GORE MYCROMESH Biomaterial 1MYM01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132601509), received between Mar 22, 2019 and Jun 22, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN BILATERAL INGUINAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020 AND (B)(6) 2020, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12046604 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, ADDITIONAL SURGICAL PROCEDURE, EXPLANTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10365193 ↗
• InjuryOct 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2004, A PATIENT UNDERWENT A PROCEDURE FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE WHERE GORE® MYCROMESH® BIOMATERIAL WAS USED. THE PATIENT ALLEGES THAT THE DEVICE ¿ERODED¿ OR HAD ¿FALLEN FROM ORIGINAL IMPLANT LOCATION¿, RESULTING IN INJURY AND PAIN. IT WAS REPORTED TO GORE THAT ON (B)(6) 2005, THE PATIENT UNDERWENT ANOTHER MESH IMPLANT PROCEDURE IN WHICH PORTIONS OF THE GORE® MYCROMESH® BIOMATERIAL DEVICE WERE REMOVED.

  Patient problems: Erosion; No Code Available; Pain

  MAUDE report 9147742 ↗
• InjuryJun 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN OPEN LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, CHRONIC INGUINODYNIA, SURGERY TO REMOVE MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 8708029 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC RIGHT LATERAL ABDOMINAL WALL HERNIA REPAIR ON (B)(6) 2005, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL CANAL HERNIA REPAIR ON (B)(6) 2006, WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AND (B)(6) 2009, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, HERNIA RECURRENCE, CHRONIC ABDOMINAL PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 8569578 ↗
• InjuryMar 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, MESH REMOVAL, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 8443905 ↗