GORE BIO-A Tissue ReinforcementRecalls & reported problems across all models

We found 6 models of GORE BIO-A Tissue Reinforcement by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2019 and Jul 16, 2024 — classified as 33 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE BIO-A Tissue Reinforcement problems

GORE BIO-A Tissue Reinforcement models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE BIO-A Tissue Reinforcement FS0915

  Mesh, surgical, absorbable, staple line reinforcement
  12 reports
• GORE BIO-A Tissue Reinforcement FS2030

  Mesh, surgical, absorbable, thoracic, chest wall reconstruction
  9 reports
• GORE BIO-A Tissue Reinforcement HH0710

  Mesh, surgical, absorbable, abdominal hernia
  6 reports
• GORE BIO-A Tissue Reinforcement FS2020

  Mesh, surgical, absorbable, abdominal hernia
  4 reports
• GORE BIO-A Tissue Reinforcement FS0808

  Mesh, surgical, absorbable, abdominal hernia
  1 report
• GORE BIO-A Tissue Reinforcement FS1030

  Mesh, surgical, absorbable, staple line reinforcement
  1 report

Recent GORE BIO-A Tissue Reinforcement adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: INCISIONAL HERNIA REPAIR WITH MESH. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(6), 20CM X 20CM] IMPLANT DATE: (B)(6) 2021 (HOSPITALIZATION DATES (B)(6) 2021). PARTIAL EXPLANT PROCEDURE: INCISION AND DRAINAGE OF SURGICAL SITE, WASHOUT, SMALL BOWEL REPAIR. PARTIAL EXPLANT DATE: (B)(6) 2021 HOSPITALIZATION DATES (B)(6) 2021) IMPLANT #1: (B)(6). IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2021 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ON (B)(6) 2021 BUNCHING UP OR FOLDING OF THE MESH IN CENTER; DRAINAGE OF SURGICAL SITE, WASHOUT, AND SMALL BOWEL REPAIR. ON (B)(6) 2021 LAPAROTOMY, WASHOUT, REPAIR OF BOWEL PERFORATION, AND ABDOMINAL CLOSURE WITH LIFECELL STRATTICE MESH PLACEMENT. THERE WAS AN ENTERIC LEAK FROM A SMALL BOWEL PERFORATION. SURGEON FOUND THAT THE REPAIR FROM THE PREVIOUS OPERATION HAD FALLEN APART AS THE BOWEL WALL WAS VERY FRIABLE. THERE WAS A FASC

  Patient problems: Bowel Perforation

  MAUDE report 19750355 ↗
• InjuryAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2013 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: INFECTED ABDOMINAL WALL MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17651426 ↗
• InjuryAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6), 2013 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: INFECTED ABDOMINAL WALL MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17651403 ↗
• InjuryApr 20, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY, ADHESIOLYSIS FOR 120 MINUTES, SEGMENTAL SMALL BOWEL RESECTION WITH PRIMARY ENTEROENTEROSTOMY, AND COMPLEX CLOSURE OF ABDOMINAL WALL WITH BIOLOGIC MESH 20CM X 30CM. IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/(B)(4), 20CM X 30 CM]. IMPLANT #1 DATE: (B)(6) 2015 (HOSPITALIZATION (B)(6) 2015). REVISION #1 PROCEDURE: REOPENING RECENT LAPAROTOMY WITH REPAIR OF FASCIAL DEHISCENCE, PLACEMENT OF VICRYL MESH OVERLAY, AND NEGATIVE PRESSURE THERAPY DRESSING 30CM X 15CM. REVISION #1 DATE: (B)(6) 2015. EXPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION X2 WITH PRIMARY ANASTOMOSIS, ABTHERA WOUND VAC NEGATIVE PRESSURE DRESSING PLACEMENT. EXPLANT #1 DATE: (B)(6) 2016 [HOSPITALIZATION (B)(6) 2016]. IMPLANT #2 AND #3 PROCEDURE: REOPENING OF RECENT LAPAROTOMY, ABDOMINAL WASHOUT, DEBRIDEMENT OF ABDOMINAL WALL (EXCISION OF SKIN MEASURING APPROX. 50 SQ. CM, PLACEMENT OF TWO 20X30 CM GORE DUAL MESH PLUS TO SKIN FOR SALVAGE ABDOMINAL CLOSURE. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL PLUS X2, 1DLMCP203/(B)(4), 20CM X 30CM X 2MM THICK AND 1DLMCP203/(B)(4), 20CM X 30CM X 2MM THI

  Patient problems: Hernia

  MAUDE report 16775863 ↗
• InjuryApr 19, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT #1 PROCEDURE: REPAIR OF INCISIONAL HERNIA WITH GORE BIO-A MESH, 10 X 15 CM PRODUCT WAS USED. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS0915/(B)(4), 9CM X 15 CM]. IMPLANT #1 DATE: (B)(6) 2014 ((B)(6) 2014) IMPLANT #2 EXPLANT #1 PROCEDURE: INCISION OF OLD MESH FROM THE ABDOMINAL WALL WITH REPAIR OF INCISIONAL HERNIA WITH GORE-BIO A MESH. LYSES OF ADHESIONS REQUIRING 30 MINUTES OF OPERATIVE TIME. PERITONEAL LAVAGE WAS ALSO DONE. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(4), 20CM X 20 CM] . IMPLANT #2 EXPLANT #1 PROCEDURE DATE: (B)(6) 2014 (HOSPITALIZATION (B)(6) - (B)(6) 2014) EXPLANT #2 PROCEDURE: NO EVIDENCE THAT AN ADDITIONAL PROCEDURE OCCURRED RELATED TO THE GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(4). IMPLANT #1: 3483-1. IMPLANT #2: 3483-2. ____________________________________________________________________________________________________________________ IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2014 AND (B)(6) 2014 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014 AND (B)(6) 201

  Patient problems: Hernia

  MAUDE report 16769968 ↗
• InjuryMar 28, 2023Contamination; Contamination

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT#: 1 PROCEDURE: LAPAROSCOPIC REPAIR OF VENTRAL HERNIA WITH POLYTETRAFLUOROETHYLENE SOFT TISSUE PATCH. [IMPLANT GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP08/05729033, 26CM X 34CM X 1MM THICK, OVAL]. IMPLANT#: 1 DATE: ON (B)(6) 2008 [HOSPITALIZATION DATES ON (B)(6) 2008]. IMPLANT#: 2 AND EXPLANT#: 1 PROCEDURE: OPEN RECURRENT INCISIONAL HERNIA REPAIR. REMOVAL OF PROSTHETIC MESH. IMPLANTATION OF MESH. ENTEROLYSIS. DEBRIDEMENT OF MUSCLE AND FASCIA, FIRST 20 SQ CM. DEBRIDEMENT OF MUSCLE AND FASCIA, ADDITIONAL 20 SQ CM. INCISIONAL NEGATIVE PRESSURE WOUND THERAPY. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/14969704, 20CM X 30CM]. IMPLANT#: 2 AND EXPLANT#: 1 DATE: ON (B)(6) 2016 [HOSPITALIZATION DATES NOT PROVIDED]. IMPLANT#: 3 [NO ALLEGATIONS] AND EXPLANT#: 2 PROCEDURE: OPEN RECURRENT INCISIONAL HERNIA REPAIR. END JEJUNOSTOMY. REMOVAL OF PROSTHETIC MESH. IMPLANTATION OF MESH. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/15116434, 20CM X 30CM.]. IMPLANT#: 3 AND EXPLANT#: 2 DATE: ON (B)(6) 2016 [HOSPITALIZATION DATES NOT PROVIDED]. IMPLANT#: 1: 2409-1. IMPLANT#: 2: 2409-2. IT WAS INITIALLY REPORTED TO GORE THAT

  Patient problems: Erosion; Fistula

  MAUDE report 16627555 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN USED THE GORE® BIO-A® TISSUE REINFORCEMENT FOR A BREAST RECONSTRUCTION PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED SEROMA AND INFECTION. IT WAS REPORTED THE PHYSICIAN REMOVED THE DEVICE DUE TO THE INFECTION. REPORTEDLY, THE PATIENT IS DOING WELL ACCORDING TO THE FOLLOW UPS. REPORTEDLY, THE DEVICE WAS EXPLANTED 3 WEEKS AFTER INTERVENTION AND WAS REMOVED VIA SKIN INCISION. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE MESH WAS REMOVED. REPORTEDLY, THERE WAS A WOUND DEHISCENCE AND THERE WERE DRAINS PLACED DURING THE PROCEDURE. IT WAS REPORTED THE SEROMA WAS ASPIRATED. DRAINED AND THE DEVICE WAS PLACED NEXT TO WELL VASCULARIZED TISSUE ON BOTH SIDES.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14680788 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN USED THE GORE® BIO-A® TISSUE REINFORCEMENT FOR A BREAST RECONSTRUCTION PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED SEROMA AND INFECTION. IT WAS REPORTED THE PHYSICIAN REMOVED THE DEVICE DUE TO THE INFECTION. REPORTEDLY, THE PATIENT IS DOING WELL ACCORDING TO THE FOLLOW UPS. REPORTEDLY, THE DEVICE WAS EXPLANTED 3 WEEKS AFTER INTERVENTION AND WAS REMOVED VIA SKIN INCISION. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE MESH WAS REMOVED. REPORTEDLY, THERE WAS A WOUND DEHISCENCE AND THERE WERE DRAINS PLACED DURING THE PROCEDURE. IT WAS REPORTED THE SEROMA WAS ASPIRATED. DRAINED AND THE DEVICE WAS PLACED NEXT TO WELL VASCULARIZED TISSUE ON BOTH SIDES.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14680195 ↗
• InjurySep 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE¿ DUALMESH¿ PLUS BIOMATERIAL WAS IMPLANTED AND ON (B)(6) 2013 WHEREBY A GORE¿ BIO-A¿ TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013 AND (B)(6) 2018, ADDITIONAL PROCEDURES OCCURRED WHEREBY A GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, RECURRENCE, REMOVAL OF MESH, ABSCESSES, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12513041 ↗
• InjuryJul 27, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Microbial Contamination of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCARCERATED VENTRAL HERNIA REPAIR ON (B)(6) 2020, WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2021, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, SURGERY TO REMOVE MESH, BOWEL RESECTION, WOUND VAC, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233994 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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, ADHESIONS. HERNIA RECURRENCE, AND BOWEL REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12093950 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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, ADHESIONS. HERNIA RECURRENCE, AND BOWEL REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12093816 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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: INFECTION, CHRONIC PAIN, HERNIA RECURRENCE, AND SWELLING ABDOMEN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12093622 ↗
• InjuryApr 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, HERNIA RECURRENCE, MESH EROSION, OBSTRUCTION, VOMITING, AND SWELLING ABDOMEN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 11668199 ↗
• InjuryJan 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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: ADHESIONS, INFLAMMATION, PARTIAL REMOVAL OF SURGICAL MESH, WEIGHT LOSS, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Dysphagia/ Odynophagia; Foreign Body Reaction; Inflammation

  MAUDE report 11239819 ↗

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