Clinical evaluation of shaped gel breast implant rotation using high-resolution ultrasound

David A. Sieber, Ran Y. Stark, Serena Chase, Mark Schafer, William P. Adams

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: Clinical trials have demonstrated through core and independent studies that anatomical devices are safe and effective with low complication rates. The rotation rate of shaped breast implants in the literature is 0 to 8.2%. Currently there are no studies evaluating the efficacy of in office ultrasound or clinical rotation vs actual rotation rates seen on high-resolution ultrasound (HRUS). Objectives: The purpose of the study is to demonstrate the ease and reliability of HRUS for evaluating the rotation rate of 2 different brands of anatomic implants and to correlate this with the presumed clinical rate, as well as independent evaluators assessments. Methods: A total of 69 patients were followed up at routine intervals and were evaluated for rotation. Any implant rotated past >30° off of midline (outside 5-7 o'clock) was considered to be rotated. To determine if radiographic rotation was clinically evident, 20 composite patient photos were blindly evaluated. Results: A random total of 69 patients underwent bilateral augmentation mammoplasty with form stable anatimic gel implants using 138 implants. Twenty-nine of the 69 (42%) patients and 37 of the 138 (27%) implants were found to be rotated-using HRUS. Eight of the 69 (12%) patients had bilateral rotations. Independent evaluators were able to identify two of 12 (17%) possible rotations, or 2 rotations in 40 (5%) total implants. Conclusions: Anatomic form stable gel implants are actually rotated up to 25 times more frequently than previously thought, but these rotations do not translate into clinically significant sequela. High-resolution ultrasound is a simple alternative for breast implant surveillance and is better accepted by patients than magnetic resonance imaging (MRI). The clinical value of HRUS is also discussed and recommendations for FDA implant labeling changes are provided in this article.

Original languageEnglish (US)
Pages (from-to)290-296
Number of pages7
JournalAesthetic Surgery Journal
Volume37
Issue number3
DOIs
StatePublished - Jan 1 2017

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Breast Implants
Gels
Mammaplasty
Magnetic Resonance Imaging
Clinical Trials

ASJC Scopus subject areas

  • Surgery

Cite this

Clinical evaluation of shaped gel breast implant rotation using high-resolution ultrasound. / Sieber, David A.; Stark, Ran Y.; Chase, Serena; Schafer, Mark; Adams, William P.

In: Aesthetic Surgery Journal, Vol. 37, No. 3, 01.01.2017, p. 290-296.

Research output: Contribution to journalArticle

Sieber, David A. ; Stark, Ran Y. ; Chase, Serena ; Schafer, Mark ; Adams, William P. / Clinical evaluation of shaped gel breast implant rotation using high-resolution ultrasound. In: Aesthetic Surgery Journal. 2017 ; Vol. 37, No. 3. pp. 290-296.
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abstract = "Background: Clinical trials have demonstrated through core and independent studies that anatomical devices are safe and effective with low complication rates. The rotation rate of shaped breast implants in the literature is 0 to 8.2{\%}. Currently there are no studies evaluating the efficacy of in office ultrasound or clinical rotation vs actual rotation rates seen on high-resolution ultrasound (HRUS). Objectives: The purpose of the study is to demonstrate the ease and reliability of HRUS for evaluating the rotation rate of 2 different brands of anatomic implants and to correlate this with the presumed clinical rate, as well as independent evaluators assessments. Methods: A total of 69 patients were followed up at routine intervals and were evaluated for rotation. Any implant rotated past >30° off of midline (outside 5-7 o'clock) was considered to be rotated. To determine if radiographic rotation was clinically evident, 20 composite patient photos were blindly evaluated. Results: A random total of 69 patients underwent bilateral augmentation mammoplasty with form stable anatimic gel implants using 138 implants. Twenty-nine of the 69 (42{\%}) patients and 37 of the 138 (27{\%}) implants were found to be rotated-using HRUS. Eight of the 69 (12{\%}) patients had bilateral rotations. Independent evaluators were able to identify two of 12 (17{\%}) possible rotations, or 2 rotations in 40 (5{\%}) total implants. Conclusions: Anatomic form stable gel implants are actually rotated up to 25 times more frequently than previously thought, but these rotations do not translate into clinically significant sequela. High-resolution ultrasound is a simple alternative for breast implant surveillance and is better accepted by patients than magnetic resonance imaging (MRI). The clinical value of HRUS is also discussed and recommendations for FDA implant labeling changes are provided in this article.",
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