Systemic Symptoms: Biospecimen Analysis Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systemic Symptoms: Biospecimen Analysis Study

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

Intervention / Treatment
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* Procedure: Surgical collection of biospecimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with breast implants and self-reported symptoms of BII<br>Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII | Procedure: Surgical collection of biospecimens<br>* Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort<br>|
| Women with breast implants and no self-reported BII<br>Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII | Procedure: Surgical collection of biospecimens<br>* Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort<br>|
| Women undergoing elective mastopexy (breast lift)<br>Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported systemic symptoms | Change in self-reported symptoms on PROMIS (NIH) questionnaires | 3-6 weeks and 6 months and 1 year |