Molecular impact surface textured implants (MISTI) alter beneficially breast capsule formation at 36 months.

Since the development of smooth silicone breast implants in 1962, over two million women throughout the world have opted for breast augmentation surgery. While initially successful, smooth implants are prone to developing surrounding scar capsules that may harden and contract--resulting in discomfort, weakening of the shell with rupture, unsightliness, and patient dissatisfaction. This phenomenon has been shown to occur in as much as 70% of implanted patients over time. Our work on the texturing of implantable prosthesis material (published in 1968), and subsequent discoveries, has led us to the development of textured silicone breast implants. Because the host interface is altered by the texture, collagen fibrils select a formation that is multiplanar which results in thinner, more pliable capsules that are more resilient and less likely to contract. At 18 months (August, 1989), with 116 implants, all remain soft, after an additional 18 months follow-up, for a total of 36 months maximum and 18 months minimum. The long-term performance of these implants must await the availability of further clinical data.