Background
For breast surgery, there are a number of implants available which 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 needs should be taken into account when making choices.
Objectives
To conduct an assessment of the safety, performance, and satisfaction rates through a two-year follow-up study for the PERLE™ mammary implant.
Methods
Retrospective, observational, multi-center, non-comparative study conducted from March 2023 to June 2023. The collection of data took place in 5 centres 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 two 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 complication consistent with the range of other smooth implants after 2-years follow up and a high rate of both patient and surgeon satisfaction.