Systemic Symptoms: Biospecimen Analysis Study (BII)

Glicksman, Caroline, M.D.

Status: Active, not recruiting

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

Treatments: Procedure: Surgical collection of biospecimens

Study type: Observational

Funder types: Other

Identifiers

NCT04255810

ASERF-BII Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

Women with breast implants and self-reported symptoms of BII

Description:

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

Treatment:

Procedure: Surgical collection of biospecimens

Women with breast implants and no self-reported BII

Description:

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

Treatment:

Procedure: Surgical collection of biospecimens

Women undergoing elective mastopexy (breast lift)

Description:

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