In the past 2 years, the FDA has approved three new form-stable, highly cohesive, “gummy bear” breast implants. The approval “frenzy” began when Sientra’s implants received the coveted nod in March 2012. Next came the approval of Allergan’s Natrelle® 410 in February 2013 and then Mentor’s MemoryShape™ implant (formerly known as the CPG®) in June 2013.
Plastic Surgery Practice sat down with Steven Teitelbaum, MD, a board-certified plastic surgeon in Santa Monica, California, and an associate clinical professor at UCLA School of Medicine, to discuss what the expanding choices of breast implants in the US means for patients and their plastic surgeons making implant choices for augmentation and reconstruction.
Teitelbaum has one of the largest 410 case series in the United States, and was also a major participant in the clinical trials of the Mentor MemoryShape™ implant and the Sientra implants. His experience with these implants goes back to 2001, and he used shaped saline implants since 1993. He has lectured on these implants worldwide, and was a prime contributor to the surgeon education for MemoryShape™ and the 410 that are required to use the implants. And he wrote one of the most comprehensive sources of information on these implants.
Here’s what he had to say:
PSP: Are these new generation “form-stable” implants really any safer?
ST: The data show that regular silicone is safe, free from the risk of the systemic illnesses that were a concern in the early 1990s. So it doesn’t make sense to state that something is safer than something else that is already safe. But local complication rates may be a different issue. Though there has been no comparison between these implants and standard implants in a single clinical trial, local complication rates in the form stable clinical trials are the lowest reported. This includes the total number of revisions surgeries, for reasons such as malposition, rupture, capsular contracture, and size change. So to the extent any revision surgery has risk, they could be considered safer if their revision rate is lower. But there is definitely a widespread belief that these are safer, and this stems from the perception that they can’t break.
PSP: Where did this perception come from?
ST: At first, surgeons and the manufacturers thought that they either couldn’t leak or that if they were to break the highly cohesive silicone would stay in place. After a while, a few ruptures were seen. True, the rates are the lowest of any implant, but it can occur. Sometimes, when the shell broke, the gel stayed in place. But we have now seen a few cases where the gel has moved outside the shell, though to my knowledge no cases have been reported of the gel migrating outside of the capsule and into the breast. No doubt this notion of unbreakability is one that manufacturers and surgeons have been happy to hear, because fear of rupture has always been a barrier to women considering augmentation. No manufacturer has ever said they could not break, though I have read it in several surgeons’ websites. The idea of “gummy bear” implants really blossomed in augmentation chat rooms and forums. This played a huge role. Some women go there and get medical advice from strangers. Bizarre, huh? As a result, gummy bear implants have achieved somewhat of a cult status.
PSP: The media played a large role in this, too!
ST: Of course. And they always do in plastic surgery. Years ago, patients came to plastic surgeons saying things like, “I don’t like the wrinkles on my face,” and the doctor would suggest the best treatment, whether it be a chemical peel, fillers, laser, or a facelift, etc. Today, they come in asking for a specific device by name. Patients frequently request “the gummy bear,” and of that type the Allergan 410 is by far the most frequently mentioned. What’s funny to me is that there was more coverage of the gummy bear implants before approval. The media has been quiet on this since approval. I guess it is because they have already all covered it, but I’m not sure. Some say in this post-Extreme Makeover age the media doesn’t think the public is as interested in plastic surgery stories as they once were. I also think that covering a new and potentially better implant back when there was concern about their safety was a more interesting topic. How many women considering implants today remember the scare-mongering of over 20 years ago. … it’s weird to think it has been that long.
PSP: How do the three “form stable” implants compare with regular silicone-filled breast implants?
ST: I should just clarify that none are really form stable. They are all a bit deformable with pressure, as they should for them to feel like a breast. I refer to them as “relatively” form stable, as compared to standard implants. There have been no toe-to-toe studies comparing gummy bears to regular silicone-filled breast implants. What we do know is that the reported complications rates for gummy bear implants are the best to date. It’s important to understand the point of these implants: for a round implant to look like a breast, the gel has to migrate from the upper part of the implant to the lower part. This requires the gel to be less solid and for the shell to be less filled up. But when the gel empties out of the top of the implant and shifts to the bottom, there are invariably some implant folds and the final shape is not predictable. The “form stable” implants have a gel firm enough to establish and maintain a shape, because it is fixed in position in the shell. This is what gives the enhanced shape.
PSP: Who most benefits from these implants?
ST: Patients who start off with very full and tight breasts are most susceptible to looking round with a round implant. The gummy bear implants can give a more gradual feathering of the upper breasts, which is more natural. This advantage exists with all breasts, but is not as profound in emptier or looser breasts.
PSP: When would you not use gummy bear implants?
ST: Gummy bear implants have the sweetest of sweet spots, but it is a narrow range. Patients have to be willing to let the implant be sized based upon their breast tissue, not a desire for a particular cup size. Patients with very loose breasts are the only ones to complain that these implants are firm, and I always worry about the potential for a deformity from implant rotation when the breast is too loose. They can be used in revisions, but it is sometimes tricky.
PSP: Is the “gummy bear” term here to stay?
ST: I think it is. It resonates with the public. It is also descriptive. It denotes something firm enough to hold a shape but soft to the touch. I don’t even like saying “highly cohesive” or “form stable.” Those just don’t roll off the tongue.
PSP: Is there a learning curve for surgeons who are incorporating these newer implants into their practice?
ST: The biggest developments in breast augmentation surgery in the past 20 years came out of meeting the increased need for precision in using shaped implants. And while they are necessary for shaped implants, they are just as helpful with regular implants. If a surgeon has stayed up with these advances, then there is little to learn. But the surgeons who have not evolved—eg, sizing by sizers in a bra rather than measuring, doing bloody, imprecise, or overdissected pockets, etc—then there will be a learning curve. So any surgeon who has been keeping up to date should have a very short learning curve. But anyone interested in learning and willing to refine their technique will be able to successfully use these implants. As I tell surgeons I’ve taught, they can start doing exactly the technique that is required for shaped implants when they do their round implant cases today.
PSP: As the three newly approved implants jockey for market share, how do you see things shaking out?
ST: Each will try to capitalize on some niche. Allergan will say that the 410 is the first, has the most published data, is the most popular worldwide, has the best texturing, and the prettiest and most long-lasting shape. Sientra will say that they are the softest of all three. Mentor will probably say that they have the perfect balance of firmness and softness, that they have the best texturing, and that they are the only implant made in the United States. Whether or not it is any better, the 410 investigators in the United Sates are unique in their degree of enthusiasm, and as I said before, it is the only one patients ask for by name. But there’s no telling how this well shake out. I can say this much: I’ve done hundreds of each of these, and I can’t tell a difference in firmness between them once in the body. But there are subtle but real differences in the shape they confer upon the breast.
PSP: Which is your favorite gummy bear implant?
ST: You’ll have to have a consultation to find out.