Systemic Symptoms: Biospecimen Analysis Study

Clinical Trial ID: NCT04255810

Description

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.

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.


Criteria

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, and 3) a patient who presents for a mastopexy(without implants or soft tissue support). Willingness to follow study requirements including 3-6 week and 6 month follow-up exams. - Exclusion Criteria: Genetic female, subject lives less 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, radiation, anti-estrogen therapy, HIV positive. -

  • Start Date

    2019-11-01

  • Last Updated

    2020-02-03

  • Sponsor

    The Aesthetic Surgery Education & Research Foundation

  • Condition Name

    Women Undergoing an Elective Mastopexy (Breast Lift)

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.