359人病9死,美國FDA證實矽膠隆乳可致癌

連結:359人病9死 美證實矽膠隆乳可致癌

據英國《每日郵報》(Daily Mail)報導,FDA接獲通報,已有359名女性聲稱,隆乳與她們罹患罕見的「退化性大細胞淋巴瘤」(anaplastic large cell lymphoma,ALCL)有關。而到今年2月1日為止,其中有9名女性已喪生。

事實上,世界衛生組織(WHO)6年前已率先警告,兩者可能有關,而美國醫療研究人員加以證實,象徵著一大成就。去年法國已確認,矽膠隆乳與這種癌症有明確的關聯,並要求廠商證明他們的產品安全,否則將面臨被禁的命運。

小編評:附上法國之前相關新聞給大家參考,iQC舊聞「法國國家藥品安全管理局:乳房植入物與癌症有關」。

連結:US regulators CONFIRM breast implants cause rare form of cancer after 9 women died from the silicone-linked disease

連結:FDA links very rare cancer, 9 deaths, to breast implants

Nine deaths from a very rare kind of cancer have been linked to breast implants, indicating a very low but increased risk in women with implants, according to the U.S. Food and Drug Administration.

The FDA said it now agrees with the World Health Organization, which concluded years ago this type of lymphoma can develop following breast implants. Concerns were first raised at the FDA in 2011, but the agency said then that there were too few cases to know if there was a connection.

In an update on Tuesday, the agency said it had received 359 reports of the cancer in women with breast implants, but cautioned that such reports are often missing key details, unconfirmed or duplicated.

小編評:每日郵報的報導,給大家參考。

連結:Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma(FDA公告)

Through February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. There are 231 reports with data on surface information at the time of reporting. Of these, 203 were on textured implants and 28 on smooth implants. There are 312 reports with data on implant fill type. Of these, 186 reported the use of silicone gel-filled implants, and 126 reported the use of saline-filled implants.

小編評:這篇才是美國FDA公告。

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