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.
Female sex and age 18 years or older.
Aesthetic breast augmentation with permanent silicone or saline implants under the final protocol.
Baker grade I or II in the analyzed breast at cohort entry, confirmed by standardized examination.
Known implantation date or year and known pocket plane, incision route, surface texture, and volume.
Baker grade III or IV contracture at cohort entry in the analyzed breast.
Reconstructive implantation after mastectomy or major trauma.
Tissue expander.
Active breast infection or open wound at enrollment.
Adult women with aesthetic breast implants and no clinically significant capsular contracture at cohort entry.
Cohort
Prospective
Breast Implant Exposure
DeviceImplant-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.
Standardized Capsular Contracture Assessment
Diagnostic testTwo 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.
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.
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