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Breast Implant Safety

October 12, 2010,


After studying 355 form-stable silicone gel breast implant patients, Dr. Grant Stevens and his co-authors have found that fifth generation silicone breast implants are safe and have a similar complication profile to other silicone breast implants.

Marina Del Rey, California (October 2010) – Since silicone gel breast implants were approved by the FDA in 2006, studies of a newer generation of silicone implants, commonly referred to as “gummy bear breast implants,” have been underway. Los Angeles breast implant surgeon Dr. Grant Stevens from Marina Plastic Surgery, a participant in the Silimed form-stable silicone cohesive gel breast implant study, recently co-authored a study evaluating the efficacy of this new implant type.

“What we found when conducting this study of fifth generation silicone gel breast implants is that they are safe and have a complication profile similar to other types of silicone gel breast implants,” says Dr. Stevens. “We actually found that form-stable silicone implants have a lower capsular contracture rate and a decreased incidence of wrinkling when compared to fourth-generation silicone gel implants.”

Fourth generation silicone gel breast implants are widely available in the United States today. These implants use thicker and more cohesive silicone gel fillers compared to older silicone implant types. Fifth generation silicone gel breast implants differ from their fourth generation counterparts because the silicone gel inside them is more highly cross-linked, helping them to retain shape better while remaining soft. They are called “gummy bear breast implants” because their texture is similar to that of a gummy bear candy – when cut in half, the implant will retain its shape without leaking or oozing.

“Due to additional cross-linking of the silicone molecules within the implant, the fifth generation implants can better retain their shape while still providing women with a very natural look and feel,” explains Dr. Stevens. “Over a 60-month period, we studied 355 Los Angeles breast augmentation patients, including women who had primary augmentation, primary reconstruction and revision breast surgery. Based on our findings, along with other ongoing research, I suspect that this new implant type will become widely available in the United States in the near future.”

The study divided complications into three categories: tissue-related, implant-related cosmetic, and implant-related. Tissue-related is defined as revisions after implant surgery that may occur following any breast surgery, implant-related cosmetic is defined as elective revisions that are cosmetic in nature, and implant-related is defined as complications related directly to the implant. The capsular contracture rate found in this study was 0.7% per implant, compared to a rate of 2.6% per implant when studying fourth generation silicone gel implants.

“Based on our study, fifth generation silicone gel breast implants appear to be a safe and viable alternative to fourth generation silicone gel implants,” says Dr. Stevens. “More research is needed to confirm our findings of a lower capsular contracture rate with the gummy bear implants, but this combined with other purported advantages of fifth generation silicone implants is an encouraging sign that breast augmentation outcomes will continue to improve in the future.”

Fifth generation silicone implants have been used for augmentation, reconstruction, and combined breast surgeries such as breast augmentation with a breast lift in Los Angeles. A natural look and feel, decreased incidence of rippling, and enhanced safety profile are all possible with this new implant type, which is still undergoing clinical trials in the United States and has yet to receive market clearance from the U.S. Food and Drug Administration.

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