Incidence of silicone breast implant rupture.

Abstract

HYPOTHESIS:

The incidence of silicone breast implant rupture varies with implantation time and type of implant.

OBJECTIVE:

To measure the incidence of implant rupture by repeated magnetic resonance imaging (MRI) among women with silicone breast implants.

DESIGN, SETTING, AND PARTICIPANTS:

In 1999, 271 women who had received breast implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic breast implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 silicone implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses.

MAIN OUTCOME MEASURES:

Implants were diagnosed with definite or possible rupture. Crude and implant age-adjusted incidence rates were calculated, and implant survival was estimated based on the observed rupture rates.

RESULTS:

We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing implant age. Double-lumen implants were associated with substantially lower rupture risk than single-lumen implants. For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years.

CONCLUSIONS:

The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.

• Authors: Lisbet R Hölmich, Søren Friis, Jon P Fryzek, Ilse M Vejborg, Carsten Conrad, Susanne Sletting, Kim Kjøller, Joseph K McLaughlin, Jørgen H Olsen
• Journal: Archives of surgery (Chicago, Ill. : 1960) (Arch Surg) Vol. 138 Issue 7 Pg. 801-6 (Jul 2003) ISSN: 0004-0010 [Print] United States
• PMID: 12860765 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Silicone Gels

Topics

• Adult
• Breast Implants
• Female
• Humans
• Incidence
• Magnetic Resonance Imaging
• Prevalence
• Proportional Hazards Models
• Prosthesis Failure
• Risk Factors
• Rupture, Spontaneous
• Silicone Gels