Brawer A E
Department of Medicine, Division of Rheumatology, Monmouth Medical Center, Long Branch, USA.
Lupus. 2017 Sep;26(10):1060-1063. doi: 10.1177/0961203317690241. Epub 2017 Jan 29.
Background Twenty-five years ago attorneys representing ailing women in class action litigation against silicone breast implant manufacturers made the procedural error of defining silicone-induced toxicity in the courtroom before it was properly studied in the exam room. This aberrant methodology perverted the proper research process, rendered verification of any real disease elusive, and cemented the groundwork for a repeat public health crisis potentially affecting two million women in the USA who possess new silicone gel devices inserted over the past 10 years. Patients and methods Six women, previously well, aged 27 to 53 (mean 42), were recipients of the new generations of cohesive silicone gel-filled breast implants approved for general use by the Food and Drug Administration (FDA) since December of 2006. They averaged seven years of total implantation time, and none experienced implant rupture. Results All six became ill on average 3.5 years from the time of implantation. By seven years the women manifested multiple types of skin rashes, polyarthritis, fatigue, protracted AM stiffness, myalgias, headaches, photosensitivity, hair loss, paresthesias, tinnitus, lymphadenopathy, chest pain, cognitive dysfunction, dry eyes, skin pigment changes, itching, muscle twitching, dizziness, nausea, easy bruising, and odor and smell sensitivity. Three of the four who were explanted noted improvement and/or resolution of at least 50% of their total disease manifestations. Conclusions These six women are representative of over 70,000 other breast implant recipients who, over the past three years, have had their new silicone devices permanently removed because of alleged gel-induced toxicity. The recurrence of this public health crisis has been fueled by manufacturers' research fraud, FDA ineptness, faulty informed consent, patient abandonment, proprietary manufacturing secrecy, misleading advertising, physician indifference, aberrant research methodology, and lax Congressional oversight.
背景 25 年前，在针对硅胶乳房植入物制造商的集体诉讼中，代表患病女性的律师犯了一个程序错误，即在诊室对硅胶诱发的毒性进行适当研究之前，就在法庭上对其进行了定义。这种异常的方法扭曲了正确的研究过程，使得难以证实任何真正的疾病，并为可能影响美国 200 万在过去 10 年中植入新型硅胶凝胶装置的女性的公共卫生危机再次爆发奠定了基础。
患者与方法 6 名既往健康、年龄在 27 至 53 岁（平均 42 岁）的女性，是自 2006 年 12 月起被美国食品药品监督管理局（FDA）批准普遍使用的新一代填充粘性硅胶凝胶乳房植入物的接受者。她们的平均植入总时长为 7 年，且均未经历植入物破裂。
结果 所有 6 名女性平均在植入后 3.5 年患病。到 7 年时，这些女性出现了多种皮疹、多关节炎、疲劳、长时间的晨僵、肌痛、头痛、光敏性、脱发、感觉异常、耳鸣、淋巴结病、胸痛、认知功能障碍、干眼、皮肤色素变化、瘙痒、肌肉抽搐、头晕、恶心、易瘀伤以及气味和嗅觉敏感。4 名接受取出植入物的女性中有 3 名指出其至少 50%的疾病表现得到改善和/或缓解。
结论 这 6 名女性代表了超过 70000 名其他乳房植入物接受者，在过去三年中，她们因所谓的凝胶诱发毒性而永久性取出了新型硅胶装置。制造商的研究欺诈、FDA 的无能、错误的知情同意、患者被遗弃、专有的制造保密、误导性广告、医生的冷漠、异常的研究方法以及国会监督不力，助长了这场公共卫生危机的再次发生。
