Systemic Symptoms: Biospecimen Analysis Study

Glicksman, Caroline, M.D.150 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Interventions

Surgical collection of biospecimensPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in self-reported systemic symptoms

Change in self-reported symptoms on PROMIS (NIH) questionnaires

Time frame: 3-6 weeks and 6 months and 1 year

Data from ClinicalTrials.gov

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