Mentor Contour Profile� Gel Implants: Clinical Outcomes at 6 Years.

Mentor Contour Profile� Gel Implants: Clinical Outcomes at 6 Years.

Plast Reconstr Surg. 2012 Feb 9;

Authors: Hammond DC, Migliori MM, Caplin DA, Garcia ME, Phillips CA

Abstract
BACKGROUND:: MemoryShape? (Contour Profile Gel [CPG]) is a textured contoured implant filled with a cohesive silicone gel intended for use in aesthetic and reconstructive breast surgery. The 6-year summary of the clinical outcomes and satisfaction rates for this device from a 10 year, prospective, open-label, multicenter clinical trial is presented. METHODS:: Per 2006 guidelines set forth by the U.S. Food and Drug Administration, 955 women were enrolled: 572 undergoing primary augmentation, 124 revision-augmentation, 191 primary reconstruction, and 68 revision-reconstruction. The cumulative incidence of selected complications was estimated using the Kaplan-Meier (KM) method. RESULTS:: For the primary augmentation cohort, KM estimated 6-year cumulative incidence rates for key complications by patient were: 2.4% Baker Grade III/IV capsular contracture, 0.9% infection, 7.0% explantation, and 18.1% any reoperation. Corresponding rates were 9.7%, 2.1%, 13.6% and 24.1% for revision-augmentation, 10.1%, 1.6%, 21.8% and 44.5% for primary reconstruction, and 16.4%, 3.0%, 34.2% and 45.4% for revision-reconstruction. The KM estimated rupture rate at 6 years was 2.1% for primary augmentation, 2.9% for revision-augmentation, 1.5% for primary reconstruction, and 0% for revision-reconstruction. Implantation of CPG breast implants resulted in a significant increase in circumferential chest size in the overall population (mean change 1.5 inches; P < 0.0001) and 96.6% of patients would make the same decision to have CPG breast implant surgery. CONCLUSIONS:: At 6-years postoperative, CPG breast implants were found to be effective and have an acceptable safety profile in women undergoing breast augmentation, reconstruction, and revision surgery. LEVEL OF EVIDENCE:: Prognostic/Risk Study Level I.

PMID: 22327894 [PubMed - as supplied by publisher]

Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?tmpl=NoSidebarfile&db=PubMed&cmd=Retrieve&list_uids=22327894&dopt=Abstract

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