Overview
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
Inclusion Criteria:
- Patient was between 18 years and 70 years of age (inclusive) at the time of surgery.
- 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.
- Patient is 6-months or more post initial surgical procedure.
Exclusion Criteria:
- Patient received a textured expander or implant.
- Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
- Patient was marijuana user (including smokeless, vaporized, etc.) within 4-weeks preceding their index procedure.
- Patient had previously undergone radiation therapy to the chest wall prior to index surgery.
Additional prospective inclusion criteria (if applicable):
- Patient agrees to return in-person for prospective portion including the completion of photographs.
Additional prospective exclusion criteria (if applicable):
- Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.