Systemic Symptoms: Biospecimen Analysis Study
Completed
Conditions studied: Women With Breast Implants With and Without Self-reported Systemic Symptoms, Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
In brief
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.
Key facts
- Study ID
- NCT04255810
- Run by
- Glicksman, Caroline, M.D.
- People needed
- 150
- Starts
- 2019-11-01
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Consecutive patients who present to investigator surgeon for:
- Self-reported BII requesting explantation;
- Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
- Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
- Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
- Genetic Female.
You may not qualify if…
- Subject lives more than three hours away from the investigator surgeon;
- Previous breast reconstruction for cancer;
- Active malignancy anywhere else in the body;
- Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
- History of radiation to the breast;
- Currently on anti-estrogen therapy; or
- HIV positive.
Where it is running
- Glicksman Plastic Surgery — Sea Girt, New Jersey, United States
Full record on ClinicalTrials.gov
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