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In March of this year the FDA approved a new breast implant in the United States.  Sientra (Silimed in Brazil) received approval to begin marketing and selling their highly cohesive, form stable breast implants.  The two breast implant companies in this country are Mentor and Allegan.  Both companies manufacture highly cohesive, form stable implants but they have not yet been approved by the FDA.  Mentor’s CPG implant and Allergan’s 410 implant are both anatomic shaped (tear-drop) textured implants.  Conversely, Sietnra offers smooth and textured round as well as anatomic textured implants.  Sientra’s current business model restricts their use to board-certified and board-eligible plastic surgeons unlike Mentor and Allergan.

So, what does this mean for women desiring breast augmentation?? The current silicone gel breast implants available are  Mentor’s Memory gel and Allergan’s Natrelle.  These implants are cohesive but not “highly-cohesive” or form-stable.  What does that mean?  I usually describe to patients the difference in feel when the implant is cut open.  The cohesive implants have the consistency of soft jello and the highly cohesive are more like a gummy bear.  In fact, gummy bear implants are often used to describe these implants.

Does it matter?  These form-stable, highly cohesive devices have advantages over the current silicone gel implants.  The two biggest advantages seen in clinical trials are a decreased rate of capsular contracture and visible rippling and a decreased rupture rate.  The shaped implants may also offer advantages in certain patients looking for a certain natural feel to the implant as well.