The Food and Drug Administration has approved a new silicone-gel breast implant from Sientra, making it the third company to market the controversial products in the U.S. This will be the third company offering silicone breast implants in the US. The implants are approved for breast augmentation or reconstruction in women who are at least 22 years old.
Breast augmentation remains very popular. According to the statistics performed by the American Society of Plastic Surgeons, 307,000 procedures were performed last year in the US; an increase of 3.6 % from the previous year.
Is it good to have another company selling breast implant in this country? I think it is. Competition is always good. It leads to better products and a less expensive price and avoids complacence.
I had a chance to compare the different gel implants the other day. They all have supposedly the same gel material inside the silicone shell. The new gels are more cohesive which means that they stay within the shell in case of rupture and do not leak as a liquid inside the capsule. Despite this similarity in the gels, the implants seem to behave differently. The Sientra implants assume their original shape after one squeezes them. They also offer textured anatomic implants, which are narrower on top and keep that shape. I think they have made the shell in such a way that it keeps its shape. These implants are in fact form stable (gummy bear) and may have a place in breast reconstruction or in very special cases in breast augmentation. I just want to reiterate that in general, I am not in favor of form stable implants and favor smooth round devices except in special situations.
Farhad Rafizadeh MD