High Unmet Need for a Safer Breast Implant
In 2011, the U.S. FDA identified a possible association between textured breast implants and the development of breast-implant-associated lymphoma (BIA-ALCL).
Further, in 2016, the World Health Organization classifies BIA-ALCL as a T-cell lymphoma. The FDA and Plastic Surgery Foundation formed the "PROFILE registry", and treatment recommendations were published. The French regulatory authorities asked textured implant manufacturers to conduct Biocompatibility testing.
As of today, NO action was taken on part of the breast implant industry towards innovation on implant safety.
To address this safety concern, Apex took the lead in developing the safer shaped implant with a smooth surface to be the alternative to teardrop textured implant.
DefyGravity is in the horizon.
A Short Time-to-market Product
DefyGravity R&D started since 2012, a design proof-of-concept study was performed and the outcomes were the backbone of the granted patents.
Further development of DefyGravity needs minimal R&D expenses and time.
Manufacturing the DefyGravity breast implant needs only a new mandrel, which will be incorporated using current manufacturing protocol, safe FDA approved silicone gel, and the same equipment and trained employees.
As a Class III medical device, DefyGravity require the submission of Premarket Approval (PMA) Supplement Application for a new style of anatomical breast implant that has changed Design.