Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction, Women With Breast Implants With and Without Self-reported Systemic Symptoms
Conditions
Brief 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.
Interventions
PROCEDURESurgical 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
The Aesthetic Surgery Education & Research Foundation
Glicksman, Caroline, M.D.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported systemic symptoms | 3-6 weeks and 6 months and 1 year | Change in self-reported symptoms on PROMIS (NIH) questionnaires |
Countries
United States
Outcome results
None listed