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FDA Approves a New 410 Breast Implant after More than a Decade of Studies

FDA Approves a New 410 Breast Implant after More than a Decade of Studies

Published February 20, 2013

The Food and Drug Administration recently approved a new type of breast implant called the Natrelle 410, developed and studied by the breast implant company, Allergan Inc. Surgeons say there will now be more choices available for women, but also more confusion.


By Carolynn Grimes
ThePlasticSurgeryChannel.com

FDA Approves Allergan Breast Implant

This newly approved implant has been available for more than a decade in Europe, Canada, Asia and South America.  Here in the United States, women have been limited in their choices and these implants have only been available in clinical trials. They’re correctly termed “form stable” implants, and this is where the confusion begins.

What Should Patients Know

Board certified plastic surgeon, William P. Adams, Jr., MD from Dallas says, “It’s actually incredible how confusing this is to  patients.  Much of the problem has been marketing and media hype that has inaccurately painted implants as all being the same.”  The result, says Adams, is patients simply can’t figure it out!

Some of the more common lingo for the newer shaped form stable implants is gummy bear, highly cohesive and cohesive silicone gel.  The Plastic Surgery Channel interviewed plastic surgeons around the country to clear up the confusion and simplify the implant choices and the new form stable implant now available to American women.

What Breast Implant Choices are There?

The saline round implant—These types of implants were approved by the FDA in 2000. Brad Bengston MD, a board certified plastic surgeon from Grand Rapids, Michigan says saline implants tend to have the most degree of rippling or wrinkling.

Form Stable ImplantThe standard round silicone gel implant—Approved by the FDA in 2006. “These implants don’t have the same degree of cohesiveness or firmness of the gel on the inside as the form stable,” says Bengston.

The form stable implant—In March 2012, Sientra was the first breast implant company to receive approval from the Food and Drug Administration and develop a newer generation of implants, says Pat McGuire MD, a board certified plastic surgeon from St. Louis, Missouri. “What’s different about the form stable implant is the gel on the inside of these implants is thick enough to hold their shape.”

Who is the Ideal Candidate for the New Implant?

Caroline Glicksman, MD, a board certified plastic surgeon from New Jersey says if a patient is looking for a more proportionate or natural look, they’re probably a good candidate for a form stable implant. “Certain breast types are ideal for these implants including, patients with constricted breasts, chest wall deformities and, breast reconstruction patients.  However, the implants require special expertise on the part of the surgeon and patients should know that these shaped form stable implants are not ideal for everyone,” says Adams.

“These implants come in variable widths, heights and projections, so it’s a little bit more technically demanding operation and requires a surgeon who really knows what they’re doing,” states Glicksman.  She says anyone considering breast augmentation with this new form stable implant should go to a surgeon who is experienced with both round and shaped devices.

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