Category Archives: Summaries of Implant Studies by Other Researchers

Who Should You Believe? A critique of the Aesthetic Society’s view of BII

Summaries of Implant Studies by Other Researchers, Testimonies and Statements by NCHR, , ,

By Diana Zuckerman, PhD.

An article entitled “A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants” was published in the  Aesthetic Surgery Journal, (Volume 42, Issue 4, April 2022, Pages 397–407). This is a journal of the Aesthetic Society, which is the second largest association of plastic surgeons.  The authors are Patricia McGuire, MD, Daniel J Clauw, MD, Jason Hammer, MD, Melinda Haws, MD, and William P Adams, Jr, MD

There are many outrageous articles denying the existence of breast implant illness, but this may be the worst since it was published after major studies documented that breast implant illness exists.  The authors are prominent plastic surgeons who are members of the Aesthetic Society and/or the American Society of Plastic Surgeons (ASPS), which are the two major associations for plastic surgeons.  All but one of the authors have financial ties to companies that make breast implants.

The theme of the article is clearly stated in the summary: “Numerous studies have explored the possibility of an association between breast implants and systemic symptoms potentially linked to exposure to silicone. Some studies show no direct association whereas others provide insufficient scientific evidence to prove or disprove an association. Nonetheless, some patients with breast implants remain concerned about the possible role of their implants in systemic symptoms they may be experiencing. This paper provides a practical approach for plastic surgeons in managing patients with breast implants who present with systemic symptoms, including recommendations for patient counseling, clinical and laboratory assessment of symptoms, and/or referral. Integral components of patient counseling include listening attentively, providing unbiased information, and discussing the risks and benefits of options for evaluation and treatment.”

In reality, there are numerous studies in major medical journals that show a “direct association” between breast implant illness and diagnosed diseases with similar symptoms.  But the plastic surgeons who wrote the article are saying there is no evidence.  They are also saying that since patients mistakenly think BII is real, surgeons should assure them that although BII it is not proven, research is underway to study the issue.  That gaslighting is intended to show the patients that their surgeon is open-minded.

You might ask what is the evidence that the authors use to conclude that BII is not real?  To me as a researcher, this is the most mind-boggling part.  In addition to misquoting a 22-year old report from the Institute of Medicine – a report that is extremely outdated — and including a few individual case studies that just happen to all illustrate the authors’ view that breast implant illness isn’t real — the authors made several major errors:

#1.  They state that “In 2019, an FDA advisory panel on breast implant safety determined that there is currently insufficient evidence of a causal relationship between breast implants and the diagnosis of rheumatologic disease or [connective tissue disease].” They footnote this statement with a document that was written by the FDA before the FDA advisory panel met in 2019 and which did not draw any such conclusions.

#2. They state that “a number of epidemiological studies taken together are felt by many experts in the field to represent convincing evidence that there is no link between SBIs and auto-immune diseases.” The authors support that statement by listing 9 articles that they do not discuss. Almost all of the articles were funded by implant manufacturers and/or plastic surgeons, and 3 were published more than 20 years ago, based on poorly designed studies. One study was described as a study of 55,000 women, but in reality a large percentage of the patients dropped out before the study was completed.  Most outrageous of all, the last 2 studies listed actually concluded the opposite to what the plastic surgeons claimed:  The Israeli study and the Baylor study that both concluded that several autoimmune diseases with symptoms similar to BII are significantly increased after women get breast  implants.

#3.  They mistakenly conclude that since women with saline breast implants also report BII symptoms, the symptoms are not related to the silicone shell.  This is a ridiculous statement since all breast implants have silicone shells.

#4.  In contrast to their uncritical acceptance of poorly designed and biased studies funded by implant manufacturers and surgeons with financial ties to those implant makers, when the authors briefly mention studies showing that women with BII symptoms that improve after their implants are removed, they speculate (without evidence) that such improvement might be temporary.  It is notable that they didn’t even mention the 2021 study by Dr. Feng and her colleagues, which showed significant improvement in lung function after explant surgery.  That is no accident, since this Aesthetic Society article was published many months later.

There are too many other careless errors in the article to list them all.  I can’t help but wonder if the authors read any of the studies they were supposedly quoting.  While urging plastic surgeons to pretend to be open-minded, the authors are anything but.  They repeatedly misrepresent research findings in order to support their biased view that the symptoms of breast implant illness are not caused by breast implants.

In summary: This article makes it clear that the Aesthetic Society is encouraging their members to “gaslight” patients with BII, rather than help them get explanted.  Women who are seeking well-informed plastic surgeons should avoid the authors and think twice before believing anything they hear from plastic surgeons that belong to the Aesthetic Society, since the journal is published by that medical group.

Free Training for BI Patient Advocates!

Summaries of Implant Studies by Other Researchers
What Do We Know?
Understanding Research Results on the Risks of Breast Implants and Breast Implant Illness

When: January 19, 2022 6:00 – 7:00 pm EST

TO:  Patients and Patient Advocates in the Breast Implant and Breast Cancer communities

WHY: To educate patients and patients advocates how to evaluate and understand study results regarding breast implants to strengthen the impact of your advocacy work

What: Speaker will be Diana Zuckerman, Ph.D. President of the National Center for Health Research, Followed by Q & A

Many studies and publications are shared on social media and mass media about breast implants and breast implant illness, but some are more credible than others. Which of the studies should you believe, and what are the common flaws of research funded by implant companies and plastic surgeons? Learn the basics about how research should be designed and conducted, and why some study results are more accurate than others. You will learn tools that will enhance your advocacy work and better prepare you when talking to stakeholders.

RSVP: To register, email Tehan at TD@center4research.org She will send you the link the day before and day of the webinar.

New Research Confirms Breast Implant Illness

How Safe Are They?, Summaries of Implant Studies by Other Researchers, ,

Diana Zuckerman, Ph.D.

The biggest controversy regarding breast implants is whether and how often women with implants become sick with a pattern of symptoms that are known as breast implant illness. A study published in Annals of Plastic Surgery in July 2020 provides clear evidence that most women with these symptoms will recover dramatically if their implants and scar capsules are carefully removed by an experienced explant surgeon.

The study by Dr. Corinne Wee and her colleagues at University Hospitals Cleveland Medical Center compares 11 common breast implant illness symptoms of 750 women whose implants were explanted and not replaced in 2017 or 2018 1. Patients were asked to rate the 11 symptoms on a six-point scale (0-5, with 5 indicating “very severe”) at three times: prior to surgery, within 30 days after surgery, and during the following year.  The symptoms included: numbness and tingling in the extremities; joint and/or muscle pain; hair loss; memory loss/cognitive problems; dry eyes and/or blurred vision; chronic fatigue; breast pain; rashes and/or hives; food sensitivity/intolerance; flu-like symptoms and/or low-grade fever; and difficulty breathing.  The average age of the implant at the time of explant was 12.6 years, and approximately half the women had saline implants and half had silicone gel implants.  Possible total scores for rating the symptoms ranged from 0 to 66; the average score prior to explant was 26.2 and within 30 days after explant was 9.5, which was a highly statistically significant improvement (p < .0001, which means that there is less than one chance in 10,000 that the improvement occurred by chance).  Although average scores on each of the 11 symptoms ranged from a low of 1.4 (for rashes and for flu) to a high of 3.5 (fatigue), each of the 11 symptoms also showed significant improvement at the .0001 level within 30 days.  When asked to rate their symptoms during the year after Day 30 (at a median of 138 days), the women’s improvement in symptoms was maintained but there was no additional improvement.

This study confirms similar results of a smaller study by De Boer and his colleagues published in 2016, which reviews and combines data from 23 studies, cases series, and case reports available at that time about the results of explanting breast implants “in patients with silicone-related complaints and/or autoimmune disease2.” These complaints (symptoms) included fatigue, myalgia, dry eyes, and memory and concentration disturbances.  Based on the research, the scientists calculated that 75% of the patients (469 of 622) had substantially improved symptoms when their implants were removed. However, the results were less promising for autoimmune diseases (such as Raynaud’s, IBS, and allergies); diseases improved only if the patients also received immunosuppressive therapy in addition to the explant surgery.

It also confirms our own research at the National Center for Health Research, not yet published, that shows dramatic improvement on these symptoms in a study of more than 300 women who had their implants removed.

It is important to know that almost 20 years ago, several studies conducted by government funded scientists were published in the scientific and medical literature indicating a statistically significant association with several connective tissue or autoimmune diseases or symptoms. Replication is the key to science; scientific literature usually builds on previous findings, or explains how they differ.  However, the studies that indicated possible risks of breast implants were generally ignored and eventually outnumbered by dozens of articles funded by implant companies or plastic surgeons, or both. None of the studies or either side of the controversy were focused on breast implants made by Mentor or any other specified company.

References

  1. Wee, C.E. Annals of Plastic Surgery: July 2020 – Volume 85 – Issue S1 – p S82-S86 https://journals.lww.com/annalsplasticsurgery/toc/2020/07001
  2. De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406477/

MD Anderson Physicians Find Increase in Rare Diseases Among Women with Breast Implants

Summaries of Implant Studies by Other Researchers
Coroneos, Christopher J., et al. “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.” Annals of surgery (2018).

A study published in September 2018 in the medical journal Annals of Surgery, entitled US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.”  The study is important because it is largest study to date, but it has limitations because it is based on data from flawed studies conducted by two implant companies, Mentor and Allergan.

The data collected from the two studies were supposed to be very similar, but because of how poorly the studies were conducted, they are not comparable.  Mentor’s data are focused on patients’ self-reporting on questionnaires, primarily on data of only 20% of the patients collected 7 years after the study was started. Allergan’s data are based on physicians’ diagnoses during the first two years after the patients had implant surgery.  Since patients’ self-reports at 7 years would be expected to include more complications than physicians’ diagnoses after 2 years, it is impossible to make meaningful comparisons between the two manufacturers. Nevertheless, it is important to note that the MD Anderson researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics.  Stillbirths increased by 450% in the women who became pregnant.  Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants.  These diagnoses were also statistically significantly higher (although not as dramatically increased) for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results certainly deserve careful attention.

It is also important to note that the women with saline breast implants who were in the Mentor and Allergan studies were not analyzed in the MD Anderson study.

FDA Response

In response to this important study, Dr. Binita Ashar of the FDA published an editorial in the same issue of the same medical journal, claiming that the MD Anderson study “failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, confound and other potential sources of bias.”  That is true.  However, Dr. Ashar did not mention that the FDA should take responsibility for all the shortcomings of the data that MD Anderson analyzed.  She did not mention that the flawed data were based on studies that were required by the FDA as a condition of approval for the breast implants made by Allergan and Mentor.  The data were flawed because women soon disappeared from the study, and the FDA did not require the companies to finish the studies, as they should have,

As a result of the FDA’s failure to enforce the study requirements, the large Allergan and Mentor studies used as the basis of the MD Anderson analyses were very flawed short-term studies rather than the 10-year studies that FDA had proudly said they were requiring.  Whereas the companies blamed the study shortcomings on the enormous number of women who “dropped out” of the study shortly after enrolling (including 80% of the women with Mentor implants after only 1 year), we have interviewed women who were enrolled in those studies who told us that they did not drop out of the studies – rather they were “dropped” from the study by the researchers without their consent.  They never heard from the researchers and hence had no opportunity to tell the researchers how sick they had become after getting breast implants.   Instead, several of those women went to the FDA this month to explain to FDA scientists what happened.  They told Dr. Ashar and other FDA officials that they were dropped from the studies.  They told Dr. Ashar and other FDA officials that they had suffered from autoimmune and connective tissue symptoms such as the ones reported in the MD Anderson study.  They told Dr. Ashar and the other FDA officials that despite being sick for years, they were unaware that breast implants could be the cause because neither the FDA nor their plastic surgeons had warned them of the risks.  When they finally found each other on social media (on Facebook pages joined by more than 50,000 women harmed by breast implants), they realized that removing their implants might help.  Much to their surprise, they experienced almost miraculous recoveries after their implants were removed by experienced explant surgeons.   The women told Dr. Ashar and other FDA officials that their symptoms disappeared entirely or improved by 85%.

The FDA editorial was written before Dr. Ashar met with the former implant patients this month, but she had previously met with several of the same women who had reported these same problems and recoveries after explant surgery.  So it is very discouraging that FDA staff have been and continue to be so close-minded about the risk of breast implants despite the MD Anderson analyses.

What Have we Learned from the MD Anderson Study?

We agree with the FDA and the MD Anderson researchers that these results can’t be considered conclusive, but the FDA needs to look at the data more carefully and require better studies so that they can reconsider their repeated claim that breast implants are only proven to cause local complications, such as leaking and painful implants.  Although the FDA admits that breast implants can cause a cancer of the immune system known as ALCL, they continue to quote industry-funded studies claiming that implants do not cause other systemic illnesses.  It should be obvious to open-minded scientists that if breast implants can cause cancer of the immune system, they can probably cause other serious immune system diseases and symptoms.  Moreover, the results of the MD Anderson study supports those concerns about autoimmune symptoms and diseases.

What should be the key information of importance to women considering breast implants or women who have them in their bodies? Clearly, these studies indicate that patients should report any new symptoms that develop after getting their implants, whether involving their breasts or other parts of their body.  Breast implant patients should know that the FDA recommends MRI imaging of silicone breast implants 3 years after the augmentation or reconstructive surgery and every 2 years thereafter.

Read the original article here.

Cancer of the Immune System (ALCL) and Breast Implants: Plastic Surgeons Study 173 Women

Can Implants Cause Cancer?, Summaries of Implant Studies by Other Researchers
Brody GS et al., “Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases.” Plastic and Reconstructive Surgery. 2015.

In 2015, plastic surgeons who have been well known for defending the safety of breast implants published a study of 173 women with cancer of the immune system caused by breast implants. 3 The study was paid for by a plastic surgery medical association and written by plastic surgeons who have defended the safety of breast implants for decades.

ALCL (Anaplastic Large Cell Lymphoma) develops near a breast implant but is not breast cancer – it is a cancer of the immune system. The authors of this study point out that the first silicone breast implant was implanted in 1962 and the first publicly reported case of ALCL in a woman with silicone breast implants was in 1997. The authors reviewed 37 medical articles reporting on 79 patients and collected information about an additional 94 women with ALCL caused by breast implants.

Results

Physicians first identified these 173 women with ALCL based on either seromas (a collection of fluid under the skin), a mass attached to the scar capsule surrounding the implant, a tumor that eroded through the skin, in a lymph node near the breast, or discovered during surgery to replace a breast implant. Whether the women had silicone gel or saline breast implants didn’t seem to make a difference, but many of the women had at least one textured breast implant.  Cosmetic augmentation patients and women who had breast implants to reconstruct their breasts after undergoing a mastectomy were both at risk of developing ALCL because of their implants. Of the women whose ALCL spread outside of their scar capsule surrounding the implant, about half died from ALCL.

The authors pointed out that ALCL can be difficult to diagnose. Although the fluid and scar capsule usually appear abnormal, they sometimes look normal. The authors recommend “that all fluid and capsule tissue from patients with seromas” should be tested for ALCL. They point out that if the tumor is inside the capsule, removing both implants and the capsules may be the only treatment necessary. However, if the tumor has developed just outside the capsule, chemotherapy with or without radiation is needed and usually effective. Unfortunately, aggressive ALCL that has spread beyond the scar capsule area is usually fatal, regardless of treatment.

2017 Update

In March 2017, the U.S. Food and Drug Administration (FDA) reported that it had received 359 reports of ALCL among women with breast implants. Unfortunately, many cases of ALCL are not reported to the FDA.  The FDA’s announcement came after the World Health Organization (WHO) officially recognized “breast implant associated ALCL (BIA-ALCL)” in 2016. In 2014, the National Comprehensive Cancer Network (NCCN) has also released a worldwide oncology standard for surgeons and oncologists to test for and diagnose the disease.

2022 Update

In April 2022, The FDA announced it hade received  1,130 reports of BIA-ALCL and of those cases, 59 reported deaths. The FDA continues to receive reports of BIA-ALCL across the globe.

 

Read the original study here. 

To read more about what you need to know about ALCL, click here.

Women with Silicone Breast Implants and Unexplained Symptoms

Summaries of Implant Studies by Other Researchers
M.C. Maijers et al., “Women with Silicone Breast Implants and Unexplained Systemic Symptoms: A Descriptive Cohort Study.” The Netherlands Journal of Medicine: December 2013

Many women with silicone breast implants suffer from symptoms that may seem unrelated to their implants, such as muscle pain, joint pain, chronic fatigue, numbness, memory loss, and dry mouth. Many women never find an answer to these “mystery illnesses” because women and their doctors do not consider a link between the two. 

A study published in 2013, by researchers in the Netherlands, sheds light on the symptoms that many women with silicone implants experience, and suggests that removing the implants can improve the women’s health dramatically. 

In this study, researchers followed women with silicone gel breast implants who were experiencing unexplained symptoms (which were called “Autoimmune Syndrome Induced by Adjuvants,” or ASIA). Eighty women volunteered and underwent chest x-rays, blood work, and a physical exam to rule out other known causes of their symptoms. The participants filled out a questionnaire about their health and history with breast implants and were followed up with telephone interviews. Most of the women (89%) had breast implants for cosmetic reasons, and had implants for an average of 14 years. Notably, 75% of the women reported that they had allergies before they got their breast implants.

All 80 women in the study had two or more of ASIA symptoms, and most women reported that they had not had new health problems for several years after getting implants, instead their symptoms developed gradually. Although it is unknown which women will develop ASIA symptoms from silicone, the authors caution that anyone who has allergies may be more likely to have a bad reaction to silicone.

Thirty-six out of the 52 women (69%) who had their implants removed experienced reduction in symptoms and 9 out of 52 experienced full recoveries after explantation.  The authors conclude that physicians should consider explanting silicone implants and the scar capsules that surrounds them as the treatment for women with silicone breast implants who have these otherwise unexplained symptoms.

A 2016 review also showed that many women who suffer from autoimmune symptoms after getting breast implants improve after removing the implants. In fact, silicone-related complaints (such as autoimmune symptoms) got better for 3 out of 4 women after they removed their implants. It wasn’t only symptoms that improved, many women diagnosed with autoimmune diseases also improved after they removed their implants, although most of these patients were also taking immunosuppressive therapy before and after removal, and it is not clear if their improved health continued after the immunosuppressive therapy ended.

Read the original 2013 study here.

Read the 2016 study here.

Breast Cancer Detection and Survival Among Women with Cosmetic Breast Implants

Summaries of Implant Studies by Other Researchers
Eric Lavigne et al., “Breast Cancer Detection and Survival Among Women with Cosmetic Breast Implants: Systematic Review and Meta-Analysis of Observational Studies.” The British Medical Journal: April 2013

According to a new research study published in the British Medical Journal, women with cosmetic breast implants who are diagnosed with breast cancer, are more likely to die from the disease compared to women without breast implants who are diagnosed with breast cancer. Combining research from 12 studies, Dr. Eric Lavigne and his colleagues found that women with breast implants were more likely to be diagnosed with a later stage breast cancer, compared to women diagnosed with breast cancer without breast implants.

In a separate analysis combining research from 5 different studies, the researchers report that compared to other women with breast cancer, women who had breast implants before they were diagnosed with breast cancer were 38% more likely to die from the disease.  This occurs because implants interfere with mammography, making it difficult to diagnose breast cancer early.

Read the original study here.

What Do Women Need to Know and When Do They Need to Know It?

Summaries of Implant Studies by Other Researchers
Susan Wood, and Scott L. Spear. “What do women need to know and when do they need to know it?.” Plastic and Reconstructive Surgery. 2007.

When a woman decides whether or not to get breast implants, she must consider how that decision will affect her life. In their 2007 article, “What Do Women Need to Know and When Do They Need to Know It,” Dr. Susan Wood and Dr. Scott Spear discuss the known and unknown risks involved in breast implants. They point out that it is the healthcare professionals’ responsibility to provide patients with information and to help them weigh the risks and benefits, but that “it is also a challenge to women to seek information, ask good questions and carefully consider the answers.”

The article is especially important because it shows substantial agreement between Dr. Susan Wood, a well-respected women’s health expert, and Dr. Scott Spear, a consultant to breast implant manufacturers and the former president of the American Society of Plastic Surgeons.

Health and Cosmetic Risks

The authors state that there are known risks. Breast implants do not last forever and women will need additional operations to replace ruptured implants. Ruptures of saline breast implants are obvious, but ruptures of silicone gel implants are often “silent,” meaning that there are no obvious signs or symptoms. The authors point out that magnetic resonance imaging (MRI) is the most accurate way to detect a rupture. They note that mammograms are often inaccurate in detecting rupture and can actually cause more harm. If an implant is already ruptured, the pressure from a mammogram could cause the silicone gel from the implant to leak outside the capsule.

The authors discuss how the removal of implants is more complicated than the initial surgery, especially if an implant has ruptured and the silicone has leaked into the surrounding tissue. Replacing broken implants also has risks: “After a second surgery, the risk of more complications, especially capsular contracture and rupture is higher than before. Revisions or secondary corrections do not reduce the need or likelihood of future surgery.” Women must not only consider the cost of the initial surgery, but of “follow-up operations, removal and replacement, and additional costs for mammography and magnetic resonance imaging…Also, insurance companies may drop coverage or raise premiums for women who have undergone breast implant surgery.”

Breast cancer detection is another potential problem. Implants can hide cancerous tumors during a mammogram. To make mammography more accurate for women with breast implants, “the additional views of the breast with implants require a specially trained technician and will cost more, take more time, and expose the woman to more radiation.” Since most women wanting breast implants plan to have them for the rest of their lives, it is important to stress these issues,  especially those who are at high risk of breast cancer.

Unknown Risks

There are still many things we don’t know about breast implants, and an “unknown risk is not the same as no risk.”  Most importantly, clinical studies for today’s breast implants only followed patients for the first 3-4 years after getting implants, even though implants may last up to 10 years. As a result, we don’t know for certain how long implants will last and how they will affect the body. We do know that many women will need to undergo surgery, and that the need for additional surgery continues every year because of complications and rupture.

More research is needed, and meanwhile some women need to be especially cautious about implants. For example, “differences in keloid formation, scarring, capsular contracture and other complications in African-American women are a potential problem that has not been studied in breast implants and thus remains unknown,” and women with autoimmune diseases were excluded from the implant makers’ clinical trials because of concerns about “whether silicone breast implants have the potential to disrupt the immune system.”

Research has also found a significant increase in suicides and some types of cancer for breast augmentation patients compared with other plastic surgery patients. And, there is the possibility that women with breast implants will have difficulty breastfeeding or that silicone or other implant substances may leak into their breast milk.

The article stresses that since breast augmentation is a choice with life-long implications, women should take the time and the care to consult with health professionals and look over the relevant literature to assess both the known and the unknown risks before undergoing these procedures. After gathering the information, the authors recommend that women take at least two weeks to assess the physical, psychological and financial consequences of breast implants before making their decisions.

Read the original article here.

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.

Read the original article here.