子宮切除設備致癌 聯調局調查強生 [2015-05-28] 消息人士透露，針對強生公司在去年被揭發，其生產的一項子宮切除設備令接受手術的婦女患上子宮癌，聯調局（FBI）正在調查公司在去年推出有關產品前，是否已知悉其危害。現時尚不清楚當局的調查進展情況。 據《華爾街日報》報道，FBI在過去數月訊問了多名相關人士，包括早在2006年向強生知會了「腹腔鏡高能粉碎器」（LPM）潛在問題的一名退休病理學家、2013年因LPM導致自身癌症惡化的一名女醫生；以及一名加州女子，據稱她成功向400名可能受到LPM傷害的病人和家屬收集簽名。 LPM主要利用微創手術來切除子宮肌瘤。食品及藥物管理局（FDA）在去年4月警告說，接受LPM手術的女性有1/350的機會無法檢測到危險的子宮肉瘤，並在進行手術後令其惡化。隨FDA在11月對LPM發出最強烈的「黑盒警告」，FBI便展開調查，全國多家醫院也陸續減少或考慮限制使用這項設備。強生公司在去年7月將LPM下架。去年5月接受FBI訊問的賓州前病理學家林柏特表示，他在2006年2月注意到LPM可能檢測不到惡性腫瘤的潛在問題後，曾經聯絡強生公司負責售賣有關儀器的子公司Ethicon。強生發言人約翰遜證實有關說法，並聲稱當時公司因此而修訂了設備使用說明。 新修訂的使用說明指出，如果醫生懷疑或知道患者出現惡性組織，在使同LPM時應配合使用「組織抽取袋」。 42歲的賓州麻醉師里德在2013年於波士頓一家醫院接受LPM手術而導致癌症惡化。她在過去數月也接受了FBI的訊問。該波士頓醫院證實了LPM令里德癌症惡化，並透露這項設備在2012年也令另一位患者的惡性腫瘤擴散。 在2個月前獲FBI接強的加州醫師助理羅賓遜，曾經在FDA的LPM聽證會上出示她收集的LPM受害者簽名。她把該386人的名單交給FBI人員，當中也包括她自己。江蘭心編譯
FBI investigating laparoscopic power morcellator, Johnson & Johnson (Ref: CNBC, The Wall Street Journal) May 27th, 2015 By: Katie Bell The FBI is investigating the laparoscopic power morcellator (LPM) and is looking into what Johnson & Johnson knew about the risk of the device before pulling its LPM off the market last year, The Wall Street Journal reported Wednesday, citing three people who have been interviewed. A Johnson & Johnson spokesman said the company is not aware of an investigation into the device. In July 2014, Johnson & Johnson asked customers to return already purchased LPMs as part of a worldwide withdrawal, having previously suspended global sales of the devices amid concerns they can potentially spread cancer in women being treated for fibroids. According to The Wall Street Journal. Robert Lamparter, a former pathologist at Evangelical Community Hospital, Lewisburg, Pennsylvania said the FBI interviewed him on May 12 about his 2006 correspondence with Johnson & Johnson's Ethicon division that sold morcellators. Lamparter had reportedly contacted the company after he began noticing more morcellated specimens in his laboratory, stating that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the device. Specifically he said he wrote to David Robinson, an Ethicon medical director at the time, that at his small hospital, gynecologists were surprised by an unexpected malignancy at least once a year, for a "1/150 to 1/300 chance that a uterus will have an unexpected malignancy." Lamparter noted at the time "if a morcellation is done, the patient's survival is jeopardised." Johnson & Johnson spokesman Matthew Johnson confirmed the 2006 correspondence with Lamparter, adding that the doctor's concerns led the company to revise the instructions for use of LPMs. Robinson wrote to Lamparter in April 2006 stating that the revision included wording stating use of the morcellator "may lead to dissemination of malignant tissue," while Johnson & Johnson's instructions already recommended that doctors who suspected malignant tissue should use a tissue extraction bag with the device. Ethicon morcellators "have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," Johnson remarked. Meanwhile, other people said their conversations with the FBI did not center on Johnson & Johnson or other manufacturers. Anesthesiologist Amy Reed noted the FBI has interviewed her several times over the past few months about her case, which involved worsening cancer after she underwent a hysterectomy with a morcellator at a Boston hospital in 2013. In April 2014, the FDA warned against using LPMs during hysterectomy or myomectomy in women with uterine fibroids due to the risk of spreading undiagnosed gynaecologic malignancies within the abdominal cavity, and later recommended that manufacturers update product labelling to include a boxed warning to that effect. In July last year, an FDA advisory panel failed to agree on whether the use of LPMs for gynaecologic indications should be banned. Many health insurance companies, and most recently Aetna, have since stopped covering routine use of LPMs.
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