Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction

The study population comprises approximately 60 cisgender women aged 18 years or older who will undergo minimally invasive breast augmentation or benign reconstruction procedures at the Sulàyöm Innovation Campus in Costa Rica.

Eligible participants will include women with breast cup sizes ranging from AA to C, classified as ASA I or II, and with sufficient breast tissue to support implant placement. The cohort will include individuals undergoing the following procedures:

• Mia Harmonization
• Mia Scarless Lift
• Mia Reconstruction
• Joy Dot
• Maxtopexia + Mia Additionally, participants may have congenital or acquired breast conditions (e.g., amastia, tuberous breasts, asymmetry) and meet the specific inclusion criteria for these advanced minimally invasive techniques.

Recruitment will focus on women scheduled for surgery between January and December 2025, with follow-up spanning 36 months. Participants must reside in Costa Rica to ensure adherence to follow-up visits.

Inclusion Criteria:

1. Gender and Age: Cisgender women, aged 18 years or older.

2. Surgical Procedure: Participants undergoing primary breast augmentation or benign reconstruction using the following minimally invasive procedures:

   • Mia Harmonization
   • Mia Scarless Lift
   • Mia Reconstruction
   • Joy Dot
   • Maxtopexia + Mia
3. Breast Size: Cup sizes AA to C, as determined by guidelines from Triumph International.
4. Health Status: ASA (American Society of Anesthesiologists) classification I or II.
5. Tissue Integrity: Adequate breast tissue available to cover the implant(s).
6. Commitment: Willingness to adhere to all study requirements, including follow-up visits and signing the informed consent form.
7. Special Cases for Reconstruction: Participants with congenital or acquired breast or thoracic conditions, such as amastia, pectus excavatum/carinatum, tuberous breasts, or asymmetry.
8. Mia Scarless Lift Specifics: Participants with mild, moderate, or pseudoptosis based on physician evaluation.
9. Timing: Women scheduled for surgery at the Sulàyöm Innovation Campus between January and December 2025.

Exclusion Criteria:

1. Non-Specified Procedures: Women undergoing augmentation or reconstruction with techniques other than those listed (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia).
2. Non-Study Implants: Use of implants other than Motiva products.

3. Compromised Tissue or Skin:

   • Existing rib lesions or significant/severe breast ptosis.
   • Poor tissue quality due to radiation damage, vascular compromise, or prior ulceration.

4. Medical History:

   • History of breast abscesses or infections.
   • Sensitivity or allergy to silicone.

5. Current Physiological Conditions:

   -Pregnancy or breastfeeding, or within six months postpartum or post-lactation.

6. Medications: Use of anticoagulants or medications that impair wound healing (e.g., corticosteroids, Warfarin).
7. Imaging Constraints: Conditions that prevent the use of MRI (e.g., implanted metal devices, claustrophobia).
8. Concurrent Research: Participation in another clinical research study involving drugs or devices.
9. Follow-Up Barriers: Residency outside Costa Rica or inability to attend required follow-up visits.
10. Timing Issues: Participants undergoing surgery outside the designated study period (January to December 2025).