detect a link between implants and connective tissue diseases because of these problems and may not be able to without a much larger study, IF THERE IS SUCH A LINK.
I understand that perhaps you are not familiar with the caveats and equivocations that we use when we are presenting data that is not clear.
Another quote from the paper:
"It is clear that a variety of selection and reporting biases may be involved, as evidenced in the present study by overreporting of conditions by both implant and comparison patients and the difficulty of confirming conditions according to defined clinical criteria. Our investigation had the most power to address relations with rheumatoid arthritis. Therefore, it is of interest that our risk estimates (on the basis of cases considered likely by expert chart review) were between 1.3 and 1.9 and not statistically significant."
To boil it down: In the authors' study, there was no statistically significant difference between women with implants and controls in rheumatoid arthritis, which is the connective tissue disorder this study had the most statistical power to examine. (And there wasn't a significant difference in any of the other connective tissue disorders, either.)
Given that this rather large study failed to find a statistically significant difference in connective tissue disorders between women with implants and controls, it is likely that if there is increased risk of connective tissue disorders due to implants, it is probably quite small. Otherwise, it very likely would not require a new, much larger study to find it.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Herman Rubin - 07 Oct 2004 15:24 GMT .................
>"These results indicate that self-reports of connective tissue disorders >are influenced by reporting and surveillance biases. Given the >diagnostic complexities of these diseases, excess risks, if they exist, >may be beyond detection even in a study of this size."
>Translation: We didn't detect a link between implants and connective >tissue diseases because of these problems and may not be able to without >a much larger study, IF THERE IS SUCH A LINK. This is a common mistranslation. There always is some sort of link; whether it is positive or negative, it is there. It may be very small, and may be very difficult to separate out from other effects.
>I understand that perhaps you are not familiar with the caveats and >equivocations that we use when we are presenting data that is not clear.
>Another quote from the paper:
>"It is clear that a variety of selection and reporting biases may be >involved, as evidenced in the present study by overreporting of [quoted text clipped - 4 lines] >basis of cases considered likely by expert chart review) were between >1.3 and 1.9 and not statistically significant."
>To boil it down: In the authors' study, there was no statistically >significant difference between women with implants and controls in >rheumatoid arthritis, which is the connective tissue disorder this study >had the most statistical power to examine. (And there wasn't a >significant difference in any of the other connective tissue disorders, >either.) You are making the common mistake of confusing statistical significance and importance. I do not have the raw data, but if the treatment and control groups were the same size, and the observed risk ratio was 1.6, there were only on the order of 100 altogether who developed problems.
>Given that this rather large study failed to find a statistically >significant difference in connective tissue disorders between women with >implants and controls, it is likely that if there is increased risk of >connective tissue disorders due to implants, it is probably quite small. >Otherwise, it very likely would not require a new, much larger study to >find it. There is the question whether it is worth finding. However, I would suggest that patients be warned of the possibility, NOT that one try to either ban the implants or to declare them safe. There are NO safe effective treatments.
 Signature This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Ilena Rose - 07 Oct 2004 15:37 GMT Links have already been found with ruptured breast implants and fibromyalgia ...
http://www.breastimplantinfo.org/what_know/fda2001.html
November/December 2001
Fibromyalgia and Ruptured Silicone Gel Breast Implants
Women whose silicone breast implants have ruptured and spread silicone gel beyond the fibrous scar that forms around the implant may be at increased risk for fibromyalgia, an FDA study indicates.
FDA researchers asked 344 women with silicone gel implants if they had experienced persistent joint pain, swelling or stiffness; rash on their breasts or chest; or fatigue. Those in the study also were asked whether a physician had diagnosed them with Raynaud's disease, Sjögren's syndrome, scleroderma, chronic fatigue, or fibromyalgia--a chronic condition marked by fatigue, musculoskeletal aches and sleep disturbances.
The women also had a magnetic resonance imaging (MRI) examination to detect whether their implants were intact or ruptured, and whether silicone gel had leaked outside of the scar tissue immediately surrounding the implant.
The study found that women with a ruptured implant in which the silicone hadn't leaked beyond the scar tissue were no more likely than women with intact implants to report that they had either the persistent symptoms or diagnosed illnesses listed on the questionnaire.
However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel.
"If other studies are consistent with these findings, women should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule," says lead study investigator S. Lori Brown, Ph.D., M.P.H., of the FDA's Center for Devices and Radiological Health.
The study, supported in part by the FDA's Office of Women's Health and the National Institutes of Health, was published in the May 2001 Journal of Rheumatology. An estimated 6 million to 8 million Americans have fibromyalgia. About 80 percent of those affected are women.
The FDA took silicone gel breast implants off the market for general use in 1992 because of safety concerns. They continue to be allowed in FDA-approved studies for women seeking breast reconstruction or revision of an existing breast implant. Additionally, those who need to have an existing implant replaced for medical reasons, such as implant rupture, are also eligible for these studies.
In 2000, the FDA approved the continued use of two manufacturers' saline breast implants. (See "Saline Breast Implants Stay on Market as Experts Warn About Risks" in the July-August 2000 FDA Consumer.)
Further information on breast implants may be found at www.fda.gov/cdrh/breastimplants.
Orac - 08 Oct 2004 02:00 GMT > Links have already been found with ruptured breast implants and > fibromyalgia ... > > http://www.breastimplantinfo.org/what_know/fda2001.html Actually, this is an old article from 2001. A key paragraph states:
"However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel."
The key problem here is that this is self-reported, and, as the VERY article you cited recently, by Brinton et al, concluded, the diagnosis of connective tissue disorders is greatly influenced by self-reporting bias. That study failed to find a statistically signficant link between fibromyalgia and implants. The relative risk was 1.3, with a 95% confidence interval of 0.9 to 1.7. The most you can conclude from the data is that, if there is an increased risk of fibromyalgia due to implants, it is likely to be small, possibly a 30% increased risk over the general population (although there may be no increased risk at all). Given that fibromyalgia is a relatively uncommon condition, this is not that alarming.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 07 Oct 2004 15:37 GMT Links have already been found with ruptured breast implants and fibromyalgia ...
http://www.breastimplantinfo.org/what_know/fda2001.html
November/December 2001
Fibromyalgia and Ruptured Silicone Gel Breast Implants
Women whose silicone breast implants have ruptured and spread silicone gel beyond the fibrous scar that forms around the implant may be at increased risk for fibromyalgia, an FDA study indicates.
FDA researchers asked 344 women with silicone gel implants if they had experienced persistent joint pain, swelling or stiffness; rash on their breasts or chest; or fatigue. Those in the study also were asked whether a physician had diagnosed them with Raynaud's disease, Sjögren's syndrome, scleroderma, chronic fatigue, or fibromyalgia--a chronic condition marked by fatigue, musculoskeletal aches and sleep disturbances.
The women also had a magnetic resonance imaging (MRI) examination to detect whether their implants were intact or ruptured, and whether silicone gel had leaked outside of the scar tissue immediately surrounding the implant.
The study found that women with a ruptured implant in which the silicone hadn't leaked beyond the scar tissue were no more likely than women with intact implants to report that they had either the persistent symptoms or diagnosed illnesses listed on the questionnaire.
However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel.
"If other studies are consistent with these findings, women should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule," says lead study investigator S. Lori Brown, Ph.D., M.P.H., of the FDA's Center for Devices and Radiological Health.
The study, supported in part by the FDA's Office of Women's Health and the National Institutes of Health, was published in the May 2001 Journal of Rheumatology. An estimated 6 million to 8 million Americans have fibromyalgia. About 80 percent of those affected are women.
The FDA took silicone gel breast implants off the market for general use in 1992 because of safety concerns. They continue to be allowed in FDA-approved studies for women seeking breast reconstruction or revision of an existing breast implant. Additionally, those who need to have an existing implant replaced for medical reasons, such as implant rupture, are also eligible for these studies.
In 2000, the FDA approved the continued use of two manufacturers' saline breast implants. (See "Saline Breast Implants Stay on Market as Experts Warn About Risks" in the July-August 2000 FDA Consumer.)
Further information on breast implants may be found at www.fda.gov/cdrh/breastimplants.
Orac - 08 Oct 2004 01:55 GMT > ................. > [quoted text clipped - 11 lines] > It may be very small, and may be very difficult to separate > out from other effects. You are making a common mistake among nonphysicians.
There is not "always" a link. Sometimes the reason no "statistically significant" link is found is because there really is no biologic link. Sometimes there is a biologic link and the study was not big enough or properly designed to find it.
> >I understand that perhaps you are not familiar with the caveats and > >equivocations that we use when we are presenting data that is not clear. [quoted text clipped - 19 lines] > You are making the common mistake of confusing statistical > significance and importance. No, I am not. You frequently assume that whenever anyone mentions statistical significance in almost any context, and you assume it now.
>I do not have the raw data, > but if the treatment and control groups were the same size, > and the observed risk ratio was 1.6, there were only on the > order of 100 altogether who developed problems. It was a retrospective cohort study done over the years 1960-1996. There were 10,778 evaluable patients (79.9% of the original cohort) and 3,214 control patients (81.7%) of the cohort evaluable. The authors stated that the reason that there were more implant patients than control patients is that the emphasis of the study was on cancer outcomes, for which external comparison incidence rates are available.
> >Given that this rather large study failed to find a statistically > >significant difference in connective tissue disorders between women with [quoted text clipped - 4 lines] > > There is the question whether it is worth finding. Well, that's sort of what I was saying. If the increased relative risk is small (as this study implies) and is likely to require a huge study to detect (which this study concludes), it is probably a relatively insignificant risk.
Given that the risk of local complications from the surgery requiring reoperation have been reported in the 25-50% range, the risk of connective tissue disorders pales in comparison.
>However, > I would suggest that patients be warned of the possibility, > NOT that one try to either ban the implants or to declare > them safe. Not unreasonable.
>There are NO safe effective treatments. I disagree. I would say instead that there are no COMPLETELY safe effective treatments. There are some quite safe treatments with low risks of side effects and adverse reactions that are quite effective, depending on the disease. The problem is, people seem to expect 100% safety, which is never achievable, even by "alternative medicine."
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 08 Oct 2004 02:55 GMT http://biz.yahoo.com/prnews/041004/dcm055_1.html
Press Release Source: National Research Center for Women & Families
National Cancer Institute Spells Out Risks of Breast Implants Monday October 4, 3:15 pm ET Data Show Increased Risks Of Death From Cancers and Suicide
WASHINGTON, Oct. 4 /PRNewswire/ -- A new research summary by the National Cancer Institute (NCI) reveals its concerns about the health risks of silicone and saline breast implants, finding that "implant patients were three times more likely to die from respiratory tract cancer, two to three times more likely to die from brain cancer, and four to five times more likely to die from suicide" compared to other plastic surgery patients of the same age.(1) NCI researchers also found an increased risk of certain connective tissue diseases, such as a doubling in rheumatoid arthritis, and even greater increases in lupus and Sjogren's Syndrome.(2) However, increases in connective tissue diseases were not conclusive because of methodological issues, including the difficulty of studying increases in rare diseases and the lack of medical exams to confirm the accuracy of the diagnoses. "This very cautious summary provides essential information for women considering implants, and the almost two million American women who already have them," noted Dr. Diana Zuckerman, President of the National Research Center for Women & Families, a Washington-based nonprofit research and policy organization. "This is the latest of several red flags, warning women that the risks of breast implants have not been adequately studied. Women in the NCI studies had implants for at least 8 years -- longer than any other studies. But, women getting implants want them to be safe for the rest of their lives, and we still need research to find out what is happening to all the women who already have had breast implants for 20 years or more."
In addition to finding a higher risk of death from certain cancers and suicide, this study crystallizes the difficulties researchers face in studying the health risks of breast implants:
* More long-term data is needed on women with breast implants; * Large samples sizes are necessary to detect rare but debilitating diseases, such as scleroderma; * Safety studies need to be based on medical exams by independent doctors; * Studies are needed to evaluate the health of women with leaking silicone breast implants.
Most epidemiological research on implants has not satisfied these criteria. The studies by NCI and the Food and Drug Administration (FDA) are the best studies thus far, because patients in their studies had implants for a minimum of six years. Most epidemiological studies that have been widely quoted, including those in the Institute of Medicine report on implants, included women who had breast implants for only a month or more.
"This report confirms how difficult it is to measure disease risks when studying breast implants, because many diseases take at least 10-15 years to develop. After years in the human body, breast implants change dramatically, and even the sturdiest silicone implants tend to break and leak. The FDA should consider these long-term risks when they consider manufacturers' applications to sell silicone breast implants without restrictions," added Dr. Zuckerman, who served on the NCI scientific advisory panel for their studies on breast implants.
This is the first time NCI has summarized all their research data in one report. The review includes findings from four published studies. These studies were ordered by Congress in the early 1990s, after a federal investigation revealed that a regulatory loophole had enabled manufacturers to sell their products for nearly forty years without conducting safety studies.
The increase in diseases and suicide among women with implants are expected to be considered by the FDA as it reviews new data recently provided by implant manufacturers. In January 2004, the FDA announced its intention to keep restrictions on the sale of silicone breast implants due to safety concerns and the lack of long-term safety data. According to the FDA, and the manufacturers' own data, nearly all implants fail, many women require corrective surgery within a few years, and patients report an increase in joint and muscle pain and chronic fatigue.(3)
In addition, breast implants interfere with the detection of breast cancer. According to a recent study published in the Journal of the American Medical Association, mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.(4)
Concerns have mounted recently, after a study presented at the American Chemical Society's August 2004 meeting found higher than normal concentrations of platinum, which is highly toxic, in women with silicone breast implants, and in the children they breast-fed after getting implants.(5)
The National Research Center for Women & Families, formerly known as the National Center for Policy Research for Women & Families, provides consumer- friendly research-based information on a wide range of health issues affecting women, children, and families. See http://www.center4research.org and http://www.breastimplantinfo.org for more information.
(1) http://www.nci.nih.gov/newscenter/siliconefactsheet (2) Brinton, LA et al (2004). Risk of Connective Tissue Disorders among Breast Implant Patients, American Journal of Epidemiology, 160: 619-627. (3) www.fda.gov/ohrms/dockets/ac/cdrh03.html#GeneralandPlasticSurgery (4) Miglioretti DL, Rutter CM, Geller BM, et al. (2004). Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association, 291: 442-50. (5) "Platinum found in women with implants.'' The Associated Press, August 26, 2004.
-------------------------------------------------------------------------------- Source: National Research Center for Women & Families
Orac - 08 Oct 2004 03:48 GMT > http://biz.yahoo.com/prnews/041004/dcm055_1.html > [quoted text clipped - 3 lines] > Monday October 4, 3:15 pm ET > Data Show Increased Risks Of Death From Cancers and Suicide Yet another cut'n'paste repetition by Ilena, already answered by me earlier in this thread.
[Snip]
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Ilena Rose - 08 Oct 2004 02:56 GMT >You are making a common mistake among nonphysicians. LOL ... that's why I claim you think you are a Medical Deity, Davey ... your ability to avoid ALL evidence that doesn't suit your agenda, coupled with unmitigated arrogance ...
Orac - 08 Oct 2004 03:46 GMT > >You are making a common mistake among nonphysicians. > > LOL ... that's why I claim you think you are a Medical Deity, Davey Heh heh. I can't decide if I should just gracefully accept the title of Medical Deity and use it to smite mine enemies, or if I should point out that perhaps your use of it is an indication of an inferiority complex.
Perhaps I should lose the 'nym "Orac" and start posting under "Medical Deity." After all, I've been posting as "Orac" for several years now. A change might be good. ;-)
> ... your ability to avoid ALL evidence that doesn't suit your agenda, > coupled with unmitigated arrogance ... Ah, but I'm not the one here who is avoiding the evidence, Ilena. I'm confronting it head-on and evaluating it relatively objectively. Any paper you cite I"m willing to look at. I've done it before in the past, and I just did it the other day with the NCI site and the very recent NCI study looking at implants and connective tissue diseases. In fact, rather than relying on second-hand accounts (sometimes distorted or biased), as you do, I try whenever possible to go straight to the source and read the original scientific paper from the original scientific journal. You, on the other hand, when faced with evidence or analysis that doesn't fit with your preconceived beliefs, almost invariably resort to a combination of either:
1. Ad hominem attacks
2. Sarcasm (http://www.butterfliesandwheels.com/rhetoricprint.php?num=17)
3. Evasion (http://www.butterfliesandwheels.com/rhetoricprint.php?num=1)
3. Mindless repetition of the same cut'n'paste job over and over again (http://www.butterfliesandwheels.com/rhetoricprint.php?num=8)
Clearly, in the case of #4 (seemingly your favorite technique lately), you probably hope that the repetition will eventually wear down your critics, who eventually get tired of dealing with the same cut'n'paste job over and over again, without actually forcing you to produce any additional evidence to defend your viewpoint.
Contrary to what you appear to believe, I have never denied that implants can cause significant problems (mainly the local complication rate from the surgery, which is too high). What I *have* been skeptical about is the evidence linking implants to all the systemic diseases claimed for them, evidence which, quite frankly, is not all that persuasive. That doesn't mean there might not be a link to systemic diseases such as connective tissue disorders. It does mean that it's probably not a particularly strong link, given that some very large studies have failed to find it.
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
Herman Rubin - 08 Oct 2004 17:05 GMT .................
>> >"These results indicate that self-reports of connective tissue disorders >> >are influenced by reporting and surveillance biases. Given the >> >diagnostic complexities of these diseases, excess risks, if they exist, >> >may be beyond detection even in a study of this size."
>> >Translation: We didn't detect a link between implants and connective >> >tissue diseases because of these problems and may not be able to without >> >a much larger study, IF THERE IS SUCH A LINK.
>> This is a common mistranslation. There always is some sort >> of link; whether it is positive or negative, it is there. >> It may be very small, and may be very difficult to separate >> out from other effects.
>You are making a common mistake among nonphysicians.
>There is not "always" a link. Sometimes the reason no "statistically >significant" link is found is because there really is no biologic link. >Sometimes there is a biologic link and the study was not big enough or >properly designed to find it. There is always a link. Having a breast implant does SOMETHING to the system; it may not be great.
>> >I understand that perhaps you are not familiar with the caveats and >> >equivocations that we use when we are presenting data that is not clear.
>> >Another quote from the paper:
>> >"It is clear that a variety of selection and reporting biases may be >> >involved, as evidenced in the present study by overreporting of [quoted text clipped - 4 lines] >> >basis of cases considered likely by expert chart review) were between >> >1.3 and 1.9 and not statistically significant."
>> >To boil it down: In the authors' study, there was no statistically >> >significant difference between women with implants and controls in >> >rheumatoid arthritis, which is the connective tissue disorder this study >> >had the most statistical power to examine. (And there wasn't a >> >significant difference in any of the other connective tissue disorders, >> >either.)
>> You are making the common mistake of confusing statistical >> significance and importance.
>No, I am not. You frequently assume that whenever anyone mentions >statistical significance in almost any context, and you assume it now. I find it difficult to think of a situation in which I would use statistical significance with a preassigned level as a means of making a decision. I would not say it means nothing, but it means nothing relevant to decision making under uncertainty, which is the problem.
Now it is true that in many situations the criterion corresponds to SOME "significance level", but this is affected by sample size, assessment of the consequences, and prior assumptions. These are unavoidable.
>>I do not have the raw data, >> but if the treatment and control groups were the same size, >> and the observed risk ratio was 1.6, there were only on the >> order of 100 altogether who developed problems.
>It was a retrospective cohort study done over the years 1960-1996. There >were 10,778 evaluable patients (79.9% of the original cohort) and 3,214 >control patients (81.7%) of the cohort evaluable. The authors stated >that the reason that there were more implant patients than control >patients is that the emphasis of the study was on cancer outcomes, for >which external comparison incidence rates are available. There is also the question whether the patients in the study were "random". The information given is als not enough for me to carry out the necessary calculations, although I suspect I am still in the ballpark.
>> >Given that this rather large study failed to find a statistically >> >significant difference in connective tissue disorders between women with >> >implants and controls, it is likely that if there is increased risk of >> >connective tissue disorders due to implants, it is probably quite small. >> >Otherwise, it very likely would not require a new, much larger study to >> >find it.
>> There is the question whether it is worth finding.
>Well, that's sort of what I was saying. If the increased relative risk >is small (as this study implies) and is likely to require a huge study >to detect (which this study concludes), it is probably a relatively >insignificant risk.
>Given that the risk of local complications from the surgery requiring >reoperation have been reported in the 25-50% range, the risk of >connective tissue disorders pales in comparison.
>>However, >> I would suggest that patients be warned of the possibility, >> NOT that one try to either ban the implants or to declare >> them safe.
>Not unreasonable.
>>There are NO safe effective treatments.
>I disagree. I would say instead that there are no COMPLETELY safe >effective treatments. There are some quite safe treatments with low >risks of side effects and adverse reactions that are quite effective, >depending on the disease. The problem is, people seem to expect 100% >safety, which is never achievable, even by "alternative medicine." Which is why it is necessary to point out the small risks.
One of my physicians suggested I see a specialist about having a particular operation. The specialist discussed the risks and benefits, and pointed out that there was approximately a 5% risk of serious results. He also was somewhat skeptical whether the benefits would result. He was willing to perform the operation if I wanted it.
Some 30% risks are tolerable, and some 1% ones might not be. It must be up to the informed patient to decide.
 Signature This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Orac - 09 Oct 2004 00:33 GMT > >>I do not have the raw data, > >> but if the treatment and control groups were the same size, [quoted text clipped - 12 lines] > enough for me to carry out the necessary calculations, > although I suspect I am still in the ballpark. The question of whether the groups are truly comparable or random is a problem inherent in all retrospective studies. However, the authors appear to have been more rigorous in trying to match the two groups than I've observed in any previous trial on breast implants and connective tissue disorders (other than previous trials done by these authors, of course).
 Signature Orac |"I am not interested in trying to compensate | for your amazing lack of observation." | | Orac
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