Breast implant illness has been a controversial topic for several decades. I wish to review the current and evolving base of knowledge and opinion regarding the safety of silicone breast implants. The reason that silicone gel breast implants are currently available is that scientific evidence strongly supports the safety of these devices. It is the patient’s decision to obtain, keep, or remove breast implants. Should you decide to have your breast implants removed, then you will be best served by consulting with a board-certified plastic surgeon with expertise in breast surgery. Breast implants are the most thoroughly studied medical devices in history, and the desire and need to continue this research continues to this day. Research continues to look for any connection to cancer and autoimmune disorders, to make certain that breast implants are safe. Patient education and awareness are also extremely important to make certain that correct information is disseminated.
There is a lot of information on the internet concerning an entity called “breast implant illness” or “silicone implant illness.” This includes "junk science" and social media. The best definition of junk science that I could find is "Junk science has been defined as: "science done to establish a preconceived notion—not to test the notion, which is what proper science tries to do, but to establish it regardless of whether or not it would hold up to real testing." There is a great deal of content on social media that aligns with this as well. The problem is that there are those that have their own opinions, and while they are entitled to these opinions, they have not been scientifically tested using what is called "scientific method" which is the framework upon which all scientific studies are conducted across many disciplines, not just medicine.
There are numerous reports of women who have a vague constellation of symptoms that seem to get better when they had their implants removed. Unfortunately, this type of evidence is not conclusive proof of this disorder, or any other disorder. This is especially true since there have been over 500 symptoms thought to be related to breast implants. How many disease states can you think of that have 500 symptoms? How about 50? 20? None I can think of!
Breast Implant Illness (BII) is a term used to describe a cluster of systemic symptoms reported by some individuals with breast implants, though it is not a formal medical diagnosis and has no specific tests for it. Symptoms can include chronic fatigue, brain fog, joint and muscle pain, rashes, and anxiety. While some people report improvement after removing their implants, the cause and exact relationship between BII symptoms and implants are still unclear, and research is ongoing to better understand the condition.
While one could consider breast implant illness a clinical entity because there are symptoms, there are no properly conducted scientific studies in a peer reviewed journal that I am aware of that shows any causal relationship between breast implants and the myriad of symptoms that have been attributed by some to these devices. While this might not make sense on the surface, the mere reporting by individuals that state that their symptoms were relieved by removal of breast implants unfortunately is not adequate proof that breast implant illness is real. Current clinical research is suggesting that there may be a "Nocebo effect", which is like the opposite of a "placebo effect." The placebo effect is that if you are ill and you take a pill that unbeknownst to you does not contain any therapeutic agent, but you get better anyway because you believe that pill has medicinal properties and will get you better. The nocebo effect is when you have something inside of you that you believe is making you ill and the mere removal of it makes you feel better.
I am not presenting this information to defend silicone implants. Rather, I am trying to provide the most up to date scientific evidence to educate my patients and website visitors. You can draw your own conclusions from the material that follows.
Silicone breast implants are used in nearly 300,000 breast augmentation and 100,000 breast reconstruction operations annually in the United States.[1] Silicone gel-filled implants were first approved by the U.S. Food and Drug Administration in 1962. Since that time, few medical devices have been studied as closely for their safety and associated adverse outcomes. Despite multiple generations of implant shells and gel fillers, the basic components remain as originally designed.[2,3]
Silicone breast implants are used in 300,000 breast augmentations and 100,000 breast reconstructions every year in this country. The very first breast implants were approved by the FDA (Food and Drug Administration) in 1962. There have been substantial improvements in silicone technology and the resulting breast implants since the first ones were created. There are no medical devices subjected to as much scientific study as breast implants.
During the 1980’s and early 1990’s, concern grew as to the safety of breast implants, eventually culminating in a moratorium on silicone breast implants. The FDA opened the door towards re-approval of these devices but required properly controlled scientific studies to document the safety of these implants AND post approval studies to monitor these devices carefully to fully ensure breast implant safety. In 2006, silicone breast implants were approved once again.
One good source for information regarding the safety of breast implants is obtained from epidemiological studies between two groups of women who have and do not have implants. With this type of study, one can then draw accurate conclusions as to whether certain disease processes occur more frequently in those women with (or without) implants. These studies are much more scientifically meaningful in terms of drawing an accurate conclusion than case reports of individual or small groups of women. The latter are not scientific studies and as such are not as reliable
To explain this a little better, here is the "Hierarchy of Levels of Scientific Evidence":
| Level | Type of evidence |
|---|---|
| I | Large random controlled trials with clear cut results |
| II | Small random controlled trials with unclear results |
| III | Cohort and case-control studies |
| IV | Historical cohort or case-control studies |
| V | Case series, studies with no controls |
As you can see by the above table, case reports and small groups of patients are at the bottom of the hierarchy of evidence, and conclusions as drawn from such are the least reliable.
Although this book is a bit dated, Appendix 2 and Appendix 3 of The Best Breast 2, written by John and Terrye Tebbetts, summarize several early but very important epidemiological studies.
(Dr. Tebbetts is my mentor who in 1994 taught me the principles and technique of performing a breast augmentation with a 24 hour recovery). Although some of the concepts in this book have changed due to improvements in silicone gel implants, I would encourage you to read his book and familiarize with the concepts presented, especially as they relate to selection of implant size – this way we will be “on the same page” at consultation time. You can find the book here. The book is a little dated (2008), but many of the concepts still hold true today. These epidemiological studies conclude the following:
- There is no connection between breast implants and breast cancer.
- Women with breast implants who do get breast cancer are not delayed in their diagnosis of breast cancer and are not diagnosed at a further stage of breast cancer than women without implants.
- There is no proven connection between breast implants and connective tissue disorders such as lupus and scleroderma.
Review Article on Breast Implant Illness (2019)
The following is a synopsis of the review article “Silicone Implant Illness: Science Versus Myth, written by Rohrich, Kaplan and Dayan, and published in Plastic and Reconstructive Surgery in 2019. (Plast Reconstr Surg. 2019;144(1):98-109.) This is the first article I have ever read that addresses this issue so comprehensively and without bias:
Cancer
Numerous scientific studies have been published with none showing any evidence that patients with silicone implants have an increased risk of developing cancer or any kind. A very large study examining long-term safety of women with Natrelle round silicone gel-filled breast implants was conducted by multiple investigators at many difference medical centers was published in 2017. The study population of 55,279 women showed no excess risk for any cancer diagnoses including brain, cervical/vulvar, lung, or breast cancer.
Anaplastic Large Cell Lymphoma
Several reports in the medical and scientific literature have suggested a possible connection between textured breast implants and a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL). A textured implant is a type of breast implant that can be filled with either saline or silicone, and has a roughened surface externally which has been created for the purpose of keeping the implant from shifting within the breast, as well as to reduce the risk of capsule contracture (a benign condition of the breast where the normal scar tissue capsule that forms around all breast implants suddenly becomes thick and tightens around the implant, making the breast feel hard). A 2018 FDA update reported 414 such cases of ALCL in the U.S. The risk of developing ALCL is thought to vary somewhere between 1 in 3800 to 1 in 30,000 women with textured implants. Although some deaths have occurred due to ALCL, it is felt that many of these were early in the study of this illness where the disease process was not yet understood, or, in the case where women did not seek medical attention early and the disease progressed unchecked. ALCL is NOT breast cancer, but rather is a malignancy that forms in the scar tissue capsule that forms around all breast implants. Note that there are no reported cases of ALCL in women who have only had smooth surface breast implants. There is additional information on ALCL on this website can be found here.
Connective Tissue Disease
Numerous studies seeking to determine whether or not there is an association between silicone breast implants and connective tissue disease have failed to prove a connection between the two.
Mental Health
There has been no study to show an association between silicone breast implants and suicide nor depression.
Neurologic Disease
There have been numerous case reports that patients with silicone breast implants who had subsequently developed various neurologic symptoms or disorders. This is not evidence enough to demonstrate an association between silicone implants and these disorders. These conditions included multiple sclerosis, “multiple sclerosis type syndrome,” both motor and peripheral neuropathies, and “atypical neurologic disease syndrome.” There has been no studies to date which show a connection between silicone implants and these neurologic disorders.
Offspring Effects
Early case reports of isolated adverse health outcomes in children born to mothers with silicone breast implants were published in the 1990’s. Such conditions included difficulty swallowing, irritability, nonspecific rashes, and fatigue, among other symptoms. Subsequent studies have failed to demonstrate any relationship between silicone breast implants and these disorders.
Recently Published Research
Resently published work by a team of plastic surgeons and other scientists published a four part study looking at the following:
- The impact of type of capsulectomy performed on the improvement of symptoms following removal of implants in women with systemic symptoms requesting removal of their implants. The findings demonstrated that the type of capsulectomy performed had no bearing on the relief of symptoms after implant removal.
- In the same group of women as in the first study (Group A), the capsule specimens were examined and compared to women who underwent the procedure with no system symptoms (Group B) and also to women who underwent cosmetic breast lift with no history of implants (Group C) to determine if there were increased amounts of heavy metals in the tissue of the women in Group A. The findings concluded that there was not a significant risk of heavy metal exposure from breast implants, whether they are saline or silicone. With some heavy metals, the findings showed lower levels of heavy metals in the breast implant group (A and B) capsules then in the breast tissue of patients who never had breast implants (C).
- The next study looked at the blood levels of inflammatory markers and other blood tests, the presence of bacteria in the capsules, and other identifiable biomarkers in those women requesting removal of their implants with systemic symptoms (Group A) and those without systemic symptoms (Group B). The findings concluded that there was no signficant difference between the two groups.
- The last study looked at the longevity of symptom improvement after implant explantation. The first three studies concluded that Group A (systemic symptoms) patients do experience symptom improvement after explantation, regardless of the type of capsulectomy. The improvement was sustained through 1 year of follow-up. Biospecimen findings did not differentiate Group A patients who self-reported systemic symptoms from the two control groups B and C. A PROMIS Global Health questionnaire was used. This is a carefully standardized psychometric instrument which measures the individuals global health. Analysis of the systemic symptoms and validated PROMIS questionnaires demonstrated a statistically significant difference between the BII cohort Group A and control cohorts Groups B and C, including higher anxiety levels and a greater number of systemic symptoms at baseline, which improved after implant removal. The consistent similarities between the non-BII implant cohort Group B and the mastopexy cohort Group C controls with respect to systemic symptom reporting and PROMIS data at all time points demonstrates that breast implants do not cause a harmful reaction in all patients. Explantation of breast implants by any method may generate long lasting improvement in anxiety and self- reported systemic symptoms. The power of negative expectations is also evidenced by the nocebo effect, in which a treatment with no therapeutic value can cause unpleasant physical symptoms based entirely on a patient’s expectations. The negative expectations held by females with BII (Group A) about the impact of their implants on their health may contribute to their symptoms. Explantation surgery removes the object of the negative expectations and could result in the BII symptom improvement seen in the current study. Placebo is defined as an inert substance that provokes perceived benefits, whereas the term nocebo is used when an inert substance causes perceived harm. Therefore, removal of the inert substance that is perceived to cause harm is removed, the patient feels subjectively better.
- The last study looked at symptom improvement if no capsulectomy at all was performed. This study demonstrated that there was no statistically significant difference in symptom improvement.
References:
- Glicksman C, McGuire P, Kadin M, Lawrence M, Haws M, Newby J, Ferenz S, Sung J, Wixtrom R. Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 1. Aesthet Surg J. 2022; 42(7): 809–819; https://doi.org/10.1093/asj/sjab417
- Wixtrom R, Glicksman C, Kadin M, et al. Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings From the Systemic Symptoms in Women – Biospecimen Analysis Study: Part 2. Aesthet Surg J. 2022; 42(9): 1067–1076; https://doi.org/10.1093/asj/sjac106
- McGuire P, Glicksman C, Wixtrom R, et al. Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 3. Aesthet Surg J. 2023; 43(2): 230–244; https://doi.org/10.1093/asj/sjac225
- Glicksman C, McGuire P, Kadin M, Barnes K, Wixtrom R, Lawrence M, Haws M, Ferenz S, Sung J, Hamilton R, Faasse K. Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 4. Aesthet Surg J. 2023; https://doi.org/10.1093/asj/sjad098
Position Statement by Multiple Societies (2023)
A position statement was issued September 2023 by the International Society of Aesthetic Plastic Surgery (ISAPS) and The Aesthetic Society, as well as The Aesthetic Surgery Education and Research Foundation (ASERF). This was also endorsed by numerous international plastic surgery societies. It appears in its entirety below:
Patient Safety Advisory - Breast Implant Removal and Capsulectomy
Joint Safety Statement of the International Society of Aesthetic Plastic Surgery (ISAPS), The Aesthetic Society, and The Aesthetic Surgery Education and Research Foundation (ASERF)
Endorsed by: Arab Association of Surgical and Medical Aesthetics (AASMA), Association of Medical Specialists in Plastic, Reconstructive and Aesthetic Surgery (AMECPRE) of Costa Rica, Australasian Society of Aesthetic Plastic Surgeons (ASAPS), Brazilian Society of Plastic Surgery (SBCP),The British Society of Aesthetic Plastic Surgeons (BAAPS), Canadian Society of Plastic Surgeons (CSPS), Canadian Society for Aesthetic Plastic Surgery (CSAPS), Emirates Plastic Surgery Society (EPSS), French Society of Plastic Aesthetic Surgeons (SOFCEP), Association of German Aesthetic Plastic Surgeons (VDÄPC), Indian Association of Aesthetic Plastic Surgeons (IAAPS), Iranian Society of Plastic and Aesthetic Surgeons (ISPAS), Israel Society of Plastic & Aesthetic Surgery (ISPAS), Italian Association of Aesthetic Plastic Surgery (AICPE), Korean Society for Aesthetic Plastic Surgery (KSAPS), Mexican Association of Plastic, Aesthetic and Reconstructive Surgery (AMCPER), Norwegian Society for Aesthetic Plastic Surgery (NSAPS), and The Spanish Association of Aesthetic Plastic Surgery (AECEP)
There has been a worldwide increase in the number of patients requesting implant removal for a variety of systemic symptoms that they attribute to their implants. This has been referred to as Silicone Incompatibility Syndrome (SIS), Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA), and Breast Implant Illness (BII).1 In the US, the Food and Drug Administration (FDA) has included systemic symptoms in a box warning that is required for all implants sold in the US which states, “Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for the development of these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.”2
Patients with self-described symptoms request removal of the implant and capsule, “en bloc”. Their concern is that toxins from the implant, such as heavy metals, including platinum, silicone, and/or bacteria and fungus, could be in the capsules and failure to remove the capsule would leave toxins behind and could preclude symptom improvement. For that reason, they seek out surgeons who guarantee total en bloc capsulectomy and this is perpetuated on some social media sites as well as by surgeons who promote themselves as “explant experts”.3
What We Know
- Systemic symptoms patients attribute to their breast implants have been reported with all types of implants: saline and gel filled, smooth and textured surfaces, and has been reported with implants from every manufacturer.
- Over 100 symptoms have been reported, in no specific configuration.
- Some patients will experience symptom improvement with implant removal.
What Is the Data?
The Aesthetic Surgery Journal has published four papers from an ASERF-funded study, “Systemic Symptoms in Women – Biospecimen Analysis Study.” This study, with Drs. Caroline Glicksman and Patricia McGuire as principal investigators, is the first prospective, blinded study comparing women with self-described BII to two control groups. The study evaluated symptom surveys, NIH-validated patient-reported outcome measures, and biospecimens (peripheral blood and implant capsules) for consistent, objective, measurable differences between the symptomatic cohort and the two control groups (women with implants without systemic symptoms they attribute to their implants, and women undergoing cosmetic mastopexy who have never had any implanted medical device) which could be used to make a diagnosis or point to a cause of symptoms in these patients.4–7
- The self-described BII cohort reported statistically significantly higher symptoms at baseline from the two control cohorts.
- The BII cohort experienced rapid symptom improvement after implant removal which was sustained through one year of follow-up. The symptom improvement was independent of whether part or all the capsule was removed. There was no statistical difference in reported symptoms between the two control groups at any time point.
- There was no measurable difference in the biospecimens between the cohorts including heavy metals testing and next generation sequencing (PCR) for bacterial and fungal DNA of the implant surface or capsule.
- Recently presented data from a parallel study in Australia, with Drs. Anand Deva and Mark Magnusson as principal investigators, has shown similar results with symptom improvement after implant removal, independent of the type of capsulectomy performed.8
- A study by Byrd and Nissen in the Netherlands prospectively followed patients undergoing implant removal and showed that symptom improvement occurred even with no capsule removed in subjects with no other indication for capsulectomy.9
Terminology Is Important
- The term en bloc describes a procedure for malignancy where a tumor is removed with a margin of uninvolved tissue. This term should not be used for a capsulectomy performed in the absence of malignancy.10
- The often self-reported term BII implies a causation by breast implants when there is currently no direct evidence of causation, only a potential association. A more accurate characterization would be to use the term “Systemic Symptoms Associated with Breast Implants (SSBI)”.
What Does This Mean for Plastic Surgeons and for Our Patients?
As board-certified plastic surgeons, we should practice evidence-based medicine. The absolute indication for en bloc capsulectomy is removal of an implant and capsule in the presence of capsular malignancy. Relative indications for total capsulectomy are capsular contracture, rupture of a gel implant, and possibly with removal and exchange of textured implants. There is currently no good peer-reviewed evidence that capsulectomy is required for symptom improvement in the absence of other indications. Patient preference may be considered with appropriate informed consent. Capsulectomy is a more invasive procedure, may be more expensive, and may carry higher risks.
- Surgeons who state that en bloc capsulectomy is required for symptom improvement should not do so without the scientific data to support their claims and potentially violate ethical standards, as it could lead patients to undergo surgical procedures that may not be indicated.11
- Surgeons promoting themselves as “explant experts” who have no additional training or other basis to deem them more of an expert than other board-certified plastic surgeons, should cease marketing themselves as such.
- Surgeons should keep abreast of scientific knowledge (AMA Principles of Medical Ethics).
- Surgeons should not falsely represent a skill set; The Aesthetic Society Code of Ethics Section 3.01, B.14.: Claiming superiority in skills or services, including superiority due to the member’s gender or ethnicity, which claims cannot be easily and factually substantiated by patients.
SSBI remain a diagnosis of exclusion so patients should have an appropriate medical evaluation to rule out other causes prior to surgery. Patients should be given educated choices using up-to-date, scientific data including removal of their implants with or without capsulectomy with the risks and benefits fully explained. It is likely patients will see at least partial symptom improvement after implant removal and their improvement may occur with partial capsulectomy, or no capsulectomy. Further prospective research is necessary, and guidance may change as more data becomes available.12
Safety Information for Patients
- Breast implants are not lifetime devices and require regular follow-ups with your plastic surgeon.2
- Implant integrity should be evaluated with high-resolution ultrasound (HRUS) or MRI five years after implant placement and every 2–3 years after.2
- Any persistent symptoms that occur in patients with breast implants should be evaluated for other medical diseases prior to consideration of undergoing implant removal surgery.
- For patients who develop symptoms that they attribute to their breast implants, if no other cause is found, it is likely that they will see at least partial symptom improvement after implant removal. The symptom improvement may occur with no or partial capsulectomy which is a procedure that is less invasive, less expensive and may carry lower risk.
- Patients should seek out board-certified plastic surgeons for any concerns with their breast implants.
REFERENCES
- Magnusson MR, Cooter RD, Rakhorst H, et al. Breast Implant Illness: A Way Forward. Plastic and Reconstructive Surgery. 2019; 143(3S): 74S–81S
- https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
- https://www.healingbreastimplantillness.com/explant/ accessed 5/2/2023
- Glicksman C, McGuire P, Kadin M, Lawrence M, Haws M, Newby J, Ferenz S, Sung J, Wixtrom R. Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 1. Aesthet Surg J. 2022; 42(7): 809–819; https://doi.org/10.1093/asj/sjab417
- Wixtrom R, Glicksman C, Kadin M, et al. Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings From the Systemic Symptoms in Women – Biospecimen Analysis Study: Part 2. Aesthet Surg J. 2022; 42(9): 1067–1076; https://doi.org/10.1093/asj/sjac106
- McGuire P, Glicksman C, Wixtrom R, et al. Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 3. Aesthet Surg J. 2023; 43(2): 230–244; https://doi.org/10.1093/asj/sjac225
- Glicksman C, McGuire P, Kadin M, Barnes K, Wixtrom R, Lawrence M, Haws M, Ferenz S, Sung J, Hamilton R, Faasse K. Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Findings From the ASERF Systemic Symptoms in Women – Biospecimen Analysis Study: Part 4. Aesthet Surg J. 2023; https://doi.org/10.1093/asj/sjad098
- Deva A. Personal Communication – Scientific Presentation, The Aesthetic Meeting 2023, Miami. Breast Implant Illness: Where Do We Stand Now. Sunrise Session; Annual Meeting of The Aesthetic Society, Miami Beach, FL, May 2, 2023.
- Bird GR, Niessen FB. The Effect of Explantation on Systemic Disease Symptoms and Quality of Life in Patients With Breast Implant Illness: A Prospective Cohort Study. Sci Rep. 2022; 12(1): 21073; https://doi.org/10.1038/s41598-022-25300-4; PMID: 36473891; PMCID: 29 PMC9726875
- Tanna N, Calobrace MB, Clemens MW, Hammond DC, Nahabedian MY, Rohrich RJ, Zhang BH, Bregman D, Perry AD. Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery. Plastic and Reconstructive Surgery. 2021; 147(4): 808–818; https://doi.org/10.1097/prs.0000000000007784
- Gerzenshtein J. The Dishonesty of Referring to Total Intact Capsulectomy as “En Bloc” Resection or Capsulectomy. Plastic and Reconstructive Surgery. 2020; 145(1): 227e–228e; https://doi.org/10.1097/prs.0000000000006362
- McGuire P, Clauw DJ, Hammer J, Haws M, Adams Jr WP. A Practical Guide to Managing Patients With Systemic Symptoms and Breast Implants. Aesthet Surg J. 2022; 42(4): 397–407; https://doi.org/10.1093/asj/sjab375
Psychological Components of Breast Implant Illness (2025)
Some women who truly believe that their breast implants have made them ill might be very offended by this, but again, this is scientifically collected and analyzed data. A recent study published in the Aesthetic Surgery Journal showed an 18 times higher rate of Somatic symptom disorder in BII vs controls (no breast implant illness symptoms) using 10 validated psychological tests. They have negative affect, catastrophizing and symptom amplification. They were higher in all of the psychiatric domains tested.
A Meta-analysis is a study where other published articles are reviewed so as to draw a conclusion upon the aggregate data in all the studies. The problem with this approach is that published studies can vary greatly in the quality of the data, how it is analyzed and the conclusions drawn. The authors of a meta analysis can even “select” which studies they want to include to fit their own narratives, and although this should not be done, this is human nature sometimes. I think that in this meta analysis, some important studies might have been included but where not. Even with this, the authors do conclude that BII (breast implant illness) is more likely to be psychological than biological. It really doesn’t contradict what we are saying for the reasons outlined below.
The 2025 paper by Ferriera from the aesthetic journal has been getting a lot of attention in the BII groups and advocates have been posting this as “definitive proof of BII as a clinical entity” saying that this shows that BII deserves a ICD-10 diagnosis code. We already know that systemics symptoms associated with implants is a clinical entity, but there are no biological markers or other diagnostic criteria and thus BII remains a diagnosis of exclusion.
For those of you who are very passionate about this topic and what more information, I will add the following:
The paper is a meta analysis where of 3600 published articles on BII, only 175 were reviewed with 36 included in the review from 33 studies (the 4 papers from Glicksman/McGuire were combined to one). Only 7 were prospective and only 3 had control groups. Prospective studies are in most cases superior to retrospective studies, especially here because in the former patients are followed after breast augmentation surgery to see if they develop symptoms of BII, and retrospective studies start with patients who have symptoms and look backwards, making it very difficult to determine incidence of the problem. Control groups are a comparative group of patients who did not undergo breast augmentation but are looked at comparatively for the development of symptoms. For instance, if you had a study to see if “pill A” causes headaches, you would study those who took pill A and those who did not to see the incidence of headaches in both groups. If the incidence is similar, them it is unlikely that pill A causes headaches.
Ferreira noted 20% of BII patients self reported autoimmune disease and a positive ANA in 24% as an indication of silicone induced autoimmune disease. Rheunatologists often don’t even look at ANA anymore because ANA can be up and down at any time and in the absence of other markers, they do not find it useful as an incidental finding. 20% of the normal population has an positive ANA at some point.
Ferriera suggested biofilms as a cause because of growth of cutibacteria and staph epi in 36% of BII subjects. The problem is that there is no controls group. Using PCR (polymerase chain reaction – allows you to detect and analyze tiny amounts of DNA) Glicksman, et al found 48% of BII subjects has positive PCR in the capsule or the surface of the implant, but 47% of non-BII subjects had positive PCR and there was not a difference in symptoms and symptom improvement between the patients with and without positive PCR. Other investigators have come to the same conclusion that biofilms are likely not involved.
Ferriera cites rupture and capsular contracture as a cause because 28% of BII patients were ruptured and 44% had cap con. The Glicksman study showed cap con was not higher in the BII cohort, they saw a higher incidence of cap con, rupture, and textured implants in their control subjects.
Ferriera stated 70% of patients had gel implants that is the indication that gel is involved, but the majority of implants used in the world are gel. In the Glicksman study it was statistically more saline than gel in the BII cohort. Ferriera stated that saline implants have silicone in the shell, so it could still be a cause of symptoms, but Alain Danino’s study showed no silicone particles in the capsules of patients with saline implants where gel implants (except Motiva) have millions of particles, even with intact implants.
Ferreira cited the Glicksman study showing higher levels of Il-13, Il-22, Il-17 in the BII cohort vs controls as evidence of an immune response, but don’t mention that this was in 6 of 50 subjects and all had confounding variables.
Ferriera stated “Glicksman, et al emphasized that synovial metaplasia is a marker in an immune response”, which they did, but fails to mention that was when Glicksman discussed how synovial metaplasia was higher in the non-BII cohort associated with textured surface implants.
Ferreira stated that “the proposition that anxiety or depression and subsequent somatization may contribute to BII symptoms with psychological amplification playing a more significant role that an direct biological reaction to implants has been postulated by many authors and is aligned with the findings of this review” which is in line with Glicksman’s most recent study showing that the BII subjects were 18 times more likely to fully meet the criteria for somatic symptom disorder than controls, had statistically significantly higher incidence of negative affect, catastrophization, and symptom amplification.
Ferreira’s article doesn’t really say anything new, but it does suggest that BII is a clinical entity, which we already know. We know that some patients with implants develop a wide variety of symptoms and that most will get better with implant removal. There is currently no direct evidence of a direct biological cause of symptoms and that there are significant contribution of neuropsychiatric factors. Ferreira does state that the symptom improvement occurs with our without capsulectomy. It goes on to state that there is strong evidence of a link between implants and inflammatory, autoimmune, microbial factors (for which there is no evidence anywhere in this paper to support this) and also acknowledges the psychological and somatization component and the negative impact of social media especially for patients with underlying psychiatric disorders and somatization. They say that social media amplifies patient’s concerns, reinforcing shared experiences that could contribute to symptom manifestation. They say that the on line groups increase anxiety, symptom awareness and spread misinformation, which is true.
So those who are promoting this paper as definitive proof that implants are essentially poisonous and are the direct cause of symptoms either did not fully read the paper or didn’t understand what they were reading.
REFERENCES
- Glicksman C, McGuire P, Barnes K, Shedden-Mora M, Faasse K, Systemic Symptoms Associated With Breast Implants: A Psychological Study of Beliefs and Emotions, Aesthetic Surgery Journal, 2025;, sjaf125, https://doi.org/10.1093/asj/sjaf125
- Ferreira, S, Barros A, Marques M, Breast Implant Illness: Symptoms, Outcomes with Explantation and Potential Etiologies-A Systematic Review and Meta-analysis, Aesthetic Plas Surg. 2025 Aug 11. doi: 10.1007/s00266-025-05142-x.
Conclusions
Few medical devices have undergone the degree of scrutiny and scientific investigation to ensure safety that silicone breast implants have. Currently, there is overwhelming evidence supporting the safety of silicone breast implants. It is up to the patient to decide if they want to keep, remove or replace their textured breast implants with a smooth device. If a patient chooses to have her breast implants removed, it is important to find a board-certified plastic surgeon with expertise in breast surgery. If a patient chooses to have implants removed, the performance of a capsulectomy should be discussed with her physician. In cases of ALCL or ruptured implants with thick calcified capsule, a total capsulectomy is recommended.
Studies should continue to collect and analyze data from silicone gel implant patients. However, the current state reveals that there are numerous scientifically sound studies in the medical literature that do not demonstrate any connection between silicone breast implants and "breast implant illness."
The reader might feel that I am biased and presenting only information that absolves silicone gel filled implants from any connection to any disease process. However, I also have some "skin" in this game. My spouse and two of my daughters have silicone gel implants. We are all very comfortable with the long term safety profile of such devices.
Updated September 2025
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Sections - BII - ALCL
Chapters – Breast Augmentation Guide
- Intro to Breast Augmentation
- Preservation Breast Augmentation – A New Era!
- Motiva Implants – What You Need to Know
- Five key decisions you need to make
- One-Day Recovery Breast Augmentation
- Anesthesia – General, Sedation or Local?
- Breast Lift (Mastopexy) with/without Implants or Fat
- What else should I know about breast augmentation?
- Important Things to Consider When You Decide to Move Forward With Breast Augmentation
- Revision of breast augmentation
- ALCL and Breast Implant Illness
Questions on Breast Implant Illness?
If you have any questions or concerns, we encourage you to contact our office at 631.689.1100. Our office proudly serves Hauppauge, LI, and surrounding areas.
