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“Gummy Bear” Silicone Breast Implants Just Approved by the FDA for Usage

Natrelle 410 Silicone Breast Implants

Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

After waiting years for approval of the widespread usage in the United States of the so called “gummy bear” silicone breast implants, the U.S. Food and Drug Administration (FDA) yesterday finally announced their formal approval to the manufacturer of this implant, Allergan, Inc. This implant will be officially known by the marketing name Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants or Natrelle® 410 for short.

Or “gummy bear” implant if all this is too technical!

This breast implant has undergone the most rigorous scientific research for years and that has also included numerous clinical studies. Additionally, it has already been used worldwide for 20 years including in Canada and Europe. What has been learned is that women love them overwhelmingly (and so do men!). In fact, the satisfaction rate in those who have them is 96.5%, which even exceeds the already extremely high rate of satisfaction associated with the silicone breast implants that we have been using.

There are a few characteristics that make this silicone breast implant unique – and its formal name says it all. It is an anatomically shaped implant in the form of a tear drop or wedge compared to the round implants which have been used for decades. It also consist of a silicone gel that is highly cohesive – it sticks together to a very high degree, far greater than any other previous breast implant. Consequently, it maintains its intended anatomic tear drop shape for a more natural look but still has somewhat of a soft feel. Additionally and importantly, there has not been noted to be any silicone gel migration from the implant at 7 years.

This gummy bear implant also has the advantage of staying in place versus what can happen at times with the round breast implants. This is a double-edged sword in some ways, though. A well trained experienced plastic surgeon can place it precisely where it is desired allowing for even greater control of shape and other factors. There isn’t the so called “dropping” effect that many people have heard about with the round implants (though this doesn’t really occur either). Conversely, if the insertion is not performed skillfully, the results may reflect this.

Because of how this implant is constituted, the associated risks of rippling or wrinkling are virtually non-existent – at less than 1% at 7 years in primary breast augmentations. This is less than that of the “present” day round silicone breast implants and light years better than that associated with the saline breast implants.

This style 410 silicone breast implant is intended for usage in breast augmentation, breast reconstruction and breast revision surgery with the additional FDA stipulation that a woman must be at least 22 years of age. It will also not be for everyone who wants silicone breast implants. In fact, it may end up be a niche type choice partially because the results will be more “natural” in appearance which is not what many women are looking for (though many are as well!). The round implants that we are presently using provide that more popular appearance of considerable fullness – that round, push-up bra look.

And then there is the cost… It will be priced higher than the round silicone breast implants.

Once these Natrelle® 410 implants become physically available within the next week or so, I will be offering them as another silicone breast implant option.

For more information on the newly introduced Natrelle® 410 silicone breast implants, on breast augmentation surgery in general or on any other plastic surgery procedure that I perform, please call my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona

Breast Revision Surgery to Change One’s Implants

For a woman who has undergone breast augmentation surgery or even a breast lift with an enlargement, it is not necessarily one and done with regard to the implants. That is, there is a substantial likelihood that those aren’t the last pair of implants that she is going to have in her lifetime.

Why?

First of all, breast implants are not permanent medical devices and will not last forever if given long enough. At some point in time, they will either need to be replaced (implant exchange) or removed due to rupture or loss of integrity. It has been my experience that most women, even those in their 70’s, elect to have new implants put back in again rather than have them removed permanently. They just don’t want to be walking around without “breasts”.

This is not the only reason for changing out breast implants, a type of breast revision surgery. Some of the other reasons that women choose or need to obtain new implants include:

1) a desire to change their breast size – usually going bigger; rarely do they elect to go smaller
2) switching their type of implant from saline to silicone; the reverse, going from silicone to saline is extremely rare
3) a desire to alter the shape and projection of their breasts such as going to a higher profile implant to obtain more projection
4) to replace very old implants with newer but similar ones
5) to treat hardness or irregularities that have developed around the implants such as significant capsular contracture
6) development of infection (exceedingly rare)

This breast revision surgery is typically associated with minimal initial postoperative discomfort and is a far easier and more pleasant experience than the initial breast augmentation or breast lift with implants. I have found this to be almost universally true in my practice over more than 25 years.

The following patient of mine exemplifies a few of the reasons why women electively decide to pursue breast implant exchange surgery. At age 18 she underwent a breast augmentation that involved the submuscular placement of smooth surfaced moderate profile saline breast implants with 240cc on the left and 265cc on the right (Fig A, C and E). This gave her the shape and “C” cup that she had wanted so that she was very happy with the results.

A) Breast augmentation with saline implants - prior to implant exchange

A) Breast augmentation with saline implants – prior to implant exchange

B) After breast implant exchange, going from saline to silicone

B) After breast implant exchange, going from saline to silicone

C) Before implant exchange - oblique view

C) Before implant exchange – side view

D) After implant exchange - oblique view

D) After implant exchange – oblique view

E) Before implant exchange - side view

E) Before implant exchange – side view

D) After implant exchange - side view

F) After implant exchange – side view

After several years and experiencing no problems whatsoever, she decided that she wanted her breasts to be even larger and to also switch to the much more natural feeling silicone breast implants. For her breast revision, she had placement of smooth surfaced ultra high profile silicone breast implants with 360cc on the left and 400cc on the right (Fig B, D and F). There was virtually no discomfort following surgery and she went back to work within a few days. The results were just what she had desired and she was extremely happy.

For more information regarding breast revision surgery, breast augmentation or on any other plastic surgery procedure that I perform, please contact my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona

Phoenix Plastic Surgeon on Common Reasons for Breast Implant Replacement

phoenix plastic surgeon, plastic surgery in phoenix, breast implant revision, breast augmentation

Phoenix, AZ — According to the American Society of Plastic Surgeons (ASPS), over the past ten years, breast implant removals have decreased by 45 percent, while the number of breast augmentation procedures has increased by 45 percent, making it the most popular cosmetic surgical procedure for 2011. As modern technology continues to advance the safety and effectiveness of breast implants, Dr. Steven Turkeltaub, a board-certified plastic surgeon in Phoenix, says breast augmentation patients are now able to enjoy the benefits of longer-lasting results and less noticeable scarring. However, Dr. Turkeltaub reminds his patients that breast implants are not permanent medical devices, and there are a number of reasons why they may need to be replaced in the future.

At his Phoenix plastic surgery practice, Dr. Turkeltaub indicates that nearly 98 percent of his patients choose silicone implants rather than saline implants for their breast augmentation. The major factors in their decision are the far superior aesthetic appearance and feel as well as the greater longevity of silicone implants as compared to the saline ones.

Dr. Turkeltaub notes that many of his breast implant revision procedures are on patients who originally chose saline but are now interested in exchanging them for their more natural-looking and feeling counterparts. In fact, he states that most of his patients who have saline implants and are seeking to have them replaced for any of a number of reasons, nearly always switch to silicone ones whereas going from silicone to saline is exceedingly rare and is never done for aesthetic reasons.

Another very common reason for breast implant revision surgery is that implants will ultimately wear down over time and either rupture (silicone) or deflate (saline), necessitating a revision surgery. However, Dr. Turkeltaub says that most patients who experience a rupture and need a replacement procedure would like to have another implant put back in.

A less frequent reason for replacing breast implants is that patients’ bodies change over the years and the proportionate relationship that once existed is no longer the right fit. Consequently, Dr. Turkeltaub says patients often state that their breasts appear disproportionate or are either too large or not big enough for their bodies and they are looking to restore a proper balance to their figure.

Dr. Turkeltaub states that recovery from a revision breast augmentation typically is far better than that experienced following the original procedure, adding that there is usually only a fraction of the discomfort in comparison and most patients have a much easier time functioning after surgery. Generally, the same incisions can be employed so that no new scars are added unless there is a need to also perform a mastopexy, or breast lift, says the Arizona plastic surgeon.

As with any plastic surgery breast procedure, Dr. Turkeltaub says that obtaining desirable results from implant revision is strongly impacted by extensive training and experience as well as a great aesthetic sense. He encourages anyone considering this type of surgery to consult with a dedicated and experienced board-certified plastic surgeon in order to help maximize the probability of obtaining the desired results.

About Steven H. Turkeltaub, MD, PC

A graduate of the Six-Year Medical Program at Boston University and the Boston University School of Medicine, Dr. Steven Turkeltaub is board-certified by the American Board of Plastic Surgery. He is also a member of several professional organizations including the American Society of Plastic Surgeons, the Arizona Society of Plastic and Reconstructive Surgeons, and the Arizona Medical Association. Dr. Turkeltaub has dedicated numerous hours to his continued education through advanced courses and lectures, in addition to being published in a variety of plastic surgery journals and textbook chapters. He has been selected as one of the “Top Doctors” in the Phoenix Metropolitan area, and also one of “America’s Top Plastic Surgeons.”

With two locations at 10290 N. 92nd St. Suite 207 in Scottsdale, AZ 85258 and 18275 N. 59th Avenue Bldg. E Suite 126 in Glendale, AZ 85308, Dr. Turkeltaub’s practice can be reached at (480) 451-3000. It can also be contacted online via the websites arizonabreast.com, turkeltaub.com, or facebook.com/drturkeltaub.

Breast Revision Surgery In A Woman Who Had Multiple Previous Reconstructive Procedures

Breast revision surgery is very commonly performed for both cosmetic and reconstructive breast procedures including breast augmentation, breast lifts, breast reduction and breast reconstruction. The reasons can be many including issues relating to size, shape, firmness, asymmetries and changes over time.

The following patient of mine illustrates an example of revisional breast surgery in a woman who underwent a subcutaneous mastectomy with immediate reconstruction 25 years ago in order to reduce an elevated risk and strong family history of breast cancer. Seeking to further improve the results, she had several subsequent procedures in attempts to improve the results. I was consulted because she was very dissatisfied with the appearance of her breasts and also was experiencing significant chronic pain in both sides.

Subcutaneous mastectomy before breast revision

After surgery

Before - side view

After surgery

Before surgery - oblique view

After surgery

The photos of her breasts clearly delineate the substantial deformities, asymmetries and implant malposition with the right side being situated too high. You can appreciate the extensive irregularities of contour and skin folds as well as the relatively low positioning of her nipple-areola complexes in relation to the breast mounds.

To achieve a more desirable result, her breast revision entailed the precise release and removal of the deforming scar tissue along with reshaping of her breasts and replacing her implants with much more appropriately configured and sized implants. In addition, I employed AlloDerm® dermal grafting material for both breasts which served to provide greater support of the implants, contouring, durability and increased soft tissue thickness.

As you can judge from the photos, the transformation from the breast revision surgery resulted in breasts that were much more acceptable and desirable in appearance which made her quite happy and thankful and boosted her self-confidence.

If you have any questions regarding breast revision surgery whether for cosmetic or reconstructive issues or for any other plastic surgery procedure that I perform or if you would like to schedule a complimentary consultation, please call my office at 480-451-3000.

Steven H. Turkeltaub, M.D. P.C.
Scottsdale and Phoenix, Arizona