Related Experiment Video
Updated: Sep 27, 2025
Endoscopic Bilateral Nipple-sparing Mastectomy via a Single Axillary Incision with Immediate Pre-pectoral Implant-based Breast Reconstruction
Published on: May 17, 2024
Safety and Performance of POLYTECH Mesmo Breast Implants: A 5-Year Post-market Surveillance Study on 919 Patients
Paolo Montemurro1,2, Giacomo Siri1, Luana Clerico2
1Department of Mathematics, University of Genoa, Genoa, Italy.
Background:
In 2007, POLYTECH Health & Aesthetics (POLYTECH, Dieburg, Germany) established an ongoing patient survey to improve the post-market surveillance of silicone gel-filled breast implants based on patient-reported outcomes in the context of the pioneering "Implants of Excellence" (IoE) program.
Objectives:
To disclose an update on safety and performance outcomes at 5 years for Mesmo breast implants.
Methods:
Between January 2014 and October 2019, 919 patients (for a total of 1816 implants) who underwent breast augmentation and reconstruction with Mesmo implants were asked to participate in the IoE program. Data were collected by mean of 1320 questionnaires received. A survival analysis assessed the onset of different complications.
Results:
Eight patients (0.9%) experienced capsular contracture Baker grade III or IV with a cumulative rate at 5 years of 1.2% (95% CI = 0.6-2.4). The proportion of revisional surgery was 0.5% with a 5-year rate of 0.6% (95% CI = 0.2-1.5). Additional adverse events such as hematoma, seroma, malposition, open wounds, and other complications were carefully monitored. Questionnaires showed that 93.9% (95% CI = 92.2-95.4) of the patients were satisfied or very satisfied with their aesthetic results with Mesmo implants.
Conclusions:
Post-market clinical follow-up revealed that the overall complications rate reported was low. Data demonstrated an excellent safety property on a large cohort of patients. This result allows the rating of Mesmo breast implants as highly competitive and a very safe choice for both surgeons and patients.
