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

New Breast Implant Approved by the FDA

 

Atlanta breast augmentation patients now have one more choice in breast implants! Allergan, one of the nation’s top breast implant manufacturers, has received approval from the FDA to market its Natrelle 410 implants for women 22 years of age or older. The first approval from the FDA since the Sientra implants in 2012, the 410 can be inserted in women of any age for cases of breast reconstruction due to cancer, trauma or severe breast asymmetry.

The FDA approval was based on 7 years of data collected from the use of the implants in 941 women nationwide. Although a small number of women had complications such as capsular contracture (tightening of the pocket around the implant) or infection, these complications are rare and similar to problems experienced with other implants.

The 410 was designed to mimic the natural slope of a breast. Its gel both helps maintain the shape of the implant and is designed to stay soft over time.

Our Atlanta cosmetic surgery practice will be offering the Natrelle 410 "gummy bear" implants! To see some of our natural breast implant before and after photos, click this link.  

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

Stem Cells--Aesthetic Miracle?

Have you seen advertisements that “stem cells” are used in all kinds of aesthetic procedures, such as breast augmentation, face lifts and wrinkle treatments? Before we all jump on the bandwagon, I’d like to share some cautionary information—not to put a damper on the exciting potential of stem cell usage, but to balance the excitement with some facts.

First, what are stem cells?

Stem cells are “undifferentiated” cells. That means that they have the potential to become any other cell type, such as skin cells, muscle cells, bone cells—you get the idea.

Where do stem cells come from?

So far, stem cells have come from one of two sources:

·           Embryos

·           Adults

Embryonic Stem Cells:

Embryonic stem cells come from labs that create embryos for in vitro fertilization. Multiple embryos are created, but only one embryo is inserted during each in-vitro cycle. What to do with the others? Throw them away? Keep them? Use them for research? There’s been an ongoing ethical debate with persuasive opinions on all sides. Fortunately, we have another source now: adult stem cells.

Adult Stem Cells:

After we’re born, we retain stem cells in the tissues of our brains, liver, blood & blood vessels, skeletal muscles, skin and liver. These stem cells are your body’s National Guard. They show up when you need them, but otherwise, they wait. If they are “activated” by disease or injury, they divide and conquer.  For example, if you cut your finger while chopping onions, your stem cells get a message to get busy and repair the tissue and skin that was damaged.

Originally, scientists thought that stem cells from the liver would only make liver cells and stem cells in bones would only make bone cells, etc, but recent studies show that most stem cells can “differentiate” to make other cell types. This is great news because everybody has stem cells, compared with the limited availability of embryonic cells, not to mention the ethical debate about using embryonic stem cells.

Stem Cell Usage in Aesthetic Medicine

There are ads all over the Internet, in magazines and newspapers and on radio & TV that you can get larger breasts through stem-cell injections instead of a breast implant; that it lasts a lifetime, is less expensive and has an easy recovery. Some doctors and centers advertise that they can plump your lips or fill your wrinkles with stem cell enriched fat instead of fillers and that it’s permanent, ie, you’ll never need to come back for a refill like you do with Juvederm.

Sounds great! So what’s the problem?

This is the problem: the marketing of stem cell treatments is way ahead of the proven safety of stem cell treatments. That creates risk for everyone who is exposed to their use before safety has been absolutely proven.

Remember what I said about stem cells’ ability to become other types of cells? Can injected stem cells become cancer cells? Can they can create a new disease? Nobody is certain yet. Scientific studies are performed over the course of several years and the scientific community simply hasn’t had those years of study to be absolutely certain whether there are side-effects of stem cell injections and if so, what those side effects might be.

What This Means To You As My Patient

I am a member of a professional association composed only of board-certified plastic surgeons: ASPS (American Society of Plastic Surgeons). The ASPS and ASAPS (American Society of Aesthetic Plastic Surgeon, also all board-certified surgeons) put together a task force to study the issue of stem cell procedures.  Because both groups are committed to the highest standards of ethics and safety in plastic surgery, they are very concerned that physicians—primarily those on the “fringe” of plastic surgery, like dentists injecting Botox, OB’s doing breast augmentations—you get the idea—are pitching “the miracles” of stem cells long before their safety is confirmed.

Led by plastic surgeon and stem cell expert J. Peter Rubin, M.D., the task force poured over every study and report they could get their hands on about stem cells and cosmetic usage. They realized this: the scientific information available right now doesn’t support the marketing claims targeted to consumers seeking aesthetic procedures and treatments. It’s just too soon to know if stem cell injections are safe. Maybe they are, but what if they aren’t?

The task force position is: until it’s proven to be safe, members of the ASPS and ASAPS are asked not to inject stem cells into their patients.

I am an aesthetic surgeon but, first and foremost, I am a doctor who, like all MD’s, took the Hippocratic oath that includes these words: “I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.” I only deliver treatments to my patients that are proven to be safe and effective. You are not my guinea pig, and you shouldn’t be a guinea pig for another physician either. The phrase, “Buyer Beware” should apply to used cars, not to human health.

For safety’s sake, please forward this blog post to everyone you know who is currently involved with, or considering, cosmetic enhancements.

To your health & beauty,

Carmen Kavali, MD

Heidi: She now wants smaller breast implants--or maybe just more press

Well, it seems that those G-cups Heidi Montag chose to have implanted less than a year ago have outlived their usefulness for her.  I thought I read somewhere shortly after her initial 10 surgeries (!) that she really wanted her breasts to be even larger, but a G cup was the best she could do at the moment.  Now, she's telling Life and Style magazine that those big breasts are causing her back pain and making it difficult to exercise---is she really surprised?!  Women with truly natural G-cup breasts typically see me for breast REDUCTIONS. 

Oh, and the real drama now is that her plastic surgeon, Dr. Frank Ryan, died in a tragic auto accident recently.  I'm certainly saddened for his family, but there is definitely no plastic-surgeon shortage in California, and I think it should be pretty easy for Heidi to find someone capable of handling her revision surgery.  I guess this was the latest angle she had to extend her 15 minutes.