With Sientra implants now unavailable, are there increased risks using a gel filled implant vs. a highly cohesive gel implant?

When I planned my surgery we chose Sientra round textured implants for many reasons. Now as we all know, they are unavailable. My PS offers all 3 brands and has chosen to use Natrelle gel-filled implants instead. Should I have any concerns with gel-filled vs. cohesive? When I started this process I was dead set on saline due to my fear of silicone (yes I saw the 20/20 episode in the 90's). I felt the cohesive was the safest silicone option. Should I postpone?

Doctor Answers 11

With Sientra implants now unavailable, are there increased risks using a gel filled implant vs. a highly cohesive gel implant?

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All FDA-approved implants have a type of cohesive gel versus older-generation implants from the 1980’s that are no longer sold. The anatomically-shaped implants have a firmer gel that retains its shape in the body to act as an internal breast form (Allergan 410 and Mentor CPG). Round implants also shape the breast, but also fill out the breast to restore volume lost after pregnancy.
The safety profile of round and anatomically-shaped implants is well-characterized. Feel free to discuss your specific concerns with your plastic surgeon regarding their experiences with gel-filled breast implants.

Sientra Implant Alternatives

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Yes, I am also bummed that Sientra implants are no longer available for my patients. However both Allergan and Mentor have highly cohesive silicone gel choices. You also might want to consider the #IDEALimplant - a saline implant made to feel like silicone and now FDA approved and available. See the below link for details. 

Choosing the correct silicone implant

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All currant silicone gel implants are cohesive gel.  Allergan and Mentor have been used for years with excellent safety records, are all FDA approved and offer a wide range of implants to fit most any choice.  Textured vs smooth should be decided after in depth talk about the benefits and possible risks/trade offs.  Your plastic surgeon can discuss all details during your visit.

Implants

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Mentor and Allergan both have excellent products that are safe and reliable. You should discuss your concerns with your surgeon. Best of luck.

With Sientra implants now unavailable, are there increased risks using a gel filled implant vs. a highly cohesive gel implant?

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All available silicone gel implants are cohesive gel-that is the only type FDA approved and available. Mentor and Allergan are excellent. Understand the difference between textured and smooth-read below:

Sientra

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Natrelle (Allergan) and Mentor offer gel and cohesive gel styles. Rediscuss with your plastic surgeon so you are comfortable pre op.

All contemporary silicone gel implants are cohesive.

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Regret that your surgery was scheduled amidst this fracas, however remember that information is power and you now can focus on the two industry leaders.  You should probably also revisit preop planning with your PS.  Textured round silicone gel implants may feel slightly firmer than their smooth counterparts and if your skin brassiere is thin, you may be plagued by palpability of lateral folds or ripples.  Cohesivity is maximal in the Natrelle Style 410 and Mentor MemoryShape, which are anatomical "tear drop" shaped implants.  In the mid 90's there were some "tear drop" anatomical shaped saline implants, which were not widely accepted because of the possibility of malrotation and deflation.  Today's "form stable", highly cohesive gel implants come in a variety of projections and heights, which I have successfully used in breast cancer reconstruction as well as revisional breast. Saline breast implants primary appeal is the unequivocal detection of implant failure, i.e. "flat tire" phenomenon.  There are also some disadvantages: palpability of implant, thinning of overlying tissue, stretch deformity, amongst them.  If you have any misgivings, defer. 

Lavinia K. Chong, MD
Orange County Plastic Surgeon
4.8 out of 5 stars 58 reviews

"Cohesive"

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They are ALL cohesive now. A few are more highly cohesive than others but the practical differences are likely overshadowed by differences in tissue characteristics etc. In my opinion, all three manufactures provide high quality implants.                                                        

Cohesive Gel implants

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 In my opinion, the closest thing to the Sientra implant other than their new number 107 is the Allergan textured implants. These days, all of the silicone gel implants from all three manufacturers are deemed to be cohesive. Some of the older gels are more responsive in that they aren't as highly cross-linked which makes the gel not as rigid feeling. I think if you're my patient an Allergan implant would be the way to go. Good luck with your surgery.

Silicone Implant Safety

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Unless you had picked a Sientra 107 the gel in the 105 and 106 is basically the same "cohesive gel" as Allergan and Mentor gel. None of the brands or styles are proven "safer" and no silicone implant has been proven to cause any systemic health issues.

Sientra was removed from the market for potential contamination and is also being sued for securities fraud. Their Silimed manufacturing plant in Brazil has since burned down. This information has been released on Friday afternoon news dumps to minimize press coverage and impact on stock price. Their stock has dropped from 26 to 3.74 and their CEO dodged questions about the company's future at a shareholder and press conference call. I'm not sure how reliable said company's data and marketing hype is/was after all of these developments. Most concerning to me is who will honor their warranty should they go bankrupt or not receive FDA approval for a new manufacturing facility. That being said no breast implant manufacturer has proven that their device looks or feels better or is "safer" once implanted despite all the marketing hype. Anytime there are many choices, it is because they all have positives and negatives. The implant manufacturers prey on the unknowing consumer to pick a device with flashy advertising, or the “newer is always better” marketing campaign strategy. You say you picked Sientra for many reasons, but don't list those reasons to get the forums opinion on their validity.

First, the good news is that no liquid silicone is still on the market in the U.S. So that means, currently, every FDA approved silicone implant in the US is silicone gel.Second, the term gummy bear implants is not technical and has no specifications (I am an engineer so I like universal, clearly defined, industry wide specifications). Therefore, it has no useful meaning and just confuses patients. It was coined by a plastic surgeon to differentiate between older generation liquid silicone and the then new gel implants he was trialing. It now is inaccurately used by some to refer to the thickest "form stable" gel, but since that is inaccurate the confusion only deepens.Now for the complex details: Silicone breast implants can have 1) Varied gel thickness or cross linking of molecules, 2) Round or Anatomic shape, 3) Smooth or textured shell and 4) Variable fill ratio. Silicone Gel ThicknessAgain all silicone gel implants in the U.S. are cohesive by definition. Then there are highly cohesive (thicker gel) or ultra-highly cohesive “form stable” gel.Cohesive Gel << Highly Cohesive Gel << Ultra Highly Cohesive GelSofter more natural -------------------------->Very Firm and less naturalHigher rippling potential ------------------------> Less Rippling potentialThe thicker the gel, the less rippling potential, but the firmer and less natural the breast. So in the case of gel thickness, when most women don’t have to worry about rippling in their textured silicone implants, more is not always better.Silicone Implant ShapeThen there are round and anatomic shaped implants. Each patient will have their own view on these and it has a lot to do with their age range, demographics and desired result. The vast majority of breast augmentation patients want full round, cleavage and therefore they would be disappointed with an anatomic shape. If you desire a more discreet look of silicone breast forms they may be a consideration, but they only come in thicker gel condemning you to a firm less natural feeling breast, when a lower profile round silicone implant can still give the natural teardrop shape, but more natural feel.Smooth vs. Textured ShellTextured silicone breast implants were introduced in an attempt to reduce capsular contracture by "disorganizing" the scar. Studies have been mixed about whether this theory is true in patients. Now texture has more to do with trying to keep anatomic devices in the proper orientation! Imagine an upside anatomic teardrop implant. The textured shell itself is thicker and less pliable when manufactured and the devices move less so it can be a firmer and less natural breast implant, many times a negative, but in the case of a lift may be beneficial. Although EXTREMELY rare it bears noting that all cases of ALCL reported have been with textured implants. So because it's, in my opinion, still just a theoretical benefit for the vast majority of primary breast augmentation patients, and may cause problems, I use mostly smooth unless a patient requests the textured or if I am trying to have the texture hold an implant in place on a large lift.Fill RatioThe Allergan Inspira line and Sientra 106 line is the same gel and shell as the Natrelle line and 105 line respectively (meaning cohesive) but is filled approximately 5-7% more giving a “fuller” look without as much volume as the next style up. It also has less rippling potential, a big positive in extremely thin patients, without as much increase in firmness as thicker gel. My thinner patients are really moving towards the Allergan Inspira and Sientra 106 implants for less rippling and more fullness than mod+, but not quite as much volume as the high profile.I make specific recommendations to each and every of the augmentation patients I see annually based on: 1) dimensional planning 2) expressed goals 3) amount and quality of tissue to hide the implant.Only a board certified plastic surgeon specializing in breast augmentation (meaning they do 300+ a year) will have the expertise, knowledge and experience to understand and explain these subtle differences to you. Don’t trust your result to an office that gave you a video, booklet or patient coordinator rather than the surgeon to answer these important questions about silicone breast implants!

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.