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Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientra’s U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel.

November 2012 . Volume 130 . Issue 5 . p 973-981
www.PRSJournal.com

Stevens, W. Grant M.D.; Harrington, Jennifer M.D.; Alizadeh, Kaveh M.D.; Berger, Lewis M.D.; Broadway, David M.D.; Hester, T. Roderick M.D.; Kress, Donald M.D.; d’Incelli, Rosalyn B.A.; Kuhne, JoAnn M.S.N.; Beckstrand, Maggi M.P.H.

Background: In March of 2012, the U.S. Food and Drug Administration approved Sientra’s application for premarket approval for its Silimed brand silicone gel implants, based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants. This article presents the results of Sientra’s study through 5 years.

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Discussion: Five-Year Follow-Up Data from the U.S. Clinical Trial for Sientra’s U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel.

November 2012 . Volume 130 , Issue 5 . p 982-983
www.PRSJournal.com

Saltz, Renato M.D.

The U.S. Food and Drug Administration approval of Sientra’s portfolio of Silimed round and shaped breast implants with high-strength silicone gel several months ago was welcomed by plastic surgeons in the United States. In addition to providing more choices for surgeons, this approval also marked the first U.S. approval and commercial availability of shaped silicone gel breast implants.

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