Join the Study
Have implants and unexplained symptoms? You might have BII. We're recruiting volunteers worldwide for this groundbreaking research study.
Inclusion Criteria
- • Female patients with breast implants experiencing BII symptoms
- • Willing to undergo en bloc capsulectomy (explantation)
- • Able to complete PROMIS-29 surveys and attend follow-up appointments
- • Willing to participate in long-term follow-up (up to 24 months)
- • Available for blood sample collection at specified timepoints
Exclusion Criteria
- • Active malignancy or cancer diagnosis
- • Inability to complete PROMIS-29 questionnaires
- • Unwillingness to participate in follow-up assessments
What You'll Receive
- • Free explant evaluation by Dr. Pedro Soler
- • PROMIS-29 symptom tracking
- • Blood tests for biomarker analysis (FGF-19, HLA-DR4)
- • Optional participation in BEMER PEMF pilot study (if choosing AFG)
- • 24/7 private chat support
- • Weekly Zoom group support sessions
- • Remote testing options available worldwide
How to Get Started
Reach out via social media or direct message for more information.
Use hashtags: #BeyondBII #IAmRecovering
What to Expect
Step 1: Initial Consultation
Schedule a consultation with Dr. Soler to discuss your symptoms, medical history, and eligibility for the study. This can be done in-person or via virtual consultation.
Step 2: Enrollment & Baseline Assessment
If eligible and interested, you'll complete the enrollment process including baseline PROMIS-29 questionnaire and blood sample collection for biomarker analysis.
Step 3: Surgery & Reconstruction Choice
Undergo en bloc capsulectomy with Dr. Soler. You'll have the option to choose between Autologous Fat Grafting (AFG) or Implant-Based Augmentation (IBA) for reconstruction, or no reconstruction.
Step 4: Follow-up & Support
Participate in follow-up assessments at 6, 12, and 24 months post-surgery. Receive ongoing support through 24/7 private chat and weekly Zoom sessions.
Step 5: Contribute to Science
Your participation will help advance the understanding of BII and improve treatment options for thousands of women worldwide. You'll be part of groundbreaking research that could change the standard of care.
Frequently Asked Questions
Yes, the study evaluation, PROMIS-29 tracking, and biomarker blood tests are provided at no cost to participants. Standard surgical fees for explantation and reconstruction apply and may be covered by insurance.
Yes! We offer remote testing options and virtual consultations. While surgery must be performed in Tampa, we can accommodate out-of-state and international participants with flexible scheduling.
That's completely fine. You can choose to have explantation only without reconstruction and still participate in the study. Your choice will be documented as part of the research data.
The follow-up period is 24 months (2 years) from the date of your surgery. You'll have assessments at 6, 12, and 24 months post-surgery.