THE AESTHETIC SOCIETY & THE AESTHETIC SURGERY EDUCATION AND RESEARCH FOUNDATION UNVEILS FINDINGS FROM THE BIOSPECIMEN STUDY ON BREAST IMPLANT ILLNESS (BII)

Study aims to understand the potential etiologies of the systemic symptoms self-reported by some breast implant patients known as Breast Implant Illness

GARDEN GROVE, Calif., Nov. 9, 2022 /PRNewswire/ -- The Aesthetic Society and The Aesthetic Surgery Education and Research Foundation (ASERF) today released the findings from a study dedicated to researching the systemic symptoms self-reported by some breast implant patients, known as Breast Implant Illness. The Aesthetic Society is recognized as the world's leading member organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body with 2,600 board-certified plastic surgeons in membership. ASERF is the philanthropic research and education arm of The Aesthetic Society. This study was funded entirely by an Aesthetic Surgery Education and Research Foundation (ASERF) grant awarded in 2019. There was no outside sponsor involvement in the research, data collection, data interpretation, data analysis, or writing of the manuscript. The full study is published in a peer-reviewed medical journal, the Aesthetic Surgery Journal.

Breast Implant Illness (BII) is a term used to describe a variety of symptoms by patients with breast implants for which there are no abnormal physical or laboratory findings to explain their symptoms. This is the first prospective, blinded study with control groups to evaluate women with breast implant illness both qualitatively with symptom surveys and quantitatively with bio specimens (blood and implant capsules). The authors sought to investigate measurable differences between the cohorts to help explain symptoms and point to potential causes.

Key findings published from the study are:

• There are women with implants who experience a variety of symptoms that they attribute to their implants;
• They have real symptoms and are distressed that no diagnosis can be made;
• The ASERF study demonstrated 94% of patients showed improvement in systemic symptoms after removal of their breast implants;
• The symptom improvement is independent of the type of capsulectomy performed and there was no statistical difference in symptom improvement whether the entire capsule was removed or partially removed at the time of implant removal;
• The study found low measurable levels of some heavy metals in implant capsules as well as normal breast tissue never exposed to any implanted medical device. None of the groups had tissue levels that exceeded the International Conference on Harmonization level of acceptable internal exposure levels to heavy metals;
• There was no significant difference in the presence of bacteria on the implants or in the capsules, between the groups validated by analysis of the presence of bacterial DNA;
• Peripheral blood analysis showed very few statistical differences between the cohorts;
• Further prospective research is necessary to determine which patients might be at risk for developing systemic symptoms after getting breast implants and how best to treat these patients; and
• The one-year follow-up data will be published early in 2023.

"The bottom line is that we found that these patient's symptoms improve after implant removal and they may improve without a capsulectomy which is a less invasive, less risky, and less expensive procedure," says Patricia McGuire, MD, co-author of the study. "We have not found any consistent measurable differences between the breast implant illness subjects and the control groups that could be used to make a diagnosis. We can now have educated discussions with our patients to help them make informed surgical decisions when deciding to remove their implants."

"There have been questions surrounding the safety of breast implants for as long as there have been breast implants. Breast Implant Illness is self-reported by a minority of women with breast implants and the symptoms being reported by these women needed to be looked at with a well-designed prospective scientific study," explains Caroline Glicksman, MD, MSJ co-author. "Our goal was to design such a study and we utilized authoritative laboratories including Brown University and Johns Hopkins University to analyze the biospecimens."

Part one of the biospecimen study "Impact of Capsulectomy Type on Post-Explantation Systemic Symptom Improvement: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 1" published July 2022 in Aesthetic Surgery Journal examined women describing medical symptoms that they attribute to their breast implants. Many groups on social media insist that an "en bloc" removal— the complete removal of the scar tissue surrounding a breast implant in one complete piece, must be done for a patient to have their symptoms resolve. The term "en bloc" refers to a procedure done for malignancy in which a layer of normal tissue is removed around a malignancy to ensure the tissue margins are clear of tumor. Thus, the term is improperly used for removal of an implant in the absence of malignancy. Removing the entire implant capsule requires a longer operative time, a longer incision, and may carry a higher risk of surgical complications, such as hematoma or a collapsed lung.  Surgeons are advised to follow evidence-based medicine and use scientific data to discuss surgical options with patients to ensure that they can make the best decision if they choose to remove their breast implants. The study demonstrated that the type of capsule removal did not affect the improvement in symptoms. Whether a partial or complete capsule removal was performed, the patients reported the same level of improvement.

Part two of the study "Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women–Biospecimen Analysis Study: Part 2" addresses claims that breast implants may contain heavy metals which could also be contained in the implant capsule and may contribute to the patient's symptoms.  In this study, implant capsule specimens from both implant groups, those reporting systemic symptoms and those not reporting symptoms they attributed to their implants, and the breast tissue of subjects who never had any implanted medical device, were evaluated for 22 heavy metals.  None of the subject's tissue levels exceeded acceptable levels of safe exposure.

Part three of the study, "Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings from the ASERF Systemic Symptoms in Women—Biospecimen Analysis Study: Part 3" sought to determine if there are quantifiable laboratory findings that can be identified in the blood, capsule tissue pathology, or microbes that differentiate women with systemic symptoms they attribute to their implants from two control groups.  On the day of surgery, blood was drawn and implant capsules (the scar tissue that forms around implants) were sent without the patient's identify or any indication of which cohort the patient was in, to Eurofins, a lab that evaluates heavy metals, Microgen DX, which evaluated for bacterial and fungal DNA, Johns Hopkins Department of Allergy and Immunology for evaluation for antibodies to bacterial toxins, and Brown University for microscopic evaluation. Peripheral blood was sent to evaluate for blood counts, inflammatory markers, thyroid function, and cytokines. The findings revealed that although there were a few markers that were statistically higher in the BII group, none were in a majority of subjects that could be used to make a diagnosis or point to a cause of symptoms. The study concluded there are few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII.

With over 98% of the BII subjects followed at 6 months, the study concluded that women with symptoms they attribute to their implants do experience symptom improvement after removal of their implants. Ninety-four percent of subjects showed improvement of at least some of their symptoms with a 68% reduction in the number of symptoms reported. The symptom improvement was the same whether the patients had the entire capsule removed or partial removal.

The comprehensive research illustrated in this scientific study published in a peer reviewed journal is good news for patients who have breast implants. If a patient does choose to have her implants removed over health concerns there is no definitive evidence for the need to have the entire implant capsule removed in the absence of other indications such as capsular contracture, a ruptured implant, or a textured implant.  Patients may experience symptom improvement with a shorter, less complicated, less expensive procedure. Additionally, although there were measurable levels of some heavy metals around implants, the levels were below safe levels of exposure, and this should not be used as an indication for total capsulectomy in women considering implant removal for systemic symptoms.  Patients considering implant removal for systemic symptoms should consult with a board-certified plastic surgeon to discuss her options. This study allows surgeons to discuss the surgical options using evidence-based data with their patients.

The Aesthetic Society is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. The Aesthetic Society is comprised of more than 2,600 members in North America and internationally; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements. The Aesthetic Society is at the forefront of innovation in aesthetic plastic surgery and cosmetic medicine globally. Visit our website: www.theaestheticsociety.org

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The Aesthetic Surgery Education and Research Foundation (ASERF) is a 501(c)(3) not-for-profit charitable foundation. Its mission is to identify and pursue those issues relevant to advancing the safety and effectiveness of aesthetic medicine through independent, unbiased, directed research, and groundbreaking education. ASERF is supported exclusively by charitable donations and research revenues. For more information, visit www.aserf.org.

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