Development of alternative breast implant filler material: criteria and horizons.
The introduction of the silicone gel-filled breast implant more than 30 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 return. However, there is a continued need for some type of breast implant in both aesthetic and reconstructive surgery. The Food and Drug Administration 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 stages, through long-term postimplantation follow-up studies. This article succinctly examines the central issues in the breast implant controversy in relation to the FDA's recommendations for the development of new implants, discusses breast implant filler materials currently under development, and offers guidelines fro the development of breast implant fillers that are safe and effective.
Rohrich
R J
RJ
Division of Plastic and Reconstructive Surgery, University of Texas Southwestern Medical Center, Dallas, USA.
Beran
S J
SJ
Ingram
A E
AE
Young
V L
VL
D018427:Breast Implants / Q000592:standards; D018795:Device Approval; D005260:Female; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration