Gummy bear implants vs. Sientra implants

Question

Confused about the terminology. Is a gummy bear implant always a Sientra implant? Is a Sientra implant always a gummy bear? Help, please!

Richard H. Tholen, MD, FACS · Answer

Sientra breast implants are made by the Brazilian company Silimed, which
 started in Rio de Janiero in 1978 to import French breast implants into
 Brazil for growing plastic surgery use in that country. In 1981 Silimed
 began to manufacture its products in Brazil, in a small 
laboratory compatible with the technical requirements of the time. One 
year later, it already exported to other countries in Latin America and,
 in the following years, expanded to foreign markets, with products 
geared towards various specialties.

Silimed began construction of a new factory in 1985, which started 
to operate in early 1989. In 2000, a second factory was built, 
starting its activities in 2003. After 35 years in the market, Silimed 
operates with two factories in Brazil and exports to all five 
continents.In 1990, Silimed began manufacturing textured mammary
 implants. In 1999, Silimed received 510K approval from the FDA (Food 
and Drug Administration) in the USA for its textured and smooth silicone
 elastomer implants. [this information from Silimed's own website 
history of the company]On March 9, 2012, Silimed's Sientra 
silicone gel mammary implants received FDA approval for sale in the USA.
 Silimed is the first manufacturer
 outside the USA whose silicone mammary implants, smooth and textured, 
are approved in the USA. Furthermore, Silimed became the first 
manufacturer in the world whose form-stable (teardrop shaped) textured 
silicone gel implants were approved in the US market. 
(Allergan--formerly Inamed--SUBSEQUENTLY received FDA approval for its 
style 410 textured-surface shaped highly cohesive silicone gel implants,
 the popularly-named "gummy bear" implants).But because 
Sientra's high-strength, cohesive, form-stable (teardrop-shaped), 
textured-surface implants were actually first to be FDA-approved in this
 country (and because they have used that terminology in their website 
information about their implants), many now call these "gummy bear" 
implants as well. The terminology is therefore confusing, like calling 
every facial tissue "Kleenex" when it might actually be a Puffs, or 
every copy machine a Xerox, when it could be a Minolta. But you know 
what I mean.Each of the 3 USA breast implant manufacturers has 
shaped, textured-surface cohesive (or ultra-cohesive) implants, and each
 manufacturer has their own patented or "trade secret" way of creating 
the textured surface--the  "proprietary" texturing method. McGhan (now 
Allergan) implants use a lost-salt technique where salt crystals create 
the high and low spots of the texture, designed to promote tissue 
adherence and ingrowth. The salt is then washed away before implant 
sterilization. This tissue adherence is not unlike Velcro, but is not 
the "hook and fabric loop" structure that Velcro uses. This 
texture mimicked the structural properties of polyurethane-covered 
implants from 2 1/2 decades ago, where tissue ingrowth was shown to 
reduce (or prevent) capsular contracture (CC). CC was much more common 
at that time, since breast implants were usually placed ABOVE the muscle
 and just below the breast tissue, where there was significant bacterial
 contamination from the normal bacteria within the breast ducts. The 
texturing was also thought to "break up" the unidirectional collagen 
scar fibers that aligned themselves along a smooth-surface implant, 
contracted, and formed CC. And it worked! CC rates diminished.Mentor
 developed their own textured-surface implants (Siltex), and their 
method of creating the surface texture was also proprietary (and 
different). It was a stamping process that created a much more 
finely-grained or almost "fuzzy" surface. My own experience with these 
implants showed that tissue ingrowth and adherence did not happen with 
this type or method of texturing, and years of experience with saline 
textured-surface implants showed a higher leak rate.Sientra's 
method of texturing implants leads to a texture much more similar to the
 Allergan texture, but their technique is, again, proprietary, meaning 
they have their own way of creating what they feel is a better texture 
designed to promote adherence, ingrowth, CC reduction, and implant 
rotation avoidance (since an upside-down teardrop-shaped implant or 
sideways-positioned implant that was "stuck" there looks really wonky!We
 know from other areas of bioengineering (such as rough-surface titanium
 hip or other orthopedic implants) that human tissues do not adhere 
equally to all man-made textured surfaces or materials. But we do know 
that textured breast implants DO reduce CC, particularly when used above
 the muscle. But since most plastic surgeons now place their breast 
implants BELOW the muscles, and have learned that even without texture 
this reduces CC significantly, the place for texture below the muscle is
 less for prevention of CC than for prevention of rotation to an 
abnormal position! We also know from X-ray studies of women with
 smooth round breast implants and women with textured teardrop-shaped 
implants, the round implants are actually teardrop-shaped when the woman
 is standing, and indistinguishable from textured teardrop-shaped 
implants. They looked identical! But when reclining, the smooth round 
implants assumed a flatter round shape and dropped slightly to the side 
of the chest, just like naturally large(r) breasts do, whereas the 
teardrop-shaped implants did not move and poked straight up in an 
unnatural still-teardrop shape, making these so-called "anatomic" 
implants LESS anatomic than the smooth round ones.Sientra's website uses the term "gummy bear" implants, and even though "gummy bear" is not medical terminology, Sientra's marketing people are clever, and have chosen to use this popular lay term in its promotional materials. But Allergan's stylee 410 implants were actually the first ones to be termed the "gummy bear" implants, long before Sientra implants were FDA approved for use in the USA (March 9, 2012). However, Allergan did not received FDA approval for their stye 410 implants until AFTER sientra's FDA approval. So it IS confusing!  I think the term should be abandoned, since it is so confusing.All 3 breast implant companies in the USA make highly cohesive, high-strength cohesive, and cohesive silicone gel implants, each with a slightly different degree of cohesiveness, firmness (softness), rupture rate (fracture), and individual shapes (round and teardrop). None of these can "leak" so MRIs are a worthless test for this, IMHO.Thus, "gummy bear" = cohesive. NOT Sientra. But Sientra (and Mentor, and Allergan) make cohesive implants often called "gummy bear" implants by the lay public. Some lay persons, AND some plastic surgeons, use the term "gummy bear" only for the highy cohesive style 410 made by Allergan, and some use the term "gummy bear" only for the high-strength cohesive Sientra implants. Some use it for both of these two options, but not for the remainder of cohesive silicone gel (smooth round) implants. AAAARRRRGGGGHHHH!! Let's avoid this generic and confusing term and call implants what they really are. So much easier, and much more informative.For more information that may be of assistance to you in selecting type of implant, smooth or textured, shaped or round, saline or silicone (all are now cohesive), please click on the web reference link below. Whew! that was a lot, but I hope it helped. Best wishes! Dr. Tholen

Robert Cohen, MD · Answer

The term “gummy bear” implant, which as far as I know was
initially coined by Dr. Grant Stevenson of Marina Del Rey, referred to the
Sientra textured round silicone implant. There is no true “gummy bear” implant
as this is just a nickname that was given because of the higher level of
cohesiveness of the gel. These days many surgeons refer to any type of silicone
implant as a “gummy bear” implant. With regards to cohesiveness and cross-linking, the silicone in 5th generation implants are either smooth round or
more form stable than Allergan and Mentor smooth round implants. All three
companies have significant form stability in their anatomical implants.

Joe Gryskiewicz, MD, FACS · Answer

Hi,You are right to be confused because it is a confusing topic!  The main investigator in the U.S. for Sientra, Dr. Grant Stevens from Marina del Rey, coined the term "Gummy Bear" for the Sientra implants he was investigating.  So, this refers to all Sientra, shaped or non shaped, but people use it for all companies, too.  All of the current silicone gels are thicker than the old implants used to be.  So this means they are all cohesive.  So overall, think of shaped versus non shaped. The shaped are a little thicker so they better hold their shape.  So yes, a Sientra is always a gummy bear!  All the best, "Dr. Joe"

Peter J. Capizzi, MD · Answer

"Gummy Bear" is a descriptive nickname for the newest, most advanced silicone gel breast implant. In my experience - over 15 years in active practice - Gummy Bear implants deliver outstanding results. I have placed over 500. As you may know, the so-called Gummy Bears are fairly recently FDA approved. I was part of an FDA Gummy Bear trail for nearly a decade. Thus, I am very familiar with this implant and have no pause recommending Gummy Bears. And, I have hundreds of patients who would agree. As to Sientra, they make an superior product. Good luck to you as your research continues. You're asking good questions and honing in on an excellent choice.

Thomas Fiala, MD, FACS, FRCSC · Answer

The term "gummy bear" was first mentioned by Dr. Grant Stevens, I believe.  It's just an easy-to-understand term about the feel of the new generation of very "cohesive" implants.Cohesive implants, with a thicker silicone fill, are made by all 3 FDA approved companies.  They can be teardrop or round shaped.  They do feel a little firmer than standard silicone implants.If you are in the Orlando area, come in for a consultation - and I can show you the different types of implants available, including the Sientra implant.All the best,

J. Jason Wendel, MD, FACS · Answer

Thank you for your question.Gummy Bear is a nickname given to breast implants that are textured form-stable, and anatomically-shaped.Sientra is the specific name of a company that makes breast implants only available to board certified plastic surgeons.All three major breast implant companies in the United States -- Sientra, Allergan and Mentor -- make anatomically-shaped, form stable, textured breast implants.Sientra was the first company to have its full portfolio of implants FDA cleared in the U.S.I hope this helps.

Ralph Trey Aquadro, MD · Answer

"Gummy bear" implants is a lay term to describe implants that hold their shape.  This means the implant can have a gentle slope to be more like a natural breast.  Also, the implant can be taller than it is wide or wider than it is tall.  Other terms for these implants are highly cohesive or anatomical shaped implants.  All three manufacturers of breast implants in the U.S. (Silimed, Allergan, and Mentor) have a line of shaped implants that are FDA approved.  Each implant has slightly different characteristics and some surgeons prefer one implant to another.  Sientra has a line of round gel implants with both smooth and textured surface.  Visit a board certified plastic surgeon to learn more about Sientra breast implants.Trey Aquadro, M.D.East Alabama Plastic SurgeryAuburn, AL

Christopher S. Verbin, MD · Answer

"Gummy Bear" breast implant is a popular term for form stable shaped breast implants.  There are three manufactures of breast implants FDA approved in the US and they all produce gummy bear shaped gel breast implants. I prefer to use the Sientra shaped implant because, in my opinion, they have the best texture surface shell and less chance of gel shell internal separation, and best overall clinical results. All three manufacturers have similar warranties, however only Sientra also offers to replace the textured implants for free if the patient gets capsular contracture within the first 2 years post-operative (if this is their first breast augmentation).

Farbod Esmailian, MD · Answer

That term has been used interchangeably for the current silicone implants.  It is not particular to Sientra, Mentor or Allergan.However, when the term first was used it was referred to the highly cohesive silicone gel, shaped implants like the Allergan 410.  But now it has become a ubiquitous for all of the silicone gel implants that are on the market.  The idea is that if the silicone shell that surrounds the gel is every compromised, the silicone gel inside will not lose it integrity and spill out into the pocket and tissues.  This was the main issue with the silicone gel from the past.  Even though the silicone implants from the 1980's felt very nice and natural, once the shell was compromised there was spillage which became very difficult to clean up.  The new silicone gel that is used now seems to not have this issue.The link below will give you some more information regarding silicone implants.Hope that helps.

Tom J. Pousti, MD · Answer

Thank you for the question. All currently FDA approved silicone gel breast implants are “cohesive”.  This “cohesiveness” makes it so that the silicone material is less likely to leak, if/when there is a failure of the surrounding shell.The “gummy bear” silicone material is a  more dense material chemically.  The term “gummy bear”  has been  used, almost as a slang term,  to encompass all silicone gel breast implants; thus the confusion. None  of the types of breast implants you mention are necessarily “better”; there are pros/cons associated with each type of implant. Every patient who presents for breast augmentation surgery has a different body type, different goals/concerns, and potentially a different “mindset” when it comes to the best breast implant for her. It is, therefore very important to individualize each patient's care.

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