Form Stable Breast Implants: Style 410 FDA Clinical Trials


Form stable implants — also called cohesive gel or gummy bear implants — have undergone years of testing and scrutiny to qualify for approval by the U.S. Food & Drug Administration. Host Lindsay Hall speaks with Dr. Bradley Bengtson, a board certified plastic surgeon in Grand Rapids, Mich., about the clinical trials for the Style 410 breast implants from Allergan, and the benefits of form stable implants. Read the full story

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Cohesive Gel Breast Implants


Cohesive gel breast implants, also known as gummy bear implants, are an alternative to silicone and saline implants.  Cohesive gel implants are a bag-like substance (approximately about the size of a hamburger bun) described as silicone rubber shell that is thickly filled with cohesive silicone gel used to improve the size and shape of the breasts.

Cohesive gel implants have been used for 10 years in Europe but are still unproven in U.S. clinical trials. However, this new breast implant technology has shown some qualities that may make them preferable over saline filled or silicone gel implants in future breast augmentation surgeries.  According to some experts, due to the thick layer of gel, cohesive gel implants are:

•    More durable

•    Less prone to rippling and leaking
•    Not likely to collapse or fold
•    Better at retaining form and stability, enabling the shape of the implant to remain the same in any position

Despite these advantages, cohesive gel implants do not shift or change shape once they are inserted, and all cohesive gel implants are the same teardrop shape that may not appeal to all women. Cohesive gel implants also feel firmer than older types of implants. Other risks include rotation, which can distort the shape of the breast, and possible fracturing, which is possible given the “solid” nature of the implants.

Cohesive gel breast implants, though, are not for everybody.  In the United States, women who are found to have certain medical health problems (a prior check up is mandatory) are not eligible for such implants. Aside from this, the FDA imposes a precondition that patients who receive these implants are required to commit and submit to a follow-up period of 10 years. In addition, not all plastic surgeons in the U.S. can perform cohesive gel implants. Only those who have been approved for participation by silicone gel manufacturers (under FDA scrutiny) in the adjunct study can do it.

Notwithstanding the potential of cohesive gel breast implants to make improve the size and shape of the breasts, one should be aware of all the advantages and disadvantages of this new cosmetic technology. It is important to research all the possible results and risks before deciding to get cohesive gel breast implants.

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