What is breast implant illness?

What is Breast Implant Illness?

Breast implant illness (BII) is a constellation of systemic, extramammary symptoms—including fatigue, brain fog, joint pain, muscle pain, and hair loss—that patients attribute to their breast implants and that typically improve or resolve after implant removal with complete capsulectomy. 1, 2, 3

Clinical Definition and Recognition

BII is distinct from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare T-cell lymphoma arising in the implant capsule 4. While BIA-ALCL is a well-defined malignancy recognized by the FDA and WHO 4, BII represents a broader syndrome of nonspecific systemic symptoms without a single pathognomonic finding 1, 5.

The FDA now requires discussion of "risks of systemic symptoms" as part of informed consent for breast implant patients, acknowledging this clinical entity 4.

Most Common Symptoms

The symptom profile is remarkably consistent across studies:

• Fatigue (92-95% of patients) 1, 3
• Brain fog/cognitive difficulties (95% of patients) 1
• Joint pain (51-80% of patients) 1, 3
• Muscle pain (44% of patients) 3
• Hair loss (74% of patients) 1
• Skin changes 5

These symptoms typically appear an average of 6.4 years after implant placement 3.

Proposed Mechanisms

While the exact etiology remains unclear, several mechanisms have been identified:

Chronic Infection and Biofilm Formation

• Microbial colonization is found in 35-68% of BII patients, with Propionibacterium acnes being the most common organism (49.6%) 2, 3, 5
• Biofilm formation on implant surfaces may trigger chronic low-grade inflammation 5

Immune Dysregulation

• Antinuclear antibody (ANA) positivity occurs in approximately 24% of BII patients 3
• Autoimmune conditions are present in 20.7% of patients 3
• Capsular inflammation is found in 58.4% of cases 3
• Synoviocyte metaplasia (a histologic marker of chronic inflammation) occurs significantly more frequently in BII patients compared to controls (P = 0.0164) 5

Fibromyalgia Association

• Fibromyalgia prevalence is 12% in BII patients, suggesting potential overlap in pathophysiology 3

Outcomes After Explantation

The evidence for symptom improvement after implant removal with complete capsulectomy is remarkably consistent:

• 81.9-97% of patients report improvement or complete resolution of symptoms after explantation with total capsulectomy 1, 2, 3, 6
• In one study, 96% of patients with positive microbial cultures reported improvement post-treatment 2
• Average symptom severity scores decreased from 3.5 to 1.9 (on a 1-5 scale), representing a 1.6-point reduction 6
• An average of 2.8 symptoms per patient were eliminated following explantation 6
• The number of symptoms present before explantation correlates with the number resolving after surgery 1

Important Clinical Distinctions

BII vs. BIA-ALCL

BII must be distinguished from BIA-ALCL, which:

• Presents with late-onset seroma (>1 year post-implantation), typically 8-10 years after placement 4, 7
• Requires CD30 positivity for diagnosis 4, 7
• Is associated predominantly with textured implants 4
• Can progress and cause death if untreated 4

No Correlation with Implant Characteristics

BII symptoms do not correlate with implant type (saline vs. silicone), surface texture, fill material, duration of implantation, or location of original surgery 5. This distinguishes it from BIA-ALCL, which is strongly associated with textured implants 4.

Psychiatric Comorbidity

Psychiatric illness is present in 16.5% of BII patients 3. While some have historically dismissed BII as psychosomatic, the high rate of symptom resolution after explantation (>80%) and identification of objective findings (chronic infection, capsular inflammation, immune markers) support BII as a genuine clinical entity 2, 3, 6, 5.

Clinical Implications

• BII is a multifactorial clinical entity involving immune dysregulation, chronic inflammation, and microbial biofilms 3
• Screening for autoimmune and psychiatric conditions is warranted in patients presenting with these symptoms 3
• Complete capsulectomy (not just implant removal) is essential for optimal symptom resolution 2, 6
• None of the 50 patients in one study would consider having breast implants again after experiencing BII 5