Breast Augmentation, Breast Augmentation and Breast Reconstruction, Mammaplasty, Tissue Preservation
Conditions
Keywords
Breast Augmentation, Breast Reconstruction, Minimally Invasive Surgery, Tissue Preservation, Mammaplasty, Mia Techniques, Motiva Implants, Surgical Innovation
Brief summary
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction. These methods, known as Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia, focus on preserving breast tissue, reducing recovery time, and improving aesthetic outcomes.
Detailed description
This post-marketing observational study evaluates the safety and efficacy of innovative, minimally invasive breast augmentation and reconstruction techniques: Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia. These techniques aim to enhance tissue preservation, minimize scarring, and promote quicker recovery compared to traditional methods. The study will enroll 60 participants undergoing these procedures at the Sulàyöm Innovation Campus in Costa Rica between January and December 2025. Participants will be followed for 36 months to monitor complication rates, tissue health, and satisfaction. Procedures utilize advanced devices like the Motiva Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, and Motiva® Reusable Channel Separator, designed to optimize outcomes while preserving natural breast structures. Key assessments include: Safety Metrics: Monitoring adverse events, such as tissue necrosis, hematoma, or infection, through regular follow-ups. Efficacy Metrics: Evaluating tissue preservation during and after surgery using imaging and clinical assessments. Patient and Surgeon Satisfaction: Measuring perceptions of outcomes and procedure success using validated scales. The study will also conduct a temperature monitoring substudy using the Motiva® Zen transponder to assess its functionality in recording implant temperature. This optional component enhances understanding of implant safety. Results will provide crucial insights into the role of minimally invasive techniques in improving breast surgery outcomes, focusing on safety, tissue preservation, and patient satisfaction. These findings will inform future surgical practices and technological advancements.
Interventions
PROCEDUREMia Harmonization
Minimally invasive technique for breast augmentation, increasing volume while preserving natural tissue.
PROCEDUREMia Scarless Lift
Minimally invasive breast lift for mild to moderate ptosis without visible scarring.
PROCEDUREMia Reconstruction
Reconstructive technique for restoring breast contour and volume after benign surgical interventions.
PROCEDUREJoy Dot
Advanced augmentation method using specialized tools to preserve tissue integrity and minimize trauma.
PROCEDUREMaxtopexia + Mia
Breast lift combining traditional techniques with advanced minimally invasive methods for tissue preservation.
Sponsors
Establishment Labs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Related to Tissue Preservation | 36 months post-surgery. | The cumulative occurrence of adverse events, such as necrosis, hematoma, infection, or tissue damage, associated with the surgical procedures. |
| Rate of Intraoperative Tissue Integrity Preservation | Day of surgery. | Proportion (%) of surgical procedures in which intraoperative tissue integrity is maintained (no damage observed), and incidence rate (%) of tissue damage events during surgery, as assessed intraoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Satisfaction Score (5-Point Likert Scale) | Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery. | Mean score and distribution of patient-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale. |
| Surgeon-Reported Satisfaction Score (5-Point Likert Scale) | Day of surgery. | Mean score and distribution of surgeon-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale. |
| Rate of Postoperative Complications | 36 months post-surgery. | Incidence rate (%) of postoperative complications, including fibrosis, capsular contracture, and scarring, during the follow-up period. |
Countries
Costa Rica
Outcome results
None listed