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New silicone breast implant receives FDA Approval

New silicone breast implant receives FDA Approval

The U.S. Food & Drug Administration has approved Sientra Inc.’s silicone gel-filled breast implant for breast reconstruction or augmentation in women aged 22 or older, the agency said news release dated March 9th.

Similar silicone breast implants made by two other manufacturers (Allergan and Mentor) have been on the market after receiving FDA approval in 2006.

Approval of the Sientra silicone breast implant followed rigorous clinical testing involving 1,788 patients. Adverse reactions included tightening of the skin and soft tissue surrounding the implant (capsular contracture), asymmetry and infection.

As a condition of approval, Sientra will be required to follow patients for seven additional years, and to conduct a 10-year study of nearly 5,000 breast augmentation and breast reconstruction patients to see if the implants are associated with diseases including rheumatoid arthritis and breast cancer.

Look for Sientra silicone breast implants to become available for breast augmentation in Dallas, Plano, Frisco and the surrounding communities in the upcoming months ahead.

East Texas woman released from hospital after fraudulent breast augmentation

Here’s yet another cautionary tale about the need to find a board-certified plastic surgeon to perform your cosmetic surgery.

An East Texas woman who spent more than two weeks hospitalized after a bogus breast augmentation procedure has been discharged. Officials say Sheena Bradford left a Longview hospital on 3/5/12 after being treated for an unknown gel injected into her breasts. For a period of time prior to discharge, her condition had been listed as critical. Her injections were performed by a beauty shop owner, who, at this time, has not revealed the substance she injected into Ms. Bradford’s breasts. The beauty shop owner, Carmel Foster, has been arrested for practicing medicine without a license and is currently being held on $200,000 bond.

Yet again, make sure your surgeon is certified by the American Board of Plastic Surgery. That way, you will know that he or she has undergone the necessary training and is qualified to perform your cosmetic surgery.

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9101 N. Central Expwy.
Suite 600, Dallas, TX 75231
Tel: 214.827.2814
Dallas | Dr. Jejurikar

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