GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH06Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132601257), received between Sep 5, 2018 and Sep 11, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: REPAIR OF VENTRAL INCISIONAL HERNIA WITH GORE-TEX DUAL MESH PLUS BIOMATERIAL. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCPH06/(B)(6), 18CM X 24 CM X 1 MM THICK]. IMPLANT DATE: (B)(6) 2008. EXPLANT PROCEDURE: ABDOMINAL EXPLORATION. LYSIS OF ADHESIONS. REMOVAL OF OLD MESH. EXTENSIVE FASCIAL RESECTION. VENTRAL HERNIORRHAPHY WITH 10 X 8¿ BARD VENTRIO ST MESH. EXPLANT DATE: (B)(6) 2014. IMPLANT #1: 5700-1. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL OBSTRUCTION, DENSE ADHESIONS, RECURRENCE, MESH MIGRATION, REMOVAL OF OLD MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 17724361 ↗
• InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ADDITIONAL SURGERIES; RECURRENCE; SEROMA,; INFECTED MESH; MESH MIGRATION; GRANULOMAS; MESH REMOVAL; WOUND VAC; DENSE ADHESIONS; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 15583610 ↗
• InjuryAug 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ADDITIONAL SURGERY; MESH REMOVAL; BOWEL RESECTION; INFECTED MESH; FISTULA; ABSCESS; WOUND VAC; SEROMA; NECROTIC TISSUE; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 15259492 ↗
• InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ADHESIONS, RECURRENCE, SEROMA, AND REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Seroma

  MAUDE report 14477614 ↗
• InjuryJan 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6), 2010 AND (B)(6), 2011 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, ADHESIONS, BOWEL OBSTRUCTION; RECURRENCE; PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 13294011 ↗
• InjuryJan 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2010 AND (B)(6) 2011 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, ADHESIONS, BOWEL OBSTRUCTION; RECURRENCE; PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 13292695 ↗
• InjuryMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: MESH EROSION TO SMALL BOWEL, BOWEL OBSTRUCTION, BOWEL RESECTION, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; Obstruction/Occlusion

  MAUDE report 11570205 ↗
• InjuryOct 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL/UMBILICAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A DEVICE BRAND] WAS IMPLANTED. THE COMPLAINT ALLEGES THAT IN APPROXIMATELY 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL; TO BE SUPPLEMENTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 9241955 ↗
• InjurySep 12, 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® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: TO BE SUPPLEMENTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9012084 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2007, WHEREBY A GORE® DUALMESH® PLUS 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: ABDOMINAL PAIN, MESH REMOVAL AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8944004 ↗
• InjuryJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REPAIR, ADHESIONS, RECURRENT HERNIAS BOUNDED BY MESH, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8797579 ↗
• InjuryApr 3, 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® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2007 WHEREBY A SECOND GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON THE SAME DAY, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE IMPLANTED ON (B)(6) /05 WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF THE (B)(6) 2005 MESH, RECURRENT HERNIA AND MESH FAILURE FOR THE (B)(6) 2007 MESH WITH AN ADDITIONAL SURGERY ON (B)(6) 2007. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8477442 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, REMOVAL OF MESH, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Infection, Pyrogenic; Unspecified Infection

  MAUDE report 8268735 ↗
• InjurySep 5, 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 INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, SMALL BOWEL OBSTRUCTION, ADHESIONS, MULTIPLE HERNIA RECURRENCES, MESH REVISION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Not Applicable; Obstruction/Occlusion; Pain

  MAUDE report 7845600 ↗