Systemic Symptoms: Biospecimen Analysis Study

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
• Interventions: Procedure: Surgical collection of biospecimens

• Registration Number: NCT04255810
• Lead Sponsor: Glicksman, Caroline, M.D.

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with breast implants and self-reported symptoms of BII	Surgical collection of biospecimens	Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII
Women with breast implants and no self-reported BII	Surgical collection of biospecimens	Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII

Primary Outcome Measures

Name	Time	Method
Change in self-reported systemic symptoms	3-6 weeks and 6 months and 1 year	Change in self-reported symptoms on PROMIS (NIH) questionnaires

Trial Locations

Locations (1)

Glicksman Plastic Surgery; 🇺🇸 Sea Girt, New Jersey, United States