
298 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
makes the breast hard, tender, and unnatural in appearance. ese problems have prompted the
FD
A to reclassify current prostheses and move them from Class I to Class III Devices requirin
ringent PMA (Premarket Approval) pathway.
Most authorities agree that capsular contraction can be effectively eliminated by “coating
e outer wall of the mammary implant with a suitable tissue ingrowth platform. No accepta
terial is currently available to manufacturers of breast prostheses that allows tissue ingrowt
ile remaining biostable.
PolyMedica has pioneered the de ...