Systemic Symptoms Associated With Breast Implants (SSBI): Current Evidence Shows Benefit of Implant Removal With or Without Capsulectomy

Great discoveries and improvements invariably involve the cooperation of many minds.

—Alexander Graham Bell¹

The association of breast implants with systemic symptoms has its origins in the mid-1950s, when both animal and human studies linked a variety of adjuvants to the development of autoimmune-like disease.² These adjuvants included inert materials such as silicon dioxide, beryllium, aluminum, as well as bacterially derived antigens (Staphylococcus, Nocardia, Salmonella, and Mycobacterium), and the resulting condition was termed adjuvant disease.² In the early 1980s, case reports accumulated in both Australia³ and the United States⁴ of women presenting with autoimmune-like disease following exposure to silicone breast implants, and this was taken as evidence that silicone exposure resulted in adjuvant disease. Although large population studies and meta-analyses refuted the association,⁵ there has been in recent years an increase in the number of women reporting a broad range of systemic symptoms, arising some years following breast implant insertion. The published literature evaluating these patients for potential causes is mostly retrospective, and consists of small case series with no long-term follow-up and no control groups.^6-9 More recently a number of large prospective studies have been initiated which are closely examining and documenting presentation, clinical and pathological workup, and outcomes following implant removal with and without capsulectomy, as well as analyzing biological samples from implants and capsules in the laboratory. At this point, prospective studies out of the United States,¹⁰ Australia,¹¹ and Europe¹² have reported their findings and it is thus timely that we summarize the evidence to date and outline pathways for further research.

THE DIAGNOSIS OF SYSTEMIC SYMPTOMS ASSOCIATED WITH BREAST IMPLANTS (SSBI) IS ONE OF EXCLUSION

Patients with systemic symptoms associated with breast implants (SSBI) often present requesting implant removal/capsulectomy following extensive medical evaluation. It is important to ensure that these patients undergo a thorough clinical evaluation to exclude underlying nutritional, iron, and vitamin deficiency, thyroid problems, renal disease, hormone imbalance, and/or active autoimmune disease. Table 1 summarizes the suggested workup.

Table 1.

Workup for Systemic Symptoms Associated With Breast Implants to Exclude Other Underlying Inflammatory Conditions or Deficiency

Workup items
Full blood count
Glucose (not fasting)
Urea, electrolytes, creatinine
Liver function tests
Coagulation screen
C-reactive protein, erythrocyte sedimentation rate
Thyroid function tests
Serum immunoglobulins
Iron studies, ferritin
Autoimmune disease markers (anti–nuclear antibody, anti–neutrophil cytoplasmic antibody, anti–double-strand DNA, anti–Sjögren's syndrome A, anti–Sjögren's syndrome B, rheumatoid factor, anti–ribonucleic acid protein, anti-smooth muscle, anti–scleroderma antibodies, anti–tissue transglutaminase)
Vitamin D
Vitamin B12, folate

REDUCED SYMPTOMS OF SSBI PATIENTS FOLLOWING CAPSULECTOMY

Patients with SSBI are likely to experience a reduction in both the number and severity of systemic symptoms following implant removal with total/partial or no capsulectomy that is sustained for at least 6 months and likely to persist for up to 12 months

Six-month follow-up data from Australia/Europe and 12-month follow-up data from the United States now show conclusively that women with SSBI who undergo implant removal with total, partial, or no capsulectomy experience a reduction in both the number and severity of their systemic symptoms.^10,11,13

BENEFIT IS SEEN FOR TOTAL AND PARTIAL CAPSULECTOMY AS WELL AS FOR NO CAPSULECTOMY

All studies report that this postsurgical benefit is independent of whether a total or partial capsulectomy was performed.^10-13 In addition, results from the prospective trial by Bird et al¹² and a “no capsulectomy” study (P. MacGuire and C. Glicksman, personal communication, April 22, 2023) show similar outcomes in reduction of symptoms at 6 months post–implant removal with no capsulectomy. Table 2 suggests the terminology to accurately describe the type of capsulectomy performed. Uniformity in documentation for the type of capsulectomy performed will aid in further comparative analysis.

Table 2.

Capsulectomy in Systemic Symptoms Associated With Breast Implants

Type	Description
Total capsulectomy	With implant intact With implant removed separately
Partial capsulectomy	Document portion of capsule removed, ie, anterior, posterior, superior, inferior
No capsulectomy	Capsulotomy with implant removal ± capsular sampling

THERE IS NO INDICATION FOR THE USE OF THE TERM EN BLOC CAPSULECTOMY IN THE SETTING OF SSBI

The absolute indication for performing an en bloc capsulectomy is in the setting of a confirmed malignant tumor arising from a breast implant capsule and in the concurrent removal of the contralateral implant/capsule. A total capsulectomy is preferred when there is associated rupture of a gel implant, or capsular contracture, and may be considered in the presence of a textured implant if it can be performed safely. Patients should be informed of the relative risks and benefits of the type of capsulectomy or the option of no capsulectomy in order to make an informed and educated choice. A recent joint statement from The Aesthetic Society/International Society of Aesthetic Plastic Surgery has further warned against the use of unsubstantiated claims by “experts” who continue to advocate en bloc capsulectomy for SSBI, adding to anxiety in vulnerable patients and putting these patients at unnecessary risk.¹⁴

FUTURE DIRECTIONS

It is important that we continue to accumulate robust prospective clinical and research data on patients who present with SSBI. Both colleagues and patients are encouraged to utilize standardized and validated data-collection resources in women presenting with SSBI and collaborate and contribute to building a larger evidence base. For Australian contributors and patients, enrolment can be found through our study page.¹⁵

Early findings suggest that strong psychological drivers are involved.^13,16,17 These may have been present prior to having breast implant surgery and be heightened by constrained choices, disempowerment, and lack of informed and educated consent.¹⁸ Psychological symptoms and personality can contribute to the development and amplification of systemic (physical) symptoms.¹⁸ Further research into this is being conducted in collaboration with psychology and neurophysiology, and utilizing biometric technology, including functional MRI.¹⁹ A prospective study of women seeking to undergo cosmetic breast augmentation and funded by The Aesthetic Society Education Research Foundation could help to further define patients who are at higher risk of subsequently developing SSBI.

There is some conflicting evidence around the role of possible inflammatory drivers^11,20-23 and this will require more detailed analysis of both preoperative blood and biological/implant specimens obtained at surgery. We are currently seeking grant funding to support this research.

The role of shared decision-making, informed educated consent, empowered choices for selecting breast implants (over other options), and ongoing lifelong surveillance following breast implant insertion form part of good practice when assessing women presenting for breast implant surgery. A clear discussion about the risks and benefits of implant removal and the type of capsulectomy offered for women with SSBI is now possible based on good prospective data and clinical evidence.

As board-certified plastic surgeons, we believe that best practice should always be guided by robust evidence. We remain committed to ongoing study of SSBI and will update clinical advice for both assessment and treatment as further findings are reported and published.

Disclosures

Dr McGuire is a clinical investigator for Establishment Labs (Alajuela, Costa Rica). Dr Glicksman is a clinical investigator and medical director for Motiva US breast implant clinical trial (Establishment Labs). Dr Magnusson is a consultant. for Abbvie (North Chicago, IL). Dr Deva is a consultant and research coordinator for Abbvie, and a research coordinator for KCI (3M; St Paul, MN).

Funding

The authors received no financial support for the research, authorship, and publication of this article

Author notes

Dr McGuire is a clinical instructor of surgery, Washington University, St Louis, MO, USA and a clinical editor for Aesthetic Surgery Journal.

Dr Glicksman is an assistant clinical professor, Hackensack Meridian School of Medicine, Nutley, NJ, USA and a clinical editor for Aesthetic Surgery Journal.

Dr Magnusson is an associate professor, Department of Plastic and Reconstructive Surgery, Griffiths University Southport, Queensland, Australia and an international editor for Aesthetic Surgery Journal.

Dr Deva is a professor, Department of Plastic and Reconstructive Surgery, Macquarie University, Sydney, Australia and an international editor for Aesthetic Surgery Journal.