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“他們殺了她”:為何乳房假體仍有致死風險

2019年上证指数半年线是多少目前大盘年线: “他們殺了她”:為何乳房假體仍有致死風險

MARIA ASPAN 2020年05月26日
這個從未將患者安全放在首位的全球性行業存在著系統性的問題。
圖片來源:LADA—SCIENCE SOURCE

2019沪指年线位置 www.839841.tw

1986年,也就是波萊特·帕爾去世前33年,她曾做過一個時髦而比較常規的手術。當時,35歲的帕爾就職于美國賽克斯頓一家醫院的人力資源部,賽克斯頓是密蘇州中一個位于圣路易斯和孟菲斯之間的小城,人口僅有1.6萬人。帕爾已經結婚了,有兩個男孩,對整形手術很感興趣。這類手術被整形醫生稱為“媽媽變身術”,通過一系列擠捏、塞入、提拉等方式,讓女性重回生孩子前的身材。于是,帕爾首次在體內植入了乳房假體。

在接下來的15年里,帕爾經歷了喪偶、再婚,在職場中晉升至醫院的采購部,她很滿意隆胸為她在外貌和心情方面帶來的改變。然而,隆胸手術中用的硅膠材料可能導致自身免疫問題和安全隱患,于1992年被美國食品和藥物管理局(FDA)列為禁用材料,帕爾開始擔心自己。2002年,帕爾發現植入身體的其中一塊硅膠出現斷裂,硅膠已流入身體,她接受了手術,將體內的硅膠填充假體替換為鹽水填充假體。帕爾體內采用了新式的Biocell乳房假體,其外部包裹了一層毛面硅膠外殼,以減少假體的移動。

但是,帕爾之后健康問題不斷,她的丈夫也因此起訴了Biocell乳房假體的制造商艾爾建公司,它是美國三大乳房假體制造商之一。2010年,帕爾體內其中一個鹽水填充假體出現滲漏,醫生將假體換為另一種Biocell毛面假體產品。這一次植入的假體采用硅膠材質,FDA在2006年重新準許硅膠投入使用。

“這種新的乳房假體制作精良,并且由一名頗受好評的醫生操刀?!痹誆ɡ程厝ナ朗潞?,她的丈夫卡爾文·帕爾說道,“我們對假體產品從未有過質疑?!?/font>

長期以來乳房假體都被視為身材的點睛之筆,人們將它嘲諷為女性的虛榮。而在嘲諷之余,大家卻忽視了胸部整形為大量女性顧客帶來的嚴重甚至是致命的健康問題。自2000年,已有超過800萬名美國女性曾接受過胸部整形手術;僅在2018年,或為了變美或為了乳房重建,超過40萬名女性接受過胸部整形手術。據美國整形外科醫生學會統計,隆胸手術是最受歡迎的醫美手術。

很多女性非常感激假體的出現,尤其是那些患有乳癌的女性?!敖郵芐夭空問質跏且桓齜淺8鋈說木齠??!畢秩蚊攔甕飪埔繳Щ嶂饗斬鰲そ芨ニ顧?。她不僅是一名整形醫師,還是一位接受過乳房術后重建的癌癥康復者?!按游業鼻暗慕】凳堇純?,植入乳房假體沒有出現任何不適?!?/font>

關于乳房假體產品,雖然曾出現過政府召回、產品責任起訴等問題,但醫藥公司在銷售這類產品時沒有太多的顧慮。艾爾建公司于今年5月被艾伯維公司收購,在全球監管部門對其部分產品加以禁止前,該公司在2017年銷售過的乳房假體價值總額為3.995億美元。強生集團旗下的曼托公司是業內的主要競爭者,在銷售額方面略遜艾爾建公司一籌。業內還有一家名為Sientra的小型公司,該公司在2019年在乳房假體方面的年收入為4640萬美元。

如果拿這些數字與行業巨頭艾爾建公司的暢銷品保妥適肉毒素瘦臉針的銷售額相比,簡直相形見絀,保妥適在去年的銷售總額為38億美元。與保妥適瘦臉針相似,乳房假體能為制造商和醫生帶來可觀的重復收入。即使在理想化狀態,FDA提醒乳房假體是“不可終生使用的”,每隔10到15年需要更換一次,每次整形手術的價格高達1.2萬美元。

關于乳房假體產品,《財富》雜志曾收集過來自醫生、患者、律師和公共衛生專家的多方意見,雖然該類產品在數十年來缺乏足夠的測試和研究,頻繁出現安全問題,監管機制并不完善,但依然被投入到市場中。在許多醫療設備中,無論是用于體外的機器還是植入體內的人造部件,都存在上述問題。然而,由于乳房假體與女性性征和外表相關,它既可用于體態美化,也可作為幫助術后乳癌患者重建正常身材的醫療工具,在近數十年來,減少了乳癌患者的術后困擾。如今,由于監管的缺失而出現越來越多的失敗案例,讓數百萬名女性面臨風險。

“有很多女性深受其害?!泵攔椅郎芯恐行鬧饗靼材取ぴ寺?,“這些產品被如此廣泛地銷售著,但每隔幾年,我們就會發現產品出現一些新問題?!?/font>

乳房假體制造商在設計產品時要兼顧安全和“真實”。目前,市面上的乳房假體主要分為鹽水填充式(更易破裂),和硅膠填充式(造型和觸感更自然,但常年有安全隱患傳聞)。假體的外表分為光面和“毛面”硅膠外殼兩種。光面假體在美國更為流行,但醫生通常建議乳房切除術后的患者使用毛面假體,因為粗糙的表面更易于組織在假體上生長。

波萊特·帕爾。圖片來源:卡爾文·帕爾

產品因這些差異變化而更易出現問題或副作用,比如:假體出現斷裂,疤痕組織會帶來疼痛感或使組織硬化;種種癥狀被統稱為“乳房假體疾病”,包括關節疼痛、偏頭痛、慢性疲勞,有時免疫系統會出現致命的癌癥,這種癌癥被稱為“乳房假體置入相關的間變性大細胞淋巴瘤”(下文簡稱淋巴瘤)。

“目前市面上的乳房假體都有問題?!甭淼呂鎪埂ぬ濫匪顧?。她曾是FDA的經理,目前創立Device Events公司,追蹤已上報的醫療設備故障?!拔也換嵯蛉魏撾以諍醯娜送萍齟死嗖??!?/font>

人們對于導致乳房假體出現種種問題的原因了解甚少,公共衛生專家將其歸咎于缺少測試或缺少研究目的,相關的長期研究沒有得到制造商在數據和資金方面的支持。根據FDA的要求,乳房假體制造商需要完整匯報相關數據,在此條件下,硅膠假體在2006年得以重回市場。

從去年起,隨著淋巴瘤病例的增多,人們開始意識到有問題的乳房假體產品終將讓顧客付出代價。已有903名女性被確診患有這種罕見腫瘤疾病,33人已因病死亡。預計數十萬女性有患病風險,但需要在數十年后出現病癥,有研究發現此類病例與毛面乳房假體有關。在接受過胸部整形而罹患淋巴瘤的女性中,她們體內的乳房假體來自于強生、Sientra等不同的生產商。而目前導致最多病例出現的是產自艾爾建公司的Biocell假體。在2018年年底,歐洲監管部門禁止艾爾建公司出售毛面乳房假體。FDA并沒有及時應對,但由于淋巴瘤病例的增多,最終在2019年7月要求艾爾建公司召回在售假體產品。艾爾建公司遵守有關規定,暫停相關產品的銷售。

截至5月,艾爾建公司已收到48宗起訴,包括與淋巴瘤病例和乳房假體召回相關的共同起訴。這些起訴認為艾爾建公司的Biocell假體存在問題,由此引發人身傷害、經濟損失、甚至意外喪命。這些案件已合并為由美國新澤西區法院受理的多區訴訟。

一位艾爾建公司的新聞發言人接受了《財富》雜志的郵件采訪,他在郵件中寫道,公司不會對暫未判決的訴訟加以評論,還表示“公司始終為患者的健康和安全而努力”,并且“遵照FDA的匯報流程,以透明公開的方式跟進植入過毛面乳房假體顧客的情況?!?/font>

在Sientra公司回復《財富》雜志郵件采訪時,他們沒有將淋巴瘤與毛面假體關聯在一起,而強生公司在回復時承認其旗下的曼托公司毛面假體產品引發了“少量淋巴瘤病例”。兩家公司均表示患者的安危重于一切。

比妮塔·阿沙爾是一名外科醫生,同時就職于FDA設備及放射衛生中心,是外科及感染防控設備辦公室的主任。她同樣認為女性的安全非常重要?!岸員仁昵?,我們現在對乳房假體已經了解了很多,并會繼續深入研究?!彼?,“為了?;せ頰叩陌踩?,我們必定會進一步采取必要的行動?!?/font>

“我的外科醫生只是對我說,‘你還記不記得90年代出現過的問題?一切終將得以解決?!甭昀鲅恰じ衩滋羋藁匾淶?。醫生對乳房假體的風險如此不屑一顧,意味著“患者在做出關于自身健康相關的決定時,沒有獲得準確的信息?!彼?。

格米特羅在2014年植入了曼托公司制造的假體后,出現了皮疹和慢性疲勞的癥狀,她現在和一大群女性團結在一起,希望醫生能對與假體相關的疾病加以重視。淋巴瘤病例的出現讓大家開始關注常見的健康問題,比如被統稱為“乳房假體疾病”的癥狀?!叭櫸考傯寮膊 痹菸從泄俜降惱鋃?,其癥狀與自身免疫紊亂相似。臉書中已有10萬多人加入一個以乳房假體疾病為主題的群組,組員們一起交流癥狀,分享移除假體后癥狀緩解的經歷。然而,有患者表示,醫生并不理會此類來自于社交平臺的醫療信息。

“現在,依然有很多人并不重視乳房假體的問題?!苯嗝貳た飪慫?。她目前以病人代表的身份與一些整形醫生一起加入乳房假體特別研究小組?!暗頤悄芤黃鹛教?,讓人們知道我們并沒有失去理智,我們是受過教育的女性,同時我們也曾受過傷害?!?/font>

“為了?;せ頰叩陌踩?,我們必定會進一步采取必要的行動?!北饒菟ぐ⑸扯?。她是一名外科醫生,同時就職于FDA設備及放射衛生中心,是外科及感染防控設備辦公室的主任。圖片來源:FDA

這些患者表示,假體已向女性銷售多年,但她們并未獲得來自生產商或來自醫生的適當的提醒,未能讓女性行使得知產品風險的權力。現有關于整體醫療設備的追蹤非常有限,因為該行業屬于分散式管理。FDA僅對生產商進行監管,無法監管醫生;生產商將假體銷售給整形醫生,而患者是假體的終端用戶,患者需要自行對體內的假體做好記錄。在以前,人們通過一個模擬系統向患者派發一張記錄了假體唯一追蹤編號的卡片。如果患者將卡片遺失,醫生退休,或醫生在七年后將記錄銷毀,很難得知體內究竟植入了哪種假體——該假體是否被召回也不得而知。

人們正在開發一個更好的追蹤系統,同時,很多受艾爾建公司召回產品影響的患者表示,她們是通過新聞和社交媒體得知淋巴瘤,而非從醫生、艾爾建公司、政府等渠道得知。

“在我買新車時發現車的空氣過濾器有問題,汽車銷售給我寄了三份保修卡,并打電話提醒我帶上保修卡進行售后?!崩琢鍘せ舳?。她是一位乳癌康復者,也是一位曾在2013年被確診為淋巴瘤的假體患者權益倡導者?!拔姨迥謨心持只嵊輾┲⒌畝?,FDA已知道這個問題,但我們從未聽到相關的提醒吧?”

如果某個醫療設備出現問題,生產商需要將此匯報至美國食品和藥物監管局的公開數據庫。但在2019年之前,監管局準許公司對設備問題上交一份不公開的“替代性”總結。正因如此,從2009年起,有超過30萬例乳房假體問題處于未公開狀態,美國食品和藥物監管局在去年對此做出承認?!罷饈且恢指咝У姆椒?,當我們發現某個問題,我們直接將它消除?!卑⑸扯?。她還補充,那些未公開的報告目前已公之于眾。

美國胸部手術總數。淺色代表隆胸,深色代表胸部重建。來源:美國整形外科醫生學會

Device Events公司的湯姆斯說,她曾在2017年與FDA的工作人員會面,告訴他們她發現艾爾建公司偶爾會以“哥斯達黎加”或“圣巴巴拉”的公司名上報設備問題(這兩個城市是其工廠的所在地),并非以“艾爾建”這個名字。湯姆斯與《財富》雜志分享了在那次會面中展示的文件,并說道:“如果你是一名醫生,你會在FDA的數據庫中搜索艾爾建這個名字,而不會搜索哥斯達黎加。他們試圖盡可能久地隱瞞問題?!保‵DA表示不會對個人會面加以評論。當前的記錄已包括公司的名字。)

一名艾爾建公司的新聞發言人表示,公司“一貫遵守FDA的所有要求,其中也包括以不正當形式匯報產品問題”,目前,公司已“對所有瞞報記錄提供完整而準確的信息,準確上報公司名稱和假體生產地”。

2006年,FDA解除對硅膠乳房假體的禁令,要求生產商對植入硅膠假體的女性進行歷時十年的大型研究。去年,強生Mentor和Sientra兩家公司因追蹤隨訪的病患人數未能滿足標準要求收到了FDA“警告信”。這兩家公司獲準繼續銷售其產品;阿沙爾稱,FDA“正監督Mentor和Sientra的整改進程”,但不會提供具體細節。強生和Sientra均表示正在努力提高研究過程中的病患參與度。

阿沙爾就此事接受《財富》雜志采訪過去一周時間后,FDA又向另外兩家乳房假體生產商發出了警告信,稱FDA當局“為患者健康不懈努力”。在向艾爾建公司簽發的警告信中,FDA指出,艾爾建同樣存在召回假體風險研究不充分的缺陷。另一封給私營企業Ideal Implant的警告信中指出,繼今年年初FDA對其設施進行檢查發現生產和質量控制問題之后,公司采取的整改措施不足;除此之外,公司也未遵守報告假體不良事件的要求。

FDA要求兩家公司在警告信發出后15個工作日內作出答復。艾爾建的一位發言人稱,公司正在反省警告信指出的缺陷,并“認真重視該問題”。Ideal Implant發言人則表示,公司正在與FDA密切合作,并“堅決支持及時準確地報告產品安全性”。

FDA也在考慮對假體的后期銷售進行更積極的監管。去年10月,FDA建議生產商在乳房假體包裝上加印更嚴格的黑框警告,警告內容包括一份清晰的患者決策勾選表格。阿沙爾表示,這份提案收到了1000多條“以贊成為主”的公眾評論,她還補充道,“FDA的首要任務就是落實這一指導意見?!?/font>

艾爾建的一位女發言人宣稱:“女性罹患這種疾病的幾率比被雷電擊中的概率還低?!閉舛窩月鄯⒈磧?011年1月,距離第一起乳房假體導致淋巴癌的報道已經過去了十年多。當時,FDA剛剛發布首個公開警告,稱植入乳房假體的女性罹患間變性大細胞淋巴瘤(ALCL)“風險可能很小,但幾率會增加”。而在密蘇里州,波萊特·帕爾剛剛接受了第二套Biocell乳房假體的植入手術。

當時,全球范圍內只有大約60起ALCL病例的報道,生產商很快就淡化了假體產品引發的風險。然而,這種威脅(至少威脅到了價格底線)的嚴重性足以讓艾爾建警醒投資者關于該疾病的潛在不良后果,包括負面報道和經濟損失。2011年3月,艾爾建發出警告稱:“乳房假體產品的生產和銷售一直是大量產品責任索賠的對象,這種情況也會持續下去?!?/font>

盡管乳房假體業務存在風險,但這并不影響艾爾建作為收購目標的前景。2015年,總部位于都柏林的阿特維斯收購艾爾建,并將艾爾建作為新的公司名稱;四年后,首席執行官布倫特·桑德斯同意將合并后的公司出售給修美樂生產商艾伯維。2019年6月,艾伯維宣布收購艾爾建,2020年5月初,艾伯維以630億美元完成收購。自此,艾伯維的多元化發展深入到了保妥適、乳房假體等其他“醫療美容”領域。桑德斯在接受美國消費者新聞與商業頻道(CNBC)旗下知名股評人吉姆·克萊默采訪時表示,這是“生物制藥領域最好的業務。乳房假體業務持久性極高,在全球范圍內都是現金交易,并且受到的監管較少,所以我們不需要和政府采購者打交道?!?/font>

隨著艾爾建經歷多輪并購,接受乳房假體植入手術的女性被診斷出患有乳房植入體相關的間變性大細胞淋巴瘤(BIA-ALCL)的幾率也在攀升:從2011年的50萬分之一,到2019年的每3800人就有一人患病。Memorial Sloan Kettering癌癥中心整形外科醫生彼得·科代羅對其患者進行了長達27年的追蹤隨訪,并且他的病患使用的幾乎都是艾爾建乳房假體。據他估算,如今他的患者罹患間變性大細胞淋巴瘤的風險為1/355。

但在2018年,這似乎仍未引發FDA擔憂,同樣不擔心這一問題的還有波萊特·帕爾,即便她注意到腋下長了一個痘痘大小的贅生物。做完檢查之后,直到11月她才知道自己患上了這種名為BIA-ALCL的癌癥。

時年67歲的帕爾已經做了祖母,剛剛退休不久的她利用周末時間短途旅行去往孟菲斯,并期待著自己的第一次紐約之旅。起初,她的診斷結果聽起來并沒有很嚴重。醫生告訴她,“我給你做6個療程的化療,贅生物就會消失?!笨ǘ摹づ煉匾淥擔骸罷庹嫻娜夢頤撬閃艘豢諂??!?/font>

患有乳腺癌或乳腺癌高風險的女性是一個特別脆弱的群體,而乳房假體問題也使得這一群體的健康狀況變得愈發復雜。

每年有超過10萬名女性(占與乳房相關的整形手術患者的四分之一)接受乳房“重塑”手術,這類手術多在乳房切除后進行。這些女性并非都是乳腺癌患者;2013年,接受預防性乳房切除手術的人數有所增加,當時,演員安吉麗娜·朱莉檢測發現自己攜帶一種會增加乳腺癌患病風險的基因突變,她投書《紐約時報》專欄,自爆她決定接受預防性雙乳房切除手術、植入乳房假體。

如今,這種包含乳房重塑的預防性乳房切除術讓眾多有惡性癌癥家族史、希望降低遺傳風險的年輕女性吃了一顆定心丸。對于這些不愿意失去乳房所帶來的女性氣質或性欲的女性而言,乳房假體已經改變了她們的生活。

紐約市喜劇演員凱特琳·布羅德尼克表示:“作為一個一生都飽受乳腺癌恐懼困擾的人,乳房假體就是一個了不起的安全保障?!彼戳艘槐凈匾瀆?,講述她在28歲時決定接受預防性乳房切除和重塑手術。

但頗具諷刺意味的是,許多為了降低患癌風險而接受手術的女性如今卻可能會感染這種叫做BIA-ALCL的癌癥。

米婭·卡爾根是紐約州韋斯特切斯特縣一家幼兒園的主任。她表示:“我們家族的所有女性都死于癌癥,這本是一個應該拯救我生命的決定,然后呢,什么!這讓我又要面臨另一個風險?!彼?014年接受了乳房切除和重塑手術?!把沽μ罅?。生活中的方方面面都受到了影響?!?/font>

替換假體,或者哪怕只是移除(“外植”)假體需要再接受一次價格不菲的手術,康復也需要時間。有這樣一個備受矚目的案例:今年3月,曼迪·金斯伯格辭去Match Group首席執行官一職,至于她為什么要離開這家營收高達20億美元的公司,她表示原因之一在于自己植入的乳房假體產品遭到召回,她剛剛接受了替換假體的手術。

乳房假體還給像波萊特·帕爾這樣的女性,以及每年為了美觀而接受乳房假體植入手術的數十萬女性帶來了其他同樣嚴重的影響。對于她們當中的許多人來說,除了巨額的醫療賬單外,罹患BIA-ALCL還伴隨著自責和別人的指指點點。

米歇爾·福尼是一家金融服務公司的人力資源經理,她如今也患有BIA-ALCL。她表示:“得了這種癌癥,別人就會對你評頭品足?!泵仔じD崾且桓隼止劭實募又萑?,在談到對自己的診斷結果感到悔恨時,她的聲音變得顫抖,斷斷續續地說:“這是我自找的。我為了滿足虛榮心植入了假體。但我就活該患病嗎?”

馬克·W·克萊門斯稱,淋巴瘤的治療費用從20萬美元到30萬美元不等,這還不包括缺勤成本或治療奔波的路費。作為德克薩斯大學MD安德森癌癥中心的整形外科副教授,克萊門斯為許多感染BIA-ALCL的女性提供治療,同時,他也在準備一項關于該疾病經濟影響的研究。他表示:“一些保險公司針對接受隆胸手術的患者制定了保險單除外條款;對被診斷出患有BIA-ALCL的患者做不予承保處理?!?/font>

華盛頓州Blue Cross Blue Shield持證保險公司Premera Blue Cross就是其中之一。該保險公司3月出臺的一項政策規定,如果患者為了美觀植入乳房假體,那么只有在“乳腺間期癌或其他需要切除或部分切除乳房的乳房疾病“的情況下,移除假體的費用才在保險覆蓋范圍之內。BIA-ALCL不作為乳腺癌或乳房疾病論處。

Premera以患者隱私規定為由拒絕對具體病例發表評論,并指出,目前FDA不建議尚未被診斷出患有BIA-ALCL的女性進行外植手術。Premera補充稱,公司會根據具體情況做出決策。Premera首席臨床官查德·墨菲在一份電子郵件聲明中表示:“每個病例都有其錯綜復雜之處,這會影響承保范疇的臨床決策?!?/font>

艾爾建為所有患有BIA-ALCL的女性提供最高7500美元的自費手術費,并承擔1000美元的診斷測試費用。對于像福尼和霍爾拉這樣已經對艾爾建提起訴訟的女性來說,這些金錢援助遠遠不夠,且為時已晚。福尼表示:“我已經花了數十萬美元,并且我有良好的保險保障。癌癥就是源源不斷的昂貴的‘賜予’?!?/font>

2019年初,艾爾建毛面乳房假體在歐洲遭遇禁售后,帕爾移除了她的假體,并繼續腫瘤科醫生承諾可以消滅她的BIA-ALCL的化療。她的金色長發開始脫落,最后她讓卡爾文用他的理發推子把她的頭發都剃光了。

在馬里蘭州,FDA正在就這種疾病以及乳房假體的整體安全性召開聽證會。艾爾建負責假體產品臨床開發的副總裁斯蒂芬妮·曼森·布朗博士證實:“有包括毛面假體在內的植入史的患者中已經出現了BIA-ALCL病例的報告。重要的是,該疾病預后良好,早期發現、治療得當的情況下尤為如此?!?/font>

但5月份的時候,FDA表示不會禁止毛面乳房假體,而帕爾的測試結果顯示,她的淋巴瘤已經轉移。6月份,艾伯維宣布收購艾爾建的計劃,此時她已住院一個月,接受了更多的治療。最終,她的醫生告訴她,她的健康狀況太差,已經無法接受似乎對其他BIA-ALCL患者有效的實驗性治療。

“她受了很多苦?!笨ǘ乃?,他的南方口音變得更加拖沓?!八耐確淺V?,甚至都無法并攏;胳膊也腫脹起來……然后我們就只能聽天由命?!?/font>

最終,7月24日,FDA要求艾爾建召回其Biocell毛面乳房假體。FDA隨后將此次召回升級為最嚴重的“I級”,并警告稱“使用這些假體可能會造成嚴重傷害或致死”。

對波萊特·帕爾來說,這一切來得太晚了。召回事件發生29天后,她在圣路易斯醫院的病床上度過了68歲生日,然后與世長辭。

對于帕爾的丈夫和他的律師、來自納什維爾的大衛·蘭道夫·史密斯來說,她死于BIA-ALCL就是乳房假體生產商過失行為的證據。但結合其他患者的情況來看,這表明了這樣一個從未將患者安全放在首位的全球性行業存在著系統性的問題。

除了帕爾的訴訟外,艾爾建和現在的艾伯維還面臨著更多由Biocell引發的多地訴訟。正如1990年代假體生產商道康寧被卷入訴訟的情況一樣,針對大型制藥公司的大規模訴訟有時可能會導致數十億美元的賠償。行業專家表示,現在估算艾伯維的潛在風險還為時過早,但瑞穗高級分析師瓦米爾·迪旺表示,“這絕對是我們正在關注的一個議題?!?/font>

但就連原告律師也承認,針對醫療器械制造商的訴訟很難進行,因為個體索賠往往會被FDA的既定產品批準先發制人。艾爾建訴訟案中原告律師詹妮弗·倫茨在描述搶占論點時表示:“即便產品存在問題,你也無權提起訴訟,因為產品已經通過了嚴格的聯邦審批程序?!?/font>

無論最終的法律結果如何,乳房假體問題顯然對銷售造成了影響。甚至在新冠疫情叫停非必要手術之前,整形外科醫生的報告就顯示隆胸需求出現下降。美國整形外科醫生協會前主席斯科特·格拉斯伯格稱,在FDA 2019年聽證會之后的一年里,“隆胸手術的數量下降了大約10%”,而“移除”手術卻出現了大約15%的增長。

3月,比佛利山整形外科醫生凱文·布倫納表示:“我做的假體移除手術比我做的植入手術還要多?!卑ㄕ倩厥錄⑸?,他的許多患者擔心自己會患上淋巴瘤,同時也提高了對于BII的認識。

乳房假體業務最終能否復蘇還有待觀察,特別是在當下,疫情和隨之而來的經濟低迷也放大了乳房假體問題。隨著消費者削減不必要的支出,隆胸手術繼上一次經濟衰退后有所下降。在艾伯維5月份的業績電話會議上,首席執行官理查德·岡薩雷斯承認,他預計隆胸手術數量收縮將對艾爾建的醫療美容業務產生“顯著”影響(假設這種影響是“暫時”的話)。

對于卡爾文·帕爾來說,疫情意味著他要一個人住在這個如今空蕩蕩的房子里,他需要努力適應波萊特離去后所帶來的更長久的孤獨。他的一個女兒住在街對面,所以他可以去看望孫輩來打發時日。但有時他會半夜醒來,撫摸妻子曾經躺過的那半張床,這才想起來妻子已然辭世。他說:“我沒有可以依靠的人了?!?/font>

一年前,他還在和波萊特一起規劃晚年退休生活。他說:“這輩子我所有的安排都是想要確保波萊特能過得很好。我們知道我會是先離開的那個。但他們害死了她,那該死的假體害了她?!?

乳房假體發展簡史

圍繞乳房假體的爭議已有近半個世紀之久。

1976

國會授權FDA監管醫療器械領域。自1962年問世以來,硅膠乳房假體一直沿用至今。

1984

瑪麗亞·斯特恩聲稱因使用道康寧硅膠假體引發疾病,獲得150萬美元懲罰性損害賠償。

1992

隨著乳房假體訴訟案增多,在國會聽證會結束之后,FDA呼吁暫停使用絕大多數硅膠假體產品。

1995

面對高達兩萬多件官司,道康寧啟動美國破產法第11章的破產?;ぃㄖ笸庖?2億美元達成和解)。乳房假體生產商百時美施貴寶公司、Baxter Healthcare和3M分別為植入硅膠假體受損的女性設立了和解基金。

2006

FDA允許硅膠乳房假體重返美國市場。

2010

一次政府突擊檢查曝光法國乳房假體生產商PIP公司非法使用工業級硅膠;公司倒閉,創始人被判入獄。

2018

艾爾建毛面乳房假體在歐洲遭遇禁售。

2019年7月

FDA要求艾爾建召回其乳房假體。(財富中文網)

本文刊載于《財富》雜志2020年6/7月刊,文章標題:《存在風險的乳房假體業務》。

譯者:楊超 唐塵

1986年,也就是波萊特·帕爾去世前33年,她曾做過一個時髦而比較常規的手術。當時,35歲的帕爾就職于美國賽克斯頓一家醫院的人力資源部,賽克斯頓是密蘇州中一個位于圣路易斯和孟菲斯之間的小城,人口僅有1.6萬人。帕爾已經結婚了,有兩個男孩,對整形手術很感興趣。這類手術被整形醫生稱為“媽媽變身術”,通過一系列擠捏、塞入、提拉等方式,讓女性重回生孩子前的身材。于是,帕爾首次在體內植入了乳房假體。

在接下來的15年里,帕爾經歷了喪偶、再婚,在職場中晉升至醫院的采購部,她很滿意隆胸為她在外貌和心情方面帶來的改變。然而,隆胸手術中用的硅膠材料可能導致自身免疫問題和安全隱患,于1992年被美國食品和藥物管理局(FDA)列為禁用材料,帕爾開始擔心自己。2002年,帕爾發現植入身體的其中一塊硅膠出現斷裂,硅膠已流入身體,她接受了手術,將體內的硅膠填充假體替換為鹽水填充假體。帕爾體內采用了新式的Biocell乳房假體,其外部包裹了一層毛面硅膠外殼,以減少假體的移動。

但是,帕爾之后健康問題不斷,她的丈夫也因此起訴了Biocell乳房假體的制造商艾爾建公司,它是美國三大乳房假體制造商之一。2010年,帕爾體內其中一個鹽水填充假體出現滲漏,醫生將假體換為另一種Biocell毛面假體產品。這一次植入的假體采用硅膠材質,FDA在2006年重新準許硅膠投入使用。

“這種新的乳房假體制作精良,并且由一名頗受好評的醫生操刀?!痹誆ɡ程厝ナ朗潞?,她的丈夫卡爾文·帕爾說道,“我們對假體產品從未有過質疑?!?/p>

長期以來乳房假體都被視為身材的點睛之筆,人們將它嘲諷為女性的虛榮。而在嘲諷之余,大家卻忽視了胸部整形為大量女性顧客帶來的嚴重甚至是致命的健康問題。自2000年,已有超過800萬名美國女性曾接受過胸部整形手術;僅在2018年,或為了變美或為了乳房重建,超過40萬名女性接受過胸部整形手術。據美國整形外科醫生學會統計,隆胸手術是最受歡迎的醫美手術。

很多女性非常感激假體的出現,尤其是那些患有乳癌的女性?!敖郵芐夭空問質跏且桓齜淺8鋈說木齠??!畢秩蚊攔甕飪埔繳Щ嶂饗斬鰲そ芨ニ顧?。她不僅是一名整形醫師,還是一位接受過乳房術后重建的癌癥康復者?!按游業鼻暗慕】凳堇純?,植入乳房假體沒有出現任何不適?!?/p>

關于乳房假體產品,雖然曾出現過政府召回、產品責任起訴等問題,但醫藥公司在銷售這類產品時沒有太多的顧慮。艾爾建公司于今年5月被艾伯維公司收購,在全球監管部門對其部分產品加以禁止前,該公司在2017年銷售過的乳房假體價值總額為3.995億美元。強生集團旗下的曼托公司是業內的主要競爭者,在銷售額方面略遜艾爾建公司一籌。業內還有一家名為Sientra的小型公司,該公司在2019年在乳房假體方面的年收入為4640萬美元。

如果拿這些數字與行業巨頭艾爾建公司的暢銷品保妥適肉毒素瘦臉針的銷售額相比,簡直相形見絀,保妥適在去年的銷售總額為38億美元。與保妥適瘦臉針相似,乳房假體能為制造商和醫生帶來可觀的重復收入。即使在理想化狀態,FDA提醒乳房假體是“不可終生使用的”,每隔10到15年需要更換一次,每次整形手術的價格高達1.2萬美元。

關于乳房假體產品,《財富》雜志曾收集過來自醫生、患者、律師和公共衛生專家的多方意見,雖然該類產品在數十年來缺乏足夠的測試和研究,頻繁出現安全問題,監管機制并不完善,但依然被投入到市場中。在許多醫療設備中,無論是用于體外的機器還是植入體內的人造部件,都存在上述問題。然而,由于乳房假體與女性性征和外表相關,它既可用于體態美化,也可作為幫助術后乳癌患者重建正常身材的醫療工具,在近數十年來,減少了乳癌患者的術后困擾。如今,由于監管的缺失而出現越來越多的失敗案例,讓數百萬名女性面臨風險。

“有很多女性深受其害?!泵攔椅郎芯恐行鬧饗靼材取ぴ寺?,“這些產品被如此廣泛地銷售著,但每隔幾年,我們就會發現產品出現一些新問題?!?/p>

乳房假體制造商在設計產品時要兼顧安全和“真實”。目前,市面上的乳房假體主要分為鹽水填充式(更易破裂),和硅膠填充式(造型和觸感更自然,但常年有安全隱患傳聞)。假體的外表分為光面和“毛面”硅膠外殼兩種。光面假體在美國更為流行,但醫生通常建議乳房切除術后的患者使用毛面假體,因為粗糙的表面更易于組織在假體上生長。

產品因這些差異變化而更易出現問題或副作用,比如:假體出現斷裂,疤痕組織會帶來疼痛感或使組織硬化;種種癥狀被統稱為“乳房假體疾病”,包括關節疼痛、偏頭痛、慢性疲勞,有時免疫系統會出現致命的癌癥,這種癌癥被稱為“乳房假體置入相關的間變性大細胞淋巴瘤”(下文簡稱淋巴瘤)。

“目前市面上的乳房假體都有問題?!甭淼呂鎪埂ぬ濫匪顧?。她曾是FDA的經理,目前創立Device Events公司,追蹤已上報的醫療設備故障?!拔也換嵯蛉魏撾以諍醯娜送萍齟死嗖??!?/p>

人們對于導致乳房假體出現種種問題的原因了解甚少,公共衛生專家將其歸咎于缺少測試或缺少研究目的,相關的長期研究沒有得到制造商在數據和資金方面的支持。根據FDA的要求,乳房假體制造商需要完整匯報相關數據,在此條件下,硅膠假體在2006年得以重回市場。

從去年起,隨著淋巴瘤病例的增多,人們開始意識到有問題的乳房假體產品終將讓顧客付出代價。已有903名女性被確診患有這種罕見腫瘤疾病,33人已因病死亡。預計數十萬女性有患病風險,但需要在數十年后出現病癥,有研究發現此類病例與毛面乳房假體有關。在接受過胸部整形而罹患淋巴瘤的女性中,她們體內的乳房假體來自于強生、Sientra等不同的生產商。而目前導致最多病例出現的是產自艾爾建公司的Biocell假體。在2018年年底,歐洲監管部門禁止艾爾建公司出售毛面乳房假體。FDA并沒有及時應對,但由于淋巴瘤病例的增多,最終在2019年7月要求艾爾建公司召回在售假體產品。艾爾建公司遵守有關規定,暫停相關產品的銷售。

截至5月,艾爾建公司已收到48宗起訴,包括與淋巴瘤病例和乳房假體召回相關的共同起訴。這些起訴認為艾爾建公司的Biocell假體存在問題,由此引發人身傷害、經濟損失、甚至意外喪命。這些案件已合并為由美國新澤西區法院受理的多區訴訟。

一位艾爾建公司的新聞發言人接受了《財富》雜志的郵件采訪,他在郵件中寫道,公司不會對暫未判決的訴訟加以評論,還表示“公司始終為患者的健康和安全而努力”,并且“遵照FDA的匯報流程,以透明公開的方式跟進植入過毛面乳房假體顧客的情況?!?/p>

在Sientra公司回復《財富》雜志郵件采訪時,他們沒有將淋巴瘤與毛面假體關聯在一起,而強生公司在回復時承認其旗下的曼托公司毛面假體產品引發了“少量淋巴瘤病例”。兩家公司均表示患者的安危重于一切。

比妮塔·阿沙爾是一名外科醫生,同時就職于FDA設備及放射衛生中心,是外科及感染防控設備辦公室的主任。她同樣認為女性的安全非常重要?!岸員仁昵?,我們現在對乳房假體已經了解了很多,并會繼續深入研究?!彼?,“為了?;せ頰叩陌踩?,我們必定會進一步采取必要的行動?!?/p>

“我的外科醫生只是對我說,‘你還記不記得90年代出現過的問題?一切終將得以解決?!甭昀鲅恰じ衩滋羋藁匾淶?。醫生對乳房假體的風險如此不屑一顧,意味著“患者在做出關于自身健康相關的決定時,沒有獲得準確的信息?!彼?。

格米特羅在2014年植入了曼托公司制造的假體后,出現了皮疹和慢性疲勞的癥狀,她現在和一大群女性團結在一起,希望醫生能對與假體相關的疾病加以重視。淋巴瘤病例的出現讓大家開始關注常見的健康問題,比如被統稱為“乳房假體疾病”的癥狀?!叭櫸考傯寮膊 痹菸從泄俜降惱鋃?,其癥狀與自身免疫紊亂相似。臉書中已有10萬多人加入一個以乳房假體疾病為主題的群組,組員們一起交流癥狀,分享移除假體后癥狀緩解的經歷。然而,有患者表示,醫生并不理會此類來自于社交平臺的醫療信息。

“現在,依然有很多人并不重視乳房假體的問題?!苯嗝貳た飪慫?。她目前以病人代表的身份與一些整形醫生一起加入乳房假體特別研究小組?!暗頤悄芤黃鹛教?,讓人們知道我們并沒有失去理智,我們是受過教育的女性,同時我們也曾受過傷害?!?/p>

這些患者表示,假體已向女性銷售多年,但她們并未獲得來自生產商或來自醫生的適當的提醒,未能讓女性行使得知產品風險的權力。現有關于整體醫療設備的追蹤非常有限,因為該行業屬于分散式管理。FDA僅對生產商進行監管,無法監管醫生;生產商將假體銷售給整形醫生,而患者是假體的終端用戶,患者需要自行對體內的假體做好記錄。在以前,人們通過一個模擬系統向患者派發一張記錄了假體唯一追蹤編號的卡片。如果患者將卡片遺失,醫生退休,或醫生在七年后將記錄銷毀,很難得知體內究竟植入了哪種假體——該假體是否被召回也不得而知。

人們正在開發一個更好的追蹤系統,同時,很多受艾爾建公司召回產品影響的患者表示,她們是通過新聞和社交媒體得知淋巴瘤,而非從醫生、艾爾建公司、政府等渠道得知。

“在我買新車時發現車的空氣過濾器有問題,汽車銷售給我寄了三份保修卡,并打電話提醒我帶上保修卡進行售后?!崩琢鍘せ舳?。她是一位乳癌康復者,也是一位曾在2013年被確診為淋巴瘤的假體患者權益倡導者?!拔姨迥謨心持只嵊輾┲⒌畝?,FDA已知道這個問題,但我們從未聽到相關的提醒吧?”

如果某個醫療設備出現問題,生產商需要將此匯報至美國食品和藥物監管局的公開數據庫。但在2019年之前,監管局準許公司對設備問題上交一份不公開的“替代性”總結。正因如此,從2009年起,有超過30萬例乳房假體問題處于未公開狀態,美國食品和藥物監管局在去年對此做出承認?!罷饈且恢指咝У姆椒?,當我們發現某個問題,我們直接將它消除?!卑⑸扯?。她還補充,那些未公開的報告目前已公之于眾。

Device Events公司的湯姆斯說,她曾在2017年與FDA的工作人員會面,告訴他們她發現艾爾建公司偶爾會以“哥斯達黎加”或“圣巴巴拉”的公司名上報設備問題(這兩個城市是其工廠的所在地),并非以“艾爾建”這個名字。湯姆斯與《財富》雜志分享了在那次會面中展示的文件,并說道:“如果你是一名醫生,你會在FDA的數據庫中搜索艾爾建這個名字,而不會搜索哥斯達黎加。他們試圖盡可能久地隱瞞問題?!保‵DA表示不會對個人會面加以評論。當前的記錄已包括公司的名字。)

一名艾爾建公司的新聞發言人表示,公司“一貫遵守FDA的所有要求,其中也包括以不正當形式匯報產品問題”,目前,公司已“對所有瞞報記錄提供完整而準確的信息,準確上報公司名稱和假體生產地”。

2006年,FDA解除對硅膠乳房假體的禁令,要求生產商對植入硅膠假體的女性進行歷時十年的大型研究。去年,強生Mentor和Sientra兩家公司因追蹤隨訪的病患人數未能滿足標準要求收到了FDA“警告信”。這兩家公司獲準繼續銷售其產品;阿沙爾稱,FDA“正監督Mentor和Sientra的整改進程”,但不會提供具體細節。強生和Sientra均表示正在努力提高研究過程中的病患參與度。

阿沙爾就此事接受《財富》雜志采訪過去一周時間后,FDA又向另外兩家乳房假體生產商發出了警告信,稱FDA當局“為患者健康不懈努力”。在向艾爾建公司簽發的警告信中,FDA指出,艾爾建同樣存在召回假體風險研究不充分的缺陷。另一封給私營企業Ideal Implant的警告信中指出,繼今年年初FDA對其設施進行檢查發現生產和質量控制問題之后,公司采取的整改措施不足;除此之外,公司也未遵守報告假體不良事件的要求。

FDA要求兩家公司在警告信發出后15個工作日內作出答復。艾爾建的一位發言人稱,公司正在反省警告信指出的缺陷,并“認真重視該問題”。Ideal Implant發言人則表示,公司正在與FDA密切合作,并“堅決支持及時準確地報告產品安全性”。

FDA也在考慮對假體的后期銷售進行更積極的監管。去年10月,FDA建議生產商在乳房假體包裝上加印更嚴格的黑框警告,警告內容包括一份清晰的患者決策勾選表格。阿沙爾表示,這份提案收到了1000多條“以贊成為主”的公眾評論,她還補充道,“FDA的首要任務就是落實這一指導意見?!?/p>

艾爾建的一位女發言人宣稱:“女性罹患這種疾病的幾率比被雷電擊中的概率還低?!閉舛窩月鄯⒈磧?011年1月,距離第一起乳房假體導致淋巴癌的報道已經過去了十年多。當時,FDA剛剛發布首個公開警告,稱植入乳房假體的女性罹患間變性大細胞淋巴瘤(ALCL)“風險可能很小,但幾率會增加”。而在密蘇里州,波萊特·帕爾剛剛接受了第二套Biocell乳房假體的植入手術。

當時,全球范圍內只有大約60起ALCL病例的報道,生產商很快就淡化了假體產品引發的風險。然而,這種威脅(至少威脅到了價格底線)的嚴重性足以讓艾爾建警醒投資者關于該疾病的潛在不良后果,包括負面報道和經濟損失。2011年3月,艾爾建發出警告稱:“乳房假體產品的生產和銷售一直是大量產品責任索賠的對象,這種情況也會持續下去?!?/p>

盡管乳房假體業務存在風險,但這并不影響艾爾建作為收購目標的前景。2015年,總部位于都柏林的阿特維斯收購艾爾建,并將艾爾建作為新的公司名稱;四年后,首席執行官布倫特·桑德斯同意將合并后的公司出售給修美樂生產商艾伯維。2019年6月,艾伯維宣布收購艾爾建,2020年5月初,艾伯維以630億美元完成收購。自此,艾伯維的多元化發展深入到了保妥適、乳房假體等其他“醫療美容”領域。桑德斯在接受美國消費者新聞與商業頻道(CNBC)旗下知名股評人吉姆·克萊默采訪時表示,這是“生物制藥領域最好的業務。乳房假體業務持久性極高,在全球范圍內都是現金交易,并且受到的監管較少,所以我們不需要和政府采購者打交道?!?/p>

隨著艾爾建經歷多輪并購,接受乳房假體植入手術的女性被診斷出患有乳房植入體相關的間變性大細胞淋巴瘤(BIA-ALCL)的幾率也在攀升:從2011年的50萬分之一,到2019年的每3800人就有一人患病。Memorial Sloan Kettering癌癥中心整形外科醫生彼得·科代羅對其患者進行了長達27年的追蹤隨訪,并且他的病患使用的幾乎都是艾爾建乳房假體。據他估算,如今他的患者罹患間變性大細胞淋巴瘤的風險為1/355。

但在2018年,這似乎仍未引發FDA擔憂,同樣不擔心這一問題的還有波萊特·帕爾,即便她注意到腋下長了一個痘痘大小的贅生物。做完檢查之后,直到11月她才知道自己患上了這種名為BIA-ALCL的癌癥。

時年67歲的帕爾已經做了祖母,剛剛退休不久的她利用周末時間短途旅行去往孟菲斯,并期待著自己的第一次紐約之旅。起初,她的診斷結果聽起來并沒有很嚴重。醫生告訴她,“我給你做6個療程的化療,贅生物就會消失?!笨ǘ摹づ煉匾淥擔骸罷庹嫻娜夢頤撬閃艘豢諂??!?/p>

患有乳腺癌或乳腺癌高風險的女性是一個特別脆弱的群體,而乳房假體問題也使得這一群體的健康狀況變得愈發復雜。

每年有超過10萬名女性(占與乳房相關的整形手術患者的四分之一)接受乳房“重塑”手術,這類手術多在乳房切除后進行。這些女性并非都是乳腺癌患者;2013年,接受預防性乳房切除手術的人數有所增加,當時,演員安吉麗娜·朱莉檢測發現自己攜帶一種會增加乳腺癌患病風險的基因突變,她投書《紐約時報》專欄,自爆她決定接受預防性雙乳房切除手術、植入乳房假體。

如今,這種包含乳房重塑的預防性乳房切除術讓眾多有惡性癌癥家族史、希望降低遺傳風險的年輕女性吃了一顆定心丸。對于這些不愿意失去乳房所帶來的女性氣質或性欲的女性而言,乳房假體已經改變了她們的生活。

紐約市喜劇演員凱特琳·布羅德尼克表示:“作為一個一生都飽受乳腺癌恐懼困擾的人,乳房假體就是一個了不起的安全保障?!彼戳艘槐凈匾瀆?,講述她在28歲時決定接受預防性乳房切除和重塑手術。

但頗具諷刺意味的是,許多為了降低患癌風險而接受手術的女性如今卻可能會感染這種叫做BIA-ALCL的癌癥。

米婭·卡爾根是紐約州韋斯特切斯特縣一家幼兒園的主任。她表示:“我們家族的所有女性都死于癌癥,這本是一個應該拯救我生命的決定,然后呢,什么!這讓我又要面臨另一個風險?!彼?014年接受了乳房切除和重塑手術?!把沽μ罅?。生活中的方方面面都受到了影響?!?/p>

替換假體,或者哪怕只是移除(“外植”)假體需要再接受一次價格不菲的手術,康復也需要時間。有這樣一個備受矚目的案例:今年3月,曼迪·金斯伯格辭去Match Group首席執行官一職,至于她為什么要離開這家營收高達20億美元的公司,她表示原因之一在于自己植入的乳房假體產品遭到召回,她剛剛接受了替換假體的手術。

乳房假體還給像波萊特·帕爾這樣的女性,以及每年為了美觀而接受乳房假體植入手術的數十萬女性帶來了其他同樣嚴重的影響。對于她們當中的許多人來說,除了巨額的醫療賬單外,罹患BIA-ALCL還伴隨著自責和別人的指指點點。

米歇爾·福尼是一家金融服務公司的人力資源經理,她如今也患有BIA-ALCL。她表示:“得了這種癌癥,別人就會對你評頭品足?!泵仔じD崾且桓隼止劭實募又萑?,在談到對自己的診斷結果感到悔恨時,她的聲音變得顫抖,斷斷續續地說:“這是我自找的。我為了滿足虛榮心植入了假體。但我就活該患病嗎?”

馬克·W·克萊門斯稱,淋巴瘤的治療費用從20萬美元到30萬美元不等,這還不包括缺勤成本或治療奔波的路費。作為德克薩斯大學MD安德森癌癥中心的整形外科副教授,克萊門斯為許多感染BIA-ALCL的女性提供治療,同時,他也在準備一項關于該疾病經濟影響的研究。他表示:“一些保險公司針對接受隆胸手術的患者制定了保險單除外條款;對被診斷出患有BIA-ALCL的患者做不予承保處理?!?/p>

華盛頓州Blue Cross Blue Shield持證保險公司Premera Blue Cross就是其中之一。該保險公司3月出臺的一項政策規定,如果患者為了美觀植入乳房假體,那么只有在“乳腺間期癌或其他需要切除或部分切除乳房的乳房疾病“的情況下,移除假體的費用才在保險覆蓋范圍之內。BIA-ALCL不作為乳腺癌或乳房疾病論處。

Premera以患者隱私規定為由拒絕對具體病例發表評論,并指出,目前FDA不建議尚未被診斷出患有BIA-ALCL的女性進行外植手術。Premera補充稱,公司會根據具體情況做出決策。Premera首席臨床官查德·墨菲在一份電子郵件聲明中表示:“每個病例都有其錯綜復雜之處,這會影響承保范疇的臨床決策?!?/p>

艾爾建為所有患有BIA-ALCL的女性提供最高7500美元的自費手術費,并承擔1000美元的診斷測試費用。對于像福尼和霍爾拉這樣已經對艾爾建提起訴訟的女性來說,這些金錢援助遠遠不夠,且為時已晚。福尼表示:“我已經花了數十萬美元,并且我有良好的保險保障。癌癥就是源源不斷的昂貴的‘賜予’?!?/p>

2019年初,艾爾建毛面乳房假體在歐洲遭遇禁售后,帕爾移除了她的假體,并繼續腫瘤科醫生承諾可以消滅她的BIA-ALCL的化療。她的金色長發開始脫落,最后她讓卡爾文用他的理發推子把她的頭發都剃光了。

在馬里蘭州,FDA正在就這種疾病以及乳房假體的整體安全性召開聽證會。艾爾建負責假體產品臨床開發的副總裁斯蒂芬妮·曼森·布朗博士證實:“有包括毛面假體在內的植入史的患者中已經出現了BIA-ALCL病例的報告。重要的是,該疾病預后良好,早期發現、治療得當的情況下尤為如此?!?/p>

但5月份的時候,FDA表示不會禁止毛面乳房假體,而帕爾的測試結果顯示,她的淋巴瘤已經轉移。6月份,艾伯維宣布收購艾爾建的計劃,此時她已住院一個月,接受了更多的治療。最終,她的醫生告訴她,她的健康狀況太差,已經無法接受似乎對其他BIA-ALCL患者有效的實驗性治療。

“她受了很多苦?!笨ǘ乃?,他的南方口音變得更加拖沓?!八耐確淺V?,甚至都無法并攏;胳膊也腫脹起來……然后我們就只能聽天由命?!?/p>

最終,7月24日,FDA要求艾爾建召回其Biocell毛面乳房假體。FDA隨后將此次召回升級為最嚴重的“I級”,并警告稱“使用這些假體可能會造成嚴重傷害或致死”。

對波萊特·帕爾來說,這一切來得太晚了。召回事件發生29天后,她在圣路易斯醫院的病床上度過了68歲生日,然后與世長辭。

對于帕爾的丈夫和他的律師、來自納什維爾的大衛·蘭道夫·史密斯來說,她死于BIA-ALCL就是乳房假體生產商過失行為的證據。但結合其他患者的情況來看,這表明了這樣一個從未將患者安全放在首位的全球性行業存在著系統性的問題。

除了帕爾的訴訟外,艾爾建和現在的艾伯維還面臨著更多由Biocell引發的多地訴訟。正如1990年代假體生產商道康寧被卷入訴訟的情況一樣,針對大型制藥公司的大規模訴訟有時可能會導致數十億美元的賠償。行業專家表示,現在估算艾伯維的潛在風險還為時過早,但瑞穗高級分析師瓦米爾·迪旺表示,“這絕對是我們正在關注的一個議題?!?/p>

但就連原告律師也承認,針對醫療器械制造商的訴訟很難進行,因為個體索賠往往會被FDA的既定產品批準先發制人。艾爾建訴訟案中原告律師詹妮弗·倫茨在描述搶占論點時表示:“即便產品存在問題,你也無權提起訴訟,因為產品已經通過了嚴格的聯邦審批程序?!?/p>

無論最終的法律結果如何,乳房假體問題顯然對銷售造成了影響。甚至在新冠疫情叫停非必要手術之前,整形外科醫生的報告就顯示隆胸需求出現下降。美國整形外科醫生協會前主席斯科特·格拉斯伯格稱,在FDA 2019年聽證會之后的一年里,“隆胸手術的數量下降了大約10%”,而“移除”手術卻出現了大約15%的增長。

3月,比佛利山整形外科醫生凱文·布倫納表示:“我做的假體移除手術比我做的植入手術還要多?!卑ㄕ倩厥錄⑸?,他的許多患者擔心自己會患上淋巴瘤,同時也提高了對于BII的認識。

乳房假體業務最終能否復蘇還有待觀察,特別是在當下,疫情和隨之而來的經濟低迷也放大了乳房假體問題。隨著消費者削減不必要的支出,隆胸手術繼上一次經濟衰退后有所下降。在艾伯維5月份的業績電話會議上,首席執行官理查德·岡薩雷斯承認,他預計隆胸手術數量收縮將對艾爾建的醫療美容業務產生“顯著”影響(假設這種影響是“暫時”的話)。

對于卡爾文·帕爾來說,疫情意味著他要一個人住在這個如今空蕩蕩的房子里,他需要努力適應波萊特離去后所帶來的更長久的孤獨。他的一個女兒住在街對面,所以他可以去看望孫輩來打發時日。但有時他會半夜醒來,撫摸妻子曾經躺過的那半張床,這才想起來妻子已然辭世。他說:“我沒有可以依靠的人了?!?/p>

一年前,他還在和波萊特一起規劃晚年退休生活。他說:“這輩子我所有的安排都是想要確保波萊特能過得很好。我們知道我會是先離開的那個。但他們害死了她,那該死的假體害了她?!?

乳房假體發展簡史

圍繞乳房假體的爭議已有近半個世紀之久。

1976

國會授權FDA監管醫療器械領域。自1962年問世以來,硅膠乳房假體一直沿用至今。

1984

瑪麗亞·斯特恩聲稱因使用道康寧硅膠假體引發疾病,獲得150萬美元懲罰性損害賠償。

1992

隨著乳房假體訴訟案增多,在國會聽證會結束之后,FDA呼吁暫停使用絕大多數硅膠假體產品。

1995

面對高達兩萬多件官司,道康寧啟動美國破產法第11章的破產?;ぃㄖ笸庖?2億美元達成和解)。乳房假體生產商百時美施貴寶公司、Baxter Healthcare和3M分別為植入硅膠假體受損的女性設立了和解基金。

2006

FDA允許硅膠乳房假體重返美國市場。

2010

一次政府突擊檢查曝光法國乳房假體生產商PIP公司非法使用工業級硅膠;公司倒閉,創始人被判入獄。

2018

艾爾建毛面乳房假體在歐洲遭遇禁售。

2019年7月

FDA要求艾爾建召回其乳房假體。(財富中文網)

本文刊載于《財富》雜志2020年6/7月刊,文章標題:《存在風險的乳房假體業務》。

譯者:楊超 唐塵

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.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ?BIA-ALCL, for “breast implant–?associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

The cost of embracing such troubled devices became painfully clear last year, after a surge in cases of BIA-ALCL. More than 903 women have now been diagnosed with that once-rare lymphoma, and more than 33 have died. Hundreds of thousands of others are estimated to be at risk of developing the disease, which can take decades to surface and has been linked to textured implants in academic studies. Cases of the lymphoma have been reported in women with implants from various manufacturers, including Johnson & Johnson and Sientra. But Allergan’s Biocell implants have by far the worst record of affected patients. By the end of 2018, European regulators stopped Allergan from selling textured implants. The FDA was slower to respond, but in July 2019 it finally asked Allergan to recall those devices from the market, citing BIA-ALCL. The company complied and suspended future sales.

By May, Allergan was facing about 48 lawsuits, including some class action claims, related to BIA-ALCL and its recalled implants. Alleging that problems with Allergan Biocell implants have caused injury, financial losses, and wrongful death, these cases have now been consolidated in a multi-district litigation in the U.S. District of New Jersey.

An Allergan spokesperson told Fortune via email that the company does not comment on pending litigation, adding that it “has a demonstrated history of dedication to the health and safety of patients” and “has followed FDA regulatory reporting procedures and acted transparently with patients about textured breast implants.”

In emailed statements to Fortune, Sientra did not address the linkages of BIA-ALCL to its textured implants, while Johnson & Johnson acknowledged “a low number of BIA-ALCL cases reported” in Mentor textured implants. Both companies said they prioritized the safety of their patients.

Binita Ashar, a general surgeon and director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, also calls women’s safety a priority. “We know more about breast implants today than we did 10 years ago, and we continue to learn more,” she says. “We will not hesitate to take further action if necessary to protect patients.”

“My surgeon basically told me, ‘Remember all the issues from the ’90s? They fixed all that,’?” recalls Maria Gmitro. Such dismissals of the risks involved with breast implants mean “patients do not have accurate information to make informed choices about our health,” she says.

Gmitro, who says she developed rashes and chronic fatigue after buying Mentor implants in 2014, is part of a growing cohort of women trying to get doctors to take implant-related health complaints more seriously. BIA-ALCL has drawn attention to more common health issues, including the constellation of symptoms known as “breast implant illness.” BII does not have an official diagnosis; some of its symptoms resemble autoimmune disorders. One Facebook group devoted to BII has more than 100,000 members, who trade symptoms and stories of relief after removing their implants—but patients say many doctors are quick to dismiss medical information that comes from such sources.

“Even now there’s a large part of the community that’s not taken seriously,” says Jamee Cook, a patient advocate who’s now on a breast implant task force with plastic surgeons. “But we’ve been able to sit at the table and have people realize that we’re not crazy, we’re educated women, and we have been harmed.”

At the very least, these patients say, implants have been marketed to women for years without adequate warnings from either manufacturers or surgeons, denying women their right to informed consent about the risks involved. Little tracking of medical devices exists in general, owing in part to the decentralized nature of the business. The FDA regulates manufacturers, not doctors; manufacturers sell their implants to plastic surgeons, yet patients are the end users and the ones in charge of keeping track of which implants they have. Historically, this was done through the extremely analog system of giving patients a card with their implants’ unique tracking number on it. If you lose that piece of paper, and your surgeon retires or destroys records after seven years, good luck figuring out which breast implants you got—or whether they’ve been recalled.

While better tracking systems are being developed, many patients affected by the Allergan recall say they found out about BIA-ALCL from the news or social media rather than from their doctors, Allergan, or the government.

“When I bought a new car that turned out to have a faulty air filter, my car dealer sent me three postcards and followed up with a phone call reminding me to bring it in,” says Raylene Hollrah, a breast cancer survivor and implant patient advocate who was diagnosed with BIA-ALCL in 2013. “But I have something in my body that causes a cancer that the FDA knew about—and hear nothing?”

When a medical device malfunctions, manufacturers are required to report it to the FDA’s publicly available database. But until 2019, the agency also allowed companies to file private “alternative” summaries of malfunctions. These allowed more than 300,000 reports of breast implant problems to remain hidden since 2009, the FDA acknowledged last year. “This was an approach to be more efficient, and when we recognized that there was a concern, we eliminated it,” says Ashar, adding that the reports are now public.

Tomes of Device Events says she met with the FDA in 2017 to discuss her findings that Allergan had, in some instances, reported problems with devices under the company name “Costa Rica” or “Santa Barbara” (locations where their implants were made), but not under “Allergan.” She shared documents from the meeting with Fortune, saying: “If you’re a physician, you go to the FDA database, and you’re going to look up the name Allergan, not Costa Rica. They were putting off the identification of the problems as long as they could.” (The FDA says it does not comment on individual meetings. The records now include the company name.)

An Allergan spokesperson says the company has “always worked to fully meet all FDA requirements, including our adverse event reporting obligations” and that it currently sends “all adverse event reports to FDA with full and accurate information using the company name and manufacturing location of the implant.”

When the FDA lifted its ban on silicone implants in 2006, it required manufacturers to conduct large, 10 year studies of the women who have their implants. Last year, Mentor and Sientra received “warning letters” from the FDA over their failure to track enough women over time. Both have been allowed to continue selling their products; Ashar says the FDA is “monitoring Mentor and Sientra’s progress” but would not provide specifics. J&J and Sientra both say they are working to increase patient participation in their studies.

A week after Ashar spoke with Fortune for this story, the FDA sent two more warning letters to breast implant manufacturers, citing its “ongoing efforts to protect patients.” One letter, to Allergan, said the company also failed to adequately study the risks of its now-recalled implants once they were on the market. The other letter, to privately-held Ideal Implant, said the company has failed to fix manufacturing and quality-control problems the FDA discovered during an inspection earlier this year. Ideal is also violating requirements for reporting problems with its implants, according to the letter.

The FDA gave both companies 15 working days to respond to its warnings. An Allergan spokesperson said the company is reviewing the letter and “takes this matter seriously.” A spokesperson for Ideal Implant said the company is working closely with the FDA and “strongly supports timely and accurate reporting on product safety.”

The agency is also considering more proactive regulation of future implant sales. In October, the FDA proposed adding a more severe black-box warning label to breast implants, along with an explicit patient-decision checklist. The proposal received more than 1,000 “mostly favorable” public comments, according to Ashar, who adds that “finalizing the guidance is a top priority for the agency.”

“A woman is more likely to be struck by lightning than get this condition,” an Allergan spokeswoman declared. It was January 2011, more than a decade after the first reported case of lymphoma tied to breast implants. The FDA had just issued its first public warning that women with breast implants “may have a very small but increased risk of developing” a disease then called anaplastic large cell lymphoma (ALCL). And in Missouri, Paulette Parr had just gotten her second set of Biocell implants.

At the time, there had been only about 60 cases of ALCL reported worldwide, and manufacturers were quick to downplay the risks. Yet the danger—at least to its bottom line—was grave enough for Allergan to warn investors about the potential negative consequences of the disease, including bad press and financial losses. “The manufacture and sale of breast implant products has been and continues to be the subject of a significant number of product liability claims,” the company warned in March 2011.

The risks of the breast implant business hasn’t dented the company’s prospects as an acquisition target. In 2015, Dublin-based Actavis bought Allergan and assumed its name; four years later, CEO Brent Saunders agreed to sell the combined company to AbbVie, maker of Humira. The $63 billion deal, announced in June 2019 and closed in early May, enables AbbVie to diversify into Botox, breast implants, and the other “medical aesthetics” which, Saunders told CNBC’s Jim Cramer, is “the best business in the biopharmaceuticals space. It’s highly durable, it’s cash pay all over the world, and it’s less regulated, so we don’t have to deal with government payers,” he said.

As Allergan rode the M&A merry-go-round, the chances that a woman with breast implants would be diagnosed with BIA-ALCL climbed from one in 500,000 in 2011 to one in 3,800 in 2019. Peter Cordeiro, a Memorial Sloan Kettering plastic surgeon who followed his patients for 27 years and almost exclusively used Allergan implants, estimates that his patients now have a one in 355 chance of developing the cancer.

But in 2018, the FDA still didn’t seem worried and neither was Paulette Parr—even when she noticed a pimple-size growth under her arm. She went in to have it checked, only to learn in November that she had this thing called BIA-ALCL.

Parr was 67 then, a newly retired grandmother, taking weekend jaunts to Memphis and looking forward to visiting New York City for the first time. And at first, her diagnosis didn’t sound so dire. The doctor told her, “You give me six sessions of chemo, it’ll be gone,” Calvin Parr recalls. “That relieved us really well.”

Problems with implants have increasingly complicated the health of one particularly vulnerable community: women with or at high risk of developing breast cancer.

Every year, more than 100,000 women—a quarter of breast-related plastic surgery patients—have “reconstructive” procedures, mostly after mastectomies. They don’t all have the disease; preventive mastectomies got a boost in 2013, when actor Angelina Jolie, who has a gene mutation that puts her at increased risk for breast cancer, wrote a New York Times op-ed about her decision to preventively remove her breasts and replace them with implants.

Today, such prophylactic mastectomies with reconstruction have become a reassurance for many young women who have seen their mothers and aunts and grandmothers die from aggressive cancers and who want to reduce their own hereditary risks. For these women, who don’t want to lose the femininity or sexuality associated with having breasts, implants have been life-changing devices.

“As somebody who was plagued with a fear of breast cancer my whole life, there was this amazing safety net,” says Caitlin Brodnick, a New York City comedian and the author of a memoir about her decision to have a preventive mastectomy and reconstructive surgery at age 28.

But one terrible irony of ?BIA-ALCL is that many women who had the surgery to reduce their risk of cancer could now contract a new type.

“To lose all the women in my family to cancer, to make this decision that is supposed to save my life—and then, just kidding! This put me at a whole other risk,” says Mia Kargen, a nursery school director in Westchester County, N.Y., who underwent the double procedure in 2014. “It was so stressful. It affects every part of life.”

Replacing implants or even simply removing (“explanting”) them requires another expensive surgery and time for recovery. In one high-profile instance, Match Group CEO Mandy Ginsberg in March stepped down from her $2-billion-in-revenue company, citing in part the surgery she had just undergone to replace her recalled breast implants.

There are separate, equally devastating effects for women like Paulette Parr and the hundreds of thousands of others who still get implants every year for cosmetic reasons. For many of them, developing BIA-ALCL has come with a side of self-recrimination and external criticism—not to mention massive medical bills.

“With this cancer, you’re judged,” says Michelle Forney, an HR manager at a financial services company who has now developed BIA-ALCL. A briskly upbeat Californian, her voice falters and breaks as she talks about the guilt she felt about her diagnosis: “I gave it to myself. I put these implants in for vanity. But do I deserve this?”

Costs for treating the lymphoma can run from $200,000 to $300,000, not including the costs of missing work or traveling for treatment, according to Mark W. Clemens. An associate professor of plastic surgery at the University of Texas MD Anderson Cancer Center, Clemens is treating many of the women who have contracted BIA-ALCL and preparing a study of its financial impact. “For patients who received a cosmetic augmentation, some insurers have policy exclusions; they will not cover a patient who’s been diagnosed,” he says.

One such insurer is Premera Blue Cross, a Washington State licensee of Blue Cross Blue Shield. A policy from March states that if a patient’s implants were placed for cosmetic purposes, removing them is covered only “if there has been interval development of breast cancer or other breast disease that requires mastectomy or partial mastectomy.” BIA-ALCL is not considered a breast cancer or disease.

Premera declined to comment on specific cases, citing patient privacy rules, and noted that the FDA does not currently recommend explantation if women have not been diagnosed with BIA-ALCL. The insurer added that it makes decisions on a case-by-case basis. “Each case has its own intricacies that guide the clinical decision of coverage,” Chad Murphy, Premera’s chief clinical officer, said in an emailed statement.

Allergan has offered up to $7,500 to cover out-of-pocket surgery costs to any woman who has developed BIA-ALCL, and $1,000 toward diagnostic testing. That’s too little, too late for women like Forney and Hollrah, who have filed suit against Allergan. “It has cost me thousands and thousands of dollars, and I have good insurance,” says Forney. “Cancer is an expensive gift that keeps on giving.”

In early 2019, after Europe halted sales of Allergan’s textured implants, Parr had hers removed and continued the chemo her oncologist promised would eliminate her BIA-ALCL. Her long blond hair started to fall out, and she eventually asked Calvin to cut it all off with his barber clippers.

In Maryland, the FDA was convening hearings to discuss the disease and the overall safety of breast implants. “Cases of BIA-ALCL have been reported in patients with an implant history that includes textured implants,” Dr. Stephanie Manson Brown, Allergan’s VP of clinical development for devices, testified. “What is important is that the prognosis is excellent, especially when identified early and treated appropriately.”

But in May, as the FDA said it would not ban textured breast implants, Parr’s tests showed that her lymphoma had metastasized. In June, as AbbVie announced its plans to buy Allergan, she spent the month hospitalized and undergoing more treatments. Eventually, her doctors told her that her health was too poor for her to qualify for an experimental treatment that seems to be effective for other patients with BIA-ALCL.

“She suffered an awful lot,” Calvin says, his Southern drawl thickening. “Her legs got so big that she couldn’t even put them together, her arms swelled up?…?and then we were just sitting and waiting for the end.”

Finally, on July 24, the FDA asked Allergan to recall its Biocell textured implants. The agency would later upgrade the recall to its most serious “Class I” designation, warning that “use of these devices may cause serious injuries or death.”

It all came too late for Paulette Parr. Twenty-nine days after the recall, after spending her 68th birthday in a St. Louis hospital bed, she died.

To Parr’s husband and his lawyer, Nashville-based David Randolph Smith, her death from BIA-ALCL is evidence of one implant-maker’s negligence. But when grouped with others, it suggests a systemic failure in a global industry that had never put patient safety first.

Parr’s lawsuit is part of the Biocell-related multi-district litigation Allergan, and now AbbVie, are facing. Large-scale suits against big pharma companies can sometimes result in multibillion-dollar payouts, as happened in the 1990s against implant maker Dow Corning. Industry experts say it’s too early to estimate AbbVie’s potential exposure, but “it’s definitely an issue we’re watching,” says Mizuho senior analyst Vamil Divan.

But even the plaintiffs’ lawyers acknowledge that lawsuits against medical device manufacturers are difficult to pursue, because individual claims filed are often preempted by the FDA’s preexisting approval of the products. “Even if there is something wrong with this product, you are not entitled to bring this action, because it has already gone through this strict federal approval process,” is how Jennifer Lenze, a lawyer representing the plaintiffs in the Allergan litigation, describes the preemption argument.

Whatever the eventual legal outcome, the problems with breast implants are clearly affecting their sales. Even before the COVID-19 pandemic shut down elective procedures, plastic surgeons were reporting a drop in demand. Scot Glasberg, a former president of the American Society of Plastic Surgeons, says that in the year following the FDA’s 2019 hearings, “we have seen the number of breast augmentations go down about 10%,” with “explants” up about 15%.

“I’ve been taking out more implants than I’ve been putting in,” Kevin Brenner, a Beverly Hills plastic surgeon, said in March. The Allergan recall made many of his patients concerned about developing the lymphoma, but also raised awareness about BII, he says.

Whether the breast implant business will eventually recover remains to be seen—especially now that its problems have been amplified by the pandemic and resulting economic downturn. Breast augmentations fell after the last recession, as consumers cut back on nonessential spending. During AbbVie’s May earnings call, CEO Richard Gonzalez acknowledged that he expects the contraction to have a “pronounced” if “transient” impact on Allergan’s medical aesthetics business.

For Calvin Parr, the pandemic means rattling around the house he shared with Paulette and trying to get used to a more permanent sort of isolation. One of his daughters lives across the street, so he’s able to break up the days with visits from his grandchildren. But sometimes he wakes up at night and feels the bed for his wife, before remembering she is gone. “I’ve got nobody to hang on to,” he says.

A year ago, he and Paulette were still planning the rest of their retirement together. “All of our life, I was the one making arrangements to make sure Paulette would be taken care of. We knew I’d be going first,” he says. “But then they killed her. The damn implants killed her.”?

A brief history of breast implants

The devices are approaching a half-century of controversy.

1976

Congress gives the FDA the authority to regulate medical devices. Silicone breast implants, on the market since 1962, are grand?fathered in.

1984

Maria Stern, who claims her Dow Corning silicone implants made her sick, wins $1.5 million in punitive damages.

1992

After more lawsuits and congressional hearings, the FDA calls for a moratorium on most silicone implants.

1995

Dow Corning, facing more than 20,000 lawsuits, files for Chapter 11 (it would later agree to a $3.2 billion settlement). Separately, manufacturers Bristol-Myers Squibb, Baxter Healthcare, and 3M establish a settlement fund for women with damaged silicone implants.

2006

The FDA allows silicone breast implants back on the U.S. market.

2010

A government raid uncovers French implant maker Poly Implant Prothese’s use of an unapproved industrial-grade silicone; it shutters and its founder is jailed.

2018

Europe halts sales of Allergan’s textured implants.

July 2019

The FDA asks Allergan to recall the devices.

A version of this article appears in the June/July 2020 issue of Fortune with the headline "The Risky Business of Breast Implants."

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