Silicone Gel's future

There's a lot of interest from patients about silicone gel breast implants. Since the early 1990's there's been an FDA moratorium on unrestricted use of gel implants. To make a long story short, in a political maneuver not support by science, the implants were severely limited to IRB-guided protocols for cosmetic & reconstructive use. Since then, silicone implants have been overwhelmingly shown to be both effective AND safe in trials all over the world. Presently, only the United States & South Korea (which defers to the FDA in many issues) have such restrictions.

Last fall, the FDA advisory panels gave approval recommendations to Mentor Corp. to remove the current restrictions. Game over, right? Well in 2004, Inamed Aesthetics likewise passed the advisory panel only to be shut down later on. (Ignoring the science advisory panel is a VERY rare event BTW)

Funny enough, the implants being considered currently are 20 year old designs. Some people label them "3rd generation" implants. They were designed and are manufactured with QA much better then previous implants. Most of the horror-stories of patients with silicone were "2nd generation" & suffered problems related to the low viscosity of the silicone gel & thin shells that surgeons of that era were asking manufacturers for. From the mid-late 1980's on, implants were made with both good durability and efficacy.

Coming down the pike are the cohesive silicone gels which feature much higher viscosity gel. These are the "Gummy Bear" implants you might hear about. They represent potential advantages of being form-stable (rather then more like a liquid) and impart real shape-defining characteristics to the breast.

Check back soon for a diary with more about the cohesive gels!

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