An observational study in Capsular Contracture of Breast Implant, 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 breast implant surveillance cohort will evaluate whether implant age, pocket plane, incision route, surface texture, and volume predict clinically significant capsular contracture. Women with Baker grade I or II aesthetic implants at enrollment will undergo standardized annual assessments for up to five years. The primary outcome is time to incident Baker grade III or IV contracture. Progression, pain, imaging, treatment, and patient-reported outcomes will also be described.
Women with aesthetic breast implants and no clinically significant contracture at cohort entry will be enrolled into a dynamic surveillance cohort. Operative and device information will be verified from records. Trained assessors will apply a locked Baker grading protocol annually, supported by photographs, symptom assessment, and imaging. Suspected incident Baker III/IV contracture will undergo independent confirmation and operative verification when available. Delayed-entry survival models will estimate the independent effects of implant age, plane, incision, texture, and volume while accounting for bilateral implants and competing implant removal.
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.
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Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
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 Baker grade I or II implants are followed prospectively. Implant and operative characteristics are modeled as exposures.
Device: Breast Implant Exposure · Diagnostic Test: Standardized Capsular Contracture Assessment
Implant-level data include age, laterality, material, surface texture, shape, volume, pocket plane, incision route, primary or revision placement, manufacturer/lot when available, and concomitant mastopexy or fat grafting. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Two trained assessors will apply a standardized Baker grading protocol, with breast firmness, distortion, pain, and imaging recorded. Suspected grade III/IV events will undergo central review or operative confirmation when surgery occurs. Linked arm/group(s): Breast Implant Capsule Surveillance Cohort.
Time to Incident Baker Grade III or IV Capsular Contracture
Implant-level time from cohort entry to the first confirmed clinically significant contracture. Grade III is visible distortion/firmness and grade IV includes pain under the locked examination manual. Bilateral implants will be clustered by participant.
Time frame: From cohort entry through years of prospective follow-up. 10 years
Capsular Contracture-Free Survival by Implant Age
Probability of remaining free of Baker grade III/IV contracture at prespecified implant ages, estimated with delayed-entry survival methods when prevalent implants are included.
Time frame: Prospective follow-up through 10 years
Plan to share: No — not contempled 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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