Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). Approximately 5 to10 million women worldwide have breast implants. According to the American…

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FDA Advises Women with Breast Implants about ALCL If you or someone you know has breast implants, or if you’re thinking about getting them, you may have heard of Anaplastic Large Cell Lymphoma or ALCL. FDA recently announced that women who have breast implants may have a very small but increased risk of developing ALCL…

FDA Advises Health Care Providers on Breast Implants and ALCL FDA is notifying healthcare providers that women with breast implants may have a very small but increased risk of developing Anaplastic Large Cell Lymphoma in the area immediately surrounding the implant. Anaplastic Large Cell Lymphoma, or ALCL, is a rare type of non-Hodgkin’s lymphoma. FDA…

Stakeholder Meeting on MDUFA III ReauthorizationJune 16, 2011, 1:30 – 3:30 PMHHS Humphrey Building, Washington, DCRoom 325A Purpose To provide an update of FDA’s negotiations with Industry and to receive stakeholder input on FDA proposals. Participants Meeting Start Time: 1:40 pm Update FDA acknowledged receiving the American Academy of Orthopedic Surgeons request for metrics from…

Issued June 27, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated July 1, 2011

Date, Time and Location Supplementary Information Transcript Meeting Agenda Registration Contact Us Date, Time and Location The meeting will be held on September 22, 2011, from 8:00 a.m. – 12:00 noon EST, at the following location: The Embassy Suites Hotel, San Francisco Airport250 Gateway BoulevardSouth San Francisco, CA 94080(650) 589-3400 The meeting will not videotaped or…

Date, Time and Location Supplementary Information Transcript Meeting Agenda Registration Contact Us Date, Time and Location The meeting will be held on September 22, 2011, from 8:00 a.m. – 12:00 noon EST, at the following location: The Embassy Suites Hotel, San Francisco Airport250 Gateway BoulevardSouth San Francisco, CA 94080(650) 589-3400 The meeting will not videotaped or…

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