| illexyVer | Дата: Среда, 11.09.2013, 15:35 | Сообщение # 1 |
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| The FDA says it is liaising with implant manufacturers so that their product labels are updated with this information. chief scientist and deputy director for science in FDA's Center for Devices and Radiological Health, said: We need more data and are asking that health care professionals tell us about any confirmed cases they identify. We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants. The National Cancer Institute informs that approximately 1 in every 500,000 American females is diagnosed with ALCL annually. Approximately 3 in every 1,000 million females without breast implants develop ALCL in breast tissue. So far, 60 cases of ALCL in women with breast implants have been reported globally. The FDA warns that this figure is tenuous at the moment and there is a risk there may have been duplication.
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Between 5 million to 10 million women worldwide have received breast implants. In a communique, the FDA writes: The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants. The FDA has mostly reviewed cases that concerned women who went to their doctors complaining of implant-related symptoms, including lumps, swellings, pain, or asymmetry which developed after the surgical area had healed. Symptoms were caused by peri-implant seroma (fluid accumulation), capsular contracture (breast area around the implant hardens), or masses around the implant. ALCL diagnoses resulted from examination of the fluid and capsule around the implant.
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