Systemic Symptoms: Biospecimen Analysis Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-12-31

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.

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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.

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with breast implants and self-reported symptoms of BII

Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII

Surgical collection of biospecimens

Intervention Type PROCEDURE

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

Women with breast implants and no self-reported BII

Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII

Surgical collection of biospecimens

Intervention Type PROCEDURE

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

Women undergoing elective mastopexy (breast lift)

Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support

No interventions assigned to this group

Interventions

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Surgical 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No