GORE SYNECOR Preperitoneal BiomaterialRecalls & reported problems across all models

We found 6 models of GORE SYNECOR Preperitoneal Biomaterial by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2019 and May 28, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 SYNECOR Preperitoneal Biomaterial problems

GORE SYNECOR Preperitoneal Biomaterial models

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

• GORE SYNECOR Preperitoneal Biomaterial GKWR2030

  Mesh, Surgical, Polymeric
  9 reports
• GORE SYNECOR Preperitoneal Biomaterial GKWV1015

  Mesh, Surgical, Polymeric
  4 reports
• GORE SYNECOR Preperitoneal Biomaterial GKWR2025

  Mesh, Surgical, Polymeric
  3 reports
• GORE SYNECOR Preperitoneal Biomaterial GKWV1520

  Mesh, Surgical, Polymeric
  3 reports
• GORE SYNECOR Preperitoneal Biomaterial GKWR1215

  Mesh, Surgical, Polymeric
  1 report
• GORE SYNECOR Preperitoneal Biomaterial GKWR3030

  Mesh, Surgical, Polymeric
  1 report

Recent GORE SYNECOR Preperitoneal Biomaterial adverse event reports

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

• InjuryMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE PRODUCT SPECIALIST THAT, ON (B)(6) 2025, HE HAD A CONVERSATION WITH (B)(6) (GORE SURGICAL SOLUTIONS FIELD SALES ASSOCIATE) WHO TOLD HIM ABOUT A MESH FRACTURE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL. ON (B)(6) 2025, THE PS HAD A PHONE CONVERSATION WITH DR. (B)(6) TO DISCUSS WHAT HE OBSERVED. ACCORDING TO DR (B)(6), HE HAS A MALE PATIENT 74 YEARS WHO WAS IMPLANTED SEVEN YEARS AGO WITH SYNECOR PRE FOR AN INGUINAL HERNIA REPAIR, SUTURING THE MESH TO THE PUBIC BONE WITH 2-0 VICRYL SUTURE. THE PHYSICIAN REPORTED HIS PATIENT IS AN AVID WEIGHTLIFTER, ALWAYS IN THE GYM DOING CORE WORK OUTS. REPORTEDLY, ONE DAY THE PATIENT WAS DOING SQUAT LIFTS AND FELT A TEAR IN HIS GROIN. ON (B)(6) 2025, DR (B)(6) OPERATED ON THE PATIENT TO DETERMINE WHAT HAPPENED. THE PHYSICIAN OBSERVED THAT THE MESH TORE FROM THE PUBIC BONE WHERE IT WAS FIXATED. HE DESCRIBED IT SPECIFICALLY AS ¿I SAW MESH, THEN TISSUE, THEN MESH.¿ IT WAS AN INDIRECT RECURRENCE. THE PHYSICIAN DID NOT TAKE ANY PHOTOS OR VIDEOS AND DID NOT EXPLANT THE DEVICE. HE PLACED ANOTHER PIECE OF SYNECOR PRE OVER THE OLD PIECE TO REPAIR THE HERNIA. REPORTEDLY, THERE WAS NO SUBSEQUENT PROCEDURES IN THE AREA OF THE DEVICE AFTER

  Patient problems: Hernia

  MAUDE report 22095605 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024) MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), ON

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20207438 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024) MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), ON

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20205019 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), O

  Patient problems: Unspecified Infection

  MAUDE report 20201414 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), O

  Patient problems: Abscess; Unspecified Infection; Wound Dehiscence

  MAUDE report 20183603 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR. DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%),

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Purulent Discharge

  MAUDE report 19775966 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024) MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), ON

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

  MAUDE report 19757196 ↗
• InjuryJul 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® SYNECOR® PREPERITONEAL BIOMATERIAL 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: DEATH (B)(6) 2022 - BOWEL OBSTRUCTION, ADHESIONS, PAIN, INFECTION, CHRONIC WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 19742053 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2021 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL 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: INFECTED MESH, SEPSIS, SEROMA, WOUND VAC, ABSCESS, NECROSIS, 12-DAY HOSPITAL STAY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 19132959 ↗
• InjuryNov 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN PERFORMED A ROBOTIC TAR ON (B)(6) 2023 (NOT A BRIDGING REPAIR). HE IMPLANTED A PIECE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL BETWEEN TISSUE PLANES AS WELL AS PLACING A DRAIN AND USING AN ABDOMINAL BINDER POST-OPERATIVELY. THIS PATIENT PRESENTED TO HIM IN CLINIC IN THE FOLLOWING MONTHS WITH A 2 CM SORE/PIMPLE THAT WOULD NOT GO AWAY. THIS WAS TREATED WITH ANTIBIOTICS AS WELL AS OPEN DRAINAGE AND YET THIS RED SORE/PIMPLE STILL WOULD NOT GO AWAY. ON (B)(6), 2023 THE SURGEON REEXPLORED THIS WOUND IN THE OR AND RESECTED INFECTED SYNECOR. THE FSA ATTENDED THE CASE AND TOOK A PHOTO OF THE PIECE OF EXPLANTED MESH WHICH HAD NOT INGROWN. THE PATIENT¿S RELEVANT MEDICAL HISTORY INCLUDES HYPERTENSION AND HAVING CEREBRAL PALSY. ON THE DATE OF REOPERATION THE PATIENT WAS A 60 YEAR OLD FEMALE AND WEIGHED 152 LBS. IT WAS STATED BY THE FSA THAT THIS INFECTION WAS NOT CONSIDERED A FISTULA, IT WAS NOT DUE TO DEHISCENCE OF A SURGICAL SITE OR TROCAR SITE. NOR WAS THE INFECTION DUE TO A SINUS TRACT/ABSCESS ASSOCIATED WITH A SUTURE SITE LOCATION. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS SENT TO PATHOLOGY ACCORDING TO HOSPITA

  Patient problems: Unspecified Infection

  MAUDE report 18133084 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE THAT A HERNIA REPAIR WAS PERFORMED ON (B)(6) 2023. THE CASE WAS A ROBOTIC ETEP WITH BILATERAL TAR, PATIENT HAD PRIOR MESH IN THE INTRAPERITONEAL PLANE THAT WAS LEFT INTACT AS A POSTERIOR SHEATH. THE PHYSICIAN IMPLANTED A LARGE PIECE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL DURING THIS PROCEDURE. APPROXIMATELY 6-7 MONTHS AFTER THE CASE THE PATIENT PRESENTED WITH A SEROMA, CHRONIC SINUS WITH GRANULATION AND PUS. THE PHYSICIAN BOOKED THIS PATIENT FOR A EXPLORATION ON (B)(6) 2023. IN THIS CASE, HE FOUND WHAT HE THOUGHT TO BE OLD VENTRALEX (PROLENE AND PTFE) AND EXCISED COMPLETELY. THE BULK OF THE INFECTION WAS ON THE VENTRALEX AND PROLENE SUTURES. A LITTLE BIT OF SYNECOR FROM THE EDGE OF THE MESH WAS REMOVED. AFTER THIS CASE WE WENT BACK TO HIS OFFICE AND LOOKED AT THE CT SCAN FROM PRIOR TO THE (B)(6) 2023 CASE WHICH DID NOT SHOW PRIOR INFECTION. WE THEN WATCHED THE RECORDING OF HIS OPERATION FROM (B)(6) 2023 TO SEE HOW THE PRIOR MESH LOOKED INTEROP AND DID NOT SEE ANYTHING OUT OF THE ORDINARY. IT WAS FURTHER REPORTED, THE DEVICE IS NOT AVAILABLE FOR EXAMINATION IT WAS DISCARDED AT THE HOSPITAL. THERE WAS ONE JP DRAIN USED AND THE

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 17909117 ↗
• InjurySep 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO GORE THAT APPROXIMATELY THREE MONTHS AGO A 20 CM X 30 CM GORE® SYNECOR PREPERITONEAL BIOMATERIAL DEVICE WAS CUT IN HALF MAKING TWO 15 CM X 20 CM DEVICES TO REPAIR EACH SIDE OF THE BILATERAL HERNIA. ABSORBABLE VICRYL SUTURES WERE USED TO FIXATE BOTH PIECES. REPORTEDLY, THE PATIENT RETURNED TO THE OFFICE 1-2 WEEKS AGO COMPLAINING OF A LUMP IN HIS GROIN ON ONE SIDE. ON (B)(6) 2023 THE IMPLANTING PHYSICIAN RE-OPERATED ON THE PATIENT AND REPORTEDLY FOUND HEAVY SCAR TISSUE AND THE MESH SURROUNDED BY FLUID AND NOT INCORPORATED INTO TISSUE. THE MESH WAS EXPLANTED AND DISPOSED OF. THE HERNIA RECURRENCE WAS REPAIRED WITH A PIECE OF BARD 3D MAX.

  Patient problems: Seroma

  MAUDE report 17778024 ↗
• InjurySep 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL 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: FOREIGN BODY GIANT CELL REACTION, MESH DETACHMENT, INFECTION, HERNIA RECURRENCE, SURGERY TO REMOVE MESH, AND SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12509519 ↗
• InjurySep 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL 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: FOREIGN BODY GIANT CELL REACTION, MESH DETACHMENT, INFECTION, HERNIA RECURRENCE, SURGERY TO REMOVE MESH, AND SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12509376 ↗
• InjuryJun 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2019, WHEREBY A GORE® SYNECOR® PREPERITONEAL BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: 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: CHRONIC GROIN PAIN, SCARRING, CHRONIC INFLAMMATION, INFLAMMATION, RIGHT ORCHIECTOMY WITH HIGH LIGATION OF VAS DEFERENS AND SPERMATIC CORD. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12034721 ↗

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