No, we are not pulling your leg. This is a nickname that has been given to a new type of breast implant that is under study for possible approval by the Food and Drug Administration for both breast augmentation and breast reconstruction. As a matter of disclosure, three of the surgeons at St. Louis Cosmetic Surgery are currently participating in clinical trials using these implants in some of our breast augmentation and breast revision patients. The plastic surgeons at St. Louis Cosmetic Surgery do not receive any financial compensation for their role in these studies. There is some compensation for the staff at St. Louis Cosmetic Surgery since they handle most of the paperwork required by these studies.
The official name of these implants is the Allergan Style 410 Breast Implant and what makes this type of breast implant different than the standard silicone-gel breast implant is that in the Style 410 breast implant, the filling material is made of a form-stable silicone-gel matrix. Because of the cross-linking of silicone-gel, the Style 410 implant will maintain its shape and form better than the older generation silicone gel implants. Similarly, if the implant should fail, it makes it less likely that the silicone-gel filling material will migrate outside of the implant shell. It is this type of filling material that gives the Style 410 implant its nickname-the gummy bear implant- as some people think the inside material feels similar to a very soft gummy bear candy. On a personal note-I think they look and feel more like a super soft gumdrop.
A recent report by Bradley P. Bengston, M.D. et al published in the Silicone Breast Implant: Outcomes and Safety Supplement of Plastic and Reconstructive Surgery reviews the three year experience of all of the participating plastic surgeons across the United States. There were 941 patients enrolled in the study-492 for breast augmentation, 225 for breast reconstruction, and 224 for breast revision. Complications were very low with implant malposition being the most common complication in 2.6% of the patients overall and slightly higher in the reconstruction and revisions patients. Capsular contracture occurred in 1.9% of the breast augmentation patients, a rate significantly lower than in saline and standard silicone-gel implants. Implant rupture rate was 0.8% in the study. Patient satisfaction for breast augmentation using the Style 410 implants was 98%-again far higher than any other type of breast implant reported to date.
Dr. Bengston’s report demonstrates some of the probable significant advantages of the Style 410 breast implants. While these implants have been available since 1994 in Europe and widely used now throughout the world, their availability is limited in the United States to patients agreeing to participate in one of the studies looking at the Style 410 implants. There are only a few centers in the United States selected to participate in these studies. The plastic surgeons at St. Louis Cosmetic Surgery will continue to participate in these studies and hopefully we soon will be able to offer the Style 410 breast implants to all of our patients.
Herluf Lund MD
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