Tag: fda

New FDA Approved Silicone Natrelle 410 Breast Implants

The U.S. Food and Drug Administration has approved a new “gummy bear” silicone breast implant. The implants, whose official title is Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implants, are made by Allergan.

Image: FDA

The implants underwent seven years of research involving 941 women. The FDA’s conclusion from all this data is that the new silicone breast implants are safe and effective. The implants are now available for increasing breast size in women at least 22 years old, and for rebuilding breast tissue (reconstruction) in women of any age.

The approval comes with the condition that Allergan must continue post-approval research for five more years to ensure the safety and efficacy of the Natrelle 410 silicone breast implants. This does not mean that the safety of these implants is particularly in question, but rather reflects the high standards that medical devices of all kinds must meet to be approved in the United States.

The introduction of the Natrelle 410 silicone breast implant to the market is the most significant new approval since Sientra’s highly cohesive silicone gel implants last year. In the pipeline and hopefully soon to be FDA approved and released will be the innovative double-lumen saline Ideal Implant® with the feel of silicone but the safety of a saline implant. This alternative to traditional silicone breast implants is and will be available at the Pacific Center for Plastic Surgery.

Despite three decades of safety testing and monitoring of silicone breast implants, there is still a public perception that silicone breast implants are more toxic or dangerous than saline implants. The truth is that there has no known toxicity from silicone gel breast implants. In fact, silicone is one of the most common materials used in medical devices and implants. Read this article on the safety of silicone gel breast implants by Dr. Nichter for more information.

Dr. Larry Nichter is proud to offer the new Natrelle 410 silicone gel breast implant at the Pacific Center for Plastic Surgery. As board certified plastic surgeons with the highest qualifications, Dr. Nichter offers his patients the most advanced breast implants with confidence in their safety and performance.

Additional source: US FDA

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