A Multicentric and Retrospective Clinical Study: 2 Year Follow-up Results for Breast Surgery With Perle Smooth Opaque Silicone Breast Implants

一项多中心回顾性临床研究:使用Perle Smooth不透明硅胶乳房假体进行乳房手术的2年随访结果

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Abstract

BACKGROUND: For breast surgery, there are a number of implants available that offer different options, such as shape, surface characteristics, gel fillers, and size/profile to meet the diverse needs of the patient population. Each implant option has its own advantages and disadvantages, and the individual patient's needs should be taken into account when making choices. OBJECTIVES: To conduct an assessment of the safety, performance, and satisfaction rates through a 2-year follow-up study for the Perle mammary implant (Nagor Ltd, Glasgow, Scotland, United Kingdom). METHODS: A retrospective, observational, multicenter, noncomparative study was conducted from March 2023 to June 2023. The collection of data took place in 5 centers across France and Italy. Patients included in the study received the evaluated device between October 2020 and June 2021 for cosmetic and medical indications. RESULTS: Of the 97 patients included in the study, only 9 patients reported complications during the 2 years following the surgery. The overall complication rate was 9.28%. All patients and surgeons were satisfied or very satisfied with the surgery and the implant. CONCLUSIONS: This patient cohort showed a rate of complications consistent with the range of other smooth implants after 2 years of follow-up and a high rate of both patient and surgeon satisfaction.

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