New silicone gel-filled breast implant comes to U.S. market

March 13, 2012


Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made by Sientra, Inc. for use in the United States.

The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.

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To learn more about the innovative treatments offered at Pacific Center for Plastic Surgery in Newport Beach, CA, contact our office by calling (949) 617-1168 or by filling out the consultation request form below.

The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.

As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.

Source: FDA – FDA approves new silicone gel-filled breast implant

Take the Next Step

As soon as you step into our Newport Beach office, our welcoming staff will carefully listen to your concerns and guide you through your treatment journey. The board-certified plastic surgeons at Pacific Center for Plastic Surgery will be happy to discuss your cosmetic goals, review the pros and cons of the treatment you are considering, and create a personalized treatment plan that will deliver the best outcome for you. 

To learn more about the innovative treatments offered at Pacific Center for Plastic Surgery in Newport Beach, CA, contact our office by calling (949) 617-1168 or by filling out the consultation request form below.


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