U.S., Oct. 30 -- ClinicalTrials.gov registry received information related to the study (NCT07904091) titled 'Evaluation of the Performance and Safety of the Monobloc(R) - Silicone SoftOne(R) Breast Implants at 10 Years' on Oct. 23.
Brief Summary: The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc(R) - Silicone SoftOne(R) breast implants at 10 years.
The primary objective is to evaluate the rate of women who had at least one re-intervention within the 10 years of follow-up. the secondary objectives are To evaluate the safety and performance outcomes of women who underwent breast augmentation and/or breas...