Breast Implant Illness- Where We Are In 2023

Over the last few years, the topic of Breast Implant Illness has gained a lot of attention, particularly on social media.  Breast implant illness (BII) is a collection of symptoms that may be related to breast implants. Though the exact cause isn’t known, BII may be related to autoimmune or inflammatory responses. Although more than 100 symptoms have been attributed to BII, the most commonly reported symptoms are anxiety, brain fog, headache, muscle pain, and chronic fatigue. All of these symptoms, though, are common in patients without implants as well. 

The topic of Breast Implant Illness has thus become a contentious one because patients who were sure that they had BII and were met with skepticism by most plastic surgeons.  This led to frustration, suspicion, cynicism, and mistrust between patients and doctors.  To a large extent, the source of this problem was mostly the lack of real scientific data about, and understanding of, BII that both patients and doctors could rely on.

This spring, a summary of the current state of this topic was presented By Drs. Haws, McGuire, and Deva at the American Society of Aesthetic Plastic Surgery in Miami.  At this meeting, BII was defined as systemic (whole body) symptoms in breast implant patients who, upon examination, had no abnormal labs or physical findings.  Because no diagnostic criteria exist, BII is thought of as a “diagnosis of exclusion”, meaning that every other cause of symptoms has been ruled out.  It was therefore recommended that the entity no longer be called Breast Implant Illness, but instead Systemic Symptoms with Breast Implants, or SSBI.  (This is not to be confused with Anaplastic Large Cell Lymphoma, ALCL, which is a rare but serious lymphoma that can occur in the breast implant capsules of patients who have or have had textured breast implants.)

Finally, some very helpful large studies performed in Australia, The Netherlands, and the United States which provided some answers to the crucial questions of what causes BII, how to treat it, how successful the removal of implants and how the removal of the implant capsule effects the success, and how we can predict who is at higher risk of developing SSBI.  This new research was performed by a multi-national, multi-specialty group of Another study utilizing plastic surgeons, PhDs researchers, toxicologists, pathologists, immunologists, and psychologists. 

Until now, patients, BII patients, BII support groups, and some in the medical community have attributed these symptoms to chronic inflammation caused by silicone gel “bleed” through the implant shells, heavy metal presence in the implants, bacterial contamination in the form of biofilms, allergic reactions, or an immune response to the foreign bodies (implants).  Results of the important new studies provide insight into the exact question of whether the breast implants themselves cause BII symptoms.

First, the suggestion the that systemic inflammation is caused by silicone gel “bleed” through the capsule has been proven incorrect because a huge review of self-reported BII patients found that MORE BII patients actually had SALINE implants, not silicone.  Also of note, BII symptoms were not related to any certain implant manufacturer or whether implants were smooth or textured.  Furthermore, the assumption that BII patients have inflammation in their bodies related to their implants appears to be inaccurate because only 1/5 of patients self-diagnosed with BII actually had blood tests showing increased C-reactive protein, a broad blood test for any kind of inflammation in the body.

The hypothesis of heavy metals as the culprit was also rigorously examined.  Twenty-two trace metals (which are in most materials in the environment in negligible quantities) were not found in any meaningful concentration in the implants themselves.  More importantly, the capsules around the implants showed levels of these metals well below what is considered a safe level of exposure. 

Furthermore, 5 of the metals that were looked for were not detected at all, and 7 of the metals were only found in 10% of patients with BII symptoms.  Even more significant, some of these metals were found in higher concentrations in the tissues of women who never had breast implants.  Therefore, presence of metals does not seem to correlate at all with BII symptoms.

Other research studied blood samples and capsule tissue from patients having their implants removed for self-reported BII symptoms.  Tests included thyroid function, blood compounds, inflammatory markers, vitamin levels, 12 cytokines (signaling molecules between inflammatory cells), and antibodies.  Next generation DNA sequencing was also used to look for any presence of bacteria- either current or past.  Results showed that the presence of bacteria in the capsules of BII patients was no different than patients without BII (although there might be more living bacteria). 

None of the laboratory values correlated to BII symptoms either.  Additionally, there was no statistical increase in the evidence of allergy in the blood or implant capsules, or any abnormal capsule growth in BII patients.  This data suggests the BII is not related to infection or an allergic response.

In summary, we do not know what causes BII (SSBI) symptoms.  

Still, patients with BII symptoms do improve significantly with breast implant removal.  The improvement is definitely not guaranteed for any individual patient though.  Nonetheless, research clearly shows that patients do report improvement in anxiety, cognitive function, fatigue, sleep disturbance, and many other symptoms.  In fact, the top 5 aforementioned symptoms of Breast Implant Illness all improved significantly.  Patients returned to baseline anxiety at 6 months. Furthermore, these improvements seem to be long-term improvements. 

One study showed that, at 1 year after implant removal, 88% of patients reported improvement in at least 2 symptoms, and a 69% reduction in the total number of symptoms.  This is not to say that all these symptoms go back to what is considered a “normal” level, but the improvements are even more than statistically significant.  It is important for patients to have this information to consider, especially because some groups on social media are now talking about patients regretting removing implants due to scarring and poor cosmetic appearance after removal.

If we know that breast implant removal often improves symptoms, the next question is how the implants should be removed.  Many websites and social media sources instruct that “en bloc” capsulectomies be performed.  This term (which is really only appropriately used for cancer surgeries) suggests that the implant and capsule should be removed inside the capsule with the whole capsule still intact. 

This suggestion was tested very rigorously by comparing the outcomes of patients who did have “en bloc” capsulectomies to patients who had total capsulectomies (not necessarily removing the whole capsule in one piece, but still removing it all)  to patients who had most but not all of the capsule removed and finally to patients in whom none of the capsule was removed. This was a very important question to answer because “en bloc” capsulectomies or even total capsulectomies are far more invasive and cause more pain, much greater expense, more bleeding, and higher risk of serious complications (such as collapsing a lung or postoperative bleeding requiring emergency surgery).

The studies agreed that there is actually no difference in symptom improvement whether an “en bloc”, total, or even partial capsulectomy was performed.  Therefore, knowing that the improvement will be the same with capsule improvement by any method, it is reasonable for the patient and the surgeon to proceed with a total or even “en bloc” capsulectomy if the patient feels strongly about it, but to also agree that if it appears more dangerous to proceed with that plan during surgery, then adjustment can be made to leave some of the capsule in the surgically “most dangerous” areas.

While this new data puts patients and plastic surgeons in a better position to discuss options and make informed decisions, it would be ideal to identify which patients are most likely to develop BII/SSBI before they decide to go ahead with breast augmentation surgery.  Although there does not exist any screening tool or questionnaire, or certainly any diagnostic laboratory, these studies have indicated that the patients at highest risk of developing BII symptoms are those who have a higher BMI (more overweight), more allergies, smokers and former smokers, marijuana users, patients on hormone replacement therapy, and patients taking antidepressants, herbal supplements, and pain medications. 

In addition, there was clearly a higher incidence of anxiety in patients with BII.  Hopefully there will soon exist a validated questionnaire that could more accurately predict patients who were at the highest risk of developing BII/SSBI symptoms, but this does not yet exist.

In summary, it is clearer now than ever that BII/SSBI patients do have real symptoms, but these symptoms need to first be carefully evaluated to identify any medical cause.  So far, impressive in-depth research has not been able to identify an actual scientific link between the actual implant and the SBB/SSBI symptoms.  Nonetheless, if no medical explanation can be found, patients who would like to have their implants removed should not be discouraged from doing so. 

If a patient chose to have the implants placed, she can obviously choose to have them removed.  Although the reasons are not clear, the majority of patients with BII/SSBI symptoms will see improvement in many of their symptoms after implant removal, and this improvement has been shown to be long-lasting. This improvement is the same whether the implant removal surgery is an “en bloc” capsulectomy, a total capsulectomy, or even a partial capsulectomy.  Therefore, it is reasonable to leave some capsule behind if doing so is overall safer for the patient.  

Hopefully this update on the current state of understanding of BII/SSBI will help empower women with more facts and useful information.  Whether considering placing or removing implants, understanding BII/SSBI can help patients make the most informed decisions.