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New Shaped Breast Implants Close to FDA Approval

New Shaped Breast Implants Close to FDA Approval

Media Hype Causes Confusion Among Patients

The Food and Drug Administration is very close to approving two new types of breast implants developed and studied by the breast implant companies, Allergan and Mentor.  The FDA has not revealed  the announcement date, but surgeons say once these implants are available to the public, there will be more choices for women, but also more confusion.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

These new implants have 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 new implants have only been available in clinical trials. They’re correctly termed “form stable” implants, and this is where the confusion begins.

Board certified plastic surgeon, William P. Adams, Jr., MD from Dallas says, “It’s 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 gelThePlasticSurgeryChannel.com interviewed plastic surgeons around the country to clear up the confusion and simplify the implant choices and the new form stable implant soon to be available to American women.

Implant Choices

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

round siliconeThe 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 Bengtson.

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.  Bengtson says, “What’s different about the form stable implant is the gel on the inside of these implants is thick enough to hold their shape.”

The Ideal Candidate

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. Adams explains, “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.”

Form Stable Implant“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 implant should go to a surgeon who is experienced with both round and shaped devices.

 

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