Microbes, Histology, Blood Analysis, Enterotoxins, and Cytokines: Findings From the ASERF Systemic Symptoms in Women-Biospecimen Analysis Study: Part 3

There has been an increasing need to acquire rigorous scientific data to answer the concerns of physicians, patients, and the FDA regarding the self-reported illness identified as breast implant illness (BII). There are no diagnostic tests or specific laboratory values to explain the reported systemic symptoms described by these patients. Objectives: The

This study adds to the current literature by demonstrating few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII. 背景: 获得严格的科学数据来回答医生、患者和 FDA 对自我报告的乳房假体植入相关疾病 (BII) 关切的需求日益增加。尚无诊断性试验和特定的实验室测定值来解释这些患者所描述的主诉全身症状。 目标: 本研究旨在确定是否可以在血液、囊组织病理学或微生物中识别出的可量化实验室结果, 将患有可归因于植入物的全身症状女性患者与 2 个对照组的患者区分开来。 方法: 这项前瞻性盲法研究招募 150 名受试者, 并纳入 3 个队列的试验组: (A) 要求取出植入物的女性患者, 其具有自身归因于植入物的全身症状; (B) 要求取出或更换乳房植入物的女性, 其没有归因于植入物的症状; (C) 接受美容乳房固定术的女性患者, 其从未植入任何医疗器械。本研究对囊组织进行了详细分析, 并从所有 3 个队列收集血液, 以评估炎症标志物。 结果: 除了在非 BII 队列中有更多滑膜样化生的囊组织外, 各队列之间没有发现显著的组织学差异。各队列在促甲状腺激素、维生素 D 水平或全血细胞分类计数方面没有统计学差异。下一代测序揭示, 队列 A、B 之间的阳性率差异无统计学意义。在测量的 12个细胞因子中, 白细胞介素 (IL) -17A、IL-13 和 IL-22 这 3 个细胞因子在队列 A 受试者血清中升高的频率显著高于队列 B、C。肠毒素数据表明, 队列 A 中免疫球蛋白G (IgG) 抗金黄色葡萄球菌肠毒素 A 升高。IgE 或 IgG 抗葡萄球菌抗体的存在与下一代测序阳性结果之间无相关性。 结论: 本研究通过证实几乎没有可识别的生物医学标志物来解释 BII 患者主诉的全身症状, 进一步补充了现有文献。 Level of Evidence: 4:

A prospective blinded study enrolled 150 subjects into 3 cohorts: (A) women with systemic symptoms they attribute to implants who requested implant removal; (B) women with breast implants requesting removal or exchange who did not have symptoms attributed to implants; and (C) women undergoing cosmetic mastopexy who have never had any implanted medical device. Capsule tissue underwent detailed analysis and blood was sent from all 3 cohorts to evaluate for markers of inflammation.

No significant histologic differences were identified between the cohorts, except there were more capsules with synovial metaplasia in the non-BII cohort. There was no statistical difference in thyroid-stimulating hormone, vitamin D levels, or complete blood count with differential between the cohorts. Next-generation sequencing revealed no statistically significant difference in positivity between Cohort A and B. Of the 12 cytokines measured, 3 cytokines, interleukin (IL)-17A, IL-13, and IL-22, were found to be significantly more often elevated in sera of subjects in Cohort A than in Cohorts B or C. The enterotoxin data demonstrated an elevation in immunoglobulin G (IgG) anti-Staphylococcus aureus enterotoxin A in Cohort A. There was no correlation between the presence of IgE or IgG anti-Staphylococcal antibody and a positive next-generation sequencing result. Conclusions: This study adds to the current literature by demonstrating few identifiable biomedical markers to explain the systemic symptoms self-reported by patients with BII. 背景: 获得严格的科学数据来回答医生、患者和 FDA 对自我报告的乳房假体植入相关疾病 (BII) 关切的需求日益增加。尚无诊断性试验和特定的实验室测定值来解释这些患者所描述的主诉全身症状。 目标: 本研究旨在确定是否可以在血液、囊组织病理学或微生物中识别出的可量化实验室结果, 将患有可归因于植入物的全身症状女性患者与 2 个对照组的患者区分开来。 方法: 这项前瞻性盲法研究招募 150 名受试者, 并纳入 3 个队列的试验组: (A) 要求取出植入物的女性患者, 其具有自身归因于植入物的全身症状; (B) 要求取出或更换乳房植入物的女性, 其没有归因于植入物的症状; (C) 接受美容乳房固定术的女性患者, 其从未植入任何医疗器械。本研究对囊组织进行了详细分析, 并从所有 3 个队列收集血液, 以评估炎症标志物。 结果: 除了在非 BII 队列中有更多滑膜样化生的囊组织外, 各队列之间没有发现显著的组织学差异。各队列在促甲状腺激素、维生素 D 水平或全血细胞分类计数方面没有统计学差异。下一代测序揭示, 队列 A、B 之间的阳性率差异无统计学意义。在测量的 12个细胞因子中, 白细胞介素 (IL) -17A、IL-13 和 IL-22 这 3 个细胞因子在队列 A 受试者血清中升高的频率显著高于队列 B、C。肠毒素数据表明, 队列 A 中免疫球蛋白G (IgG) 抗金黄色葡萄球菌肠毒素 A 升高。IgE 或 IgG 抗葡萄球菌抗体的存在与下一代测序阳性结果之间无相关性。 结论: 本研究通过证实几乎没有可识别的生物医学标志物来解释 BII 患者主诉的全身症状, 进一步补充了现有文献。 Level of Evidence: 4: