Breast Implant Illness (BII): How Concerning Is It Really?

Breast Implant Illness, commonly abbreviated as BII, refers to cases where patients experience systemic symptoms such as fatigue, joint pain, and brain fog after receiving breast implants.

It is not an official medical diagnosis, and scientific evidence proving implants as the definitive cause has not yet been established.

However, studies show that most symptomatic patients improved after implant removal, meaning there is insufficient evidence to abandon surgery based purely on fear of BII.

Is Breast Implant Illness an Official Medical Diagnosis?

"No, it is not."

BII is a term coined and shared by patients themselves; there are currently no established diagnostic criteria or definitive diagnostic tests.

The U.S. Food and Drug Administration (FDA) also states that these symptoms and their underlying causes remain poorly understood.

Reported symptoms span a wide range, including chronic fatigue, brain fog, joint pain, and hair loss.

Notably, most of these symptoms are also prevalent among individuals who do not have breast implants.

What Does the Scientific Evidence Show So Far?

A clear causal relationship proving that breast implants induce these symptoms has not been proven.

The Aesthetic Surgery Education and Research Foundation (ASERF) conducted a prospective study following 50 symptomatic implant patients, 50 asymptomatic implant patients, and 50 control patients without implants over a one-year period.

Researchers tested for heavy metals, bacterial infections, fungal colonization, and inflammatory markers, but found no statistically significant differences that could explain the symptoms.

The research team suggested the possibility of a nocebo effect—where negative expectations themselves manifest as real physiological symptoms.

Do Symptoms Improve After Implant Removal?

The majority of symptomatic patients reported improvement following explantation.

In the same ASERF study, 88% experienced relief from at least some of their symptoms one year after removal.

Moreover, whether the capsule was completely removed (total capsulectomy) or only partially removed showed no statistically significant difference in the degree of symptom improvement.

However, not all symptoms resolved completely, and it remains unconfirmed whether this improvement was caused directly by the physical removal of the implants itself.

Is BII Less Prevalent Among Asians?

To date, the vast majority of reported cases originate from the Netherlands, Israel, the United States, and Brazil.

There is minimal documented data regarding Asian patients, including those in South Korea.

Whether this scarcity of reports stems from a genuine demographic difference in incidence or differences in awareness and reporting habits requires further investigation.

Can You Still Proceed with Breast Surgery?

Fear of BII alone does not provide sufficient scientific grounds to abandon surgery.

However, the FDA has mandated boxed warnings in breast implant labeling detailing reports of systemic symptoms.

The same warning also clarifies that an individual's specific risk has not been established and notes that some patients report complete resolution of symptoms following explantation.

It is vital to understand this information prior to surgery and select a board-certified surgeon with whom you can openly communicate should any symptoms arise.

What to Check Before Surgery

Does the surgeon clearly review the warnings in the implant labeling?

Do they evaluate your pre-existing conditions and history of autoimmune disorders?

Do they explain removal techniques and criteria for capsule management if explantation becomes necessary?

A specialized plastic surgeon focusing on breast procedures should neither dismiss BII outright nor exaggerate its risks, but instead provide objective, evidence-based guidance.

References

[1] U.S. FDA. Risks and Complications of Breast Implants. https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants

[2] Magno-Padron DA, et al. A population-based study of breast implant illness. Arch Plast Surg. 2021. doi:10.5999/aps.2020.02117

[3] Glicksman C, et al. Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: ASERF Systemic Symptoms in Women–Biospecimen Analysis Study: Part 1. Aesthet Surg J. 2022;42(7):809. doi:10.1093/asj/sjab417

[4] Glicksman C, et al. Longevity of Post-Explantation Systemic Symptom Improvement and Potential Etiologies: Part 4. Aesthet Surg J. 2023;43(10):1194. doi:10.1093/asj/sjad098

[5] Clinical Characteristics of ASIA Syndrome in Patients with Silicone Breast Implants: A Scoping Review. World J Plast Surg. 2025. PMID 41019240

[6] ISAPS & The Aesthetic Society Patient Safety Advisory (2023) — Advisory on total "en bloc" capsulectomy marketed as a cure for systemic symptoms. https://www.isaps.org/articles/statements-guidelines/patient-safety-advisory-breast-implant-removal-and-capsulectomy/

Frequently Asked Questions

Is BII (Breast Implant Illness) an official disease?

No, BII is not an official medical diagnosis. It is a patient-coined term with no defined diagnostic criteria or testing, and the U.S. FDA emphasizes that its causes remain unestablished.

Is there scientific proof that implants cause systemic symptoms?

No clear scientific causality has been established yet. Studies by ASERF found no biological differences in heavy metals, bacteria, or inflammation between groups, suggesting a possible nocebo effect.

Do systemic symptoms improve after implant removal?

Yes, studies show that most patients experience relief after explantation. Around 88% reported symptom improvement at one year, though not all symptoms disappear entirely.

Does the entire capsule need to be removed during explantation?

Not necessarily. Studies found no statistically significant difference in symptom improvement between total capsulectomy and partial capsulectomy.

Is BII common among Asians, including Koreans?

No, reports among Asian patients are currently very rare. Most documented cases come from Western countries, though whether this reflects true incidence or reporting awareness remains to be confirmed.