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