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High Resolution Ultrasound in the Detection of Silicone Gel Breast Implant Shell Failure: Clinical Results

Terri A. Zomerlei MD Bradley P.Bengston MD
The Ohio State University
2016-02-01

Presenter: Terri A. Zomerlei MD

Affidavit:
Gregory Pearson

Director Name: Gregory Pearson

Author Category: Resident Plastic Surgery
Presentation Category: Clinical
Abstract Category: Breast (Aesthetic and Recon.)

Background:
Several recent studies have questioned whether Magnetic Resonance Imaging (MRI) is the best first diagnostic test for potential silicone gel breast implant shell failure and follow-up. Currently, there is a void in the clinical detection and simple follow-up of breast implants. The purpose of this study was to determine the accuracy, sensitivity and specificity of current High Resolution Ultrasound (HRUS) technology in the detection of silicone gel breast implant failure and to compare this technology to MRI.

Methods:
Initially, in vitro data analyzing intact and intentionally cut shells was obtained. An initial pilot study of fifteen patients was performed comparing the two diagnostic methods was then performed. Finally, a prospective study has been completed comparing HRUS and MRI in patients proceeding to surgery for implant replacement.

Results:
HRUS easily detected both intact and intentionally divided shells in both the standard gel and highly cohesive gel devices. The results of the prospective study including over 200 patients found that HRUS had a sensitivity of 94% and a specificity of 100% for implant shell disruption.

Conclusion:
HRU has a high sensitivity and specificity that is comparable to MRI for detecting silicone implant shell failure. Ultrasound has some limitations but a need for higher compliance rates for implanted patient follow-up exists. High Resolution Ultrasound's availability, accessibility, lower cost, dynamic real-time viewing, and use in multiple other applications makes it a valuable tool for the plastic surgeon's armamentarium.
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