Letter to the Editor
Clarification on Rotation Rates of Textured Breast Implants Roger N. Wixtrom, PhD; and John Canady, MD, DSc (hon), FACS, FAAP
silicone gel devices, the rotation rate was 1.1% among patients who underwent primary breast augmentation.” Additional long-term follow-up results are now available from the same large, multicenter, prospective Core Study of Mentor’s (Santa Barbara, CA) MemoryShape™ Breast Implants for primary augmentation patients, and they indicate a cumulative incidence of rotation by Kaplan-Meier analysis through 10 years of 1.5%.3
Disclosures Dr Wixtrom is a consultant and Dr Canady is a full-time employee and stockholder of Mentor Worldwide LLC (Santa Barbara, California).
REFERENCES 1. Maxwell GP, Scheflan M, Spear S, Nava MB, Hedén P. Benefits and limitations of macrotextured breast implants and consensus recommendations for optimizing their effectiveness. Aesthet Surg J. 2014;34:876-881. 2. Baeke JL. Breast deformity caused by anatomical or teardrop implant rotation. Plast Reconstr Surg. 2002;109:2555-2564. 3. Mentor Worldwide, LLC. 10-Year Core Gel Clinical Study results. Data on file. 2013.
Dr Wixtrom is a toxicologist in Springfield, Virginia. Dr Canady is the medical director at Mentor Worldwide LLC, Santa Barbara, California. Corresponding Author: Dr Roger N. Wixtrom, LSCI, 8473 Rippled Creek Court, Springfield, Virginia, USA. E-mail: [email protected]
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We have read the article by Maxwell et al entitled “Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.”1 One statement in particular is strongly deserving of clarification. One of the paragraphs in the article begins with a discussion of the reported rates through six years of malposition (including rotation) for the Style 410 shaped cohesive silicone gel-filled implants. That discussion is followed by a statement that “In contrast, in a single-center study by Baeke of various Siltex microtextured implants, rotation rates were as high as 14%.” The authors did not disclose that the cited study by Baeke2 was not reporting rotation rates for the Siltex™ (imprintedtextured) surface among the available shaped (“anatomic”) cohesive silicone gel-filled implants. They were reporting results on anatomic saline-filled devices (specifically Style 2700 and 2900 implants) that were implanted between 1995 and 1999. The “various” implants used in the Baeke study were 317 anatomical saline-filled devices, including 118 Style 2700, 197 Style 2900, and 2 McGhan Style 163. Rotation rates of anatomic saline-filled devices do not contribute to a discussion of shaped (“anatomic”) silicone gelfilled breast implants. As noted by the authors, “in the 6-year follow-up of the core study of Siltex microtextured
Aesthetic Surgery Journal 2015, Vol 35(5) NP123 © 2015 The American Society for Aesthetic Plastic Surgery, Inc. This is an Open Access article distributed under the terms of the Creative Commons AttributionNonCommercial-NoDerivs licence (http://creativecommons.org/ licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. DOI: 10.1093/asj/sju114 www.aestheticsurgeryjournal.com
Clarification on Rotation Rates of Textured Breast Implants Roger N. Wixtrom, PhD; and John Canady, MD, DSc (hon), FACS, FAAP
silicone gel devices, the rotation rate was 1.1% among patients who underwent primary breast augmentation.” Additional long-term follow-up results are now available from the same large, multicenter, prospective Core Study of Mentor’s (Santa Barbara, CA) MemoryShape™ Breast Implants for primary augmentation patients, and they indicate a cumulative incidence of rotation by Kaplan-Meier analysis through 10 years of 1.5%.3
Disclosures Dr Wixtrom is a consultant and Dr Canady is a full-time employee and stockholder of Mentor Worldwide LLC (Santa Barbara, California).
REFERENCES 1. Maxwell GP, Scheflan M, Spear S, Nava MB, Hedén P. Benefits and limitations of macrotextured breast implants and consensus recommendations for optimizing their effectiveness. Aesthet Surg J. 2014;34:876-881. 2. Baeke JL. Breast deformity caused by anatomical or teardrop implant rotation. Plast Reconstr Surg. 2002;109:2555-2564. 3. Mentor Worldwide, LLC. 10-Year Core Gel Clinical Study results. Data on file. 2013.
Dr Wixtrom is a toxicologist in Springfield, Virginia. Dr Canady is the medical director at Mentor Worldwide LLC, Santa Barbara, California. Corresponding Author: Dr Roger N. Wixtrom, LSCI, 8473 Rippled Creek Court, Springfield, Virginia, USA. E-mail: [email protected]
Downloaded from http://asj.oxfordjournals.org/ by guest on August 19, 2015
We have read the article by Maxwell et al entitled “Benefits and Limitations of Macrotextured Breast Implants and Consensus Recommendations for Optimizing Their Effectiveness.”1 One statement in particular is strongly deserving of clarification. One of the paragraphs in the article begins with a discussion of the reported rates through six years of malposition (including rotation) for the Style 410 shaped cohesive silicone gel-filled implants. That discussion is followed by a statement that “In contrast, in a single-center study by Baeke of various Siltex microtextured implants, rotation rates were as high as 14%.” The authors did not disclose that the cited study by Baeke2 was not reporting rotation rates for the Siltex™ (imprintedtextured) surface among the available shaped (“anatomic”) cohesive silicone gel-filled implants. They were reporting results on anatomic saline-filled devices (specifically Style 2700 and 2900 implants) that were implanted between 1995 and 1999. The “various” implants used in the Baeke study were 317 anatomical saline-filled devices, including 118 Style 2700, 197 Style 2900, and 2 McGhan Style 163. Rotation rates of anatomic saline-filled devices do not contribute to a discussion of shaped (“anatomic”) silicone gelfilled breast implants. As noted by the authors, “in the 6-year follow-up of the core study of Siltex microtextured
Aesthetic Surgery Journal 2015, Vol 35(5) NP123 © 2015 The American Society for Aesthetic Plastic Surgery, Inc. This is an Open Access article distributed under the terms of the Creative Commons AttributionNonCommercial-NoDerivs licence (http://creativecommons.org/ licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. DOI: 10.1093/asj/sju114 www.aestheticsurgeryjournal.com
