An observational study in Breast Implant Malposition and Breast Implant Rotation, 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 inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be recorded. Standardized clinical and photographic assessments will identify displacement and rotation. The primary outcome is time to clinically significant implant malposition or rotation; direction, reoperation, patient-reported outcomes, and early postoperative predictors will also be analyzed.
Participants will be enrolled before aesthetic breast implantation. A standardized preoperative anatomic assessment and detailed operative record will establish implant and pocket characteristics. Postoperative month 1 will serve as the reference position after early swelling decreases, and assessments will be repeated through years. A locked landmark-based definition will distinguish clinically significant inferior, superior, medial, and lateral displacement and rotation. Time-to-event and mixed-effects models will evaluate implant, surgical, and patient predictors while accounting for bilateral implants.
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 undergoing primary or revision aesthetic breast implantation with complete operative and device documentation.
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 are enrolled at implantation and followed prospectively. Implant characteristics and operative technique are exposures rather than assigned groups.
Procedure: Aesthetic Breast Implantation · Diagnostic Test: Standardized Implant Position Assessment
Primary or revision aesthetic implantation is performed according to independent clinical care. The study records incision route, pocket plane, pocket dimensions, implant texture, shape, volume, fixation or internal support, mastopexy, and postoperative support. Linked arm/group(s): Aesthetic Implant Position Cohort.
Bilateral photographs, surface landmark measurements, clinical examination, and ultrasound when indicated will assess implant center, inframammary fold relationship, medial/lateral displacement, vertical position, and orientation. Rotation assessment is prespecified for shaped implants. Linked arm/group(s): Aesthetic Implant Position Cohort.
Time to Clinically Significant Implant Displacement or Rotation
Time from implantation to the first confirmed inferior, superior, medial, or lateral malposition or clinically significant rotation that is visible, symptomatic, requires treatment, or meets the locked landmark-based threshold. Rotation is evaluated only for shaped implants unless a validated orientation marker is available.
Time frame: 10 years
Incidence by Direction and Type of Malposition
Proportion of implants with inferior, superior, medial, lateral, or rotational malposition, reported separately and per 100 implant-years.
Time frame: 10 years
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.
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