Silicone Gel Breast Implants Approved by FDA for Mentor
Silicone Gel Breast Implants & FDA Approval of Mentor / Allergan Silicone Gel Implants
Mentor's silicone breast implants get FDA OK
Thu Jul 28, 2005 4:59
WASHINGTON, July 28 (Reuters) - Silicone gel-filled breast implants won conditional approval to return to the broad U.S. market after a 13-year ban on Thursday when U.S. health officials backed a version made by Mentor Corp. (MNT.N: Quote, Profile, Research)
The U.S. Food and Drug Administration said the device maker must satisfy a number of conditions before it receives final approval to sell the implants. FDA officials said they would not make the conditions public. "Federal law and regulations prohibit the government from discussing the specific contents of the letter," the agency said. Mentor said the conditions were "generally consistent" with recommendations from an expert FDA advisory panel that met earlier this year.
Shares of the Santa Barbara, California-based firm were halted in after-hours trading after closing down 84 cents, or 1.87 percent, at $44.20. It was not immediately clear what the decision meant for competitor Inamed Corp. (IMDC.O: Quote, Profile, Research), which had also sought approval for its implants.
Dan Cohen, Inamed's vice president for global corporate and government affairs, said he was not aware that the FDA had made any decision about his company's silicone implants. Shares of Inamed, which is being bought by Medicis Pharmaceutical Corp., closed down 28 cents at $71.41 ahead of the Mentor announcement.
The United States banned silicone breast implants for most women in 1992 amid allegations that leaking silicone caused disabling, long-term illnesses such as rheumatoid arthritis and lupus. In April, an FDA advisory panel voted 7-2 to recommend approval of Mentor's silicone implants and 5-4 against sales of Inamed's implants.
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