Just about anyone considering silicone breast implants has heard the term ‘gummy bear’ breast implants. Some women even come in requesting this specific ‘type’ of breast implant. Besides the catchy name, what is the appeal of it?
Gummy bear implants are made of a highly cohesive silicone gel which does not act like a liquid. Rather it acts like a soft solid…just like the gummy bear candy. Compared with the previous types of liquid silicone gel implants, the silicone particles in the gummy bear implants are highly cross-linked so the gel is held more closely together. This creates a breast implant that has a more natural feel. It also creates a breast implant that when cut in half, the gel stays put. (as demonstrated in the video) This eliminates any concern about what happens when the implant shell ruptures which will inevitably occur in some patients over their lifetime. There would be no errant gel getting loose and running amuck in or beyond the breast implant pocket.
What most don’t realize is that today all silicone breast implants are of the gummy bear variety. The breast implant term, ‘gummy bear’, is really an urban and not a manufacturer’s term. While at one time unique to one specific manufacturer, all breast implant manufacturer’s have them.Three gummy bear implants are approved by the Food and Drug Administration (FDA) for use in the United States: Sientra’s Silimed implants, Allergan’s Natrelle 410 breast implant and Mentor’s MemoryShape™ Breast Implants, formerly known as the contour profile gel (CPG).
The only downside to a gummy bear breast implant is that its stiffer feel may necessitate a larger incision in which to insert it through. But this concern is overcome by the use of an insertion funnel which allows even large implants to be put in through relatively small incisions.
Background:In the pursuit of satisfying breast augmentation results, the most common denominator amongst patients is that of achieving the desired size. Too small or too large of an augmented breast size can lead to an unhappy patient and the need for revisional surgery. Women understandably spend the vast majority of their time before surgery contemplating size and many methods exist for trying to determine what that actually is before surgery.
By far and away, however, the vast majority of women want their breasts to look natural after surgery. Very few women come in and say they want an unnatural looking breast augmentation result. The concept of ‘natural’ is a qualitative description whose interpretation, however, is open to individual opinion which can be surprisingly diverse. What is natural to one patient may be seen differently by another.
But despite this somewhat vague term, natural breast augmentation can be quantitatively described. I define a natural breast augmentation by three parameters. First, a natural breast size is either one in which the patient originally had and lost (through pregnancy or weight loss) or one in which the size of the implant stays within their breast base diameters. Second, the shape of the breast is not completely round in that the upper pole of the breast is not as full as the lower pole. Third, the breast does not feel overly firm or tight and does not have palpable implant wrinkling or folds. These are natural implant results because they are what a normal breast looks and feels like.
Case Study:This 32 year-old female wanted breast implants to restore her breasts after having twins. Between the pregnancy and breast feeding, she felt she had lost much of her breast volume and shape, Her breasts had essentially gone flat. She emphasized that she did not want to be ‘too big’ and would be happy if she just had want she had before the children. (or maybe just a little bit more) She repeated the phrase of wanting a natural breast augmentation result.
Under general anesthesia, she had 355 cc high profile,high-strength silicone gel (gummy bear) breast implants placed in a partial submuscular dual plane position. Her lower inframammary crease incision was able to be used and was a size of only 3.5 cms because a funnel technique was used for insertion.
Her postoperative course was typical in that the implants initially were a little high early after surgery. But with the resolution of the swelling and some skin relaxation, the implants settled into the desired position rather quickly. She went back to work as a nursein less than one week after surgery.
She felt that her breast were quite natural in appearance and feel. They were soft without any palpability of the implants. Their size was about what they were before becoming pregnant so it was perfectly natural to her. In fact, if she had to do it over again she might had gone just a little bigger.
· Natural breast augmentation is the combination of a soft breast-like feeling implant that keeps the new size well within one’s existing breast base diameter.
· Silicone implants, particularly the new high-strength gel material (gummy bears), give a very natural feel to the augmented breast.
· For the women who has lost breast tissue from pregnancy (involution), a natural breast augmentation is one that primarily restores the lost volume and returns the patient to their original size.
Breast implants remain a popular plastic surgery procedure with over 350,000 women being implanted last year in the U.S. alone. Up until several months ago, only two U.S. manufacturers existed after many other producers folded from the breast implant controversy from the early 1990s. Allergan and Johnson & Johnson (subdivision Mentor) have maintained a duality on the breast implant market ever since. That was until several months ago when the Sientra company entered as a new supplier and now offers a third option for board-certified plastic surgeons when choosing breast implants for their patients.
Sientra is a new California-based company that received FDA approval for its breast implants in early 2012. An interesting question is why is a third company needed to supply breast implants and what do they bring to the table that the other companies don’t? The current providers certainly can fulfill all the needs of the U.S. breast augmentation market and, after all, a breast implant is just a breast implant isn’t it? Besides the always entrepreneurial and business reasons to provide any medical device, what makes Sientra implants different if anything?
There are several interesting twists that the Sientra company provides in its breast implant offerings. First, it does not at this time provide saline breast implants. They currently only offer silicone gel implants for both cosmetic augmentation and breast reconstruction. While a similar silicone elastomer shell (containment bag)is used for both silicone and saline breast implants, their initial product line is focused on silicone implants only. Whether saline implants will be added in the future remains to be seen. Secondly, it offers both round and shaped silicone breast implants. The shaped or teardrop implant can be very useful for those women that want to lessen the likelihood of too much upper pole fullness or have some tissue sagging that needs to be picked up by the greater location of the implant volume.
The third and most interesting distinction of the Sientra silicone breast implant is its standard use of an ultra strong cohesive gel in all of their implants. This type of silicone gelmay be more recognizeable by patients of being of the ‘gummy bear’ form. The use of the term ‘gummy bear’ is an urban term that is not one any manufacturer uses or promotes. And while all three breast implant manufacturers have their formulations of a more cohesive or held-together silicone gel, Sientra is the first to be approved with this most cohesive gel. The implant can be cut in half, or pieces cut out of it, and only the most severe squeezing of any remnant will allow the gel to be extruded. Despite this degree of cohesiveness, the implant is remarkably soft and pliable. It is anything but stiff. And it comes in both a round and a textured implant shell.
The relevance of a very strong cohesive gel is more than just reducing the fear of silicone gel displacement and migration from a breast implant pocket. Such a formulation also reduces the risk of inadvertent rupture during the insertion through small breast incisions. While no one really talks about shell weakening from implant insertion, and how it may impact the rate of long-term implant rupture, it is always a concern. The advantages of a strong cohesive gel is seen in the very low five year rupture rates reported by Sientra in its FDA-submitted data of around 2%.
The availability of the new Sientra breast implants provides new options for breast reshaping in women. Such competition in the medical market is almost always good for implant quality and long-term results of which the patient is ultimately the beneficiary.
Breast augmentation remains one of the top cosmetic plastic procedures requested with over 300,000 performed in the U.S. in 2011. The majority of these breast enhancement operations were done with silicone gel implants, accounting for nearly 70% of devices placed. Unlike ten years earlier, almost all breast implants placed were saline-filled. But that changed dramatically when silicone implants were approved again for commercial use in 2006.
Why has silicone gel become favored over saline for many breast augmentation patients…even though they cost more? Two simple reasons…how they feel and how long they last. Saline implants have a tendency, particularly in thin women with little breast tissue cover, to give a rippled or wavy feel to them. This is particularly evident if they are placed above the muscle. Silicone implants have a much lower occurrence of this aesthetic problem whether they are above or below the muscle. In addition, all breast implants have a limited lifespan before they will need to be replaced. Silicone implants usually last longer because their mode of failure is not instantaneous, unlike saline which can suffer abrupt deflation.
But silicone gel breast implants are not perfect. While a gel filling is still better than water, it is an implant that will eventually fail with extrusion of the material outside of the containment bag. This will still necessitate replacement at some point. This one liability has led to the development of the “gummy bear” breast implant. The recently FDA approved breast implant is a high-strength or highly polymerized silicone gel that holds its shape. Even if the implant shell should rupture, the implant will hold its shape. The feel of this new material, soft and squishy, has led it being coined with the name like that of the gummy bear candies.
Because of its shape retention, these gummy bear implants have no significant risk of material migration or leakage. This can be appreciated when you cut into them as the material does not run or have any flow to it. If you completely removed the surrounding containment bag or shell, the material maintains its shape, very similar to removing the mold after making Jello.
With the FDA approval for the company, Sientra, to manufacture and distribute gummy bear breast implants, they will soon be available for women to choose as an option for their breast augmentation. The other two breast implants manufacturers, Allergan and Johnson & Johnson, will undoubtably be following with their approvals shortly. New devices releases will catch a lot of press and expect to hear a lot about the gummy bear breast implants for the rest of 2012.
Are gummy bear breast implants perfect…no. With their advantages comes their own set of liabilities. They will likely cost more per device and their slightly more stiff silicone shape means a bigger incision may be needed to put them into place.
The Gummy Bear breast implant captures a lot of patient and press attention and may represent a valuable role in the future of breast augmentation. While under clinical trial investigations for years by the two U.S. breast implant manufacturers, it is rumored that they are the verge of being approved by the FDA for widespread clinical use sometime in 2011. Given their potential availability, I thought it a good time to discuss the facts from the myths about these type of breast implants.
The name, gummy bear, is very appropriate based on how the implant material looks. Rather than being like a thick Karo syrup or more congealed like a pudding, it is more form stable. It is closer to refrigerated Jell-O in appearance and form. If you cut these breast implants in half with a knife, the two pieces would just stay intact. Like gummy bear candy, the implant will stay solid although it does not feel as hard as the actual candy.
The gummy bear implant is not a name ascribed to it by any of the manufacturers or the FDA. It is really an urban term coined by a plastic surgeon. It has different names by various nmanufacturers such as the Mentor CPG and the Allergan 410. It is really a fifth generation silicone implant, generically known as a form-stable cohesive gel implant. These implants were invented over 15 years ago and have a theoretical basis of being a longer-lasting breast implant that keeps its shape. The gel is more cohesive and firm. The gummy bear implants that will be initially available will have a teardrop and not a round shape. The implant’s teardrop shape anatomically matches that of a natural breast which projects more at the bottom than at the top. As the implant is thinner at the top, it will more naturally blend into the upper chest without an upper bulge which creates a round-looking breast.
Plastic surgery investigators of these implants state that they have a lower capsular contracture (hardening) risk, fewer problems with implant wrinkling and folding and an improved appearance of the breasts. They also offer the psychological benefit that should the implant fail (shell disruption), the implant material would remain intact and not migrate from the original breast pocket.
One of the criticisms of a more form-stable implant is that they can not be put in through very small incisions. They don’t deform as easily as the less stable forms of silicone gels. Some investigators have stated that it is not a problem, going even through a periareolar or nipple incision. Others, however, felt that it is easier to go through a lower breast fold incision. The shaped implant also can suffer from turning or rotating of the implant causing a distortion in the shape of the breast.
The gummy bear implant may be most ideal for the primary breast augmentation woman. This is because its teardrop form is most likely to remain positionally stable with a fresh pocket. In those patients who has indwelling implants, who are unhappy with certain aspects of their implants or want to change the size of their implants, a teardrop-shaped implant is less ideal. This is because existing breast pockets are much more likely to allow the implant to shift around its smooth interior pocket lining. This concern will eventually be obviated when form-stable silicone gel breast implants which are round are introduced.
Gummy bear breast implants have undergone clinical trial investigations in the United States for much of the last decade. Those clinical trials are now closed and the FDA is currently evaluating the data. Both existing U.S. breast implant manufacturers, Mentor and Allergan, have conducted clinical trials with their versions of the gummy bear implant. Mentor’s implant is known as the CPG, Allergan’s is known as the 410. The manufacturer’s do not use the term gummy bear, that is a plastic surgery and layman’s term. These newer breast implants may be available for patient use later this year.
The gummy bear implant is not just a cute nickname. Rather it speaks to the unique nature of the filler material. It is soft and pliant but firm and strong. Most importantly, it will not run or leak from the implant as it is form-stable since it is not a liquid or loose gel. Because of its unique silicone gel form, it has numerous characteristics that have certain breast augmentation. advantages and disadvantages.
Less risk of rupture and no risk of silicone leakage is undoubtably the main advantage of the gummy bear implant concept. If this type of implant ruptures it will actually hold itself together. Unlike the original silicone implants, this implant has a thick outer shell and for all practical purposes can not leak. This advantage can not be debated.Whether they will end up being more durable (not needing to be replaced over one’s lifetime) remains to be seen but it theoretically appears that it should.
One of the other main advantages that has been given to this type of breast implant is that they will look and feel more natural. They are better at holding their shape. They are more resistant to wrinkling and folding over time and have next to no rippling. Due to their composition they will tend to remain in an upright position and are less likely to sag.The density of the silicone composition makes the implant feel much more like the natural tissue of your breast. Feel and natural looking are more subjective assessments and it is not really clear how they differ from the cohesive gel implants that we currently implant.
The stiffness of this implant makes the choice of access incisions limited. Only the lower breast crease incision (inframammary fold) can be used. The resultant scar will be a bit larger to allow the stiffer implant to fit through it. Incision locations like the armpit, nipple or belly button can definitely not be used.
The shape of a gummy bear implant will be anatomical, meaning that it has tear drop shape. This is also why it needs to be placed from the lower breast fold so there is no turning of the implant causing a postoperatively misshapen breast. This shape may be desireable for some patients but for those that want a fuller rounder breast look, this preformed shape will be a disadvantage.
While the gummy bear implant is not yet commercially available, it is fair to say that it will have some increased cost to use over the current silicone gel breast implants.
While gummy bear implants for breast augmentation has certain advantages, its disadvantages make it not desireable for all women. Its advantages are borne at the expense of having a textured tear-drop shaped implant placed with a resultant lower breast fold scar.
Breast augmentation is one of the most successful and sought after of all body contouring procedures in plastic surgery. A huge part of any breast result is the implant. Prior to 1991, silicone gel breast implants were the most widely used. From 1991 to 2006, saline breast implants were the only option as the FDAremoved silicone implants from the market. Since 2006, silicone gel implant have come back to add two implant options for women considering breast augmentation.
While having two breast implant options is a definite advantage, it also causes considerable patient confusion. Misconceptions and myths surround silicone implants largely because of its checkered FDA history from nearly twenty years ago. As a backdrop to the current silicone implant has been the development of a new generation silicone implant, known by his public name as the gummy bear breast implant.
Patients frequently ask about the gummy bear implant. Whether because of its cute name or the perception that it is better, women often want them specifically for their breast augmentation. In understanding the gummy bear implant, one has to appreciate the current silicone gel breast implants reintroduced in 2006. These are really fourth generation silicone implants that have a thicker, more cohesive silicone gel filler. (it is not a liquid nor is it a solid…but it is more cohesive or solidified than previous forms of silicone gel) They are not what is known as the gummy bear implant, a term by which this fifth generation silicone implant has been coined by some plastic surgeons. (not the manufacturers)
What is the gummy bear implant? It is an implant that is filled with a silicone gel material, which is not just thick and cohesive, it is what is known as “form stable.” This stability of the material occurs because it is more ‘cross-linked’ which creates a gel that is both solid and soft. Just like the gummy bear candy, the implants feel soft and pliant but bounces back from the touch. Equally importantly, when the implant is cut the material retains its shape. This means that compared to all previous generation silicone implants there is no chance of filler leakage. It can not leak or run because its form is stable.
Many people confuse the cohesive silicone breast implants released in November 2006 as the gummy bear implant. They are not. Gummy bear implants have been in long-term clinical trials in the United States for many years but have never been available outside of these clinical studies. Both existing U.S. breast implant manufacturers, Mentor and Allergan, have conducted clinical trials with their versions of the gummy bear implant. Mentor’s implant is known as the CPG, Allergan’s is known as the 410. The manufacturer’s do not use the term gummy bear nor do they sanction such a term. Those clinical trials have now been closed for some time as their clinical data has been submitted to the FDA for review. This means that gummer bear implants are not available for us in the U.S. currently. They have been been widely available in Europe and elsewhere for years.
The gummy bear implant, while being a cute nickname, specifically speaks to the nature of the filler material. It is soft and pliant but firm and strong. And just like those colored bear-shaped candies, you can push, pull and even cut the material and it won’t lose its shape. This fifth generation silicone breast implant may possibly be available for patient use in the U.S. later in 2011 but is not currently available.
While many women perceive breast augmentation as done using a breast implant, most are not aware of the diverse array that are available. Since silicone gel breast implants have been commercially available again since 2006, the two choices that women have of implant fillers is between saline and silicone. Saline is a simple filler concept and is nothing more than a ‘bag of water’ on a practical basis. Silicone is a much more complex polymer molecule that can be made in a near endless variety of physical states.
The history of silicone as a filler for breast implants was much like a thick liquid, similar to a thick syrup. (type 1 silicone) That form of the material is no longer manufactured although women still do exist with indwelling implants with this original consistency. (they are getting fewer and fewer with each passing year) The newer form of silicone is much like a gel (jello) and carries the term of a cohesive or more cohesive gel. (type 2 silicone) It is tacky and will not run or escape from the implant like a more liquid material should the surrounding shell become broken or develop a tear or hole in it. This is what is in every currently sold FDA-approved silicone breast implant.
Another more polymerized silicone gel has also been undergoing FDA-sanctioned clinical trials for the past several years. Known as a more cohesive silicone gel (type 3 silicone), it is also known as the gummy bear breast implant. It is not available for widespread commercial use and has remained restricted to those plastic surgeons who are participants in this clinical trial. Similar to the consistency of a gummy bear candy, it is more cohesive or ultracohesive and behaves more like solid than a gel. It can literally be cut like a piece of pie. While neither of the two existing U.S. breast implant manufacturers have coined the gummy bear term or use it, it has worked its way into the public’s mind and common terminology.
The perceived benefits of gummy bear breast implants to most patients is one of safety. Women fear, unjustifiably so, that a very cohesive silicone materialis more ‘safe’ because it can not escape into the body. In essence, it will not run or leak. While cohesive or type 2 gel breast implants will not do this either, it is a simple matter of perception. The other perceived benefit, although not as widespread, is that it will feel more natural or more like a real breast. What a real breast feels like can be quite variable and I doubt very highly that anyone could tell the difference in an augmented breast between a type 2 and 3 gel implant. (short of a plastic surgeon)
Despite this precise material definition of a gummy bear breast implant, it is a loosely used term. As previously stated it is not a manufacturer or FDA sanctioned name and is largely a plastic surgery marketing term. Because of this vagueness, the concept of gummy bear breast augmentation can be open to interpretation. Some plastic surgeons are using it to refer to type 2 silicone gel while others are specifically referring to type 3 silicone gel.
Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.