WHERE ARE WE WITH BREAST IMPLANT SYNDROME?
So in 1962 the first silicone implant went into a patient. Before that renowned German surgeon in 19th century had tried to use a benign fat tumour for better breast mounds. Dow Corning the company that made the first implant was a chemical manufacturing company that used inertness of Silicone as the basis of its use as an implant. Improvements in the silicone implants were made to create different generations of silicone implants which we have discussed in our other blogs.
In the 1980s a group of women in the USA started complaining of joint and connective tissue disorders and they thought it linked with their breast implants. The subsequent class action sent Dow Corning into bankruptcy and in the USA resulted in an FDA moratorium on the use of silicone implants for cosmetic breast augmentation 1993-2006. That is to say you could have a silicone implant if you had a cancer reconstruction but not if you were having a cosmetic breast augmentation. In 2006 FDA after 13 years of research said that there were no causative links between silicone and connective tissue disorders. That is the end of that right? No it turns out that in recent years some women have been experiencing a constellation of symptoms, including, brain fog, metallic taste, lack of energy, joint pain, bowel symptoms and other that is called Breast Implant Illness Syndrome. Enbloc resection, where the capsule and implant is removed together is argued by some would remove the possibility of biofilm (bacteria or fungus living on the capsules of the implant impervious to blood circulating antibiotics but enough to wage a slow ongoing chronic inflammation), thereby alleviating the symptoms associated with this clinical entity. This was strengthened somewhat by what is considered a controversial study from MD Anderson looking at approximately 100, 000 patients with implants that suggested that patients were at slightly higher risk of developing some forms of connective tissue disorders. That set the proverbial cat amongst the pigeons.
SYDNEY’S RENOWN PLASTIC SURGEON EXPLAINS BREAST IMPANTS ILLNESS SYNDROME
So what is the evidence for all of this. Here is the distilled summary that I put together for a book chapter I recently published on the topic of breast augmentation in one of our standard international reference textbooks:
Breast Implant illness-type symptoms were increasingly reported by patients as far back as the 1980s–early 90s along with a series of autoimmune disorder that were linked with women who had breast implants. This resulted in temporary withdrawal from the US market by the FDA between 1993-2006. These were replaced by saline filled, single lumen implants. In the event of rupture, extravasation of saline solution was thought preferable to leakage of silicone. Breast implant associated illness remains a controversial topic and in the only study of its kind in 1997 Peters et al. reported the effects of explantation in 100 women compared with a control group of 100 women. Subgroup analysis of the women who had explantation were grouped as follows:
Group 1: In this group of women the symptoms experienced were pain, breast firmness, fatigue, joint pain, GI symptoms, rashes, memory loss and sleep disturbance. They experienced the most positive effects of implant explantation without evidence into rheumatic or autoimmune disease.
Group 2: This group had proven rheumatic disease and complaints similar to group one. The majority of patients who had improved symptoms post explantation had these return within 12 months with six patients having ongoing severe symptoms.
Group 3: Proven autoimmune disease (RA, SLE, Raynauds, MS). None of these patients had improvement post explantation.
Autoantibody titre analysis for autoimmune diseases did not show a statistically significant difference between groups. The authors admitted a limitation of the study was an inherent bias as all patients had been referred by their rheumatologists for negative symptoms.
Recently, a controversial cohort study by Coroneos et al., addressed safety and efficacy of implants in 99,993 patients. This is the largest multi-centre implant outcomes study and the first with significant power to identify risks of acquiring connective tissue disorders. They highlighted the potential problems in relation to breast implants. They found that there was an increased risk of developing Sjogrens syndrome, scleroderma, rheumatoid arthritis, still birth and one recorded case of melanoma.
The paper highlights the low potential overall risk of developing any of the published illness for multiple reasons:
1) Data shows a combination of increased and decreased illness risk with breast implants.
2) Reported risk rates are extremely low when looking at the data ranging from 0.004% – 0.6%.
3) Most data relies on self-reporting by patients and is related to the single manufacturer ‘Mentor’ implants only. Allergan self-reported data are confirmed by a physician with ‘true’ diagnoses (but has shorter follow up of only 2 years).
BREAST IMPLANTS STUDIES ARE NOT CONCLUSIVE
Breast implant patients are grouped together, but cosmetic and reconstructive groups are very different (e.g. melanoma risk may be significantly increased in cosmetic patients who are more likely to sunbathe after their augments). General population figures for comparison are taken from heterogenous papers that include significantly older data with a broad spectrum of different cases. Significant attrition rate is demonstrated during follow-up in these studies with retrospective analysis and no control group comparison. This suggests unreliable conclusions despite high numbers in the study.
Coroneos’ study shows illness risk increase, but also a ‘protective’ nature of breast implants and in all cases the percentage of risk protection is extremely small. However, patient reported symptoms are real and must be taken seriously. Properly designed, prospectively enrolled, controlled, diagnosis-confirmed, long term follow-up studies are required to present the data accurately.
Auto-immune disease was identified as a potentially related factor, however Shon’s 1992 study did not support this with only 28 cases being reported from 1– 2,000,000 women in the USA who had implants. A small study of 38 implant cases by Rohrich et al., retrospectively matched for implant removal, found temporary improvement in breast implant related illness-type symptoms. Fryzek et. al’s study in 2,500 patients randomly selected from Swedish breast implant registry, when compared to 3,500 breast reduction patients, found that although breast augmentation patients were more likely to report illness-type symptoms, the lack of specificity and absence of a dose-response relationship suggests no causal association.
In an attempt to offer a pathological basis for these symptoms De jong et al.’s study of 42 silicone breast implant patients self-reported illness-type symptoms in a questionnaire. They found 12/48 had increased polymer binding immunoglobulins and none of these patients were categorised as being ‘severe’ in their symptoms and clinical examination reports. Furthermore, the 17 years (average) silicone exposure in the ‘minimal symptoms group’ did not result in induction of polymer binding Ig. The only conclusion here is that there is no strong association between silicone exposure and detectable immunoglobulins levels in the blood.
There have been a variety of generalised symptoms reported making it difficult to ascertain ‘true’ related illness features. There has been no biochemical associations demonstrated. There may also be a psychological pre-disposition for developing symptoms. Such as in the case of 100 capsulectomy patients who had improved symptoms from implant illness post explantation.
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Our Sydney clinic is conveniently located in Darling Point while our Canberra clinic is located in National Capital Private Hospital.
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