Breast Implant with Macroporous Shell for Improved Safety and Stability

Background & Unmet Need

• In 2020, there were >193 K breast augmentations and ~138 K breast reconstructions in the US, the majority of which used breast implants
• In the past, textured breast implants were preferred to smooth implants as they provide greater positional stability, allowing them to be made in more natural shapes
• Textured implants also reportedly decreased rates of capsular contracture, implant malposition, reoperation, and improved aesthetic outcomes
• However, textured implants have recently been associated with Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and many have been recalled from the market
• As a result, there is a lack of suitable shaped implant alternatives to replace textured implants
• Unmet Need: Breast implant technology that promotes long-term implant positional stability without the use of traditional textured surfaces

Technology Overview

• The Technology: A novel silicone breast implant with a macro-well surface architecture for implant positional stability
• The Discovery: Anecdotal observations in revision cranioplasty cases using implants with macro-well surfaces have revealed that soft tissue ingrowth into the cranioplasty implants held them in position
• By incorporating macro-pores into smooth breast implant shells, capsular tissue can grow into the pores, thereby anchoring the implant to the surrounding tissue securely
• PoC Data: In an in vivo rat model, rats receiving the experimental macro-well implants demonstrated in-growth of soft tissue into the wells
• Rats implanted with anatomically shaped experimental implants, consisting of soft silicone gel inside a macro-well shell, demonstrated decreased rotation over a four-week period compared to those receiving smooth implants

Technology Applications

• Breast implants with improved positional stability and more natural shape
• Soft tissue implants for other parts of the body with with improved positional stability and improved safety profile

Technology Advantages

• May facilitate rapid tissue ingrowth to promote positional and rotational stability
• Shape may be more alike to native breast anatomy
• Potential to reduce long-term capsular contracture by disrupting planar myofibroblast arrangement

Figure 1: Three-dimensional rendering of breast implant with macropores using Fusion 3D rendering software.