Silicone Gel Breast Implants Approved by FDA

Silicone Gel Breast Implants & FDA Approval of Mentor / Allergan Silicone Gel Implants

FDA Statement: FOR IMMEDIATE RELEASE 

July 28, 2005
FDA Statement on Approvable Letter to Mentor Corporation

The U.S. Food and Drug Administration (FDA) today issued an approvable letter to Mentor Corporation for their application for silicone gel-filled breast implants. Federal law and regulations prohibit the government from discussing the specific contents of the letter.

However, an approvable letter is one of several intermediate steps in the FDA review process of new products. Previously at their April 2005 meeting, the General and Plastic Surgery Devices Advisory Committee voted 7-2 that Mentor’s application was “approvable with conditions.” This letter does not mean that the device is approved for marketing in the United States at this time.

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News Articles Regarding Silicone Gel Implants

Recovering, finally, from the breast implant panic - Chicago Tribune - November 30, 2006
Silicone implants' return could keep doctors busy - USA Today - 11/19/2006
Ban on Silicone Breast Implants Lifted - AP - 11/17/06
FDA Lifts 14-Year Moratorium on Implants - ABC News - 11/17/06
Allergan, Mentor May Sell Silicone Implants in Canada - Bloomberg 10/20/06
Investigation Nixes Silicone Breast Implant Allegations - AP- 7/28/06
Inamed Silicone Implants Get Conditional Approval from FDA- AP- 9/21/05
Inamed Breast Implants Get Conditional FDA OK - Reuters - 9/21/05
Inamed Silicone Implants Get Conditional Approval from FDA- AP- 9/21/05
Where's the Choice? - Sally Satel - The National Review - 8/22/05
Last Implant Gasp? - The Washington Times - 8/21/05
Controversial silicone implants may return - UPI - 8/16/05
FDA: Silicone-gel breast implants on way back - 7/30/05
FDA Move on Breast Implants Draws Swift Reactions - 7/30/05
Breast-Implant Maker Gets 'Approvable Letter' From FDA - 7/29/05
Plastic Surgery Societies Applaud FDA 'Approvable with Conditions' Letter - 7/28/2005 6:09:00 PM
Mentor Gets Conditional Approval for is Silicone Gel Breast Implants - Street.com 7/28/05
FDA Statement on Approvable Letter to Mentor Corp. re: Silicone Gel Breast Implants - 7/28/05
Mentor's Silicone Gel Breast Implants Get FDA OK - Reuters 7/28/05
Mentor Approvable Letter From FDA for Silicone Gel-Filled Breast Implants - 7/28/05