Category Archives: Summaries of Implant Studies by Other Researchers

Summary of Published Study by MD Anderson Physicians on the Increase in Rare Diseases Among Women with Breast Implants

National Center for Health Research: September 17, 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.

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.

Do Breast Implants Cause Disease?


Do breast implants cause the symptoms that women refer to as “breast implant illness?” Joint pain. mental confusion (“brain fog”), exhaustion, hair loss, dry eyes, depression, and “flu like symptoms that never go away” are just a few of the commonly reported health problems among women with implants that seem to be caused by connective tissue or autoimmune disorders. However, plastic surgeons, breast implant manufactures, and others continue to say that breast implants are “proven safe” and that there is no evidence that these symptoms are caused by breast implants.

These questionable safety claims date back to a meta-analysis of 20 studies, which was published in the New England Journal of Medicine in 2000, and was intended to determine whether breast implants cause connective-tissue diseases. This was essentially the same meta-analysis that was conducted by Judge Pointer’s scientific panel during the law suits against breast implant manufacturers. The authors of the meta-analysis concluded that the studies show no association between silicone breast implants and connective-tissue disease. A careful review of the studies that were included in the meta-analysis reveals that hose studies have a number of flaws, however. The accuracy of any meta-analysis depends on the quality of the studies included in that analysis. We scrutinized these 20 studies in 2000 and pointed out their shortcomings as follows:

  • Five of 20 studies cited were not published in peer-reviewed journals. Instead they were papers presented at scientific meetings or unpublished doctoral dissertations. There was therefore limited information on methodology available to evaluate the validity of the study designs.
  • The studies do not provide a comprehensive evaluation of diseases among breast implant patients. Most evaluate a few connective-tissue diseases, including such rare diseases as scleroderma. Most do not evaluate the “atypical” connective-tissue disease symptoms or fibromyalgia-type symptoms that many patients report.
  • Even for the illnesses that they evaluate, the studies have limitations. In order to conduct an accurate study of implant patients’ health, patients should undergo a comprehensive medical exam. In contrast, most of these studies relied on medical records, which might omit vague symptoms that would be reported in the early stages of disease. Several studies relied on self-report, but only the one that found a significant risk due to implants was criticized because patients might exaggerate their health problems. In contrast, studies that determined whether women had implants based on self-report were included and not criticized as biased, even though it would be expected that some women would fail to mention that they have implants. This failure to report implants is especially likely when information was gathered in person or on the telephone, rather than in a questionnaire.
  • Several of the studies relied on hospital records. Very few implant patients would have been hospitalized for their symptoms, since most health problems that implant patients have reported do not require hospitalization.
  • The studies included women who had implants for a short period of time, such as a few months or years. If implants cause connective-tissue diseases, it would be expected that the disease would develop over a period of years. Diseases might also be more likely after a silicone gel implant breaks, which usually occurs after 7-10 years. Therefore, a well-designed study would include women who had implants for at least 7-10 years, not an average of 7-10 years.
  • Many of the studies do not evaluate the safety of implants for mastectomy patients, and therefore the results may not be relevant to them.
  • Many of the samples are too small to study rare diseases, and thus, have limited power to detect increases in the rates of disease, even increases as large as 50-100 percent.
  • Older implants (from 1964-75) were made of a thicker silicone shell than newer implants. Those implants were less likely to “bleed” silicone through the shell or to break. Therefore, studies with women who had implants for a wide range of years would not be expected to show a “dose” response, and studies with women having implants for an average of 7-10 years often include many women with implants for very short periods and women with these thicker, potentially less damaging, implants. That minimizes the likelihood of results showing significant risks from implants.
  • In at least one of the studies, women were included in study even if they had their breast implants removed shortly after they got them. It is impossible to tell from that study how long the women had breast implants. The other studies do not mention whether women who were identified by medical records as having implants still had them years later. Those omissions potentially bias the findings because women who had implants removed do not have the same amount of exposure as women who have implants continuously.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

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.

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.

Next Steps for Breast Implant–Associated Anaplastic Large-Cell Lymphoma

Anna E. Mazzucco. “Next steps for breast implant–associated anaplastic large-cell lymphoma.” Journal of Clinical Oncology: June 16, 2014

To the Editor:

The excellent analysis by Miranda et al1 based on extended follow-up of patients with breast implant-associated anaplastic large-cell lymphoma (ALCL) adds to the mounting evidence of the potential for aggressive clinical behavior of this disease.2,3For the first time, these researchers identified two patient subpopulations with distinct clinical outcomes: 75% of the patients with solid ALCL tumors had survived at 5 years postdiagnosis, compared with 100% of patients with effusion-type ALCL. In contrast, earlier studies suggested that breast implant–associated ALCL was likely to be clinically indolent and more similar to primary cutaneous, anaplastic lymphoma kinase (ALK) –negative ALCL, rather than the more aggressive systemic form of the disease.4,5

Although ALCL is rare, breast implants increase the risk by an estimated odds ratio of 18.2.6,7 Miranda et al1 found aggressive ALCL and potential mortalities associated with either saline or silicone-filled implants in both cosmetic and reconstruction patients, and point out that the lack of routine pathology examination of seroma or excised tissue could result in an underestimation of ALCL occurrence. Extrapolating from their findings, the lack of routine pathology is likely to delay the diagnosis when women with implants seek medical care from plastic surgeons or primary care physicians for swollen breasts that are assumed to be infected.

Timely diagnosis will depend on the millions of women with breast implants having access to heightened surveillance, knowledgeable physicians, and appropriate testing and medical care. All of the ALCL cases described in Miranda et al1 were ALK negative, which has a poor overall prognosis and is treated with cytotoxic chemotherapy.8 Others have proposed that all seromas associated with implants, especially those which are therapy resistant, should therefore be carefully monitored, and any patient presenting with recurrent seroma 6 months or more after implantation should undergo aspirate analysis without delay.9,10 The question is, how can such monitoring be ensured?

The track record for monitoring the health of patients with breast implants is not encouraging, however. For example, the US Food and Drug Administration recommends that all women with silicone gel breast implants undergo regular magnetic resonance imaging scans starting 3 years after implantation to check for implant rupture, but most insurance policies do not cover such screening; therefore, few women follow these guidelines. Moreover, many health insurance policies currently exclude any services related to complications from cosmetic surgery; this excludes the approximately 75% of women whose breast implants were originally for cosmetic purposes rather than reconstruction after mastectomy. Our research center’s recent review of health care policies under the Affordable Care Act found no evidence that the growing literature on breast implant–associated ALCL has influenced health insurance coverage for either cytology cultures of seroma or removal of breast implants and capsules that are causing ALCL.

Future studies are needed to elucidate what factors determine whether specific types of breast implants are more likely to increase the risk of ALCL, particularly solid tumors. The collaboration between the US Food and Drug Administration and the American Society of Plastic Surgeons to create a registry of implant recipients who develop ALCL should provide useful information. As new data become available, they should quickly be used to improve early diagnosis and treatment. That will require insurance coverage of medically necessary services for women with serious breast implant complications, including those with implants originally for cosmetic purposes.

Read the original article here.

References:

  1. Miranda RNAladily TNPrince HMet al. (2014) Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol32:114120Abstract/FREE Full Text
  2. Carty MJPribaz JJAntin JHet al. (2011) A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg 128:112e118eCrossRefMedlineGoogle Scholar
  3. George EVPharm JHouston Cet al. (2013) Breast implant-associated ALK-negative anaplastic large cell lymphoma: A case report and discussion of possible pathogenesis. Int J Clin Exp Pathol 6:16311642MedlineGoogle Scholar
  4. Aladily TNMedeiros LJAlayed Ket al. (2012) Breast implant-associated anaplastic large cell lymphoma: A newly recognized entity that needs further refinement of its definition. Leuk Lymphoma 53:749750CrossRefMedlineGoogle Scholar
  5. Ralfkiaer EWillemze RPaulli Met al. (2008) in Tumours of the Hematopoietic and Lymphoid Tissues (ed 4) Primary cutaneous CD30 T-cell lymphoproliferative disorders, eds Swerdlow SH, Campo E, Harris NL, et al.(International Agency for Research on Cancer, Lyon, France), pp 300301Google Scholar
  6. US Food and Drug Administration. Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, 2011.http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239996.htm.
  7. de Jong DVasmel WLde Boer JPet al. (2008) Anaplastic large-cell lymphoma in women with breast implants. JAMA 300:20302035CrossRefMedlineGoogle Scholar
  8. ten Berge RLde Bruin PCOudejans JJet al. (2003) ALK-negative anaplastic large-cell lymphoma demonstrates similar poor prognosis to peripheral T-cell lymphoma, unspecified. Histopathology 43:462469CrossRefMedlineGoogle Scholar
  9. Kim BRoth CYoung VLet al. (2011) Anaplastic large cell lymphoma and breast implants: Results from a structured expert consultation process. Plast Reconstr Surg 128:629639CrossRefMedlineGoogle Scholar
  10. Taylor KOWebster HRPrince HM

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.

Prevalence of Rupture in Patients with Silicone Breast Implants

Brown, S. Lori, et al. “Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama.” American Journal of Roentgenology: 2000.

In 2000, researchers at the FDA published a study showing that silicone breast implant rupture was much more common than previously thought. The study included 907 women in the Birmingham, Alabama area who had silicone gel-filled breast implants for at least six years. The study had two components.

In the first part, FDA researchers interviewed the 907 women to ask how many had removed their implants due to rupture or suspected rupture. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured. Researchers found that one-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. The most common reason for additional surgery was due to complications such as pain, capsular contracture, rupture, or suspected rupture. Women also cited concern about the safety of silicone as a reason for removal.

In the second part of the study, the FDA researchers recruited 344 women from the Interview Study to have a breast coil MRI exam to determine if their implants were ruptured. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured. Researchers found that 77% of the women had at least one breast implant that was ruptured or suspicious for rupture. Researchers also noted that 21% of the women with at least one ruptured implant had silicone gel that had leaked outside the scar tissue capsule that formed around the breast.

There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle. Almost half of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79%, of the women who had implants for 11-15 years had at least one ruptured implant. Researchers also found that women whose implant was above the chest muscles were less likely to have a ruptured implant than women whose implant was below the chest muscle.

In summary, the study found that breast implant rupture and leakage was much more common than previously thought. Most rupture was “silent” in that there were no symptoms that warned the women that they had a rupture.  Silicone from a ruptured implant can migrate into the breast and arms and into the lymph nodes under the arm; from there it can go to the lungs, liver, or other organs.

The most accurate way to check for rupture is to get a breast coil MRI. The FDA recommends getting an MRI starting three years after receiving your implants and every two years after that.

Read the original study here

Read the FDA analysis of the interview portion here

Study of Silicone Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women

Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. “Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women.” The Journal of Rheumatology 2001.

The first study to systematically evaluate the health of women with ruptured breast implants has raised serious concerns about silicone implants. A team of scientists led by Dr. Lori Brown of the Food and Drug Administration (FDA) reported that women whose ruptured breast implants leaked silicone outside the scar tissue surrounding the implant were significantly more likely to have been diagnosed with fibromyalgia (a painful soft-tissue disease), pulmonary fibrosis, and connective-tissue diseases such as dermatomyositis.

Magnetic resonance imaging (MRI) was used to examine the status of the breast implants of the women participating in the study. Based on the implant’s condition, researchers assigned cases to three groups: intact, ruptured, or indeterminable. (Those implants that appeared ruptured but were not able to be confirmed, were classified as indeterminable.) Radiologists also determined which ruptured cases had silicone that migrated outside of the scar capsule that surrounds the breast implant. A majority of the women had at least one ruptured implant, even though they were often unaware of that condition. Also, 21% had silicone that migrated outside of the breast area from at least one broken and leaking implant.

Women with ruptured implants where the silicone had traveled outside of the scar tissue were compared to women in the intact and indeterminable groups; investigators found an increase in fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, pulmonary fibrosis, eosinophilic fascitis, and polymyalgia. The significant association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and manufacturer. Therefore, once the silicone from a broken implant migrates outside of the breast area, the woman’s risk for these serious diseases increases considerably.

This study raises serious concerns for women with ruptured implants, because it indicates that women who are unaware that an implant is ruptured and leaking could be at increased risk for health problems due to their exposure to silicone.

Read the original study here.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Government Study Links Breast Implants to Cancer, Lung Diseases, and Suicide

Brinton, LA, Lubin, JH, Burich, MC, Colton, T, and Hoover, RN. “Mortality Among Augmentation Mammoplasty Patients”, Epidemiology 2001; 12: 321-326.

A new study raises questions about the long-term safety of breast implants. A team of researchers led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI) found that women with breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients.

This study is the first to look at all types of cancer and all causes of death among breast implant patients. While the authors were not able to determine whether implants caused these illnesses, the results show a doubling of brain cancer and a tripling of lung cancer, emphysema, and pneumonia for women with implants. Even though these findings were described as “unexpected,” they are consistent with previous research that shows brain abnormalities and lung problems related to breast implants. There was also a four-fold increase in suicide for breast implant patients, which seems to contradict the manufacturers’ assertion that implants improve a woman’s feeling of self-worth.