The Science and Art of Implant Design

DefyGravityTM is the Safer Smooth Shaped Breast Implant

Apex LLC. is the only company in the breast implant manufacturing sector that conducted an innovation towards a safer breast implant. Being the first smooth-surfaced SHAPED implant, DefyGravity overcomes a major safety concern that links implant surface texturing with a rare type of lymphoma (BIA-ALCL).

DefyGravity will add a new shape option to current round implant from 1960s and teardrop implant from 1990s.

DefyGravity is the ONLY breast implant granted United States and International patents, and are proposed for sale or licensing.

In a highly competitive breast implant market, you can establish and protect market leadership through 2036.

Regulatory Agencies, plastic surgeons and their patients are always looking for safer improved products and a new option. 

 The FIRST Shaped Implant with a Smooth Surface

We are introducing a shaped breast implant mirroring the anatomy and configuration of the breast subcutaneous compartmentalized fatty tissue, the one and only tissue that give the breast volume, shape and proportion with ample cleavage with flawless upper breast fullness.

DefyGravity proposes a new concept where the implant is designed on non-spherical configuration with a flat base and no “axis of rotation” as seen in the above figure.

Tapered edges combined with a flat base in a tall implant can snuggly fits the anatomy of the chest surgical pocket.

DefyGravityTM Design Objectives

DefyGravity design objectives are to improve on "design-related" aesthetic complications that are caused by current implant thick edges as wrinkling, palpable implant edges, and wide medial cleavage.

DefyGravity design provide customized breast implant height and fill distribution for an appearance that is both push-up youthful and natural compared to current improper upper breast fullness (either very rounded from round implants or subtle from teardrop implants); this new implant offers increased patient satisfaction.

The name DefyGravity describes the implant relocated “center of gravity.” 

Therefore, DefyGravity breast implant design is the "One Solution for FIVE Problems", and will be the future industrial standard. 

 

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.

This is a unique licensing opportunity for breast implant manufacturers who are interested in new pipeline product in order to broaden their product portfolio and strengthen industry presence.

DefyGravity is in the horizon!

Licensing Opportunity

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On Our Blog

News and Insights

Blog 1: Aesthetic Breast Anatomy: Novel Insight for Improved Breast Implant Design

The female breast is an organ with dual functions of milk production and aesthetic appeal.

Accordingly, the breast anatomy can be described in two different ways: 

  • Functional breast anatomy,
  • Aesthetic breast anatomy related to subcutaneous compartmentalized fat that give the breast volume, proportion and perkiness with a footprint extending between the 2nd and 6th rib.

Blog 2: Round or Teardrop Implant? Insight into a 30-Year-old Controversy

Since the introduction of teardrop anatomically shaped breast implant in the 1990s, and to date, research and surveys have failed to demonstrate visible differences in aesthetic outcomes!

Looking at this controversy from a different perspective, we’re left to question why we would expect different aesthetic outcomes when round and teardrop implant designs have more similarities than differences, most important is that both leave an un-augmented cresent-shaped area at the top of the breast footprint.

Is it possible to influence this outcome?

Breast Crescent
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