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Big news for breast augmentation. On February 20th, with absolutely no fanfare or advance warning, the FDA finally cleared the unrestricted use of highly cohesive silicone gel implants – AKA the “Gummy Bear” implants. The usual silicone gel is a soft liquid substance with a consistency similar to that of honey. These implants are firmer and the gel does not “run.” Indeed, it is more solid than liquid. When one of these implants is cut in half, it simply sits in place and looks very similar to cutting a candy gummy bear in half. The main benefit is that they hold their shape better and have a dramatically lower incidence of rippling of the implant. If you aren’t familiar with rippling, it appears when folds in the softer implants are visible through the skin and a Google search will show hundreds of photos. At present, only Allergan has met approval, although competing implant manufacturers Mentor Corporation and Silimed Corp. are also in the approval process. This is good news for anyone with a problem with rippling currently, and for those at high risk. They will not replace the current implants, but in certain patients they will be a better choice. Dr. Romans and I are both going to offer the new implants. Feel free to contact us with questions.
The official press release from the FDA can be found here:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340447.htm
and here is a link to a quick news story from ABC news:
http://www.cbsnews.com/8301-204_162-57570812/fda-approves-new-gummy-bear-silicone-breast-implant/