An observational study in Breast Implant Complication and Breast Implant Shell Defect, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Observational
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 72 across 51 observational studies indexed under Surgical Wound.
Browse Surgical Wound studies →Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women with aesthetic breast implants that are intact and without a documented shell fissure at baseline.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with no baseline shell defect are followed prospectively. Implant and surgical characteristics are modeled as exposures.
Device: Breast Implant Exposure · Diagnostic Test: Structured Implant Shell Imaging
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.
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.
Time to First Confirmed Breast Implant Shell Fissure
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.
Time frame: From cohort entry through years of prospective follow-up. 10 years
Fissure-Free Survival by Implant Age
Probability of remaining free of confirmed fissure at prespecified implant ages using delayed-entry survival methods.
Time frame: 10 years
Plan to share: No — not considered in the patient informed consent
Ran from Jan 2014 to primary completion in Jan 2026, 143 months.
Of 31 observational studies under Surgical Wound, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's 143 months is above that.
How these figures are worked out, and which studies are left out of them.
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