Category Archives: Summaries of Implant Studies by Other Researchers

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

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

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. 1 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.

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

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

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?

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

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

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.

An Association of Silicone-gel Breast Implant Rupture and Fibromyalgia

S. Lori Brown, H.J. Duggirala, and G. Pennello. “An Association of Silicone-gel Breast Implant Rupture and Fibromyalgia.” Current Rheumatology Reports: August 2002.

In 2002, researchers at the FDA published an article reviewing several studies that looked at the association between breast implants and fibromyalgia. Fibromyalgia is a disorder characterized by widespread musculoskeletal pain and stiffness, fatigue, and sleep issues. One study compared the health problems of women with ruptured silicone breast implants to those with intact silicone breast implants. The researchers found that women with ruptured implants who had silicone gel migrate outside the scar tissue capsule were 2.7 times more likely to report fibromyalgia symptoms.

The researchers also analyzed several other studies, which concluded that nearly 55% of breast implant patients with symptoms, had fibromyalgia. However, these studies had many limitations, for example they did not differentiate between women with ruptured implants and intact implants, and between silicone and saline implants. The results of their review suggest that breast implants, and specifically ruptured silicone implants, may contribute to fibromyalgia.

Read the original study here.

Epidemiology of Silicone-Gel Breast Implants

Lori S. Brown. “Epidemiology of silicone-gel breast implants.” Epidemiology. 2002.

Silicone breast implants have been marketed in the United States since 1963. Questions remain unanswered on the safety of these medical devices despite their popularity and availability. In 1992, the Food and Drug Administration restricted the availability of silicone-gel breast implants to women requiring them for reconstruction after breast cancer or for other medical indications. Inflatable saline breast implants have remained available for either reconstruction or for cosmetic augmentation while manufacturers completed studies addressing issues of safety and effectiveness. The Food and Drug Administration (FDA) has less concern today regarding a putative association between breast implants and autoimmune disease because of epidemiologic studies that have indicated that there is not a large increase in risk for connective tissue disease in women with breast implants. These studies have not ruled out a small increase in risk of connective tissue disease to these women nor have they addressed the issue of an atypical syndrome related to silicone. The FDA has continuing concerns over local complications that are related to breast implants. The current review provides a brief discussion of the regulatory history of silicone implants and of FDA concerns over breast implants, implant prevalence, studies of systemic and local complications related to breast implants, and a brief description of the FDA study of silicone-gel breast implant rupture.

Read the original article here.

Cancer Risk at Sites Other Than the Breast Following Augmentation Mammoplasty

Brinton, Louise A., et al. “Cancer risk at sites other than the breast following augmentation mammoplasty.” Annals of Epidemiology: 2001.

In 2001, researchers at the National Cancer Institute studied cancer rates among more than 13,000 women who had breast implants for an average of 12 years. The women were 35 years old, on average. The researchers compared those results to the expected rates of cancer in the general population and to more than 3,000 women who had other types of plastic surgeries.

There were 359 cases of cancer in the women with breast implants, compared to approximately 295 cases of cancer that would be expected in the general population. Women with breast implants had double or triple the expected rates of leukemia and cancers of the stomach, cervix, vulva, and brain. When compared to other plastic surgery patients, these cancer rates as well as respiratory cancers were also higher among breast implant patients, but the differences were not statistically significant. The researchers were not able to determine if breast implants caused these cancers. Lifestyle differences might account for some of these differences, although there was no obvious lifestyle cause of increased respiratory or brain cancers; for example, there were no differences in smoking habits.

Read the original here.