Silicone Gel Breast Implants Approved by FDA

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

FDA Says 'Yes' to Silicone Breasts: Agency Lifts 14-Year Moratorium on Implants

Source: ABC News Medical Unit
Reported by: Dan Childs

Nov. 17, 2006 — After 14 years, silicone breast implants will once again be available to women in the United States.

The decision by the Food and Drug Administration makes silicone implants available to all breast reconstruction and revision patients, as well as women 22 years of age and older seeking cosmetic breast enhancement.

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A number of conditions come attached to the approval, including studies and follow-up of a projected 40,000 women over the next 10 years, says the director of FDA's Center for Devices and Radiological Health Dan Schultz.

The move comes less than a month after health officials in Canada allowed such implants back onto the market after the country's moratorium, which began in 1999.

The decision has big implications for the industry, as breast augmentation is the second most-popular cosmetic surgery procedure in the United States today. According to statistics from the American Society for Aesthetic Plastic Surgery, nearly 365,000 women had breast augmentation surgery in 2005 — a number topped only by that for liposuction.

Since the 1992 moratorium, only saline-filled implants have been allowed on the general market, and silicone implants had been available only to special patients through FDA-approved trials.

"The moratorium was put in place in 1992 by the FDA because they felt that there was insufficient evidence to determine if [silicone implants] were safe," said Dr. Michael Olding, chief of the division of plastic surgery at George Washington University Medical Center in Washington, and a member of the FDA's General and Plastic Surgery Devices Panel.

"This does not mean that they were unsafe," he said, "but rather that more information was necessary, so they pulled them from the market temporarily."

Olding said scientific studies conducted since the moratorium have concluded that there is no scientific link between silicone implants and the systemic diseases many believed were connected to their use.

"It's sort of a vindication because we all knew there was no scientific evidence back in 1992 that necessitated the moratorium," said Dr. David Song, chief of plastic surgery at the University of Chicago Pritzker School of Medicine in Chicago. "Since 1992, there have been several landmark studies, two of which were in the New England Journal of Medicine, that showed there was no correlation between silicone leakage and all the health conditions that were being described. 

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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