Meso BioMatrix® Acellular Peritoneum Matrix 30063-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812337025331), received between Feb 22, 2022 and Feb 22, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL BREAST IMPLANT EXCHANGE WITH MESO BIOMATRIX MESH PLACEMENT FOR CAPSULAR CONTRACTURE AND ASYMMETRY. APPROXIMATELY 5 MONTHS POST-OPERATIVE, THE PATIENT HAD SWELLING, REDNESS AND IMPENDING IMPLANT EXTRUSION IN THE RIGHT BREAST. THE BREAST IMPLANT AND MESO BIOMATRIX WERE SUBSEQUENTLY EXPLANTED FROM THE RIGHT BREAST. APPROXIMATELY, 2 MONTHS LATER, THE BREAST IMPLANT WAS REPLACED.

  Patient problems: Erythema

  MAUDE report 13577845 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL BREAST IMPLANT EXCHANGE WITH MESO BIOMATRIX MESH PLACEMENT FOR CAPSULAR CONTRACTURE AND ASYMMETRY. APPROXIMATELY 4 MONTHS POST-OPERATIVE, THE PATIENT HAD SWELLING, REDNESS AND IMPENDING IMPLANT EXTRUSION IN THE LEFT BREAST. CULTURES WERE TAKEN AND RESULTS WERE NEGATIVE. THE BREAST IMPLANT AND MESO BIOMATRIX WERE SUBSEQUENTLY EXPLANTED FROM THE LEFT BREAST. APPROXIMATELY, 3 MONTHS LATER, THE BREAST IMPLANT WAS REPLACED.

  Patient problems: Erythema

  MAUDE report 13577828 ↗