Rj. Rohrich et al., DEVELOPMENT OF ALTERNATIVE BREAST IMPLANT FILLER MATERIAL - CRITERIA AND HORIZONS, Plastic and reconstructive surgery, 98(3), 1996, pp. 553-560
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.