Systemic Symptoms: Biospecimen Analysis Study (BII)

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.

Study Overview

• Status: Completed
• Conditions: Women With Breast Implants With and Without Self-reported Systemic Symptoms; Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction
• Intervention / Treatment: Procedure: Surgical collection of biospecimens

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Sea Girt, New Jersey, United States, 08750
      • Glicksman Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: 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
Women with breast implants and no self-reported BII; Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII	Procedure: 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
Women undergoing elective mastopexy (breast lift); Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glicksman, Caroline, M.D.
• Collaborators: The Aesthetic Surgery Education & Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ASERF-BII Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anticipated completion of biospecimen and qualitative data collection in 2022, with publication in the Aesthetic Surgery Journal. Four peer reviewed publications in Aesthetic Surgery Journal- ASERF Biospecimen Study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No