Silicone Gel Breast Implants Approved by FDA for Inamed
Silicone Gel Breast Implants & FDA Approval of Mentor / Allergan Silicone Gel Implants
Allergan, Mentor May Sell Silicone Implants in Canada
Souce: Bloomberg News
By Rob Waters
Oct. 20 (Bloomberg) -- Allergan Inc. and Mentor Corp., two competitors selling breast implants, won Canadian approval to sell silicone-filled versions for breast enlargement.
Allergan was granted a license to sell implants in Canada for breast augmentation, reconstruction and revision surgery, the Irvine, California-based company said today in a statement. A similar announcement was made by Santa Barbara, California- based Mentor.
The companies are counting on the Canadian action to lead to a similar decision in the U.S., expanding the market. In the U.S., silicone-filled versions are now limited to women who lose their breasts to cancer or have deformities. The Food and Drug Administration may lift its 14-year-old curbs on the implants, imposed because of safety concerns.
"If Canada has approved, one would hope that the FDA would hopefully come to the same conclusion,'' Joshua Levine, chief executive officer of Mentor, said in a telephone interview.
Women in the U.S. who wish to use implants to enlarge their breasts for cosmetic reasons now must use the saline versions, which feel less natural, according to the makers.
In 2005, nearly 340,000 American women had breast-implant surgery, according to the American Society for Aesthetic Plastic Surgery, based in Los Alamitos, California. More than 85 percent of the operations were cosmetic breast enlargements using saline implants.
Canada's ``decision to approve the implants is consistent with our determination in 2005 that the devices are approvable pending resolution of certain issues,'' said Megan Moynahan, an FDA spokeswoman, in a telephone interview. She declined to specify the concerns.
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