GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH08Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132601271), received between Oct 24, 2018 and Nov 15, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004 AND (B)(6) 2017, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, MESH REMOVAL, RECURRENCE, ADHESIONS, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED. INFORMATION FROM OUTSIDE OF GORE RECEIVED ON SEPTEMBER 16, 2022 CHANGED THE ALLEGATIONS TO: ADDITIONAL SURGERIES; ENTEROTOMY; INFECTION, MESH REMOVAL, RECURRENCE, ADHESIONS, WOUND VAC; SERMOA; SMALL BOWEL OBSTRUCTION; EMESIS; PAIN AND SUFFERING. INFORMATION FROM OUTSIDE OF GORE RECEIVED ON SEPTEMBER 16, 2022 CONTAINED THE FOLLOWING: EXPLANT PHYSICIAN #2 CHANGED FROM (B)(6) M.D. TO (B)(6) MD.; EXPLANT DATE #3: (B)(6) 2017, EXPLANT PHYSICIAN #3: (B)(6) M.D.; EXPLANT LOCATION (HOSPITAL, STATE) #3: (B)(6) MEDICAL CENTER .

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 18140929 ↗
• InjuryFeb 20, 2023Patient-Device Incompatibility; Insufficient 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® 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: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16405243 ↗
• InjuryMay 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: PAIN AND DISCOMFORT, MESH INFECTION, FAILED INCORPORATION OF MESH, AND SEROMA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14436211 ↗
• InjuryNov 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2005 AND (B)(6) 2007 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, (B)(6) 2012, AND (B)(6) 2012 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF INFECTED GORE MESH, RESECTION OF BOWEL DUE TO GORE MESH EROSION. RECURRENT VENTRAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, FISTULA, EXTENSIVE HERNIATION OF INTESTINE AND OMENTUM INTO HERNIA DEFECT, DRAINAGE OF FLUID AROUND THE GORE MESH, EXTENSIVE ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10862564 ↗
• InjurySep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL OBSTRUCTION AND REVISION SURGERY ON (B)(6) 2014; PARTIAL REMOVAL OF MESH DUE TO INFECTION (B)(6) 2016; EXPLANT OF MESH DUE TO INFECTION AND ADDITIONAL SURGERY (3X) (B)(6) 2016. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 9110014 ↗
• 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) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2005, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, ABSCESS, INFECTED MESH, MULTIPLE DEBRIDEMENT PROCEDURES, MESH REMOVAL, ADDITIONAL SURGERY ((B)(6) 2005, (B)(6) 2006). ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8946649 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® PLUS 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: PALPITATED MESH, INDWELLING MESH, MESH REMOVAL AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8890534 ↗
• InjuryJun 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, INFECTION, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8702253 ↗
• InjuryOct 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE FOLLOWING WAS REPORTED THAT ON (B)(6) 2015: ¿¿PATIENT PRESENTED WITH COMPLAINTS OF INCREASINGLY PAINFUL ABDOMINAL MASS. CT SCAN REVEALED FINDINGS CONSISTENT WITH INFLAMMATORY/INFECTIOUS PROCESS. PATIENT UNDERWENT OPEN SURGERY FOR WOUND DEBRIDEMENT AND PARTIAL MESH REMOVAL. THE MESH WAS NOTED TO HAVE "FOLDED UP AND CONTRACTED AND FORMED A 'MESHOMA'". THE MESH WAS OPENED AFTER REMOVAL AND "A CLEAR SINUS TRACT EXTENDING FROM THE MESH TO THE SKIN WITH [SIGNIFICANT] AMOUNT OF WHAT APPEARED TO BE FAT NECROSIS AND CHRONIC GRANULATION" WERE NOTED. PATIENT HAS ALSO HAD A SEROMA DRAINED. [CULTURES] OF THE SEROMA WERE NEGATIVE FOR BACTERIA. THE RESULTING HERNIA WAS NOT REPAIRED BUT RATHER A WOUND VAC WAS PLACED. THE PATIENT HAD A WOUND VAC FOR 30 DAYS AND THEN HOME HEALTH CARE 3 X WEEKLY FOR ABOUT 18 MONTHS UNTIL THE WOUND CLOSED.¿ THE COMPLAINTS STATES: ¿ON (B)(6) 2016, PLAINTIFF UNDERWENT ANOTHER OPEN SURGERY DUE TO THE GORE MESH BEING INFECTED AND CAUSING A SEVERE [INFLAMMATORY] RESPONSE. A LARGE ABSCESS, WHICH WAS NOTE

  Patient problems: Abscess; Adhesion(s); Fistula; Unspecified Infection

  MAUDE report 8001614 ↗