对于帕尔的丈夫和他的律师、来自纳什维尔的大卫·兰道夫·史密斯来说，她死于BIA-ALCL就是乳房假体生产商过失行为的证据。但结合其他患者的情况来看，这表明了这样一个从未将患者安全放在首位的全球性行业存在着系统性的问题。 除了帕尔的诉讼外，艾尔建和现在的艾伯维还面临着更多由Biocell引发的多地诉讼。正如1990年代假体生产商道康宁被卷入诉讼的情况一样，针对大型制药公司的大规模诉讼有时可能会导致数十亿美元的赔偿。行业专家表示，现在估算艾伯维的潜在风险还为时过早，但瑞穗高级分析师瓦米尔·迪旺表示，“这绝对是我们正在关注的一个议题。” 但就连原告律师也承认，针对医疗器械制造商的诉讼很难进行，因为个体索赔往往会被FDA的既定产品批准先发制人。艾尔建诉讼案中原告律师詹妮弗·伦茨在描述抢占论点时表示：“即便产品存在问题，你也无权提起诉讼，因为产品已经通过了严格的联邦审批程序。” 无论最终的法律结果如何，乳房假体问题显然对销售造成了影响。甚至在新冠疫情叫停非必要手术之前，整形外科医生的报告就显示隆胸需求出现下降。美国整形外科医生协会前主席斯科特·格拉斯伯格称，在FDA 2019年听证会之后的一年里，“隆胸手术的数量下降了大约10%”，而“移除”手术却出现了大约15%的增长。 3月，比佛利山整形外科医生凯文·布伦纳表示：“我做的假体移除手术比我做的植入手术还要多。”艾尔建召回事件发生后，他的许多患者担心自己会患上淋巴瘤，同时也提高了对于BII的认识。 乳房假体业务最终能否复苏还有待观察，特别是在当下，疫情和随之而来的经济低迷也放大了乳房假体问题。随着消费者削减不必要的支出，隆胸手术继上一次经济衰退后有所下降。在艾伯维5月份的业绩电话会议上，首席执行官理查德·冈萨雷斯承认，他预计隆胸手术数量收缩将对艾尔建的医疗美容业务产生“显著”影响（假设这种影响是“暂时”的话）。 对于卡尔文·帕尔来说，疫情意味着他要一个人住在这个如今空荡荡的房子里，他需要努力适应波莱特离去后所带来的更长久的孤独。他的一个女儿住在街对面，所以他可以去看望孙辈来打发时日。但有时他会半夜醒来，抚摸妻子曾经躺过的那半张床，这才想起来妻子已然辞世。他说：“我没有可以依靠的人了。” 一年前，他还在和波莱特一起规划晚年退休生活。他说：“这辈子我所有的安排都是想要确保波莱特能过得很好。我们知道我会是先离开的那个。但他们害死了她，那该死的假体害了她。” 乳房假体发展简史 围绕乳房假体的争议已有近半个世纪之久。 1976 国会授权FDA监管医疗器械领域。自1962年问世以来，硅胶乳房假体一直沿用至今。 1984 玛丽亚·斯特恩声称因使用道康宁硅胶假体引发疾病，获得150万美元惩罚性损害赔偿。 1992 随着乳房假体诉讼案增多，在国会听证会结束之后，FDA呼吁暂停使用绝大多数硅胶假体产品。 1995 面对高达两万多件官司，道康宁启动美国破产法第11章的破产保护（之后同意以32亿美元达成和解）。乳房假体生产商百时美施贵宝公司、Baxter Healthcare和3M分别为植入硅胶假体受损的女性设立了和解基金。 2006 FDA允许硅胶乳房假体重返美国市场。 2010 一次政府突击检查曝光法国乳房假体生产商PIP公司非法使用工业级硅胶；公司倒闭，创始人被判入狱。 2018 艾尔建毛面乳房假体在欧洲遭遇禁售。 2019年7月 FDA要求艾尔建召回其乳房假体。（财富中文网） 本文刊载于《财富》杂志2020年6/7月刊，文章标题：《存在风险的乳房假体业务》。 译者：杨超 唐尘 Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.
For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device. That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006. “They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.” |
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