Update on Breast Implant Illness (BII) Clinical Research
Plastic Surgeons have always been at the forefront of clinical research. We are also under the scrutiny of the media – reality television, social media, YouTube, TikTok, you name it. Breast implant surgery (putting them in AND taking them out), facial cosmetic surgery and non-surgical aesthetic treatments are promoted by millions of non-Plastic Surgeon “influencers” who have singlehandedly created a demand for huge lips, out-of-proportion bigger booties, threads in the face and do-it-yourself home injection pens (which we do NOT recommend).
In follow up to a blog post about Breast Implant Illness (BII) where my colleagues Dr. Glicksman and Dr. McGuire found that en bloc capsulectomy is NOT required for relief of perceived symptoms related to breast implants, the following is an alert published today by the first-ever woman President of The Aesthetic Society, Dr. Jennifer Walden.
Since I perform a great deal of breast implant surgery, both cosmetic and reconstructive, and since I have had breast augmentation myself, I felt it was important to share this research with my readers and followers. To be clear, BII is not a medical diagnosis, but was born from social media and misinformation spread by non-clinical research. Breast implant-associated anaplastic large cell lymphoma (bia-ALCL) is a different issue altogether, although it is often confused with BII. My colleagues are working hard to study the science and share their findings, to which we are all grateful.
Dear Aesthetic Society Members,
This Joint Presidential Advisory is to alert you to the recent publication in Aesthetic Surgery Journal of Part Two of the largest ever ASERF-funded study evaluating the BII (Breast Implant Illness) phenomenon:
Drs. Caroline Glicksman and Patricia McGuire are to be congratulated for leading this landmark, multidisciplinary study with contributions from Pathologists, Plastic Surgeons, an Immunologist, a Toxicologist and a Clinical Psychologist. This second paper comes on the heels of the first Biospecimen Analysis Study which revealed that the type of capsulectomy: partial, complete or en bloc had no impact on the resolution of symptoms. In this second study, the authors demonstrated that all metals found were trace levels similar to what is typically found in all items foods, water et. More specifically any metals detected in implant capsules are well below safe levels of exposure and were also detected in the breast tissue of subjects without breast implants.
Findings:
In this study, the authors looked at tissue levels of a variety of heavy metals in 3 groups of patients:
- Patients claiming to have symptoms caused by their implants (BII),
- Patients who were having their implants removed or replaced and had no symptoms they attributed to their implants and
- A control group of mastopexy patients who never had implants. The findings were very interesting in that none of the groups had any tissue or blood levels of heavy metals that exceeded EPA maximum acceptable internal exposure levels.
Impact of these BII Studies:
Prior research recommended en bloc capsulectomy for ALCL treatment only. Despite the lack of scientific support, social media groups and practitioner marketing campaigns began recommending exclusively en bloc capsulectomies for BII patients a practice noted as a social media phenomenon. The above ASERF studies now confirm that en bloc capsulectomies for BII patients provide symptom relief no better than total or partial capsulectomies. This likely also includes no capsulectomy; however, in this ASERF study capsular biopsies were taken in all patients and deemed “partial capsulectomy.”
Ethical Considerations:
Member surgeons are expected:
- To keep abreast of scientific knowledge (AMA Principles of Medical Ethics);
- To “only practice based upon a scientific basis” (The Aesthetic Society Code of Ethics, Section 1.02(b) and ASPS Code of Ethics, Preamble); and
- To advance “the art and science of plastic and reconstructive surgery.” (ASPS Code of Ethics, Section 1: General Principles III).
Our Recommendations:
Please read the studies and consider them carefully when treating BII patients. We commend and appreciate our ASERF researchers for their dedication to this very important topic. We all appreciate their hard work and commitment to patients through good science.
Sincerely,
Jennifer Walden, MD, FACS
President, The Aesthetic Society
Bruce W. Van Natta, MD
President, ASERF
