The Surgeon Minute

FDA Close to Approving New Breast Implants

FDA Close to Approving New Breast Implants

“New implants can produce beautiful, long lasting results in the right patient” — Caroline Glicksman, MD

The Food and Drug Administration is close to approving two additional form stable silicone gel breast implants manufactured by Allergan and Mentor.  In March of 2012, Sientra became the first of the three manufacturers to receive FDA approval for the sale of their version of the newest generation of shaped form stable breast implants. For the last 12 years, the only way a woman could obtain these devices in the United States was if she was willing to participate in a long-term clinical trial that studied the safety and effectiveness of these implants. As board certified plastic surgeons begin to offer their patients more options in breast augmentation and reconstruction, there will be more choices, but this may also lead to more confusion.

By Caroline Glicksman, MD
and Carolynn Grimes

Am I a Candidate for Breast Implants

To help you decide what type of breast implant is best for you, Caroline Glicksman MD, a board certified plastic surgeon from New Jersey says start your research early by learning as much as possible about the different shapes, fills, and shells available.  Women considering a breast augmentation, reconstruction, or even a revision of existing breast implants, should be aware that not only are these newer generation breast implants different from the round gels approved in 2006, but that the Allergan style 410, the Mentor CPG, and Sientra’s newest shaped breast implants, all differ from each other as well.

Selecting an ImplantThe next step, says Dr. Glicksman, is to find a board certified plastic surgeon with extensive experience and expertise using both round and shaped implants. “There’s a lot more to breast augmentation than just the surgical procedure, and some of the most important decisions in breast augmentation, reconstruction, and especially implant revisions, occur long before the actual procedure. The most responsible decision a woman can make is to prioritize her breast health and long-term results above her immediate desires.”


More Choices for Women

Glicksman makes the point that there’s no one perfect implant for each woman. It depends on the woman’s existing breast tissue and her ultimate goal of how she wants to look.  However, she says there are some basic guidelines that may help you choose between the less cohesive round gels and the newer shaped form stable implants.

  • Be aware that each of the newer form stable breast implants are shaped, but differ  with varying degrees of cohesivity, percentage of gel fill, and differences in the texture of their shells
  • The newest generation of form stable breast implants have demonstrated lower rupture rates and capsular contracture rates and may be a better choice for more safety conscious women.
  • These newer shaped breast implants are probably best suited for first time breast augmentation patients who desire a more proportionate breast augmentation.
  • With a few exceptions, the shaped form stable breast implants may not be the right choice for women who want to be full in the upper portion of the breast, and are looking for a rounded, higher look.

The expected FDA approval of two additional form stable breast implants in the near future comes after years of clinical trials by all three manufacturers.  It is also important for women to realize that the nick-name “Gummy Bear”  has been extensively used to describe a wide variety of silicone breast implants, and does not always identify an implant as a 5th generation or form stable device.   “The newest form stable gels require careful patient selection, education, and planning, but can produce very beautiful, long lasting results in the right patient,” says Glicksman.

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