Long Term Patient Reported Outcomes After Breast Explantation for Breast Implant Illness

Study on Breast Implant Removal Effects

Primary Investigator
M
Mithun Sinha

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
20 participants needed

Brief description of study

After breast augmentation or breast reconstruction with implants, some women experience a phenomenon called Breast Implant Illness which is a constellation of symptoms which include fatigue, joint pain, hair loss, brain fog, chronic pain, and a variety of other symptoms. Anecdotally, these women feel better after having their breast implants removed. The purpose of this study is to evaluate the women for symptom improvement one year after surgery or more by ways of a brief survey regarding their symptomatic improvement and the collection and analysis of blood samples.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be contacted by the study personnel over the phone or in clinic at Meridian Plastic Surgeons by study personnel.

Detailed description of study

Participants will be assessed for symptom improvement one year after surgery or more by way of a brief survey regarding their symptomatic improvement and the collection and analysis of blood samples. The survey and blood draw will each occur once, and will take about 15-30 minutes each.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Implant Illness, Breast augmentation, Breast reconstruction
  • Age: 18 years - 100 years
  • Gender: All

Inclusion criteria

a. Age ≥ 18 years b. Undergoing removal of breast implant c. Willing and able to comply with protocol instructions

 

Exclusion criteria

a. Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e., unable to provide informed consent) b. Pregnant females c. Immunodeficiency (HIV/AIDS, SCID) d. Currently on immunosuppressive medications e. Prisoners f. Non English speaking subjects

This study investigates the effects of removing breast implants in women experiencing Breast Implant Illness. Breast Implant Illness is a group of symptoms that some women report after getting breast implants. These symptoms can include feeling very tired, pain in the joints, losing hair, feeling confused, and having ongoing pain. The purpose of this study is to see if these symptoms get better after the implants are removed.

Participants in the study will complete a short survey and provide a blood sample to assess symptom improvement. The survey and blood draw will each occur once and take about 15-30 minutes each.

  • Who can participate: Women aged 18 years and older who are having their breast implants removed can participate. They must be willing and able to follow the study instructions. Pregnant women, those with immunodeficiency, or those on immunosuppressive medications cannot participate. Individuals unable to understand procedures, prisoners, and non-English speakers are also excluded.
  • Study details: Participants will take part in a survey and a blood sample collection to see if their symptoms improve after implant removal.
  • Study visits: The study requires 1 visit.
Updated on 14 Aug 2026. Study ID: 23049
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only