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.
Although form stable breast implants have been approved in Europe for more than 15 years, the FDA still mandated extensive testing here in the U.S. Currently, more than 8000 patients in the U.S. have the Style 410 breast implant, a form stable implant that has proven to have a lower rate of complications and revisions compared to routine round silicone and saline implants.
Dr. Bradley Bengtson, MD, FACS, a lead investigator in the trials, explains the main advantages of the Style 410 gummy bear implant, compared to current silicone gel implant technology. He also clarifies who is an ideal patient for the Style 410, and who should consider a smoother round silicone implant.
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debbie responded:
do you have any clinical trials right now or coming up? thanks
Jeannine responded:
How can I get involved in the trial study for the style 410 breast implants? I have had a Mastectomy and expanders Oct. of 2009 and have been waiting….for FDA approval in the US. A trail opportunity after investigating options. I am confident that I would be a good candidate for this. Look forward to your response.
Best Regards Jeannine
Answer from PSC Doctor:
William P. Adams, Jr., MD
CMO responded:
Jeannine,
You would want to go to an approved investigator for this implant. You might start with the site http://www.cohesiveimplants.com a good resource on these implants.