Systemic Symptoms: Biospecimen Analysis Study

NCT04255810•Glicksman, Caroline, M.D.

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.

Detailed Description

An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. The term Breast Implant Illness or "BII" originated with several social media groups. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. Recently several studies have been designed and funded to study the role of psychological and social behavioral factors. This study has been designed to scientifically analyze biospecimens from three cohorts of age matched women in the United States. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Eligibility

Age

30 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Consecutive patients who present to investigator surgeon for:
•1. Self-reported BII requesting explantation;
•2. Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
•3. Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
•4. Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
•5. Genetic Female.

Exclusion Criteria

•1. Subject lives more than three hours away from the investigator surgeon;
•2. Previous breast reconstruction for cancer;
•3. Active malignancy anywhere else in the body;
•4. Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
•5. History of radiation to the breast;
•6. Currently on anti-estrogen therapy; or
•7. HIV positive.

Locations (1)

Glicksman Plastic Surgery

Sea Girt, New Jersey, United States

Key Dates

Start Date

November 1, 2019

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2023

Last Updated

August 22, 2025

Enrollment

150

ACTUAL participants

Conditions

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

Interventions

Surgical collection of biospecimens

PROCEDURE