A Retrospective Assessment of OviTex PRS (OviTex)

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.

Inclusion criteria

• Patient was between 18 years and 75 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 has undergone their initial surgical procedure and exchange surgery (if applicable).

Exclusion criteria

• Patient received a textured permanent breast implant.
• Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding 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.