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

A few days ago, there were countless headlines and stories in the media about a woman whose breast implant was “swallowed” by her body while doing Pilates. These were in response to a medical report documenting an unusual case that was just published in the Dec. 15th issue of the New England Journal of Medicine.

These reports garnished quite a lot of attention and also provoked some anxiety, concern and questions particularly in some women who already have breast implants. They want to know: “Is there a risk that the body can really “swallow” a breast implant?”

This case report involved a 59 year old woman who had previously undergone a bilateral mastectomy for breast cancer and had reconstruction with breast implants. During a Pilates stretching exercise, her right breast implant … disappeared. Gone in a flash! No external trace. She experienced no symptoms such as pain or shortness of breath.

A medical evaluation was performed including obtaining an ultrasound, chest X-ray and CT scan. What was discovered was that her intact breast implant was in her right chest cavity. It had been sucked into it during her stretching exercise.

She was taken to surgery during which the implant was extracted from the chest cavity and repositioned on the chest wall again where it belonged. A defect between the ribs which had allowed the implant to be displaced, was repaired. And she lived happily ever after. (Well, I don’t exactly know about that!)

So how did this bizarre situation occur?

This was the result of a confluence of issues and factors that together created the “perfect storm” for this rarity. The patient already had weak, flexible ribs. Her implants were not very large. And most importantly and what wasn’t clearly disclosed: she recently had undergone a mitral valve (a heart valve) replacement for a leaky heart valve and the approach used to access the heart was between the same two ribs that the implant slid between. The normal anatomy was disrupted by the surgery and a significant defect remained between these two ribs. Now, add to all of this a stretching maneuver that separated the ribs and created a negative force and, voilà, her breast implant was sucked into the chest cavity.

As you can see, the odds of this happening are less than being struck by lightning or winning the lottery. It is about on par with the probability of Obama suddenly becoming an adherent of conservative policies and slightly higher that the likelihood of taking a snapshot of the Loch Ness monster frolicking with its family or eating lunch with the Abominable snowman.

There are more important things to worry about in life.

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

As a result of research and technological advancements, there have been fundamental improvements in the design and construction of silicone breast implants over the years. These have translated into breast implants filled with a cohesive gel (like taffy) that are stronger, far more durable and resistant to a multitude of forces and factors and which will last considerably longer compared to previous generations of implants. They will not, however, necessarily last forever.

In 2006, the FDA issued recommendations (not a mandate) that women who have silicone breast implants as a results of breast augmentation or breast reconstruction should have an MRI starting three years after their surgery and then every other year subsequently. However, there was no scientific data to support this approach. Given the considerable expenses (and inconvenience) incurred by having these MRI’s which may not even be covered by insurance, we need to consider whether the FDA’s recommendations are really a prudent and necessary.

Research conducted at the University of Michigan and published in the March 2011 issue of the Plastic and Reconstructive Surgery® journal provides some compelling answers to this issue. This research combined and analyzed 21 previous studies that assessed the ability of MRI’s to detect silicone breast implant rupture in order to arrive at their conclusions.

What they discovered was that the MRI’s overall were fairly accurate in detecting ruptured silicone breast implants. However, in certain situations their accuracy rate was extremely high. In fact, they discovered that in women who presented with symptoms related to their breast implants, the MRI’s were 14 times more likely to discern a rupture than in those women who had no symptoms. Thus, in women who were asymptomatic, they were far less helpful.

How can we use this information to formulate reasonable recommendations?

Given that silicone gel breast implants will last on average well in excess of 10 years, MRI’s are not a cost effective tool to screen for ruptured breast implants in otherwise asymptomatic women during this first decade. Instead, mammograms and/or ultrasounds should be performed. If evidence arises or there is a significant index of suspicion for rupture, an MRI can then be considered.

If you would like more information on silicone gel breast implants, breast augmentation, breast reconstruction or for any other plastic surgery procedure that I perform or to schedule a complimentary consultation, please call my office at 480-451-3000.

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

The term “gummy bear” breast implants has been used in the public realm for several years now yet most people know little about them. What they have heard is that they are the latest type of silicone breast implant and something that they may just want to have for their breast augmentation or breast reconstruction.

You might have wondered: “Exactly what are these breast implants and why are they named after a candy?”

You may even be thinking: “Can I have them for my surgery?”

“Gummy bear” implants are a new generation of silicone breast implants that have some of the characteristics of the candy that they were nicknamed after – though they are not also edible! These implants differ from all earlier versions in that they are composed of a very highly cohesive and form-stable (maintains their shape) gel that resembles the candy though softer.

These 5th generation breast implants have been used elsewhere around the world for breast augmentations and reconstructions since the early 1990’s. They have been extensively researched for years including in large clinical trials but have not yet been cleared by the FDA (Federal Drug Administration) for usage here in the United States although approval may be imminent. (Note: Plastic surgeons here in the United States have been hearing this for several years now – and we are still waiting!)

These new silicone breast implants do offer at least a few advantages over the current cohesive silicone gel ones (as well as some disadvantages). They have been noted to be more durable and last longer and the potential of the silicone gel migrating elsewhere is close to zero. The risk of developing hardness around the implants known as capsular contracture has been found to be lower, around an incidence of 3% as compared to 5 – 10% or more with previous generations of silicone implants.

A definite disadvantage of these “gummy bear” implants is the cost which is expected to be significantly more expensive than those that are used now. Whether this difference is an additional several hundred dollars or much more is not known as of yet. Their increased cost will definitely have some effect on their popularity and selection. Ultimately, however, several factors will play a role in influencing each woman’s decision regarding which type of silicone breast implant is right for her.

For more information on silicone gel breast implants, breast augmentation surgery or for any other plastic surgery procedure that I perform or to schedule a consultation with me, please call my office at 480-451-3000.

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

For any breast procedure requiring the placement of breast implants, my patients are offered the option of using either silicone or saline implants. This would include women who are considering breast augmentation, breast lift with implants, breast implant exchange and breast reconstruction. I thoroughly discuss with them all the important and relevant information about these two types of implants such as appearance, feel, durability, aesthetics, rupture, risks and possible areas of concern. They also are able to touch and closely examine both the silicone and saline implants.

What have I found is the overwhelming majority of my patients select the silicone implants for both cosmetic and reconstructive procedures and they definitely don’t regret the choice. The aesthetic results and much higher level of satisfaction irrefutably support the substantially greater superiority of silicone implants as compared to the saline ones. This is true for both cosmetic and reconstructive procedures. In my practice it is quite rare now for a woman to opt for saline implants and when they do it is virtually always because they cost $1,000 less a pair which then makes the cosmetic surgery affordable.

This finding is consistent with the medical literature including research just published in the November issue of “Cancer”. This multicenter study examined and analyzed the responses obtained from 672 women who had post-mastectomy (for breast cancer) breast reconstruction utilizing either silicone or saline implants. The results revealed a statistically significant greater level of satisfaction in women who chose the silicone breast implants for their reconstruction as opposed to the saline ones.

So, if you are interesting in pursuing either a cosmetic or reconstructive breast procedure that involves the usage of breast implants and were initially leaning toward saline implants you may want to strongly reconsider.

For additional information on silicone or saline breast implants, breast augmentation, breast reconstruction or for any other plastic surgery procedure that I perform or to schedule a consultation, please call my office at 480-451-3000.

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

It is universally accepted that smoking is bad for you and your health. Not only is it unequivocally associated with premature aging, both physiologically and in appearance, but also with an increased incidence of numerous diseases and cancers as well as a reduced quality of life. Smoking also significantly elevates the rate of complications and other untoward issues in several cosmetic and reconstructive breast surgical procedures.

For the more than 23 years that I have been practicing in the Scottsdale and Phoenix areas, I have been routinely informing and warning my smoking patients of the substantially elevated risks that smoking has on many surgical procedures and their outcomes. The chemicals in cigarettes cause a constriction (narrowing of the diameter) of the blood vessels in the tissues which results in a decreased blood supply to the tissues and therefore less of the vital oxygen and other nutrients important for cell survival and healing. For areas that have undergone surgery, this can directly translate into delayed or improper healing or worse – lack of survival of some tissues which may then require the need for corrective reconstructive procedures such as skin grafting.

Though I do make my patients aware of the risks that smoking has on their health and surgery, for certain procedures I do request and many times demand that they at least stop smoking for a specific period of time prior to their scheduled date because the impact from such smoking can be far more severe. The breast procedures at substantially higher risks for healing problems such as skin necrosis (where the skin turns black and dies) include primary (immediate) breast reconstruction, secondary breast reconstruction in those who have had radiation treatments, breast reductions and breast lifts.

Patients having these procedures are instructed to stop smoking starting one month prior to their surgery until at least two to four week postoperatively. It takes but a few cigarettes just prior to or after surgery to jeopardize the healing process. Chronic smokers who are able to stop smoking during this period of time do better than those who continue even at reduced levels.

To put this in even clearer perspective and provide additional motivation, I ask my patients whether it worth the prolonged healing time, expenses, inconveniences, compromised aesthetic results and the possible need for additional surgery just to continue smoking. Stated this way, most will make a serious effort to quit.

For more information on any plastic surgery procedure that I perform or to schedule a complimentary consultation with me, please call my office at 480-451-3000.

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

Women who undergo bilateral breast reconstruction have the best possible chance of obtaining relatively symmetrical results. This would be independent of the technique employed, whether it is immediate insertion of implants, utilization of tissue expanders or flap procedures such as a TRAM flap.

A significant exception to this would be unilateral radiation treatments as adjunct therapy for breast cancer. As I described in a previous post (Tissue Expansion for Breast Reconstruction Can Be Challenging In Women With Previous Radiation Therapy), radiation treatment causes permanent damage to the skin and underlying tissues resulting in scarring, thickening and rigidity often with some associated change of skin color and texture. It does impede the ability to stretch the skin as is required for breast reconstruction using tissue expanders and will substantially affect the final outcome.

The following patient of mine exemplifies this effect. She underwent a bilateral mastectomy and unilateral radiation treatments on the left side. This converted a situation that could have provided her with relatively symmetrical results to one in which this was an impossibility. The method of breast reconstruction that she chose was to use tissue expanders.

a.) Bilateral mastectomy and left breast irradiation. Preoperative

b.) Postoperative insertion and inflation of tissue expanders

c.) Preoperative

d.) Postoperative

e.) Preoperative

f.) Postoperative

Identical tissue expanders were inserted on both sides with the radiated side requiring a greater amount of inflation to reach what appears to be a less substantial sized mound. This is a clear manifestation of the effects of radiation on the tissues.

If you have some questions with regards to breast reconstruction, breast implants or any other plastic surgery procedure that I perform or if you would like to schedule a consultation with me, you can contact my office at 480-451-3000.

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

Most patients undergoing a breast reduction should have a fairly recent mammogram prior to surgery if they are past a certain age. The reason for this is that if any abnormal findings are detected that need further delineation, they should be pursued before proceeding with the planned breast reduction. A finding of breast cancer would preclude the need and indication for a breast reduction as this would be an inadequate treatment for breast cancer.

It would be ideal if mammograms could detect all occurrences of breast cancer but they do not. A fairly small percentage of breast cancers as well as pre-malignant lesions do escape detection but can be identified pathologically – from the specimen. This is why all breast tissue that is removed by the procedure is assessed by a pathologist.

A few studies have been performed over the years to determine the exact incidence of these “occult” breast cancers that can only be identified pathologically. The results indicate that the percentage is around 0.16% to 0.40% or up to 4 cases per thousand women. Nevertheless, these women are very fortunate because the early identification of their tumors translates into extremely high cure rates. If not for their initial desire for a breast reduction, they might not have had these cancers detected until a much later date at which point the prognosis would not be nearly as favorable.

The following patient exemplifies this scenario. She was a 39 year old woman wearing a 34G bra seeking a breast reduction. There were no abnormal detected masses on breast examination, her mammogram was unremarkable and there was no family history of breast cancer. Despite this, the breast tissue sent for pathological evaluation revealed the presence of early breast cancer.

Her treatment then consisted of bilateral mastectomies with immediate breast reconstruction. The photos below included her preoperative appearance, immediately following her breast reduction and then the final results after reconstruction.

Before breast reduction - Frontal view

Before breast reduction - Side view

Immediately following breast reduction - frontal view

Immediately following breast reduction - Side view

After breast reconstruction - in bra

After breast reconstruction - Frontal view

After breast reconstruction - Oblique view

After breast reconstruction - in bra

Following breast reconstruction - Side view

Following breast reconstruction - in bra

If you would like more information on breast reduction, breast reconstruction, information on any other cosmetic surgery procedure or to schedule a complimentary consultation, you can contact my office at 480-451-3000.

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

Though radiation therapy is important in many situations for the treatment of breast cancer, it does present a challenge for breast reconstruction. Its permanent effects on the tissues of the chest can be significant and will have some impact on the reconstructive results.

The ionizing radiation injures and destroys healthy cells leading to scarring, thickening and rigidity of the tissues often with some associated change of color and texture. The outcome is skin and underlying tissues that feel firm, somewhat rigid and more resistant to stretching which is required for breast reconstruction using tissue expansion. In addition, nutritional blood flow to the area exposed to the radiation is significantly decreased due to permanently injured blood vessels. The consequences of this are an increased risk of infection, prolonged healing times from surgery and injury and greater susceptibility to trauma.

Because of these manifestations of radiation, it is not uncommon to be unable to stretch the tissue out to the predetermined volume and it definitely requires more time and patience. Infections are more common as is the incidence of capsular contracture, the formation of additional restricting scar tissue that further limits expansion. Incisions take much longer to heal and may reopen during the expansion. The tissue expanders not infrequently erode through the skin requiring an immediate surgical response.

Breast reconstruction employing tissue expanders in previously irradiated tissue can be successful but the risks and challenges should be understood as well as other options that may be available.

If you would like additional information on breast reconstruction or any other surgical procedure or to schedule a consultation, you can contact my office at 480-451-3000.

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