LTFU of PCL Breast Scaffolds Used in 2021-BRV-004

BellaSeno

Status: Not yet enrolling

Conditions: Breast Implant Revision

Study type: Observational

Funder types: Industry

Identifiers

NCT07383012

2025-BRV-006

Details and patient eligibility

About

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 answer are:

• "Is the PCL Breast Scaffold combined with autologous fat grafting a safe and effective method of soft-tissue reconstruction following breast implant revision?"
• "Is mammography a suitable follow-up screening and diagnostic tool for patients implanted with the PCL Breast Scaffold?"

Participants will attend annual follow-up visits from 3 to 5 years after PCL Breast Scaffold implantation for clinical assessments and patient-reported outcome questionnaires.

Enrollment: 19 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients implanted with at least one PCL Breast Scaffold who took part in the 2021-BRV-004 study.
• Patients who provide written informed consent to participate in this study.

Exclusion criteria

• Patient unwilling and unable to comply with the study requirements.

Trial design

19 participants in 1 patient group

PCL Breast Scaffold Follow-up Group

Description:

Participants from the 2021-BRV-004 study receiving long-term follow-up assessments at 3-, 4- and 5-years after implantation of the PCL Breast Scaffold