Silicone Gel Breast Implants Approved by FDA for Inamed
Silicone Gel Breast Implants & FDA Approval of Mentor / Allergan Silicone Gel Implants
Inamed Silicone Implants Get Conditional Approval from FDA
The Associated Press - Wednesday, September 21, 2005; 10:51 AM
The Food and Drug Administration said Wednesday it has given a second manufacturer of silicone gel-filled breast implants a conditional approval, moving the company a step closer to returning the implants to the market.
The FDA told Inamed Corp. that its implants can be approved under certain conditions. Those conditions were not detailed by the government.
In July, the government gave a similar, conditional approval to manufacturer Mentor Corp. after an FDA advisory panel voted 7-2 to recommend approval of the company's application to market the implants, which had been banned because of health concerns.
But the panel voted at the time against recommending Inamed's implants, citing safety concerns. However, the FDA said Wednesday that Inamed has subsequently provided additional information to address those concerns.
Inamed also said it would not sell a particular style of implant that had raised particular safety concerns, according to the FDA.
Proponents who have sought the return of the product say silicone-gel implants look and feel more natural than the salt water-filled implants sold without restriction.
Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. They were banned 13 years ago.
The implants largely have been exonerated of concerns that they might cause serious or chronic illnesses such as cancer or lupus. But aside from the risk of breakage, they can cause infection and painful scar tissue.
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