First, the”duopoly” that existed between Allergan and Mentor is over. They now have another competitor. Just how this new kid on the block will fare is yet to be seen. It appears that they have a good, comparable product that has been marketed throughout the world, although not here in the USA. Certainly they will gain some market share from the bigger kids. How much, from whom, and over what time period they acquire their piece of the pie will be interesting to watch. Suffice it to say that Sientra definitely has the attention of Mentor and Allergan.“Gummy Bear” Implants?
The other thing that has come front and center, is the issue of “gummy bear” or form stable silicone breast implants. Many are touting this as the ultimate implant and it looks like Sientra’s form stable implants have been covered in this approval, while Mentor’s and Allergan’s form stable breast implants are still in clinical trials.
The question I have is simple: are the gummy bear implants a truly “better” implant for most women?
Let me at the outset provide the disclaimer that I have not used the fifth generation, form stable, aka “gummy bear” implants. But I have to wonder whether the “advantages” are really advantages? There is no doubt in my mind that these will be better implants for some patients, but are they better implants for all patients?
Pros and Cons
The benefits of form stable implants are supposed to a decreased incidence of rippling, a lower rate of capsular contracture (firmness after healing), a lower rupture rate, and a better shape. On the other hand the disadvantages are: longer scar, higher cost, firmer implant, and possible rotation of anatomic or “tear drop” shaped implants.
Let’s really look at this.
- Rippling- For me, rippling is rarely if ever a problem with our current cohesive silicone gel implants (Mentor Memory gel). Rippling can be a major problem with saline implants, but they have never been a big issue with silicone implants.
- Capsular Contracture (firmness after healing)- In terms of capsular contracture, I really need to see the data. But if there is a bit of a somewhat decrease in this with these newer implants, will it be offset by the fact that these are firmer implants in all patients?
- Better Shape- I am not so sure about the better shape of cohesive gel implants. As the memory gel are softer and more compliant, they will have more change in their shape depending upon the body position. And I think you want this as this is what a normal breast looks like. But there will be less of a “gravitational” affect on the gummy bears, and I am really not sure that this is an advantage.
- Rupture- True, gummy bears do not rupture and memory gels can. However, rupture does not create health problems, even though the implants will need to be replaced. But what is the life expectancy of the form stable implants? Do they last forever? Doubtful, in my mind. I would expect that over time there will be some fatiguing of the form stable implants. Will this be fraying at the edges? Will some silicone particles be shed into the surrounding capsule? Probably, although this is not problematic or harmful. But we just do not have a lot of data on how these implants perform after they have been implanted for 20 years.
Just Because It’s New, Doesn’t Make It Better.
Like I said, there will no doubt be patients for whom these are the best implants. But there will be many people (the majority?) for whom current implants will still be the best. The longer incision, higher cost and firmer implant may outweigh the supposed benefits. Time will tell who is who, as in all things. And, ultimately, it may just come down to what a woman wants her breasts to feel like.
All the best,