A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
Tela Bio Inc
Summary
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
Description
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. Patient was between 18 years and 75 years of age (inclusive) at the time of surgery. 2. At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction. 3. Patient has undergone their initial surgical procedure and exchange surgery (if applicable). Exclusion Criteria: 1. Patient received a textured permanent breast implant. 2. Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure. 3. Pa…
Interventions
- DeviceOviTex® PRS
OviTex® PRS is a reinforced tissue matrix intended to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Locations (11)
- Aesthetic Surgery CenterNaples, Florida
- Castrellon Aesthetic SurgerySouth Miami, Florida
- Y Plastic SurgeryAlpharetta, Georgia
- Massachusetts General HospitalBoston, Massachusetts
- Janineh Plastic SurgeryRochester Hills, Michigan
- David L. Abramson, MDEnglewood, New Jersey