DR. EPSTEIN’S COMPREHENSIVE Breast Augmentation Guide

Intro to Breast Augmentation

Five key decisions you need to make

One-Day Recovery Breast Augmentation

Anesthesia – General, Sedation or Local?

Breast Lift/Mastopexy

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

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Breast Implant Illness

Breast implant illness has been a controversial topic for several decades. I wish to review the current 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.” 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.

Properly conducted research and clinical studies follow strict methodology to make certain that the conclusions drawn from the data presented are correct to a high level of probability. There are no such studies that prove that breast implant illness is a real entity. There are also no studies that prove that it is not a real disease, either. 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.

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.

The following is a synopsis of the article “Silicone Implant Illness: Science Versus Myth, written by Rohrich, Kaplan and Dayan, and published in Plastic and Reconstructive Surgery this year. (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.

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:

  1. 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.
  2. 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).
  3. 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). There was no signficant difference between the two groups.
  4. 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.
  5. 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:

  1. 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
  2. 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
  3. 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
  4. 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

So Where Are We At Now?

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 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)

Updated: September 8, 2023

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

  1. The self-described BII cohort reported statistically significantly higher symptoms at baseline from the two control cohorts.
  2. 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.
  3. 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.
  4. 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
  5. 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

  1. Breast implants are not lifetime devices and require regular follow-ups with your plastic surgeon.2
  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
  3. 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.
  4. 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.
  5. Patients should seek out board-certified plastic surgeons for any concerns with their breast implants.

REFERENCES

  1. Magnusson MR, Cooter RD, Rakhorst H, et al. Breast Implant Illness: A Way Forward. Plastic and Reconstructive Surgery. 2019; 143(3S): 74S–81S
  2. https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
  3. https://www.healingbreastimplantillness.com/explant/ accessed 5/2/2023
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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.
  9. 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
  10. 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
  11. 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
  12. 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

 

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 some of my daughters have silicone gel implants. We are all very comfortable with the long term safety profile of such devices.

 

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