Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

Establishment Labs

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Motiva Flora TE

Study type: Observational

Funder types: Industry

Identifiers

NCT05459064

CLINP-001013

Details and patient eligibility

About

The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.

All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.

The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.

Enrollment: 144 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
• Patient has been informed correctly according to to the applicable national and local regulations.

Exclusion criteria

• Not applicable