Clinical and Immunological Characteristics of Patients with Biopolymers and Autoimmune Inflammatory Syndrome Induced by Adjuvants

Abstract

Background: Biopolymers consist of non-biocompatible allogeneic materials. They have been associated with autoimmune inflammatory syndrome induced by adjuvants, as described by Yehuda Shoenfeld and Nancy Agmon-Levin. Therefore, this study aimed to evaluate the clinical and immunological characteristics of patients with autoimmune inflammatory syndrome induced by adjuvants treated at a plastic surgery clinic in Colombia. Methods: This cross-sectional, descriptive observational study included 190 patients with biopolymers in the buttocks with no evidence of autoimmune disease who were diagnosed with autoimmune inflammatory syndrome induced by adjuvants and underwent treatment at a private plastic surgery clinic from 2017 to 2020. The clinical and paraclinical parameters were measured preoperatively, when the diagnosis of autoimmune inflammatory syndrome induced by adjuvants and the need for material removal were established, and postoperatively after 3 months. Results: The most frequent symptoms were myalgia (92%), arthralgia (77.9%), asthenia (77.9%), adynamia (77.9%), and neurological symptoms (55.8%). Preoperatively, patients were positive for antinuclear antibody, lactate dehydrogenase, complement proteins C3 and C4, and lupus anticoagulant. However, after removal of the biopolymer, there was a decrease in positivity or conversion to a negative status of paraclinical tests. Moreover, there was an association between LDH positivity and disease severity (odds ratio: 4.1, 95% confidence interval: 1.94-8.92). Conclusions: The removal of biopolymers using an open surgical technique in symptomatic or asymptomatic patients is crucial for functional and reconstructive purposes and to improve the quality of life. Therefore, this condition should be known as "human adjuvant disease caused by biopolymers." Further, this condition mimics autoimmune diseases, with clinical and paraclinical manifestations that improve biopolymer removal.

Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease

“…18,19 Lactate dehydrogenase is a factor of severity in the behavior of the biopolymer 9–11 and makes it possible to define an early surgical approach, mitigating the symptoms and chronic inflammatory behavior of the disease. 3…”

“…In addition, all patients should have rheumatology follow-up to monitor autoimmune markers such as ANAs, complement C3 and C4 proteins, and lupus anticoagulant. 3…”

“…The surgical technique used in these patients for biopolymer removal was the Meticulous Approach Safer and Keeper (MASK) technique, which has six main objectives: to remove as much biopolymer compromised tissue as possible, to minimize esthetic sequelae, to improve the local compartment syndrome produced in the area of administration, to improve local and systemic symptoms with consequent recovery of functionality and positively impact the patient's quality of life, to manage the migration pattern of the product, and finally‚ to provide the best possible esthetic result. 3 The structure of the scale is based on local and systemic signs and symptoms, radiology imaging and paraclinical studies, each of which is assigned a score that will be used to determine the degree of severity. Qualitative variables were analyzed through frequencies and percentages, and quantitative variables were analyzed with measures of central tendency and dispersion.…”

“…Patients presenting one or more of the following symptoms: myalgia, arthralgia, asthenia, adynamia, and predominantly sensitive neurological symptoms; positive for any of the following: ANAs, complement proteins C3 and C4, LDH, lupus anticoagulant, or rheumatoid factor; and showing improvement with removal of the material were selected for the study. 3…”

“…This is due to the fact that a gold standard has not yet been established that makes it possible to compare findings; however, the purpose of the present study was to explore the research field in relation to BHAD. 3…”