The FDA approved the use of gummy bear breast implants in the US in 2012. Designed and developed by Sientra, Allergan and Mentor, the gummy bear breast implant has become very popular over the last few years, especially after the FDA approved it.
The implant contains a cohesive gel that has a perfect balance of firmness and softness. These qualities enable the implant not only to deliver natural results but also retain their shape in better ways than traditional breast implants.
The clinical trial of the gummy bear implants started in 2001 with the Style 410 implant from Allergan. Since then, a large volume of data pertaining to the safety and complications of the gummy bear implants has been collected.
The clinical trials focused on the medical strategy, the device and its composition, and their safety and effectiveness in breast augmentation. The trials also covered the medical and surgical approaches that work best for the gummy bear implant and for certain types and shape of breasts.
According to findings of the clinical trials, the Allergan 410 demonstrated far better in terms of implant rupture and leak, implant rotation and malposition, and implant hardening when the data were compared to the clinical trials of the standard breast implants that were approved in 2006.
Furthermore, a study found that the gummy bear implants entail a lower risk of capsular contracture than other breast implants. The study involved 355 patients and extended over five years. It also found a relatively lower risk of rippling and formation of folds in the gummy bear implants.
As part of the clinical trial, thousands of patients received the cohesive gel silicone breast implants. The findings were carefully determined, analyzed, and reported. The findings thus led to the approval of the 410 and Sientra implants by the FDA in 2001.