Tag: sientra

Sientra TRUE Texture™ Implants come with Unique Guarantee

sientraBreast implant maker Sientra has announced their Capsular Contracture Care Program, the first of its kind in the industry. The C3 Program provdes breast implant patients with a guarantee beyond the standard manufacturer’s warranty. From Sientra:

Under the C3 program, a primary augmentation patient will qualify for a free replacement implant if she requires revision surgery to correct Baker Grade III or IV capsular contracture within the first two years after implantation.

Capsular contracture is an unusual response of the body to medical implants, including all types of breast implants. It involves tightening of the tissues around the implant, which makes the breast feel firm to the touch and possibly alter its aesthetics.

Sientra’s TRUE Texture™ implants were found to carry a significantly reduced risk of capsular contracture compared to its smooth implants, according to a study published this month in Plastic and Reconstructive Surgery. The analysis looked at more than five thousand implants over a five-year follow up process, providing a very robust set of data as a foundation for this finding. It is with this statistical confidence in the resilience of their textured implants against capsular contracture that Sientra introduces the C3 Program.

As with the implants themselves, Sientra’s C3 Program is only available through plastic surgeons certified by the American Board of Plastic Surgery. This is done to improve patient confidence even further — it ensures that surgical procedures using Sientra implants are only done by the most qualified doctors.

Dr. Larry Nichter is proud to offer Sientra’s implants at the Pacific Center for Plastic Surgery, as well as the C3 Program and the warranty that comes with all Sientra implants.

New Breast Implant on U.S. Market

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.

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