AESTHETIC SOCIETY AND FOUNDATION FOR EDUCATION AND RESEARCH IN AESTHETIC SURGERY REVEAL FINDINGS OF BIOSAMPLING STUDY ON BREAST IMPLANT DISEASE (BII)

AESTHETIC SOCIETY AND FOUNDATION FOR EDUCATION AND RESEARCH IN AESTHETIC SURGERY REVEAL FINDINGS OF BIOSAMPLING STUDY ON BREAST IMPLANT DISEASE (BII)

The study aims to understand the possible etiologies of self-reported systemic symptoms by some patients with breast implants known as Breast Implant Disease.

GARDEN GROVE, Calif., November 9, 2022 /PRNewswire/ — The Aesthetic Society and The Aesthetic Surgery Education and Research Foundation (ASERF) today released the findings of a study dedicated to investigating self-reported systemic symptoms by some breast implant patients, known as breast implant disease. The Aesthetic Society is recognized as the world’s leading membership organization devoted entirely to aesthetic plastic surgery and aesthetic medicine of the face and body with 2,600 board-certified plastic surgeons as members. ASERF is the philanthropic research and education arm of The Aesthetic Society. This study was fully funded by a Foundation for Education and Research in Cosmetic Surgery (ASERF) grant awarded in 2019. There was no involvement of external sponsors 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 Journal of Cosmetic Surgery.

Breast implant disease (BII) is a term used to describe a variety of symptoms in patients with breast implants for whom 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 disease both qualitatively with symptom surveys and quantitatively with biological samples (blood and implant capsules). The authors sought to investigate measurable differences between the cohorts to help explain symptoms and pinpoint possible causes.

The published key findings of 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 a diagnosis cannot be made;
  • The ASERF study showed that 94% of patients showed improvement in systemic symptoms after removal of their breast implants;
  • Symptom improvement is independent of the type of capsulectomy performed and there was no statistical difference in symptom improvement if the capsule was completely or partially removed at the time of implant removal;
  • The study found low measurable levels of some heavy metals in the capsules of the implants, as well as in normal breast tissue that was never exposed to any implanted medical device. None of the groups had tissue levels that exceeded the International Conference on Harmonization level of acceptable levels of internal exposure to heavy metals;
  • There was no significant difference in the presence of bacteria in 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;
  • More prospective research is needed to determine which patients might be at risk of developing systemic symptoms after receiving breast implants and how best to treat these patients; Y
  • One-year follow-up data will be published in early 2023.

“The bottom line is that we found that these patients’ symptoms improve after implant removal and may improve without a capsulectomy, which is a less invasive, less risky and less expensive procedure,” he says. patricia mguire, MD, study co-author. “We have not found any consistent measurable differences between subjects with breast implant disease and control groups that could be used to make a diagnosis. We can now have educated conversations with our patients to help them make informed surgical decisions when they decide to have their implants removed.” . .”

“There have been questions surrounding the safety of breast implants for as long as breast implants have been around. Breast implant disease is self-reported by a minority of women with breast implants and the symptoms reported by these women needed to be analyzed in a prospective scientific study.” well designed”, explains Caroline Glickmann, MD, MSJ coauthor. “Our goal was to design such a study and we used authorized laboratories, including brown university Y Johns Hopkins University to analyze biological samples.

Biological Specimen Study Part One “Impact of Capsulectomy Type on Improvement of Post-Explantation Systemic Symptoms: Findings from the ASERF Systemic Symptom Biological Specimen Analysis Study in Women: Part 1” published july 2022 in Journal of Cosmetic Surgery examined women who described medical symptoms they attribute to their breast implants. Many groups on social networks insist that an “en bloc” extraction must be performed, that is, the complete removal of the scar tissue surrounding a breast implant in one piece, so that the patient resolves the symptoms of it. The term “en bloc” refers to a procedure performed for a malignancy in which a layer of normal tissue around a malignancy is removed to ensure that the margins of the tissue are free of tumor. Therefore, the term is incorrectly used for the removal of an implant in the absence of malignancy. Removal of the entire implant capsule requires a longer surgical time, a longer incision, and may carry a higher risk of surgical complications, such as hematoma or lung collapse. Surgeons are advised to follow evidence-based medicine and use scientific data to discuss surgical options with patients to ensure they can make the best decision if they choose to have their breast implants removed. The study showed that the type of capsule extraction did not affect symptom improvement. Whether partial or complete capsule removal was performed, patients reported the same level of improvement.

Second part of the study “Heavy Metals in Breast Implant Capsules and Breast Tissue: Systemic Symptom Findings in Women: Biological Sample Analysis Study: Part 2” addresses claims that breast implants may contain heavy metals that could also be contained in the capsule of the implant and can contribute to the health of the patient. symptom. In this study, 22 heavy metals were evaluated in implant capsule specimens from both implant groups, those who reported systemic symptoms and those who did not report symptoms that they attributed to their implants, and breast tissue from subjects who never had any. implanted medical device. None of the subject’s tissue levels exceeded acceptable safe exposure levels.

Third part of the study., “Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings from the ASERF Systemic Diseases in Women—Biospecimen Analysis Study: Part 3” sought to determine if there are quantifiable laboratory findings that can be identified in blood, tissue pathology of the capsule, 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 patient identification or any indication of which cohort they were in, to Eurofins, a laboratory that tests metals. heavy, Microgen DX, which evaluated bacterial and fungal DNA, Johns Hopkins Department of Allergy and Immunology for evaluation of antibodies against bacterial toxins, and brown university for microscopic evaluation. Peripheral blood was sent to evaluate blood count, inflammatory markers, thyroid function, and cytokines. The findings revealed that although there were some markers that were statistically higher in the BII group, in most subjects there were none that could be used to make a diagnosis or pinpoint the cause of symptoms. The study concluded that few identifiable biomedical markers exist to explain self-reported systemic symptoms by patients with BII.

With over 98% of BII subjects followed up at 6 months, the study concluded that women with symptoms they attribute to their implants experience symptom improvement after removal of their implants. 94% of subjects showed improvement in at least some of their symptoms with a 68% reduction in the number of symptoms reported. Symptom improvement was the same whether patients had the capsule completely or partially removed.

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 chooses to have her implants removed due to health concerns, there is no conclusive evidence of the need for the entire implant capsule to be 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, and less expensive procedure. Additionally, although there were measurable levels of some heavy metals around the 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 their options. This study allows surgeons to discuss surgical options using evidence-based data with their patients.

About the Aesthetic Society:

The Aesthetic Society is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and aesthetic medicine of the face and body. The Society of Aesthetics is made up 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 full spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards in their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet strict 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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About the Cosmetic Surgery Education and Research Foundation (ASERF):

The Foundation for Education and Research in Cosmetic Surgery (ASERF) is a 501(c)(3) nonprofit charitable foundation. Its mission is to identify and pursue those issues relevant to advancing the safety and efficacy of aesthetic medicine through independent, impartial, and targeted research and innovative education. ASERF is supported exclusively by charitable donations and research income. For more information visit www.aserf.org.

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