Cohesive Breast Implants: What’s the Latest Buzz?
Three studies commenced sometime ago to identify the FDA take on safety and efficacy for Allergan Style 410 Form Stable implant, also known as Gummy Bear Implant. Over the past 16 years, the same form stable breast implants have been used in Europe and Brazil with a high satisfaction level. Plastic surgeons in the U.S. who are participating in the studies have used the Allergan Style 410 Form Stable implant for the past eight years. In the process of the studies and pending FDA approval, the outlook is promising. The Allergan Style 410 Form Stable implant may be used for primary breast augmentation, revision breast augmentation and breast reconstruction for study participants over age 18.
Early Outcome Gummy Bear Report
Many members of the medical community in European countries contend that form stable implants are the preferred choice among women who qualify for this type of breast implant. The attraction to silicone form stable implants is the fact that silicone is of a gummy bear consistency which provides greater leak-prevention when compared to traditional silicone implants. Also, form stable implants are designed in a tear drop shape much like a natural form. For these reasons, form stable implants have found to be superior and provide longer lasting shapeliness when compared to traditional breast implants. Women who are 18 may participate in the study for form stable implants, even though women interested in other silicone implants must wait until they are 22 to receive silicone breast implants.
Because form stable implants are tear drop shaped, precautions must be taken to ensure that the breast implant does not rotate. This is accomplished through two methods. First, the form stable implants are textured to allow for better adherence to underlying breast tissue which helps prevent rotation. Secondly, a precise technique must be used through highly accurate breast measurements by the plastic surgeon to help ensure that the breast implant fits tightly in place to maintain positioning. Conversely, traditional breast augmentation involves a blunt technique whereby the breast implant may move around.
Form Stable Silicone Limitations
There are round un-textured form stable implants in Europe and those are not affected by rotation, but round form stable implants are not available in the U.S. studies. Some women interested in revision breast augmentation may not be candidates for form stable implants because the previous breast pocket dissection was done using a blunt technique too large for the tight fit required in form stable implants. Also, women interested in Gummy Bear implants may have the incision placed in the armpit, under the breasts creases, or the areola, but not the belly button. There may be other reasons why select women are not candidates for Gummy Bear implants and other breast implant types may be more appropriate.
Currently, the only way for women in the U.S. to receive form stable implants is by participating in one of the studies. Requirements for the study include: candidacy for the procedure, diagnostic tests, ongoing health screenings and physical exams. Women interested in Gummy Bears must also agree to have photos taken and be willing to see other physicians involved in the study. This is a ten year follow up requirement.