OviTex® PRS P20263-1020GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810055070770), received between May 16, 2024 and Jul 25, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Disintegration” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FLUID COLLECTION AND WOUND DRAINAGE APPROXIMATELY ONE MONTH AFTER A COSMETIC REVISION PROCEDURE PERFORMED WITH BREAST IMPLANTS AND OVITEX PRS. THE SURGEON PERFORMED A WASHOUT TO ADDRESS THE DRAINAGE ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 22609630 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FLUID COLLECTION AND WOUND DRAINAGE APPROXIMATELY ONE MONTH AFTER A COSMETIC REVISION PROCEDURE PERFORMED WITH BREAST IMPLANTS AND OVITEX PRS. THE SURGEON PERFORMED A WASHOUT TO ADDRESS THE DRAINAGE ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 22609557 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FLUID COLLECTION AND WOUND DRAINAGE APPROXIMATELY ONE MONTH AFTER A COSMETIC REVISION PROCEDURE PERFORMED WITH BREAST IMPLANTS AND OVITEX PRS. THE SURGEON PERFORMED A WASHOUT TO ADDRESS THE DRAINAGE ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 22609555 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED FLUID COLLECTION AND WOUND DRAINAGE APPROXIMATELY ONE MONTH AFTER A COSMETIC REVISION PROCEDURE PERFORMED WITH BREAST IMPLANTS AND OVITEX PRS. THE SURGEON PERFORMED A WASHOUT TO ADDRESS THE DRAINAGE ISSUE.

  Patient problems: Fluid Discharge

  MAUDE report 22609554 ↗
• InjuryFeb 26, 2025Material Disintegration; Material Disintegration

  A PATIENT UNDERWENT BILATERAL MASTOPEXY WITH REVISION AUGMENTATION (BREAST IMPLANTS WERE APPROXIMATELY 20 YEARS OLD) ON (B)(6)2024. A PARTIAL CAPSULECTOMY WAS PERFORMED ANTERIORLY WITH MENTOR BOOST 480CC IMPLANTS AND OVITEX PRS LTR. ON (B)(6)2025 IT WAS NOTED THAT THE LEFT INCISION OPENED WITH OVITEX PRS PARTIALLY RESORBED WITH SOME POLYMER REMAINING. THE BREAST IMPLANT WAS REMOVED WITH THE NON-REMODELED OVITEX PRS. A SIMILAR EVENT OCCURRED AT THE RIGHT INCISION ON (B)(6)2025. PARTIAL OVITEX PRS INTEGRATION WAS NOTED ON BOTH SIDES.

  Patient problems: Fluid Discharge

  MAUDE report 21472954 ↗
• InjuryFeb 26, 2025Material Disintegration; Material Disintegration

  A PATIENT UNDERWENT BILATERAL PRIMARY MASTOPEXY AUGMENTATION ON APPROXIMATELY (B)(6) 2024 WITH OVITEX PRS LTR USED AS LOWER POLE SUPPORT. THE PATIENT'S COURSE WAS UNREMARKABLE UNTIL 5 WEEKS POST-OP WHEN INCISIONS BROKE DOWN WITH IMPLANT EXPOSED. IT WAS NOTED THAT THE DEVICE WAS MOSTLY INCORPORATED SUPERIORLY BUT HAD RESORBED INFERIORLY. NON-INCORPORATED PORTIONS WERE REMOVED ALONG WITH THE BREAST IMPLANTS. THE PATIENT WAS LEFT TO HEAL PRIOR TO FINAL BREAST IMPLANT PLACEMENT.

  Patient problems: Fluid Discharge

  MAUDE report 21472837 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT BILATERAL PREPECTORAL TWO STAGE BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND OVITEX PRS. WITHIN APPROXIMATELY TWO WEEKS, ONE SIDE DEVELOPED A SEROMA. ON THE CONTRALATERAL SIDE DRAINAGE WAS NOTED THROUGH THE SURGICAL WOUND. THE SURGEON REMOVED BOTH TISSUE EXPANDERS AND OVITEX PRS DEVICES.

  Patient problems: Seroma

  MAUDE report 19330854 ↗