GORE DUALMESH Biomaterial 1DLMC05Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00733132600984), received between Jun 26, 2018 and Oct 17, 2023 — classified as 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY A GORE® DUALMESH® 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: MESH REMOVED DUE TO INFECTION AND RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17950604 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED PATIENT UNDERWENT LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003, (B)(6) 2004 AND (B)(6) 2007, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE OR DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, RECURRENCE, ADHESIONS, INFECTED MESH, ABSCESS, FISTULA, PERFORATED COLON, BOWEL RESECTION, WOUND VAC, SERMOA, DYSURIA, INFLAMMATION, PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16523370 ↗
• InjuryFeb 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® 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: EARLY RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 16404936 ↗
• InjuryAug 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE¿ DUALMESH¿ BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, HERNIA RECURRENCE, MESH REMOVAL, MESH FAILURE, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12368205 ↗
• InjuryJun 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABSCESS, SEROMA, INFECTED MESH, REMOVAL OF MESH, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Seroma; Unspecified Infection

  MAUDE report 12001393 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, EXPLANT. FISTULA. DENSE ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 11761429 ↗
• InjuryMar 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 AND (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003 AND (B)(6) 2005, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEROMA, INFECTED MESH, ABSCESS, INFLAMED ABDOMINAL WALL MASS, CONSTANT ABDOMINAL PAIN, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Seroma; Unspecified Infection

  MAUDE report 11592825 ↗
• InjuryMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONICALLY DRAINING GRANULOMA, WITH EXCISION OF THE UMBILICAL GRANULOMA AND DEBRIDEMENT OF MESH MATERIAL, INFECTION OF THE MESH, DENSE ADHESIVE CHANGES AROUND THE BASE OF THE UMBILICUS, EXPOSED MESH, EXPLANTATION OF MESH, RECURRENT HERNIA, SINUS TRACT FROM SKIN TO THE MESH WITH SOME PORTION OF THE MESH NOT INCORPORATING INTO THE ABDOMINAL WALL AND WITH EVIDENCE OF CHRONIC INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; Tissue Breakdown; Unspecified Infection

  MAUDE report 11570136 ↗
• InjuryMay 8, 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 DUALMESH 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) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF MESH, REPAIR OF RECURRENT HERNIA, LYSIS OF ADHESIONS, INFECTION AND MESH ADHERED TO VALVE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 10038126 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2009 AND (B)(6) 2010 WHEREBY A GORE® DUALMESH® BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010 AND (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH ROLLED UP TO THE CORNER AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9492338 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH ROLLED UP TO THE CORNER AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9379603 ↗
• InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® 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: SEROMA FORMATION WITH DRAINAGE CATHETER PLACEMENT ((B)(6) 2008), MESH INFECTION AND REMOVAL (B)(6) 2008. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9120681 ↗
• InjurySep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN FEMORAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH ADHERED TO THE BLADDER AND HAD TO BE DISSECTED REQUIRING REVISION SURGERY ON (B)(6) 2018. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9107308 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. 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: CONTRACTION OF MESH, REMOVAL OF MESH, AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 8920626 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY A PORTION OF THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY REQUIRED DUE TO "MESH HAVING CONTRACTING AND FAILING TO ADHERE TO THE ABDOMINAL WALL"; "MESH PULLING AWAY FROM THE ABDOMINAL WALL AND CREATING MULTIPLE DEFECTS;" AND PORTION OF MESH WAS REMOVED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8897664 ↗
• InjuryJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, MESH REMOVAL, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8798225 ↗
• InjuryJun 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL AND UMBILICAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, MESH REMOVAL, ADDITIONAL SURGERY, DEBRIDEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8691124 ↗
• InjuryJun 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS UNABLE TO BE REMOVED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, MESH RETRACTION, UNABLE TO REMOVE MESH DURING (B)(6) 2010 SURGERY, ADDITIONAL SURGERY, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Code Available; Pain; Unspecified Infection

  MAUDE report 8691093 ↗
• InjuryJun 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2007 WHEREBY AN ALLEGED GORE DEVICE WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED (TO THE EXTENT ABLE). IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL (TO THE EXTENT ABLE); EXTENSIVE ADHESIONS; BOWEL ADHERED TO MESH; RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8686258 ↗
• InjuryApr 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2002, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, MESH REMOVAL, LOOSE MESH, RECURRENT HERNIA, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

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

  MAUDE report 8510465 ↗
• InjuryApr 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

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

  MAUDE report 8472824 ↗
• InjuryJun 26, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE DUALMESH® BIOMATERIAL DEVICE WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009, THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN AND DISCOMFORT, CHANGE IN BOWEL HABITS, SEVERE ADHESIONS, MESH REMOVAL, AND ADDITIONAL SURGERIES TO REPAIR HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS WERE NOT PROVIDED BUT HAVE BEEN REQUESTED.

  Patient problems: Abscess; No Code Available; Not Applicable; Pain

  MAUDE report 7639222 ↗