Newest “Gummy Bear” Breast Implant Approved by FDA

Atlanta breast augmentation patients may want to now that one of the two larger breast implant manufacturers, Mentor Corporation, announced on June 14^th that its style of “gummy bear” silicone gel implants was approved by the FDA for cosmetic use in women 22 years of age and older, and for reconstructive use for women of any age. 

A 6-year study of nearly 1,000 women was undertaken to ensure reasonable safety and effectiveness of the new implant. Similar to other “gummy bear” implants, the risks of capsular contracture, asymmetry and wrinkling do exist, though Mentor states that the consistency of this implant will minimize wrinkling and rippling two complaints often made by thinner women with other implants. As with all other gel implants, the FDA will require post-approval studies focusing on long-term safety. 

What does “Gummy Bear” Mean?

The term, “gummy bear implant,” indicates that the consistency of the gel inside is similar to a gummy bear candy than is the gel inside other implants. The texture of the gummy bear implant is tighter and thicker, reducing the potential for capsular contracture, and maintaining a consistent shape.

Although I prefer Allergan's Natrelle 410 implants, I hope knowing your options is helpful to all my Atlanta breast implant patients! 

To your health & beauty,
Dr. Carmen Kavali
Board Certified Atlanta Plastic Surgeon

Do You Need to Change Your Breast Implants?

I’d like to talk to you about the “shelf life” of breast implants. Atlanta TV commercials tell us that “diamonds are forever,” right? Unfortunately, breast implants aren’t.

Why Replace Breast Implants?

There are several reasons you might wish to switch out your implants in a procedure called a breast implant revision. Here are a few of them:

1.    A desire to change implant size (larger or smaller)

2.    A desire for a change in shape or projection

3.    A wish to switch from saline-filled to gel-filled or vice versa

4.    A capsular contracture

5.    Deflation of saline implants (one or both)

6.    Visible wrinkling, rippling, bottoming out or the presence of the “double bubble”

7.    Breast sagging that requires implant changes during a breast lift. It’s not always necessary to replace the implants in a breast lift performed long after breast implants were inserted. Much depends on the age of the implants and whether or not my patient is satisfied with the size of her breasts, not withstanding her dissatisfaction with the sagging of them.

How Long Do Implants Last?

While most women are told that their implants will last about ten years, some women will have no need or desire to change implants for 20 years. In other words, it varies among women.

Will There Be More Scars if I Replace My Breast Implants?

Usually no. Unless the scars are hypertrophic, the same incisions are used as were used in the initial breast augmentation procedure.

How Do I Know If My Breast Implants are “Too Old?”

Unless you have one of the problems noted in the list above, if it’s not broken, don’t fix it. If you have any concerns about your implants, however, set an appointment to see me. Remember, in saline-filled implants a rupture is obvious, but a gel-filled implant failure isn’t. If you’re experiencing “women’s intuition” about your implants, come in and I’ll examine you. If I think you need an MRI to identify a possible gel-filled implant failure, I’ll tell you. If we aren’t sure, you can decide if you want to have an MRI. But be seen and put your mind at rest about it.

To your health and beauty,

Carmen Kavali, MD

Atlanta, GA Board Certified Plastic Surgeon

FDA Approves New Brand of Breast Implants

This past Friday, March 9th, the Food and Drug Administration approved a new brand of gel-filled breast implants; those manufactured by Santa Barbara, CA-based firm, Sientra.


As part of its efforts to garner FDA approval, Sientra provided three years of clinical data gathered from 1,788 women who received Sientra's implants. The clinical results were in line with those provided previously by Mentor and Allergan, the other two breast implant manufacturers here in the US. As a condition of approval, however, Sientra must conduct post-approval studies to assess the implants' long-term safety and effectiveness.


Who qualifies for these new implants? Like the gel-filled implants manufactured by Mentor and Allergan, these new breast implants are available to women aged 22 years and older, as well as for women of any age in need of implants for breast reconstruction due to trauma or breast cancer, and/or women with abnormal breast development, such as those with one breast very different in size from the other.

Why another implant? The supposed benefits of the Sientra implants are additional shapes and a better price than implants available through Mentor and/or Allergan.

Will our practice offer these implants? Before using them in my Atlanta plastic surgery practice, I want to be certain that (A) they're as safe as the brand I've been using; (B)they offer a real difference in terms of shape and (C) they will save my patients money.

To your health and beauty, 

Carmen Kavali, MD