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Systemic Symptoms: Biospecimen Analysis Study

NCT04255810 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-08-22

No results posted yet for this study

Summary

An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Conditions

  • Women With Breast Implants With and Without Self-reported Systemic Symptoms
  • Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction

Interventions

PROCEDURE

Surgical collection of biospecimens

Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort

Sponsors & Collaborators

  • The Aesthetic Surgery Education & Research Foundation

    collaborator OTHER

  • Glicksman, Caroline, M.D.

    lead INDIV

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255810 on ClinicalTrials.gov