U.S., Feb. 4 -- ClinicalTrials.gov registry received information related to the study (NCT07383012) titled 'LTFU of PCL Breast Scaffolds Used in 2021-BRV-004' on Jan. 15.
Brief Summary: The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with autologous fat grafting (AFG) in the 2021-BRV-004 clinical trial (ClinicalTrials.gov ID: NCT05437757). In addition, this study will investigate the suitability of mammography in the subset of patients that fall into the national breast screening age category - individuals aged 40 years and older.
The main questions this study aims to ans...