Over 400,000 women choose breast implant augmentation surgery annually in the U.S. Approximately 75% are for enhancing healthy breasts with the other 25% going for reconstruction after a mastectomy. The popularity of breast implants continues to rise, although the increase in breast implant surgery may be due partly to replacing old implants that have ruptured or caused other types of problems.
Debate about breast implants also continues to grow especially in the face of the conflicting data available. Once old concerns seem to resolve, new controversies arise. For instance in 2011, the FDA announced that silicone breast implants (versus saline implants) might cause a rare type of lymphoma called ALCL, after an international scandal disclosed that tens of thousands of breast implants had been filled with industrial silicone instead of medical grade silicone.
The FDA has played a role in driving the ongoing debates. Its focus on complications such as breast pain or hardness (called capsular contracture), implant rupture, and cosmetic problems in the breast area. At the same time, the FDA repeats that studies “do not show evidence that silicone gel-filled breast implants cause connective tissue disease or reproductive problems” and that “the FDA does not have evidence suggesting breast implants are associated with health conditions such as “chronic fatigue, cognitive issues and muscle pain.”
That hasn’t stopped women from complaining about an array of symptoms now called “breast implant illness.” In fact, one Facebook group on breast implant illness has over 131,000 members, and Facebook has many more support groups on the condition with thousands of followers. In September 2018, administrators and advocates from two of the Facebook groups met with FDA officials and urged them to take greater action regarding autoimmune conditions, connective tissue disease, and breast implant illness.
How the food and drug administration plays a role
When breast implants first became available in the 1960s, the FDA had no authority to regulate medical devices. The law changed in 1976, which created three categories of medical devices according to risk with Class III being “high risk.” Existing devices such as breast implants were “grandfathered” onto the market. However, early controversy began in the late 1970s both scientists and doctors expressed apprehension over their overall safety. Initially, an FDA Advisory Panel suggested that breast implants be categorized as moderate-risk Class II devices, which would not require any clinical trials proving safety or effectiveness for new implants to be sold.
Instead, the FDA proposed a Class III designation in 1982. The following year, an FDA Advisory Panel unanimously agreed. In 1988, the FDA Advisory Panel listed the possible risks of breast implants that needed to be studied, including:
- Capsular contracture (the painful tightening of the scar tissue around the implant)
- Breakage
- Micro-leakage (sweating or bleeding of silicone outside the shell)
- Silicone leakage to the lymphatic system
- Interference with the accuracy of mammography
- Immune disorders
- Cancer
These are still the most significant concerns surrounding breast implants, and the incidence of complications as the implants age is still undetermined.
Frequency of local complications
Any type of surgery has risks associated with the procedure, and breast implant surgery is no different. These risks include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.
Breast implants also have “local complications” in the breast area. However, no long-term studies have occurred to determine how often local complications happen. These are the most common local complications:
- Breast pain and capsular contracture
- Rupture
- Leakage
- Interference with mammography and causing delay in diagnosis
- Interference with breastfeeding
The ongoing controversy: autoimmune conditions, connective tissue disease, and breast implant illness
The most significant controversy surrounding silicone breast implants concerns the question of whether they cause or increase the risk of acquiring autoimmune disease and connective tissue disease. This debate has garnered attention now that it is known that implants can cause ALCL, a lymphoma of the immune system. This knowledge leads to the question of whether the implants induce other immune disorders.
As noted above, hundreds of thousands of women on Facebook have joined support groups for breast implant illness. Frequently, doctors classify many of the symptoms they report as connective tissue or autoimmune symptoms. However, many of the women in these online groups have not been diagnosed with a specific autoimmune or connective tissue disorder (CTD).
Even so, implant manufacturers and cosmetic surgeons point to “no evidence” of autoimmune or connective tissue conditions caused by breast implants. This isn’t necessarily true. The evidence exists in studies, and the results are often ignored because the studies had certain flaws.
A few studies point to breast implants being associated with autoimmune or connective tissue symptoms, rheumatoid arthritis (RA), scleroderma, Sjögren’s Syndrome, and other specific diseases.
A large retrospective study published by Watad et al in 2018 reported a statistically significant 22% increase in several autoimmune or rheumatic disorders. The prevalence of Sjögren’s syndrome, MS, and sarcoidosis each increased by at least 60%. That analysis was based on nearly 11,500 Israeli women with breast implants confirmed by medical records and close to 46,000 women who had no breast implants. The study looked at 20 years of medical records on the participants.
Another large study published 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 analyzed nearly 100,000 women with Mentor or Allergan silicone gel breast implants. However, close to 80% of the 50,000 patients with Mentor implants dropped out before their self-reported questionnaire data were collected. The Allergan data were based on diagnoses of 60% of their patients two years after their implant surgery.
Although the studies had flaws, it is crucial to recognize that the researchers reported increased risks in certain autoimmune diseases for women with breast implants: an 800% increase in Sjogren syndrome, 700% increase in scleroderma, and 600% increase in arthritis among women with Mentor breast implants versus of women of the same age and demographics without Mentor breast implants. Allergan patients had double the rates of many of the same diseases, but there were fewer diagnoses since they were based on diagnoses after only 2 years.
These two large studies indicate a link between breast implants and autoimmune or connective tissue diseases, which repeats the findings of older, smaller studies. For instance, an FDA study in the 1990s found a statistically significant link between breast implants and fibromyalgia and several connective tissue diseases. The study included women with silicone breast implants for at least six years. It found that women with implants that leaked silicone were significantly more likely to report a diagnosis of diseases like fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia. The risk of fibromyalgia remained the same after controlling for the patient’s age, the implant manufacturer, and the age of the implant.
During the same time, researchers at the National Cancer Institute (NCI) found a significant increase in reported connective tissue diseases among breast augmentation patients. In this study, the women had their implants for a minimum of seven years. The researchers also discovered that many of the participants made errors when self-reporting. For instance, some women reported having rheumatoid arthritis rather than osteoarthritis. Still, the study shows an increase in symptoms for women with breast implants, even if the connections with specific conditions were not established. The scientists concluded that further study was necessary to examine the role of breast implants in relation to arthritis, scleroderma, Sjögren’s syndrome, and other connective tissue diseases.
One study by the National Center for Health Research showed that women typically have their implants removed and not replaced due to symptoms associated with autoimmune and CTDs. These women frequently report a wide array of symptoms that do not fit the exact criteria of known diseases. In fact, a significant weakness in many breast implant studies (typically funded by implant manufacturers) is that they examine known diseases rather than the symptoms themselves. When the studies include women who have had implants for a short period of time, the weakness is compounded because many symptoms appear long before an actual diagnosis.
However, Mentor and Allergan submitted additional data when the companies applied for approval of the silicone gel implants in 2005. The information compared both signs and symptoms of connective tissue diseases before the women received the implants and two years after they received the implants. The data showed that these signs and symptoms increased significantly in those two years, although the companies asserted that the patient’s age caused the increases in symptoms.
Indeed, scientists who compiled the official FDA summary regarding the Allergan patients noted that the evidence does exist that breast implants are associated with an increase in some connective tissues diseases and that in Allergan’s data, “the increases in the following CTD categories occurred despite age: general issues, muscle weakness, joint pain, and skin symptoms.”
For Mentor implants, the FDA reported statistically significant increases in fatigue, exhaustion, joint swelling, frequent muscle cramps, joint pain, and fibromyalgia among augmentation patients, which the FDA concluded were not due to age.
Another study comparing symptoms before and after women had their breast implants removed. It examined 95 women who had silicone gel-filled breast implants and diagnosed rheumatologic symptoms. The researchers found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed and not replaced. In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.
Another important study reported significant increases in connective-tissue and autoimmune problems for women with breast implants. However, the researchers concluded that exposure to breast implants did not appear to be related to autoimmune symptoms or diseases. The women had their implants for an average of 19 years and reported issues such as fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), memory loss, and other cognitive symptoms more frequently than women of the same age without breast implants. Ten percent of the participants had reduced symptoms after their implants were removed and not replaced. Amazingly, the study concluded that there was no apparent link between the implants and symptoms despite also reporting that women with implants were two to three times more likely to report symptoms. However, the study went further and noted that the women with breast implants were six times more likely to be using antidepressants versus women who had breast reduction surgery and four times more likely as women in the general population. Unfortunately, that is the part many people quote instead of the actual results. One author was a director of the International Epidemiology Institute, which receives funding from Dow Corning, a maker of silicone.
It is important to note that some studies from a variety of countries indicate an increase in suicides among women with breast implants, and depression as a component should be included in future studies.
In addition to the examples above, former FDA researchers have reported that silicone stimulates an immune response, and their cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.
Final thoughts
There are many more studies examining the links between silicone breast implants and autoimmune and CTD diseases. The evidence continues to show that women with breast implants tend to experience an increase in both symptoms and diagnoses than do women in the general population without implants. The strength of the associations varies greatly depending on which disease was examined and how the studies were conducted. Studies that relied upon patient-reported symptoms or women with implants longer than seven years, the associations were stronger and more significant.
The issue is that patients need to have all the information available to make the right decisions for their own situations. More objective studies are needed that rely on a larger number of women. This includes data collected on women with implants for a short period, because many drop out before long-term data is collected for analysis.The FDA has pointed to using device registries to collect data on breast implants, as well as other types of implants. However, the focus needs to be on the symptoms, rather than the number of surgeries to remove or replace implants. And, studies must look at the symptoms reported in comparison to women in the general population without breast implants in order to pinpoint the root cause of “breast implant illness.”
REFERENCES
- FDA Summary Panel Memorandum. “Inamed PMA Review Team.” March 2, 2005. https://web.archive.org/web/20060819041515/http:/www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf
- Coroneos CJ, et al. “US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.” Annals of Surgery. 2018.
- Brown SL, Pennello G, Berg WA, et al. “Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women.” Journal of Rheumatology. 2001. https://www.ncbi.nlm.nih.gov/pubmed/?
- Brinton LA, Buckley LM, Dvorkina O et al. “Risks of connective tissue disorders among breast implant patients.” American Journal of Epidemiology. 2004. https://academic.oup.com/aje/article/160/7/619/136686
- Zuckerman D, et al. “Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide.” Women’s Health Issues. 2016. https://www.whijournal.com/article/S1049-3867(16)00031-1/pdf
- Breiting VB, Holmich LR, Brandt B. “Long-term health status of Danish women with silicone breast implants.” Plastic and Reconstructive Surgery. 2004. https://www.ncbi.nlm.nih.gov/pubmed/15220596