Breast Implant Complication, Breast Implant Shell Defect
Conditions
Keywords
Breast Implant Fissure, Shell Integrity, Implant Age, Pocket Plane, Incision, Volume
Brief summary
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up to five years. Implant age, pocket plane, incision route, surface texture, and volume will be evaluated as predictors. The primary outcome is time to first confirmed focal shell fissure; progression to complete rupture, symptoms, inter-reader agreement, and revision will also be assessed.
Detailed description
A locked radiologic and operative definition will distinguish focal shell fissure from complete rupture, deformation, porosity, and leakage. Eligible women will enter only after baseline imaging shows no shell defect. Annual ultrasound and confirmatory MRI will prospectively identify incident events, which will undergo central blinded review and surgical confirmation when available. Delayed-entry time-to-event models will evaluate implant and surgical predictors and will account for bilateral implants and competing removal. A multi-state analysis will explore progression from intact implant to fissure and rupture if the event count is adequate.
Interventions
DEVICEBreast Implant Exposure
Recorded characteristics include implant age, material, surface texture, shape, volume, pocket plane, incision route, manufacturer/lot when available, primary or revision placement, and laterality. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
DIAGNOSTIC_TESTStructured Implant Shell Imaging
Annual high-resolution ultrasound and confirmatory MRI will apply a locked definition of focal shell fissure, complete rupture, deformation, porosity, and silicone leakage. Event images will undergo blinded central review. Linked arm/group(s): Implant Shell Integrity Surveillance Cohort.
Sponsors
Research Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female sex and age 18 years or older. * Aesthetic breast implant with known implantation date or year and known pocket plane, incision route, surface texture, and volume. * No fissure or rupture identified by the baseline imaging algorithm. * Ability to undergo annual ultrasound and confirmatory MRI when indicated. * Written informed consent.
Exclusion criteria
* Confirmed fissure or rupture at cohort entry. * Reconstructive breast implantation or tissue expander. * Immediate planned implant removal or exchange. * Missing core implant characteristics. * MRI contraindication when MRI is required to adjudicate a suspected event. * Recalled/PIP implant if excluded by the final analytic plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Confirmed Breast Implant Shell Fissure | From cohort entry through years of prospective follow-up. 10 years | Implant-level time from cohort entry to the first focal partial-thickness or noncomplete shell discontinuity meeting the locked MRI, ultrasound, or operative criteria and not meeting the definition of complete rupture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fissure-Free Survival by Implant Age | 10 years | Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods. |
Countries
Colombia
Contacts
CONTACTJuan Velez, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORjuan velez, MD, plastic surgery
Outcome results
None listed