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Silicone gel breast implant failure and frequency of additional surgeries: Analysis of 35 studies reporting examination of more than 8000 explants

James S. Marotta 1, Christopher W. Widenhouse 1, Mutaz B. Habal 1 2, Eugene P. Goldberg 1 *

1Biomaterials Center, Department of Materials Science and Engineering, University of Florida, Gainesville, Florida

2Tampa Bay Craniofacial and Plastic Surgery Center, Tampa, Florida

*Correspondence to Eugene P. Goldberg, Biomaterials Center, Dept. Materials Science, 317 MAE, University of Florida, Gainsville, FL 32611

None of the authors has a financial interest in or financial relationship with any company whose product was studied in this research. One author (E.P.G.) served as a consultant in breast implant litigation both on behalf of women as plaintiffs and plastic surgeons as defendants.

Funded by:

University of Florida Foundation

Biomaterials Center

Department of Materials Science and Engineering

University of Florida

Keywords

silicone gel breast implants • explant analysis • silicone implant complications • failure • rupture

Although it is well known that silicone gel breast implants (SGBIs) produce many local complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure (not intact) was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0.63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3.9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be not a safety standard that the FDA can accept. © 1999 John Wiley & Sons, Inc. J Biomed Mater Res (Appl Biomater) 48: 354-364, 1999

Received: 2 November 1998; Accepted: 23 February 1999

Digital Object Identifier (DOI)

10.1002/(SICI)1097-4636(1999)48:3<354::AID-JBM21>3.0.CO;2-# About DOI