Study Details
A comprehensive overview of the Beyond the Implant Illness research study, including methodology, aims, and expected outcomes.
Specific Aims
We hypothesize that the normalization of serum FGF-19 levels will correlate significantly with the improvement in BII symptoms (measured by PROMIS-29) at 6 and 12 months post-explantation.
Additionally, we predict that the presence of the HLA-DR4 allele will be associated with a significantly lower rate of symptom resolution, serving as a predictor of non-response.
We hypothesize that Autologous Fat Grafting (AFG) will yield superior long-term patient-reported outcomes (PROMIS-29) and a lower rate of BII symptom recurrence compared to Implant-Based Augmentation (IBA) in the post-explantation setting.
Cost Comparison (Lifetime)
- • Fat Transfer: $80,000 total → lifetime solution
- • Implants: $24,000 initial + $90,000 replacements/MRIs over 40 years = $114,000+
- • Only 20-36% of patients replace implants every 10 years (ASPS/FDA data)
We will conduct a randomized, controlled pilot study (n=50 AFG patients) to determine if the application of BEMER Pulsed Electromagnetic Field therapy significantly increases the percentage of fat graft retention.
Expected Outcomes
- • BEMER PEMF: +15-30% microcirculation improvement
- • Target: 80-90% fat survival rate (vs. historical 30-70%)
- • MRI retention measurements at 6 and 12 months
Study Design & Methodology
Patient Population
Female patients presenting with BII symptoms who elect to undergo en bloc capsulectomy at Soler Cosmetic Plastic Surgery in Tampa, FL.
- • Inclusion: BII symptoms, willingness to participate in long-term follow-up
- • Exclusion: Active malignancy, inability to complete PROMIS-29 surveys
Data Collection Timeline
| Timepoint | Measurements |
|---|---|
| Baseline (Pre-op) | PROMIS-29, HLA-DR4 (one-time), FGF-19, Reconstruction choice |
| 6 months Post-op | PROMIS-29, FGF-19, MRI (BEMER pilot only) |
| 12 months Post-op | PROMIS-29, FGF-19, MRI (BEMER pilot only) |
| 24 months Post-op | PROMIS-29 |
Patient Support
- • 24/7 private chat support
- • Weekly Zoom group sessions
- • Remote testing options available worldwide
- • Free participation and evaluation
Statistical Analysis
Correlation analysis for FGF-19 vs. PROMIS-29 change scores, logistic regression for HLA-DR4 prediction, repeated measures ANOVA for AFG vs. IBA comparison, and two-sample t-test for BEMER pilot outcomes.
Background & Significance
What is Breast Implant Illness?
Breast Implant Illness (BII) is a constellation of systemic symptoms—including neurocognitive decline, chronic fatigue, anxiety, depression, and pruritic dermatoses—reported by patients with breast implants. While the etiology remains unproven, clinical evidence shows that explantation provides partial or complete relief in the vast majority of cases (81.9% improvement rate).
The Need for Objective Markers
Currently, BII is a diagnosis of exclusion. The identification of reliable biomarkers such as FGF-19 (which normalizes in responders) and HLA-DR4 (associated with autoimmune risk) would revolutionize BII care by providing objective measures for diagnosis, prognosis, and patient counseling.
The Reconstruction Dilemma
Following explantation, patients face a choice between returning to implants or pursuing autologous options like fat grafting. AFG is increasingly preferred due to its natural feel and avoidance of foreign materials, but concerns about graft survival persist. This study directly compares these options in the BII population.