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The Gummies are Coming!

New FDA-Approved Gummy Breast Implants

“410 approved”

After years and years of waiting, that simple text sent by our Allergan breast implant representative yesterday at 4 pm signaled the FDA approval of the Natrelle® style 410, form-stable, highly-cohesive fifth generation “gummy” implants.  We will now have access to an implant for cosmetic and reconstructive breast surgery that has been extremely popular in the U.K., Australia, Canada, and the many other countries that have had it for the past 10 years, and we’re really excited.  What does it mean for us , and for our Denver patients?

The 410’s are fundamentally different than other silicone breast implants.  During their manufacture, the silicone that fills them is treated to make it more tightly cross-linked, essentially creating a soft solid form of the liquid which fills other Allergan silicone implants.  This offers several advantages, and a few disadvantages which are important to understand if you’re going to make an informed decision about which breast implant is right for you.

Shape is the key feature of these implants.  Solid implants are “form stable”, meaning that they hold their shape regardless of the position they’re in, unlike the standard liquid silicone implants that we’ve had for the past 25-odd years.  This can lead to maintenance of fullness in the upper pole of the breast and a tapered shape that some people find appealing.  It can be a very natural look.

Where it will almost certainly be a game-changer is in post-mastectomy reconstruction.  With the 410’s, a skilled reconstructive surgeon can create a new breast that is, in my opinion, unmatched by the standard round implants.

These new implants appear to be more resistant to rupture, and in the pre-approval data are associated with fewer capsular contractures than standard silicone implants.  We have a broader choice with regards to dimensional planning with these, as well.  There are different “cells” of implants, with different heights, widths, and projections.  The initial availability of all of the various shapes will be somewhat limited to the most popular choices, but I expect that all of the different options will become available over time.

What are the disadvantages?  First and foremost, there is a learning curve with these implants.  They require precision from the surgeon that is not necessary with standard round, smooth implants.  Because the 410’s hold their shape, they must be oriented correctly within the breast, and must maintain that position permanently. If they rotate, visible deformity can occur and requires reoperation.  Because of this, the implant pocket created during the surgery must be correctly sized for the implant being used to hold it in place until the tissues surrounding it can grow into the textured shell and fix it in place.  (I’ve been using this implant for 7 or 8 years as part of the FDA-sanctioned study evaluating them, and most of my patients have been very happy with them.  I have not had any implant rotations or malpositions that required a return to the operating room.)

Other disdvantages? The incision used to place them is larger by a centimeter or so, as these implants can actually be fractured during insertion.  They feel somewhat firmer than standard silicone, though they soften over time. They will cost a bit more than standard silicone (and a lot more than saline) but may have a longer lifespan which offsets that cost differential.

So who is going to want these implants?? In short, the ideal patient has relatively snug tissues and wants a natural-appearing breast without much roundness in the upper pole.  The 410’s don’t give the classic round appearance that lots of patients desire.  That’s simply a matter of taste.  And when it comes to taste, more options can’t hurt.

(Of note, Mentor’s version of this implant, the CPG, has not yet been approved.  We do anticipate approval fairly soon, and will keep you updated.)

To learn more about the Mentor Natrelle style 410 breast implant, and if it’s right for your breast enhancement, contact us today to schedule a consultation with one of our breast specialists.

AJW


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