As lead author in a recently published international collaboration, Associate Professor Mark Magnusson writes, we have published our paper on Breast Implant Illness in the Plastic and Reconstructive Surgery Journal on 28 February 2019. We reviewed the evidence available to date to re-evaluate if there is a link between breast implants and systemic disease, referred to as breast implant illness. The downloadable version of the paper is available here.
Sometimes it is easy to focus on the discussion; however, regardless of a provable link, the focus should be squarely on the women with symptoms. Some women continue to struggle with real symptoms and worry about the implications for their health and their future. The rise of patient advocacy and communication through social media has subsequently led to an increasing number of patients presenting to Specialists Plastic Surgeons with concerns about their breast implants.
A link between silicone and systemic disease has been reported since the 1960s, and many studies have looked at either supporting or refuting its existence. In general the studies are hampered by poor design, confounding factors or find no evidence, and consequently, the debate continues.
Human Adjuvant Disease
Silicone Induced Human Adjuvant Disease, Autoimmune/Inflammatory Syndrome induced by Adjuvants, Silicone Implant Incompatibility Syndrome are a few terms that have been used to link a systemic disease to silicone. In this age of social media, the term Breast Implant Illness has been applied to include these entities and sometimes more broadly to encompass all complications related to silicone breast implants whether local or generalised.
The term “Human Adjuvant Disease” describes potential autoimmune connective tissue disorders arising following the injection of liquid paraffin, processed petroleum products and liquid silicone-containing injections. A possible connection with scleroderma was explored by Kumagai in 1979.
Reports linking breast implants to Human Adjuvant Disease started in the early 1980s. From the onset, it was felt that it was unlikely that silicone acted as a primary antigen but likely as an adjuvant and could be allowing the body to respond to another source which may be a subclinical infection.
Chemistry of Silicon and Silicone
Silicon is the second most abundant element of earth it exists in nature as crystalline silica composed of silicon dioxide or in silicates such as talc and asbestos. Crystalline silica is known to be a powerful activator of the immune system and is correlated with an autoimmune disease associated with Progressive Systemic Sclerosis in Stonemasons and silicotic patients.
Silicone doesn’t exist in nature and is created from silica forming polydimethylsiloxane (PDMS).
Medical grade silicone generally exists in one of three chemical forms (liquid, gel or elastomer/rubber). It differs from non-medical grades of silicone due to tighter control of additives during synthesis.
A review of the literature
Extensive reviews have been performed by many groups including
The National Academy of Medicine’s (formerly called the Institute of Medicine) Committee on the Safety of Silicone Breast Implants. They made a clear distinction between local complications and systemic health concerns concluding that there was no evidence of systemic health effects such as autoimmune disease.
Tugwell et al. (2001) reported on a further systematic review of published studies on the association of between silicone breast implants and systemic connective tissue disorders that they felt the National Science Panel established by the US District Court didn’t adequately assess. They also found no evidence to support an association between silicone breast implants and connective tissue diseases.
Janowsky et al. (2000) published a meta-analysis after three prior meta-analyses had failed to demonstrate an increased risk of connective tissue and autoimmune diseases after implantation of silicone breast prostheses. Yet again, no evidence of an association between breast implants and a significant increase in the summary adjusted relative risk of individual connective tissue, and autoimmune diseases could be demonstrated.
Yet, patient numbers are growing
Breast implants have been in use in Australia since the 1960s. They are amongst the most researched medical devices. Last year about 1.5 million implants were inserted globally. It is important to note that these are not lifetime devices, and they will at some point in time need to be removed and, if a patient chooses, replaced.
While there are millions of women who coexist comfortably with their breast implants and most have their implants for at least 10 years, the rate of revision surgery increases after this time.
Like the patient who doesn’t respond well to anti-wrinkle injections, there are some women whose bodies don’t fit well with breast implants.
We need to separate those with identifiable symptoms from recognised local complications. Local complications include symptoms related to recognised complications such as capsular contracture, implant migration, infection and scarring from surgery. These do not represent autoimmune or rheumatic conditions.
Although the evidence in the literature is not strong, we see an indication of how patients presenting with broad systemic symptoms may respond to implant removal. In general, there are three groups of women:
- Women with symptoms but no abnormal blood tests are highly likely to be improved by explant surgery physically and psychologically.
- Women with a documented rheumatic disease but no autoimmune disease: e.g. fibromyalgia, these patients may have a limited reprieve when their breast implants are removed. However, symptoms tend to recur after 6-12 months.
- Women with a diagnosis of a defined autoimmune disease tend to have no improvement.
Where to from here?
Women with concerns about their breast implants need to be provided with a pathway to check on their implants both clinically and with imaging and pathology. We have commenced an international collaboration to investigate this disease by thoroughly examining patients with symptoms to classify the local versus systemic disease status and specifically to look for autoimmune and rheumatic diseases. Patients will then be followed with repeat investigations to monitor changes in symptoms and abnormal tests following explant surgery.
We aim to strengthen the science around this condition and provide women with greater certainty about how to proceed and what their likelihood of improvement is.
The relationship between breast implants and systemic disease including autoimmune disease has been postulated, studied and claimed since 1964 but the debate continues even today. The only way forward is a systematic prospective evaluation of breast implant outcomes and study of samples from patients with Breast Implant Illness, correlating their preoperative symptoms and morbidity to measurable post explantation improvement. Only then will we be able to provide patients with the most reliable information on whether or not they can comfortably coexist with breast implants.
Magnusson M, Cooter RD, Rakhorst HA, McGuire P, Adams WP Jr, Deva AK. Breast Implant Illness: A Way Forward. Plast Reconst Surg. 2019;143(3S):74S–81S. doi:10.1097/PRS.0000000000005573.