The  of Breast Implants

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

And now that the Food and Drug Administration has lifted a 14-year ban on the marketing of silicone implants, Cummings, who runs www.implantinfo.com, predicts plastic surgeons' offices will be getting more phone calls than usual today about breast augmentation.

SILICONE IMPLANTS OK'ED: FDA lifts ban

"I had women say back last spring, 'Should I wait? Should I wait?' " Cummings, 39, of Lake Worth, Fla., said Sunday.

One woman who posted Sunday on Cummings' website wrote that she had just returned from getting silicone implants in another country when she learned that the FDA late Friday had lifted restrictions on their use in the USA. The agency emphasizes that breast implants don't last forever and advises women to get an MRI three years after surgery and every two years afterward to check for "silent ruptures."

Since 1992, when safety concerns led then-FDA chief David Kessler to pull silicone implants off the market, the devices have been available only in clinical trials and then only to women who have had a mastectomy, were born with a deformity or needed to replace other implants, as Cummings did.

"I believe most women are going to opt for silicone," says Cummings, who had breast enlargement surgery with saline implants in 1998 and replaced them with silicone implants this year.

Roxanne Guy, president of the American Society of Plastic Surgeons, says, "I think most of the plastic surgeons do expect an increase in breast augmentation initially, sort of a big blip."

Guy, who practices in Melbourne, Fla., says she has fewer than 20 patients who have been waiting for approval of silicone implants before getting breast augmentation surgery. "There's not a great number, because they kind of got tired of waiting," Guy says.

Though manufacturers say silicone implants represent 90% of the European market, where their use has never been restricted, they're only about 15% of the U.S. market.

Josh Levine, CEO of Mentor, which, with Allergan, got FDA approval to market silicone implants, says his company expects that 40% of breast implant surgeries in the next year will use silicone implants. "In virtually every region of the world, it ends up over time becoming the dominant choice," Levine said Sunday.

Caroline Van Hove of Allergan says, "I really think there will be a place for both" types.

One of the FDA's conditions for approval requires that doctors who want to use silicone implants first complete the maker's training program. Surgeons who have participated in studies of silicone implants can continue using them for 90 days without completing the training program, Levin notes.

He says doctors began logging on to Mentor's Web-based training program right after the FDA announced it had approved silicone implants. Mentor expected doctors would need 90 minutes to take the course, which focuses on "getting comfortable" with the product labeling, but doctors report finishing it in about an hour, Levine says.

Silicone implants cost more than saline implants, although for now, at least, surgeons charge the same for implanting them, Guy says. Allergan's list for about $900 and $450 apiece, respectively, and Mentor's list for $800-$950 and $550-$625.

Up to the Minute: News Articles about 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
 Silicone gel breast implants approved for return to Canadian market - CP 10/21/06
 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

Up to the Minute: News Articles about 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
 Silicone gel breast implants approved for return to Canadian market - CP 10/21/06
 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

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