Gummy bear implants overview

Initial reports provide positive results

In the past we had talked about the so-called Silicone high-strength gel implants (Gummy bear implants) that are currently undergoing trial. Looks like we now have some information on how the tests are going and what the initial results look like. According to a recent study in the Plastic and Reconstructive Surgery, the new devices are more cohesive than those currently being considered by the FDA. They have a gummy consistency, which allows them to hold their shape better than saline.  It has also been found that the gummy consistency decreases the likelihood of rippling and provides greater safety because, being more solid, the silicone may not escape from the shell if it were to rupture. The more cohesive silicone material and its textured shell also give the implant a very natural and proportionate breast shape.  (Related:  Breast augmentation pros and cons)

According to the study, another benefit of the more cohesive gel implants is the availability of a wide variety of shapes and sizes to more closely match breast shapes and chest dimensions. For example, plastic surgeons can use a patient's breast measurements to custom select an implant specific to each breast. Beyond the cosmetic advantages of the more cohesive implants, these implants also have a low complication rate. 

  The FDA is currently considering the reintroduction of silicone implants for sale in the United States, 13 years after it restricted access to them due to safety concerns. In 1992, the FDA imposed a moratorium on the sale of silicone implants and saline implants have dominated the North American market. In the second half of 2005, after the manufacturers presented data at a panel hearing, the FDA issued "approval with conditions" for the sale of silicone implants, stipulating a number of conditions the manufacturers must satisfy in order to receive FDA approval. Data regarding this new type of silicone implant, the more cohesive silicone implants, has not yet received an FDA panel hearing.  "The more cohesive gel implants are going to play a major role in aesthetic and reconstructive breast surgery if they are approved for sale in North America," said Dr. Mitchell Brown. "We have already seen their potential through studies in Europe. Now, through our own research, we are finding with these implants, re-operation is rare, the complication rate is low and patients are extremely pleased with their outcome."

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