The FDA has just recently approved a third manufacturer of silicone breast implants in the United States. Sientra Inc. officially joined the scene on March 9 alongside Allergan and Mentor.
MD and President of the American Society of Plastic Surgery, Malcolm Z. Roth, says "The ability to offer our patients a wider variety of treatment options is good for everyone. Innovation and patient safety drive our specialty, so we welcome the opportunity to provide yet another FDA-approved alternative for both breast augmentation and reconstruction patients."
The approval of Sientra came after three years of clinical trials including nearly 1800 participants. Complications from Sientra’s implants were similar to those found in other previous breast implant trials including infection, asymmetry, capsular contracture, and implant removal to name a few.
Of course complications are to be expected with both breast augmentation and breast reconstruction.
"It's important to remember that breast implants are not lifetime devices," points out deputy director of science for the FDA Dr. William Maisel. He goes on to say that "Women should fully understand [the] risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential."
With the approval of Sientra comes a commitment from the company to conduct post-operative studies that will prove long-term safety as well as to uncover any potential risks.
Sientra has agreed to conduct a study of about 4700 women receiving the Sientra silicone gel implants over a period of ten years to evaluate the long-term complications and any rare but potential disease outcomes.
Dr. Maisel speaks of the importance of safety regulations with breast implants saying "The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness.”
To learn more about breast augmentation contact a plastic surgeon near you.Sources
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