GORE MYCROMESH PLUS Biomaterial 1MYMP07Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132601653), received between Aug 6, 2019 and Sep 25, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2008, AND (B)(6) 2011, WHEREBY A GORE® MYCROMESH®PLUS AND GORE DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH SEPARATION, HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10589066 ↗
• InjurySep 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL VENTRAL HERNIA HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® MYCROMESH®PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: OPEN DRAINING WOUND, EXPOSED MESH, ABSCESS HERNIA RECURRENCE, INFECTION, FOREIGN BODY, GIANT CELL REACTION, INFLAMMATION, DENSE FIBROSIS, ADHESIONS, SURGERY TO REMOVE MESH, HONEYCOMB DEFECTS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Tissue Breakdown; Unspecified Infection

  MAUDE report 10584040 ↗
• InjuryOct 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2004 AND (B)(6) 2007 WHEREBY A GORE® MYCROMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF MESH AND SMALL BOWEL OBSTRUCTION ((B)(6) 2006); REMOVAL OF MESH AND INFECTION ((B)(6) 2017). ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 9217579 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT A PATIENT ASSERTS A COMPLAINT ARISING FROM THE IMPLANTATION OF A GORE MYCROMESH® PLUS BIOMATERIAL DEVICE ON APRIL 10, 2001 BASED ON AN UNSPECIFIED ALLEGED INJURY AND/OR ALLEGED PRODUCT DEFICIENCY. AS NO SPECIFIC INFORMATION WAS PROVIDED AS TO THE PATIENT¿S COMPLAINT ABOUT THE GORE MYCROMESH® PLUS BIOMATERIAL DEVICE, THIS EVENT IS BEING DOCUMENTED BASED ON A GENERAL ALLEGATION OF AN UNKNOWN PRODUCT DEFICIENCY AND/OR ALLEGED INJURY.

  Patient problems: Erosion; No Code Available; Unspecified Infection

  MAUDE report 8864006 ↗