DEVELOPMENT OF ALTERNATIVE BREAST IMPLANT FILLER MATERIAL - CRITERIA AND HORIZONS

The introduction of the silicone gel-filled breast implant more than 3 0 years ago changed the nature of alloplastic breast augmentation and reconstruction. Over the last three decades, it is estimated that one million American women have undergone implantation with some variation of these devices. Recent medical, legal, and regulatory developments have forced a moratorium on the unrestricted uses of the silicone gel- filled implants, and it appears unlikely that its general use will ret urn. However, there is a continued need for some type of breast implan t in both aesthetic and reconstructive surgery. The Food and Drug Admi nistration has proposed testing guidelines for the development of any new breast implant before unrestricted clinical use. These guidelines will direct the creation of new filler materials from their earliest s tages, through long-term postimplantation follow-up studies. This arti cle succinctly examines the central issues in the breast implant contr oversy in relation to the FDA's recommendations for the development of new implants, discusses breast implant filler materials currently und er development, and offers guidelines for the development of breast im plant fillers that are safe and effective.