All posts by BIeditor

FDA Panel Backs Breast Implants From One Maker

We Are Quoted, , , ,
Gardiner Harris, The New York Times: April 14, 2005.

Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems.

The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected.

On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation. […]

The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants.

Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears. […]

At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed. […]

Inamed and women’s groups complained about the votes.

“I’m stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data,” a vice president of Inamed, Dan Cohen, said.

Dr. Diana Zuckerman, president of the National Research Center for Health Research, called the conflicting votes illogical and predicted that the drug agency would reject both applications.

[…]

Read the original article here.

Risking Women’s Health

We Are Quoted, , , ,
SF Gate: April 12, 2005.

IT LOOKS as if two California manufacturers just won’t take no for an answer — even if women’s health is at stake.

In their third attempt, Santa Cruz-based Inamed Corp. and Mentor Corp., have submitted applications for FDA approval that would allow them to sell their silicone-gel breast implants to the general public. […]

If approved, the Food and Drug Administration would lift its ban, imposed in 1992, which limited the use of the implants to controlled research.

Lest the FDA and these manufacturers forget, there’s a reason the ban was imposed.

Numerous reports linked the implants to arthritis, vascular disease and a range of autoimmune disorders that followed after the implants ruptured.

“All the data indicates that rupture is inevitable,” said Diana Zuckerman, president of the National Research Center for Women & Families. “What have these companies shown to prove that it is now safe?”

Not much. […]

Read the original article here

Testimony of Diana Zuckerman, PhD at the FDA on Silicone Gel Breast Implants

Testimonies and Statements by NCHR
Diana Zuckerman, PhD, National Research Center for Women and Families,  April 2005

I’m Diana Zuckerman. I am President of the National Research Center for Women and Families, and I’m very pleased to be here. I have no conflicts. I’m a psychologist and epidemiologist and president of a nonprofit center that scrutinizes research to see what the implications are for health and safety.

We’ve heard that implants are the most studied medical product in the United States, but in 1991 there were about a million women with breast implants. The number of empirical published studies at that time was zero.

And at that time when they submitted their PMA, Inamed had only studied 39 breast cancer patients. Thirty-nine. And in their augmentation sample they had lost 65 percent of their augmentation patients at three to six months, according to the FDA summary.

Now, it brings us to 2003. Things have changed a little. We’re looking at the two to three year data that was available in 2003. It showed very high complication rates, including a lot of reoperations. It showed an increase in auto-immune symptoms, just about all of them that were measured. And it also showed no improvement and some worsening in most self-esteem and self-concept measures.

Now we know that most of the people talking have said this product has improved the quality of their life. But as has been pointed out by Panel members, the data just don’t support it. There is some improvement on body image, but not on quality of life, not on all of these other measures that have been touted as the main advantage of implants.

It’s very worrisome that all the patients in these studies are white, just about all of them. And, yes, I understand that most people getting breast implants for augmentation are white, but that is certainly not true of reconstruction patients. There are many, many thousands of reconstruction patients in this country that are women of color, and yet just a handful — I thought it was six African-American women, and five Asian American women, but according to the data shown this morning, it’s actually even lower. And I don’t understand how it could possibly be acceptable to approve a product with no data.

The reason why it’s important to have racial diversity in these samples is because there are racial differences in scarring and in auto-immune disease. African-American women are more likely, more susceptible to auto-immune disease. So we’d want to know are they more at risk, and we can’t conclude that because not only weren’t they analyzed separately, there weren’t even enough women to analyze separately.

That brings us to 2005. I thought that we’d have additional year of data. I was very interested to see what would the new data show and how would it be different. So I thought there’d be more data on complications compared to last time, but no, there aren’t. And I thought that there’d be another year of data on auto-immune, and no, there aren’t. And I thought there’d be another year of data on self-esteem and quality of life, and no, there aren’t. There is rupture data, and that’s great. But it was really for the three-year MRI data. It’s called four-year data, but since MRIs were done in the third year, it doesn’t take us very far.

When Inamed compared ruptured and intact implants, they did not evaluate connective tissue disease symptoms for most women with ruptures. I say that based on the FDA’s scientific analysis in your package.

They did find a significant increase in muscle pain. They didn’t find too many increases, but they had a very, very small sample to work with, partly because it just wasn’t measured.

The Adjunct Study has, according to Inamed, included 25,000 paients, but they didn’t follow-up on them. This is very upsetting because this was such a great opportunity to provide really good data and longer term data. And let me say that the young woman who testified about her problems not being reported, whether she was in the Adjunct Study or the Core Study, her problems should have been reported. And it says something about the commitment of the sponsor that they seem to think as long as it was the Adjunct Study, it doesn’t matter. I think it does matter. They should be taking care of patients in their studies, and they should be reporting them regardless of which — I don’t know which study she was in, but whichever one it is, she should have been reported.

And also remember that Inamed started their studies in 1990. Had they followed those women, we’d have at least a dozen years of safety data, the data we want. But they didn’t do that.

The literature review that FDA did talked about the Danish registry, but the mean number of years of women, and that was less than four years –not long enough.

It talked about the Danish rupture study. Forty percent of the implants were tested with a faulty MRI, so that study was not helpful.

And basically the data that many of you talked about showing up to ten years of rupture is faulty data. And I hope that Dr. Blumenstein will say something more about that later.

The FDA study did have a 21 percent extracapsular leakage for implants that were seven years old or more, and they also found an increase in fibromyalgia, which has not really been discussed at this meeting.

Thank you.

Teenagers and Cosmetic Surgery

Published Journal Articles
Diana Zuckerman. “Teenagers and Cosmetic Surgery.” Commentary published in the online ethics journal of the American Medical Association
Virtual Monitor, March 2005.

In 2003, more than 223 000 cosmetic procedures were performed on patients 18 years of age or younger, and almost 39 000 were surgical procedures such as nose reshaping, breast lifts, breast augmentation, liposuction, and tummy tucks.1 As we consider under what circumstances plastic surgery is appropriate for teens, it is important to recognize that very few studies have been conducted to examine the risks for teens of these increasingly common procedures. Research is especially needed for the more controversial procedures such as breast implants, liposuction, and genital plastic surgery.

There is no question that reconstructive surgeries can benefit children and youth. Surgical procedures to correct cleft lips and palates, for example, are not controversial. Plastic surgery to correct unattractive facial features that can attract ridicule from other children, such as prominent noses and ears, are generally accepted in the United States. Cultural phenomena such as surgical makeovers on numerous television programs, however, make it increasingly difficult to agree on what constitutes a “normal” appearance and when the desire to improve one’s appearance is questionable or even crosses the line to psychopathology.2 In this commentary, I will focus on elective, cosmetic procedures on an otherwise healthy adolescent with no illness or defect.

Plastic Surgery in a Developing Teen
One of the concerns about plastic surgery on adolescents is that their bodies are still maturing. In addition to development that may occur in the late teens, growth charts indicate that the average girl gains weight between the ages of 18 and 21, and that is likely to change her desire or need for breast augmentation as well as liposuction. There are no epidemiological studies or clinical trials on the safety and long-term risks of these procedures for adolescents. Although the FDA approved saline breast implants for women ages 18 and older 3, it is legal for physicians to perform breast augmentation for anyone under 18 as an “off-label” use, and the number of teens 18 and younger undergoing breast augmentation tripled from 2002 to 2003. It was not until December 2004 that the American Society of Plastic Surgeons stated an official position against breast augmentation for patients under 18.

Understanding the Risks of Surgery
Will adolescents who want to improve their appearance rationally consider the risks? Studies by implant manufacturers report that most women have at least one serious complication within the first 3 years, including infection, hematomas and seromas, capsular contracture (a sometimes painful hardening of the breasts), loss of nipple sensation, and hypertrophic scarring.4 Since breast implants typically last 10 years, an adolescent will require repeated surgeries throughout her lifetime.5 Breast implants also interfere with mammography and increase the likelihood of insufficient lactation when a woman tries to breast-feed.

The economic costs of surgery are substantial, since corrective surgery is rarely covered by health insurance. With many plastic surgeons offering breast implants on the installment plan, our Center (National Research Center for Women and Families) is contacted regularly by young women who need to have a broken or painful implant removed but are still paying for the initial augmentation surgery and unable to afford corrective surgery.

Liposuction also carries potentially serious risks. Primary risks include infection, damage to skin, nerves, or vital organs, fat or blood clots (that can migrate to the lungs, leading to death), and excessive fluid loss that can lead to shock or death. In addition, the different techniques are associated with complications such as skin or deep tissue damage, lidocaine toxicity, and fluid accumulation in the lungs.6

The long-term physical, emotional, and economic sequelae of many popular cosmetic surgeries, including implants and liposuction, are unknown. Despite the documented risks, the general public has an inflated sense of the benefits and a minimized sense of the risks of plastic surgery.7 Teenagers are often oblivious to the well-documented long-term health consequences of smoking, tanning, and other risky behaviors, and are likely to pay even less attention to the risks of cosmetic surgery, making informed consent difficult.

In addition to the influence of persuasive and pervasive advertising and television makeover programs that stimulate demand, it is difficult for a physician to neutrally present both the risks and benefits of an elective procedure that he or she is simultaneously selling.8 Requiring parental consent for patients under 18 does not ensure informed consent, since research is lacking on long-term risks for many cosmetic procedures.

Screening
One way to help ensure that teenagers are mature enough to make decisions about plastic surgery is to screen potential patients using psychological testing. In media interviews, plastic surgeons often describe careful interviews aimed at determining why the teen wants plastic surgery. Unrealistic expectations or having the surgery to please a boyfriend is considered inappropriate, but having surgery so that “I will feel better about myself” or “clothes will fit better” are considered reasonable responses. By the same token, teenagers who use drugs, drive while inebriated, and have unprotected sex may also make those decisions to please themselves, and not others, so that response alone is not sufficient evidence of a mature decision. Currently, there is no evidence that effective screening is widespread.

Teen Self-Consciousness and Plastic Surgery
Teens expect that plastic surgery will improve their self-confidence, but does it? There are no empirical studies examining the long-term benefits among adolescents. One study found that body-image satisfaction improved after cosmetic surgery, but so did satisfaction among the control group, suggesting that improved body image may occur with increasing age, regardless of whether the patient undergoes plastic surgery.9 In fact, a longitudinal study that followed adolescents from age 11 to 18 found body image satisfaction rates were highest at age 18 in both sexes and that the satisfaction of individual participants varied as a function of their age and developmental stage.10 This indicates that many adolescents who are very dissatisfied with their appearance will feel more satisfied a few years later, whether or not they undergo surgery. The same study also found that the physical features with which participants were most dissatisfied reflected culturally determined stereotypes of idealized attributes emphasized in books, mass media, and advertisements.

Research indicating that breast augmentation patients are 4 times as likely to commit suicide compared to other plastic surgery patients11 raises questions about the mental health of the women who choose implants and the psychological benefits of the surgery. Liposuction is also of particular concern because of its association with eating disorders. The average onset of body dysmorphic disorder (BDD), defined as “a preoccupation with an imagined or slight defect in appearance that leads to significant impairment in functioning,” is 16 years of age.12 However, since the goal of cosmetic surgery is to improve and transform appearance, it may be difficult to distinguish between this desire and a pathological preoccupation.13

Who decides?
Will most plastic surgeons make an accurate and objective judgment about whether a teenage girl is an appropriate candidate for plastic surgery? If plastic surgeons are performing surgeries that many physicians and psychologists would question, should medical societies and ethicists provide more guidance than is currently being provided by plastic surgery associations?

In the ideal world, informed consent would enable teens and their parents to decide carefully what is best for them. However, in the absence of longitudinal research, it is impossible for physicians to warn patients, or their parents, about the risks of performing cosmetic surgery on bodies that have not reached maturation, the operative complications and long-term physical effects of these surgeries and the psychological implications of surgery on developing body image, or the extent to which distorted body image common among adolescence may result in the pursuit of plastic surgery.

Read the original article here.

More Teens See Implants As a Right

We Are Quoted, ,
Jodi Mailander Farrell, Knight Ridder Newspapers: December 07, 2004.

Melissa Gonzalez knew her family intended to give her enough money to buy a new car when she turned 18. But she had her heart set on something else: Bigger breasts. […]

Gonzalez is not alone. In just one year, the number of girls 18 and younger getting breast implants jumped nearly threefold — from 3,872 in 2002 to 11,326 in 2003, the American Society for Aesthetic Plastic Surgery reports. […]

Dr. Jose M. Soler-Baillo, a South Miami plastic surgeon who performed Gonzalez’s augmentation, says getting implants has become a ”coming-of-age type of thing” for many young women, “especially here in Miami.” […]

Critics say the timing couldn’t be worse for adolescent girls, who are often unhappy with their looks. They say teenagers are too young and shortsighted to comprehend the long-term affects of surgery, particularly the risks, which include the possibility of rupture or permanent scarring, the need for periodic operations to replace or remove the implants and the potential problems with breast-feeding and mammography. Also, little is known about the implants’ long-term safety; no studies have been done on females this young.

”It might feel to a 17-year-old like it’s the end of the world to wait a few years, but their bodies are still changing,” says Diana Zuckerman, president of the National Research Center for Women & Families. ‘Those breasts are likely to get larger, especially when they go off to school and gain the `freshman 15,’ the pounds girls often put on between ages 18 and 21. Their whole body begins to look more voluptuous.” […]

There is no law forbidding implants in patients younger than 18, but the FDA advises against it. In the past 15 years, implants have been the subject of furious controversy over their safety. The FDA has banned silicone-gel implants because of unanswered questions about their safety, but it permits the use of saline-filled implants, which have a silicone shell. Both types are the subject of ongoing FDA studies.

Zuckerman, the mother of two teenagers, says girls should wait until they are 21 to consider breast surgery. […]

Read the original article here.

Teens’ Cosmetic Dreams Don’t Always Come True

We Are Quoted, , , ,
Robert Davis, USA TODAY: July 28, 2004.

As a kid, Kacey Long would escape her hometown of Ennis, Texas, by imagining herself as a professional businesswoman. […]

At 19, Long decided to get breast implants. “I was all about doing anything I could to improve myself,” she says. […]

In 2003, almost 336,000 teens 18 or younger had some kind of cosmetic surgery or procedure, a 50% increase over 2002.

Patient-safety advocates believe that many of the teens having surgery are unnecessarily putting themselves at risk of injury or even death. Teens face different obstacles in making a decision like this, experts say. They are often insecure and naive about medical risks. And they literally are not always finished growing up.

Plastic surgery, like any surgery, can go wrong, as it did for Long. […]

Although research has not proved that implants can cause serious diseases, Long says she has been diagnosed with systemic silicone poisoning from the shells surrounding the saline implants, rheumatoid arthritis, fibromyalgia and chronic fatigue syndrome. […]

Nobody tracks deaths or injuries caused by plastic surgery, but one study found that one in 50,000 liposuction surgery patients die. […]

“The big problem with adolescents is they are being operated on at the most tumultuous time in their bodies. They may not recognize the permanence of what they’re doing,” says David Sarwer, a psychologist at the Center for Human Appearance at the University of Pennsylvania medical school. […]

“You’re not going to have too many plastic surgeons saying you don’t really need this,” says Diana Zuckerman, president of the National Center for Policy Research for Women & Families. “Once you get in the door, of course, the doctors are saying everything they can to persuade you to have surgery.”

Zuckerman wants rules to protect girls from plastic surgery.

“Breast implants are not approved for anyone under 18, but any doctor can perform the surgery legally,” she says. “I’d like to see the American Society of Plastic Surgeons have a policy saying we think our doctors shouldn’t do this on anyone under 18.”

Experts disagree on whether teens are too young for surgeries such as breast augmentation.

Zuckerman says girls should be encouraged to develop more before having surgery. “A lot of teens gain weight during their freshman year in college,” she says. “If they had just waited a few years, they might have been less flat-chested.[…]

Read the original article here.

The European Perspective: Do Silicone Breast Implants Cause Disease?

How Safe Are They?
Elizabeth Santoro, RN, MPH & Diana Zuckerman, PhD: March 2004

Several studies have been conducted on breast implant patients in Europe, primarily Scandinavia. There is one consistent thread that runs through them: they have spun their findings to make the data appear less damaging. In some cases, the study designs are flawed and therefore cannot support the conclusions that are made. In other cases, findings are inconsistent with those of other independent researchers at the Food and Drug Administration and the National Cancer Institute. These European studies have examined several health topics, such as the risk of autoimmune disease, implant rupture, suicide, and lung cancer.

What Do European Studies Say About Breast Implants and Autoimmune Disease?

A major health question about breast implants has been whether they cause autoimmune disease. Most of the research that has been conducted finds no statistically significant connection between silicone implants and diseases such as lupus, fibromylagia, scleroderma, rheumatoid arthritis, and Sjogren’s syndrome. However, many of these studies have shortcomings that limit their usefulness for drawing meaningful conclusions.

Several of these studies were conducted in Europe, although they were co-authored by scientists at the International Epidemiology Institute, a Maryland company that receives money from the company that makes silicone, Dow Corning. The articles that were quoted in the Institute of Medicine report on breast implants include those by Friis and colleagues in 1997, Giltay and colleagues in 1994, and Nyren and colleagues in 1998.14 15 16

Which Diseases Were Studied?

Autoimmune diseases typically present with relatively common and subjective complaints such as pain, fatigue, muscle aches, and sleep disturbances. As a result, it can be difficult to properly diagnose these disorders. For some disorders, such as Sjogren’s syndrome, it can take more than six years to correctly diagnose the problem.17 Since many of the symptoms characteristic of autoimmune diseases are subjective and most do not require surgery or inpatient care, it seems unlikely that the women will be hospitalized for them. The treatment of lupus, for example, is managed mostly by medications, diet, exercise, and the pacing of daily activities. This regimen can be handled on an outpatient basis.18 Similarly, researchers believe that scleroderma takes years to develop and even longer to properly diagnose.19 Several autoimmune conditions, such as scleroderma and Sjogren’s, are rare and require large numbers of study participants in order to ensure that increases risks can be detected. These characteristics that are typical of autoimmune diseases should be addressed in the study designs. Unfortunately, many of these factors were not properly incorporated into the study methodologies.

Description of the Three Studies

Friis and colleagues evaluated the presence of connective tissue diseases including lupus, Sjogren’s syndrome, rheumatoid arthritis, scleroderma, and other rheumatic conditions with a sample of 2,570 women with implants and 11,023 controls in Denmark. The minimum time that women had implants was less than one year and the average time with implants was 7.2 and 8.4 years for the reconstructive and augmentation groups, respectively. The control group was of women who had breast reduction surgery or mastectomy without receiving implants. The outcome measure was women who were hospitalized for connective tissue diseases, and did not include women who were treated on an outpatient basis.

Giltay and colleagues studied a sample of 235 women with implants and 210 controls from The Netherlands who were matched for age and year of the operation. They administered a questionnaire to determine if women with breast implants reported more rheumatic symptoms than the controls. They also looked at the use of anti-rheumatic drugs and the number of medical consultations that were for rheumatic symptoms. The minimum length of time with implants was two years and the average amount of time with implants was 6.5 years. The control group was composed of women who had cosmetic procedures that did not include silicone.

Nyren and colleagues studied 7,442 Swedish women with implants and 3,353 Swedish controls. They evaluated the number of women with connective tissue type disorders including lupus, Sjogren’s syndrome, rheumatoid arthritis, and scleroderma among women with breast implants. One month was the minimum time required to be in the study and the mean length of time with implants was six years and 10 years for the reconstructive and augmentation patients, respectively. This control group was comprised of women who had breast reduction surgery. This study used hospitalization as its outcome measure.

Methodological Flaws

There were four major types of flaws in these studies. One of these was the choice of the outcome measure, which in two of the studies was hospitalization. This outcome assumes that the people with autoimmune diseases are treated in the hospital for their symptoms. Another flaw of the studies was the amount of time that women were exposed to implants. Ideally, implants that were only a few months or years old would not be permitted in the study because the chance of illness from exposure to breast implants is likely to increase as the implant ages and leaks. An additional flaw is the size of the samples. Many autoimmune diseases, such as scleroderma, are rare (affecting less than one woman in 10,000) and require very large samples in order to detect even small significant changes. The comparison samples were also inappropriate, often consisting of women who had breast reduction surgery. A better designed study would have included a comparison group who did not have breast surgery, but were otherwise similar to the implant group.

These flaws in the study design can skew the findings so that a particular outcome is more likely to occur. In the case of these European studies, the study methodologies can diminish the possibility of a relationship between breast implants and autoimmune diseases. As published, the articles suggest breast implants are not associated with autoimmune disease. However, after careful scrutiny, the possibility of a relationship becomes much more plausible. Being able to determine what the studies actually show, requires a reader with expertise in research, statistics, and study design.

How Do You Evaluate Who is Sick?

In all three of these studies, the patients were neither questioned nor directly examined by a healthcare professional. Moreover, in the Nyren and Friis studies, the outcome measure was hospitalization rather than diagnosis. This would inevitably result in underreporting, since most women would not be hospitalized for these diseases unless they had the diseases for such a long enough time that their condition had greatly deteriorated. The Giltay study sent a questionnaire to women who had silicone breast augmentation surgery and to a matched control who had a cosmetic operation not involving silicone in that same year and department. The questionnaire queried whether the women experienced rheumatic complaints and symptoms. The information obtained in questionnaires must always be critically assessed since responders can be different than non-responders. The response rate was 82% for patients and 73% for controls. However, a more serious problem for the Giltay study was the small sample.

Exposure to Implants

A related weakness of all three studies is that they included women who had implants for a short period of time. These studies had inadequate minimum requirements for the length of time a woman had implants: one month (Nyren), less than a year (Friis), and two years (Giltay). The average years that the women had implants ranged from six to fourteen. Even if a woman with breast implants immediately developed an autoimmune disease, it would probably take several years for her to be diagnosed, and even longer for her to be ill enough to be hospitalized. If a disease develops after years of exposure, or after silicone leaks from the implant, that would take even longer before she was diagnosed or hospitalized. Including women who had implants for just a few months or years obviously biased the results, making it less likely to find a significant association between implants and autoimmune disease. Women should have been implanted for at least 6-10 years instead of having implants for an average of 6-14 years.

Sample Size

A very large sample size is essential in a study of implants and autoimmune diseases, because so many of these diseases are rare and because half the patients had implants for a short period of time. Nyren and Friis acknowledge that the size of their samples was inadequate. Nyren had a sample of 7,442 women who chose implants for cosmetic purposes or for reconstruction after mastectomy and 3,353 women who had breast reduction surgery. Friis included 2,570 women with implants and 11,023 controls. These sample sizes do not seem that small, but given the rare nature of these diseases, more study participants are needed. The Giltay study included only 287 women with silicone breast implants, and each was age-matched to a control who in that same year had a cosmetic operation. The limited power of these studies made it unlikely that an increased risk of disease — even a doubling or tripling — would be statistically significant.

Comparison Sample

Another weakness of two of these studies was the use of breast reduction patients for a comparison sample in the Nyren and Friis studies. This comparison group helps control for any health impact of surgery, which is an appropriate design if the goal is to determine the health risks of the implant itself. However, if the goal is to determine the health risks of getting breast implants, surgery is an essential component of that product and the impact of surgery therefore should be part of the “treatment” variable. And of course, women are not deciding whether to get their breasts increased or decreased in size. Women considering implants want to know if getting implants will pose health risks compared to not getting implants, so the comparison group should be women who did not undergo breast surgery, but who are like the implant group in as many other ways as possible.

In the study by Giltay, breast implant patients were compared with patients who had other unspecified cosmetic procedures which did not include silicone. It seems likely that this is an appropriate comparison group since the women were matched according to age and the other year of operation. Unfortunately, the authors do not report the comparison surgeries.

Even with the various methodological flaws, all of which were likely to minimize health risks associated with implants, the results indicated potential health problems among women with implants. Although not statistically significant, Friis and colleagues found a 30% increase in scleroderma, lupus, and Sjogren’s syndrome for mastectomy patients with implants compared to women who had breast reduction surgery, or mastectomy without implants. Giltay and colleagues found that women with silicone breast implants report more rheumatic symptoms when compared with controls who had an unspecified plastic surgery that did not involve silicone. Similarly, Nyren and colleagues found that breast surgery patients (either reduction or augmentation) had slightly higher rates of connective tissue disorders than was expected based on rates in the general population of the same age. Had these studies been larger, with more women who had implants for a longer period of time, and had they been based on diagnoses or self-reported symptoms rather than hospitalization, these differences might have been statistically significant. Because of these study flaws, it is impossible to know if implants are linked to autoimmune diseases.

What Do European Studies Say About Implant Rupture?

European studies on rupture tend to be favorable about implants, and their findings are inconsistent with studies conducted in the United States on the same topic. A Danish study by Lisbet Holmich and colleagues on rupture rates of silicone breast implants illustrates this point.20 It reported that 10% of implants had definitely ruptured and 7% had possibly ruptured over a two year period. Based on that information, the authors conclude that at least 15% of modern implants will probably rupture within three to ten years following implantation. This conclusion seems to conflict with a study by the FDA, which found that all breast implants will eventually break, and that most augmentation patients have at least one broken implant within ten years.21

Is it possible that implants last longer in Denmark than in the U.S.? Apparently not. First of all, by focusing on implants rather than women, the Holmich article estimates 15% of implants will break, which is approximately 30% of women with at least one broken implant. Secondly, by saying “at least 15%” they are focusing on the low number but not denying that the percentage could be considerably higher. Even more important, in a table in Holmich’s paper, the data indicate that the chances of implant rupture increases dramatically after 10 years. According to their own data, while most implants are intact for ten years, most will break between 11-20 years, and almost all will be broken in 20 years. For example, during the two years of the study, 41% of the implants that were between 22 and 25 years old definitely ruptured and 23% had possibly ruptured. These data suggest that as the age of the implant increases, the chance of having a ruptured implant also increases substantially. Although these trends are presented in the table, they are barely mentioned in the paper and ignored in the summary and conclusions. Instead, the authors focused on the estimated rupture rate of “at least 15%” during the first ten years of having implants, and ignore the bad news after that.

Like the autoimmune studies, this research was conducted with researchers from the International Epidemiology Institute, which was funded by Dow Corning.

What Do European Studies Say About Implants and Suicide or Lung Cancer?

Two European studies found that breast augmentation patients were more likely to kill themselves compared to women without implants. The study of Swedish women by Dr. V.C.M. Koot and colleagues as well as the study of Finnish women by Dr. Eero Pukkala and colleagues report that women with implants are three times as likely to commit to suicide when compared to the general population of Sweden and Finland, respectively.2223

The authors explain the high suicide rates by claiming that women who decide to get plastic surgery such as breast implants have a pre-existing propensity toward suicide due to mental problems and low self-esteem. However, this conflicts with findings by Brinton and colleagues at the National Cancer Institute, who reported that breast augmentation patients were four times as likely to kill themselves as other female plastic surgery patients of the same age. There is no reason to believe that women who decide to undergo breast augmentation have lower self-esteem or poorer mental health than other plastic surgery patients.

Women with breast implants who testified before the FDA in October 2003 explained the suicide data differently than the Scandinavian researchers. Several women described being depressed and suicidal because of debilitating pain, fatigue, and mental confusion years after getting silicone breast implants. They explained that when their implants were removed, their health improved, and their depression and suicidal feelings diminished.24

The Koot study also found an excess number of deaths from lung cancer. However, the authors assumed it was due to smoking, even though they did not evaluate whether women with implants were more likely to smoke than other women in the study. The National Cancer Institute study by Brinton and colleagues had also found an increase in deaths from lung cancer among breast augmentation patients compared to other plastic surgery patients, even though the implant patients were not more likely to smoke than other plastic surgery patients. It therefore is inappropriate to assume that smoking explains the increase in lung cancer. Research is needed to determine if that is the most likely explanation.

The Koot and Pukkala studies were conducted with the help of the International Epidemiology Institute, which was funded by Dow Corning.

What Can Be Learned From The European Studies?

What do all of these studies have in common? They all found problems associated with breast implants, but they were described with rose-colored lenses to make the findings sound like a clean bill of health for breast implants. In some cases, the study design minimized problems by including women who had implants for just a few months, or by studying rare diseases in small samples. Even when the findings are consistent with studies conducted by independent researchers at the FDA or NCI, the summaries and conclusions sound dramatically different — and much less worrisome. In some cases, damaging findings are ignored, or spun to neutralize the findings. Only when the studies are carefully scrutinized and compared with other research does it become obvious that the findings are quite troubling. The bottom line: even studies funded by Dow Corning find a link between breast augmentation and poor health outcomes and show that most implants break in a relatively short period of time. These findings add to the growing evidence that implants may be associated with increased morbidity and mortality over the long-term.

FDA Rejects Silicone Gel Breast Implants

We Are Quoted, ,
Steve Sternberg, The Associated Press: January 9, 2004.

Silicone breast implants were dealt a new blow Thursday when the Food and Drug Administration rejected Inamed Corp.’s bid to bring them back on the market a decade after earlier versions were ruled unsafe and banned. […]

“There’s additional information that we think is necessary for this product to pass the threshold of what we consider necessary for open marketing,” said Daniel Schultz, the FDA’s director of device evaluation.

Silicone breast implants are now allowed only for reconstruction after breast cancer surgery and in controlled trials for women who want them for cosmetic reasons. […]

Some women say they prefer silicone-filled breast implants over those made with saline because silicone implants have a more natural feel. Critics worry about the long-term health consequences when implants break and leak. They cite studies linking silicone implants with cancer, immune disorders and crippling fatigue. But a 1999 Institute of Medicine analysis found no proof that silicone implants cause severe health problems. […]

“Even the FDA advisers who recommended approval all agreed that we don’t know the long-term safety (of these devices). It’s terrific that the FDA heard that message,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families, a Washington-based think tank.

Zuckerman hailed a provision in the FDA guidance document calling for the development of new external performance tests that better mimic conditions within the breast. […]

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Canadian Study Confirms Women with Breast Implants Require Greater Medical Care

Summaries of Implant Studies by Other Researchers
Aleina Tweed, “Health Care Utilization Among Women Who Have Undergone Breast Implant Surgery.” British Columbia Centre of Excellence for Women’s Health: November 2003

A 2003 study by the British Columbia Centre of Excellence for Women’s health examined if having breast implants led to an increased use of the public health system. The study included 147 women with breast implants and a control group of 583 women without breast implants. The study found that women with breast implants had more doctors’ visits and were more than 4 times as likely to be hospitalized compared to women without breast implants. The study also found that 51% of participants with breast implants reported at least one additional breast-implant related surgery after the initial implantation. The type of implant, silicone gel or saline, did not significantly affect hospitalization or doctors visits.

The differences were statistically significant when age, marital status, education level, exercise, alcohol consumption, and geographic region were controlled. The researchers concluded that breast implant surgery results in more use of the public health system.

Read the original article here.

 

Where There’s Smoke, There’s Fire: The Silicone Breast Implant Controversy

Summaries of Implant Studies by Other Researchers
Frank B. Vasey, MD, S. Alireza Zarabadi, DO, Mitchel Seleznick, MD, Louis Ricca, MD. “Where there’s smoke there’s fire: the silicone breast implant controversy continues to flicker: a new disease that needs to be defined.” The Journal of Rheumatology: October 2003

The bonfires of the silicone breast implant controversy in the 1990s have been reduced to coals in 2003. The burning medical and legal issues have been extinguished. The spark in North America occurred in 1979 when a woman in Pittsburgh developed an acute illness suggesting toxic shock immediately post implant placement. No organism could be cultured and she had to have her silicone breast implants removed 10 days after placement. She made a complete recovery.

Case reports and case series as well as press coverage of this formerly emotionally charged issue resulted in epidemiologic studies focusing on defined connective tissue diseases as well as undefined symptom complexes. Studies of defined diseases were either negative or showed only a small but statistically significant relative risk. Studies of systemic lupus erythematosus (SLE) and systemic sclerosis did not show an association with silicone breast implants, but studies of symptoms did. Because of a lack of consistency in methodology of symptom searches and in study findings, some reviewers do not believe there is fire to be found. Since then, a Dow Corning-funded study (2496 reduction mammoplasty patients versus 1546 silicone breast implanted women, 1/6 of whom had saline-filled silicone envelope implants) has documented that all 28 symptoms were increased in silicone patients (16 of 28 were statistically increased). In a comparison study, there was a statistical correlation between local problems and systemic problems.

Also important, in the first full article detailing the benefits of silicone breast implant removal on symptom expression, the authors cautiously interpreted their data as showing a “temporary” improvement in that they had only 6 months of followup post-removal. Our study with 21-month followup confirms and prolongs these observations. Prompt onset of local and systemic symptoms, delayed removal after becoming symptomatic, and ruptures found at the time of removal all predict delayed improvement. Exercise-induced exacerbations of pain, fatigue, and bladder irritability help separate women with silicone-related symptoms from “personally driven” fibromyalgia, in which exercise helps.

In women with defined diseases, case reports and case series showed a suspiciously high improvement rate post implant removal. These observations suggested women could have a combination illness expressing both a naturally occurring defined rheumatic disease with co-expressing silicone component. Rheumatologists were urged to suggest the consideration of silicone breast implant removal in women with SLE or scleroderma. Insurance companies who deny benefits to very symptomatic women who only worsen while implant removal is delayed particularly frustrate all concerned. The women become disabled, lose their insurance, and have no way to fund removal.

The literature suggests that the vast majority of symptomatic women had a fibromyalgia/chronic fatigue-like illness, which has still not been defined. It is time for organized medicine to convene a group of clinicians who understand the disease (rheumatologists, plastic surgeons, and others) and epidemiologists who know how to define the disease in order to document the medical necessity of implant removal. Eosinophilia myalgia, with only 3500 sufferers, was defined within 4 years of the initial case reports. We propose criteria to be tested. Other authors have proposed and tested criteria, but they have not been published.

[…]

Dow Corning recently quietly sent settlement packages to distribute 4.6 billion dollars to injured women. Other manufacturers including Bristol Myers Squibb, 3M, and Baxter have largely settled their cases as well.

In this issue of The Journal, Dutch investigators throw fuel on the fire by further correlating the high rate of self-reported envelope rupture with statistically increased frequency and severity of symptoms including muscle pain, joint pain, memory loss, and post-exertional malaise, among others. The mechanism behind this phenomenon remains unproven; however, the loss of envelope integrity would allow a greater load of silicone/silica gel to escape into the surrounding tissues, regional lymph nodes, and possibly into the bloodstream (if the element silicon can be taken as a marker for silicone polymer). They also reported compelling data to demonstrate that the symptom complex of silicone breast implant recipients with chronic fatigue differed markedly from those patients with the “naturally occurring” chronic fatigue syndrome.

It’s time to end the burning disagreements over silicone breast implants. Happily, informed consent before silicone breast implant placement has gone from a few paragraphs to many pages. Nevertheless, we believe the significant problems of eventual undetected silicone envelope rupture and risk of systemic symptoms should dictate removal of silicone gel-filled breast implants from the market as too dangerous for human use as the physiologic equivalent of the injection of loose silicone gel into the human body.

An extensive informed consent does not deter women who are obtaining silicone breast implants at a higher rate than ever. They do not appear to understand that “saline implants” have a silicone envelope. Some of our patients with “saline implants” have the same symptom complex and local complications as patients with gel-filled implants, but they should be safer because there is less silicone load and any rupture releases saline.

Plastic surgeons as well as rheumatologists and clinical epidemiologists who are on the front lines in seeing these patients need to be involved in the definition process. A definition that surgeons and everyone else can use should improve insurance coverage and speed implant removal in women requiring it.

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