An observational study in Breast Implant Rupture, 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 dynamic cohort will follow women with intact aesthetic silicone breast implants to evaluate predictors of rupture. Implant age, pocket plane, incision route, surface texture, and volume will be recorded, and participants will undergo annual clinical and imaging surveillance for up to five years. Confirmed rupture will require MRI or operative evidence. Delayed-entry survival models will estimate the independent association of implant and surgical characteristics with rupture risk.
Women with new or existing aesthetic silicone breast implants will enter the cohort only after baseline assessment confirms that the analyzed implant is intact. Implant and operative characteristics will be verified from device cards and operative records whenever possible. Annual high-resolution ultrasound will screen for integrity loss, with MRI or surgery used for confirmation under a standardized algorithm. Implant age will serve as the survival time scale, and prevalent implants will enter at their age on enrollment. The study will estimate rupture-free survival, symptomatic and silent rupture rates, adjusted predictor effects, and management after detection.
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 silicone breast implants documented as intact at cohort entry, including new implant recipients and prevalent implant carriers.
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.
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.
Women with intact silicone implants at enrollment are followed prospectively. Pocket plane, incision, texture, volume, and implant age are modeled as exposures rather than recruitment groups.
Device: Silicone Breast Implant Exposure · Diagnostic Test: Prospective Breast Implant Surveillance Imaging
Implant-level exposure data include implantation date, laterality, pocket plane, incision route, surface texture, shape, volume, manufacturer/lot when available, primary versus revision placement, and concomitant mastopexy or fat grafting. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Baseline and annual high-resolution ultrasound will assess implant integrity. Suspicious or indeterminate findings will undergo MRI according to the locked diagnostic algorithm. Rupture is confirmed by MRI, operative inspection, or both. Linked arm/group(s): Intact Aesthetic Breast Implant Surveillance Cohort.
Time to First Confirmed Breast Implant Rupture
Implant-level time from cohort entry to the first MRI- or surgically confirmed full-thickness implant shell rupture. Implant age is used as the survival time scale with delayed entry at age on enrollment. Contralateral implants are accounted for by patient-level clustering.
Time frame: From cohort entry through years of prospective follow-up. 10 TO 12 YEARS
Rupture-Free Survival by Implant Age
Kaplan-Meier or model-based probability of remaining free of confirmed rupture at prespecified implant ages, using delayed-entry methods.
Time frame: 12 YEARS
Plan to share: No — not contempled in the patient informed concent
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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