Web Log – March 2013 – “Gummy Bear” Implant Released by FDA

On February 20, the FDA released a long awaited silicone gel breast implant, commonly called the “gummy bear implant” that has already been on the market in the rest of the world for over a decade.

The implant is by Allergan and is called the 410.  Its gel is more cross-linked, so it is firmer than previously available silicone implants.  This allows the new implant to maintain a molded shape, as opposed to the looser round gel implants which collapse their upper pole.  The looser gel has had fewer leakage problems than old, very liquid implants of the 80’s that gave silicone such a bad name.  After exhaustive study by the FDA and extensive international experience, the new gel has been shown to leak even less with fewer associated problems like hard scarring because the gel, even with a shell failure, is less likely to migrate.

These 410 implant should be very helpful for post mastectomy breast cancer reconstruction patients.  Those patients have loss of volume to their upper pole and thin coverage, so an implant that fills the upper pole and is less liquid so it does not ripple should hopefully improve their results.  Most breast augmentation patients like the more augmented shape of a standard round gel implant and have adequate soft tissue coverage to hide most implant rippling, so the 410 will most likely be used in those patients who want a relatively smaller and more natural looking augmentation.
Although proven to be fewer, there are still potential rupture and leakage related issues with the 410 implant.  The problem with more crosslinking, however, is that it is definitely firmer and less natural feeling, especially in augmentation patients. Another issue is that a shaped implant can rotate and look very odd, as opposed to a round implant that can rotate all day and no one would know the difference.  To help minimize this, it is advised to place a drain – a small rubber tube that drains out fluid into a reservoir – for about a week.  You also have to choose the height as well as the projection of the implant appropriately.  So, surgeon selection judgement and operative technique are important.  Finally, since the new implants cost about twice what a softer gel implant would and there is more surgeon work, using them will be more expensive.
Breast Reconstruction patients who are dissatisfied with their current silicone or saline implants should consider having a consultation to see if the 410 implant would be appropriate and provide a beneficial change.  First time breast augmentation patients who want a more natural sloped look to the upper breast, as opposed to a more rounded or augmented look, may also benefit from the 410.  You can learn more at the manufacturer’s web site. https://www.natrelle.com/410_landing.aspx
Mark D. Wigod, MD, FACS, providing cosmetic and reconstructive plastic surgery to Boise, Meridian, Treasure Valley and Southeastern Idaho.

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