First New Brand of Breast Implants In Over Ten Years FDA-approved and why this is such a big deal

This is huge news. I first heard about this new company, Sientra when they sponsored a St. John’s Hospital Plastic Surgery Division dinner meeting about a year ago. The speaker bragged about how their implant line was already going strong in Europe, but I ignored their threats to become FDA-approved in the U.S. I figured the company as a whole was delusional and I actually felt sorry for them for spending so much money on all the free food and alcohol at the four-star restaurant. I mean, it’s nearly impossible to get anything FDA-approved in this country, especially something as invasive as a silicone breast implant. (Which, as I tell my patients should make you feel better about having the ones that are approved.) But Mentor and Allergan have pretty much been the Coke® and Pepsi of breast implants for as long as I can remember. (Actually, Allergan started out as McGhan, then became Inamed and then really pulled ahead when it got taken over by Allergan and the sales reps started bundling our breast implant purchases with free Botox® and Juvederm®.)

So why is this such a big deal?

 Most of the implants from this new company Sientra will probably not be significantly different from the ones already offered by the other two giant manufacturers. (I’ll let everyone know what they feel like in comparison to the others as soon as the company brings by samples, which I imagine will be as soon as all of the plastic surgeons in town open their doors for business on Monday morning.)

But the big story here is that this new company, Sientra has in its available armamentarium, a teardrop-shaped implant comparable to the “gummy bear” one that Allergan and Mentor have been trying to get approved for nearly a decade.

So what is this “Gummy Bear” implant, anyway?

All of the silicone implants that are available today are third generation. They are made of a cohesive gel, which means that if you cut one in half it will just stay the way it is, and the silicone won’t run out all over the place:

Truthfully, their consistency is more like Jell-o® than a Gummy Bear, but it’s the same idea.

The implants that have been nicknamed the “Gummy Bear” implants are the fourth generation silicone, which are made of an even more ”cohesive” gel. This means that not only do they not leak, they barely move(think stiffness of Jell-O® vs. Gummy Bears.) The difference is that they are teardrop-shaped, and to keep their shape they are firmer and don’t move at all, even if you lie down. This is what is known as “form stable.” There has been a lot of hype about how “great” they are–especially by the small number of plastic surgeons who have access to them through the Mentor and Allergan clinical trials.

Except now everyone’s going to be able to get them from Sientra.

But the FDA tends to keep things fair and square. Seven years ago Mentor and Allergan both got approval for silicone implants on the same day. If form-stable Gummy Bear implants by Sientra are getting approval, the same thing will probably happen for Mentor and Allergan by the end of the week.

However, don’t let the supply/demand thing fool you. Just because they’re less accessible doesn’t mean they’re necessarily better for everyone. The way I like to think of it is that instead of the implant taking the shape of the breast, with these “form stable” implants the breast takes the shape of the implant, which is most useful in a case of reconstruction after mastectomy or in a tuberous breast. In fact, these implants were initially intended for breast reconstruction patients, and somehow became another marketing tool for the plastic surgeons who not only have access to them, but get paid to use them and talk about them.

I have personally seen results with these form-stable implants, and while they definitely have advantages in breast reconstruction (both in congenital breast deformities and mastectomy patients) my opinion is that the third-generation ones that feel more like Jell-O® are better for most primary cosmetic procedures, and these are the ones that I would choose for myself. By the way, the form stable implants require a bigger incision in the breast (pretty much always at the inframammary crease) because you can’t manipulate them as much to insert them. (They were obviously developed by a man.) So don’t be upset that you missed out on something if you just got breast implants a few weeks ago and you suddenly hear about this “superior new Gummy Bear implant” fresh on the market.

Regardless, I also predict that along with everyone else in Beverly Hills, I will be getting a call (if not a knock on my door) from the Sientra sales rep on Monday morning. So for all of you considering breast implants, imagine that every plastic surgeon in town is probably going to be getting at least one free pair to try from Sientra, and then Mentor and Allergan are going to have to up the ante, get off their laurels, and give us each at least one complimentary pair. Whether or not your plastic surgeon decides to pass the savings on to you is up to them, but I think it’s a good time to get a breast aug…I’m just saying…;-)

Have a great weekend!



P.S. Here’s a link to one of the newsflashes if anyone is interested:

FDA clears 3rd silicone-gel breast implant for US

  1. Susan said:

    Oh BOY! What news!!! My hairdresser swears by her gummy bear implants.She had them done in Costa Rica.What advise might you have for my friend who is barely healed from her “naturelle” implant’s?Is there a safer option? No leaking and less movement sound like a good idea.I wated implants so that I never had to wear a bra.WRONG!!! I can’t even take a shower without a bra!!!!!Back where I started I guess…..

    • I see a lot of you are searching for “do I have to get my breast implants removed?” Unless you don’t like the way they look or feel, they really don’t have to be replaced unless they are ruptured, which will be obvious with a saline implant because it will go flat (sometimes over a few days) and is usually caught on a mammogram with silicone implants. After ten years, saline implants could deflate at any time. The company won’t lifetime guarantee any implants but if they’re not bothering you, leave them alone.

  2. Rita said:

    I am pleased to hear about the new implant. But I am so pleased with the ones I just got. So I don’t feel like I missed out on something better. This is why I think you are the best. Always letting us know what is new.

  3. pron said:

    Pretty! This was an incredibly wonderful post. Thanks for supplying this info.

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