Development of alternative breast implant filler material: criteria and horizons.

R. J. Rohrich, S. J. Beran, A. E. Ingram, V. L. Young

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalPlastic and Reconstructive Surgery
Volume98
Issue number3
StatePublished - Sep 1996

Fingerprint

Breast Implants
Silicone Gels
Guidelines
Reconstructive Surgical Procedures
Mammaplasty
United States Food and Drug Administration
Plastic Surgery
Equipment and Supplies

ASJC Scopus subject areas

  • Surgery

Cite this

Rohrich, R. J., Beran, S. J., Ingram, A. E., & Young, V. L. (1996). Development of alternative breast implant filler material: criteria and horizons. Plastic and Reconstructive Surgery, 98(3).

Development of alternative breast implant filler material : criteria and horizons. / Rohrich, R. J.; Beran, S. J.; Ingram, A. E.; Young, V. L.

In: Plastic and Reconstructive Surgery, Vol. 98, No. 3, 09.1996.

Research output: Contribution to journalArticle

Rohrich, R. J. ; Beran, S. J. ; Ingram, A. E. ; Young, V. L. / Development of alternative breast implant filler material : criteria and horizons. In: Plastic and Reconstructive Surgery. 1996 ; Vol. 98, No. 3.
@article{076818ecccca4d07b420cb38a1c91d7f,
title = "Development of alternative breast implant filler material: criteria and horizons.",
abstract = "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.",
author = "Rohrich, {R. J.} and Beran, {S. J.} and Ingram, {A. E.} and Young, {V. L.}",
year = "1996",
month = "9",
language = "English (US)",
volume = "98",
journal = "Plastic and Reconstructive Surgery",
issn = "0032-1052",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Development of alternative breast implant filler material

T2 - criteria and horizons.

AU - Rohrich, R. J.

AU - Beran, S. J.

AU - Ingram, A. E.

AU - Young, V. L.

PY - 1996/9

Y1 - 1996/9

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0030240928&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030240928&partnerID=8YFLogxK

M3 - Article

C2 - 8700998

VL - 98

JO - Plastic and Reconstructive Surgery

JF - Plastic and Reconstructive Surgery

SN - 0032-1052

IS - 3

ER -