gms | German Medical Science

43. Jahrestagung der Deutschen Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen e. V. (DGPRÄC), 17. Jahrestagung der Vereinigung der Deutschen Ästhetisch-Plastischen Chirurgen e. V. (VDÄPC)

13.09. - 15.09.2012, Bremen

An evidence-based evaluation of implant rotation in form-stable shaped silicone gel-filled breast implants with textured silicone surfaces

Meeting Abstract

Search Medline for

  • presenting/speaker R. Wixtrom - LSCI, Springfield, United States

Deutsche Gesellschaft der Plastischen, Rekonstruktiven und ─sthetischen Chirurgen. Vereinigung der Deutschen ─sthetisch-Plastischen Chirurgen. 43. Jahrestagung der Deutschen Gesellschaft der Plastischen, Rekonstruktiven und ─sthetischen Chirurgen (DGPR─C), 17. Jahrestagung der Vereinigung der Deutschen ─sthetisch-Plastischen Chirurgen (VD─PC). Bremen, 13.-15.09.2012. DŘsseldorf: German Medical Science GMS Publishing House; 2012. DocFV103

doi: 10.3205/12dgpraec113, urn:nbn:de:0183-12dgpraec1133

Published: September 10, 2012

© 2012 Wixtrom.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Introduction: Implant rotation is observed relatively infrequently in form-stable shaped silicone gel-filled breast implants with textured silicone surfaces. The two key factors proposed for preventing such rotation are meticulous pocket preparation and suitable friction of the implant surface. There have also been suggestions that tissue adherence associated to some degree with more aggressively textured implants might also be a factor.

Materials and Methods: The incidence over time of implant rotation from prospective “Core” and “Continued Access” clinical trials of two different form-stable silicone gel-filled breast implants - one with a highly aggressive (salt-loss) textured silicone surface (Type #1) and one with a moderate (imprinted) textured surface (Type #2) - were compared, along with newly completed laboratory findings on the implant / tissue interface.

Results: Clinical experience of implant rotation from two individual surgeons who used both types of implants and participated in the ongoing prospective “Core” and “Continued Access” clinical trials revealed similarly low incidences of implant rotation. The first surgeon reported a cumulative incidence of implant rotation of 1.7% (2/118; mean follow-up 3.6 years) for Type #1 breast implants and 0% (0/117; mean follow-up 4.3 years) for Type #2 breast implants, while the second surgeon reported similar findings of a cumulative incidence of implant rotation of 2.7% (1/37; mean follow-up 1.7 years) for Type #1 breast implants and 0% (0/135; mean follow-up 2.5 years) for Type #2 breast implants. Available results from the “Core” prospective clinical trial of Type #2 breast implants revealed a cumulative incidence of implant rotation of 1.1% through 3- and 6-years post-implantation in primary augmentation patients. New laboratory findings focusing on the implant / tissue interface of the two different surfaces provide supportive evidence for the clinical observations.

Discussion: An evaluation of both preclinical laboratory-based evidence and prospective clinical study evidence supports a similar occurrence of implant rotation in form-stable shaped silicone gel-filled breast implants with highly aggressive versus moderate textured silicone surfaces and does not support tissue adherence as a significant risk factor.