VENTRALEX 0010302Recalls & reported problems

Summary

The FDA's MAUDE database contains 531 adverse event reports that list this exact device (DI 00801741016479), received between Jun 26, 2014 and Sep 30, 2026 — classified as 4 deaths, 520 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (486 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 531 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On b)(6) 2011 ¿ Patient was diagnosed with Multiple incarcerated ventral incisional hernias thereby underwent open repair with the implant of Ventralex Mesh (Device 1, 2). Per op notes, ¿The hernia sac was identified. Hernias were noted in inferior portion and periumbilical area. A Ventralex Mesh (Device 1) was placed in right upper quadrant using sutures. The periumbilical hernias were noted. A medium Ventralex Mesh (Device 2) was placed against the fascial edge and secured using sutures.¿ On (b)(6) 2013 ¿ Patient was diagnosed with recurrent incarcerated multiple ventral hernia, infected mesh with necrotic fasciitis, abscess thereby underwent open repair with the removal of meshes (Device 1, 2). Per op notes, ¿The larger hernia sac or two was identified. A significant chronic inflammation with necrotic fascia. The hernia sac was resected. A incarcerated hernia which was located just right and lateral to the umbilicus. The two infected mesh was identified with obvious purulent fluid were removed. A synthetic mesh was placed and secured to the defect using sutures.¿

  Patient problems: Hernia; Purulent Discharge; Unspecified Infection

  MAUDE report 50942962 ↗
• InjurySep 22, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2011- Patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "The hernia sac with omentum was identified in umbilical region and the omentum was reduced. A Ventralex Mesh (Device 1) was placed and sutured." (b)(6) 2011 - Patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of Ventralight ST Mesh (Device 2). (Note: There is no operative notes provided for this procedure).(b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with implant of Ventralight ST Using Echo PS (Device 3). Per op notes, "Some adhesions of the omentum to the abdominal wall in upper abdomen was noted. The Recurrence hernia was noted in central portion of previously placed mesh. The surface of mesh was cleared and the hernia sac was dissected. A Ventralight ST Using Echo PS (Device 3) was placed in the abdomen and was sutured." (The previously placed mesh mentioned in the procedure was unknown).

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50850437 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2011 - Patient was diagnosed with epigastric hernia and umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1 and 2). Per op notes, "A small incision was made in the epigastrium region and dissected down on the large hernia sac. The hernia sac was freed up and excised. A large Ventralex Mesh (Device 1) was placed and secured through both the superior and inferior areas with suture. A keyhole incision was made to the right of the umbilicus around the umbilicus. The hernia sac was identified and amputated. The hernia sac was closed with suture, reduced the hernia sac and developed a preperitoneal plane. A medium Ventralex Mesh (Device 2) was placed in this preperitoneal space and secured with suture." (b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of Composix L/P Mesh (Device 3). Per op notes, "Multiple Swiss cheese defects extending the length of the midline abdominal incision was made. Omental adhesions were to the anterior abdominal wall were taken down. The defect was measured and a Composix L/P Mesh (Device 3) was placed to cover the defect a

  Patient problems: Abdominal Pain; Adhesion(s); Hernia

  MAUDE report 50801945 ↗
• InjuryJul 1, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH MIDLINE VENTRAL HERNIA X2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "TWO HERNIAS WERE LARGE BUT IN CLOSE APPROXIMATELY IN THE MIDLINE. MIDLINE SCAR WAS EXCISED AND DISSECTED. BOTH HERNIAS WERE IDENTIFIED AND DISSECTED FREE FROM THE SURROUNDING TISSUES. THE HERNIAS WERE DISSECTED FROM FASCIA AND BOTH HERNIAS WERE REDUCED. TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED FOR BOTH HERNIAS INDIVIDUALLY AND SUTURED." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL VENTRAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "MULTIPLE OMENTAL ADHESIONS TO THE INCISIONAL HERNIAS WERE LYSED. THERE WAS A MORE INFERIOR VENTRAL HERNIA FIXED WITH PRIOR INTRA-ABDOMINAL MESH (DEVICE 1) THAT HAD RECURRED. THE HERNIA CONTENTS WERE REDUCED. THERE WAS A SECOND EPIGASTRIC HERNIA RECURRENCE ALSO WITH DENSE ADHESIONS TO THE EPIGASTRIC MESH (DEVICE 2) WAS NOTED AND IT CONTAINED OMENTUM WAS REDUCED. BOTH MESHES (DEVICE 1 AND 2) WERE CURLED UP ON EDGES. THE VEN

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25680975 ↗
• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A CURVILINEAR INCISION WAS MADE AROUND THE UPPER PORTION OF HERNIA SAC. REMOVED THE HERNIA SAC FROM THE FUNDUS OF THE UMBILICUS, DISSECTED OUT THE INCARCERATED OMENTUM. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SECURED WITH SUTURES." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED PERIUMBILICAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿AN INCISION WAS MADE OVER THE HERNIA SITE JUST TO THE LEFT OF THE UMBILICUS. DISSECTED OFF THE INCARCERATED OMENTUM WHICH WAS ADHERENT TO THE WALL OF THE SAC. A VENTRALEX MESH (DEVICE 2) WAS PLACED WITHIN THE DEFECT AND WAS SECURED WITH SUTURES FROM THE POSTERIOR SIDE THROUGH THE ANTERIOR MESH THROUGH THE FASCIA AND THEN THROUGH THE STRAP." ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH CHRONICALLY INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS MESH (DEVICE 3). PER OP NOTES, "AN INCISION WAS MADE IN THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25659304 ↗
• InjuryMay 28, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF BARD/DAVOL VENTRALEX MESH ON (B)(6) 2019. POST IMPLANT PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AS THE EDGE OF THE MESH WAS HERNIATED AND ALSO THE MESH WAS ADHERENT TO THE UNDERSIDE OF THE UMBILICAL STALK. LAPAROSCOPIC REVISION HIATAL HERNIA REPAIR WAS PERFORMED WITH EXCISION OF MESH. ALONG WITH IMPLANT OF BARD/DAVOL VENTRIO MESH ON (B)(6) 2025. PATIENT CONTINUED EXPERIENCING ABDOMINAL PAIN, TEARING SENSATIONS, AND SWELLING. ATTORNEYS ALLEGES THAT THE PATIENT EXPERIENCING RECURRENCE, CHRONIC PAIN, DISABILITY WHICH HAVE IMPAIRED DAILY ACTIVITIES AND UNDERWENT ADDITIONAL SURGICAL INTERVENTION. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 25315855 ↗
• InjuryMay 14, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2015: PATIENT WAS DIAGNOSED WITH UMBILICAL AND EPIGASTRIC HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "THERE WERE TWO LARGE FASCIA DEFECTS IN THE SUPRAUMBILICAL MIDLINE WERE NOTED. BOTH HERNIAS WERE HERNIATED WITH PREPERITONEAL FAT WERE AMPUTATED. UMBILICAL HERNIA WAS NOTED AND REDUCED. TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED TO COVER THE EPIGASTRIUM AND UMBILICAL REGION AND SECURED USING SUTURES." (B)(6) 2020: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF VENTRALEX MESH (DEVICE 1 AND 2) IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "THE OLD MESHES (DEVICE 1 AND 2) WERE IDENTIFIED. TWO SEPARATE LAYERS OF MESHES WERE NOTED. OPENING THE TOP LAYER OF THE MESH. ONE OF THE LAYERS HAD COMPLETELY COILED ITSELF AND WAS TRAPPING OMENTUM WITHIN IT WAS RELEASED. ALL THE OMENTUM FREED FROM THE MESH. DEEP LAYER OF MESH THAT WAS COILED ITSELF WAS REMOVED. THE ANTERIOR LAYER OF MESH WAS INCORPORATED LEFT IN PLACE. THE RECURRENT HERNIA DEFECT WAS NOTED AND REDUCED. A SYNTHETIC MESH WAS PLACED AND SUTURED."

  Patient problems: Hernia

  MAUDE report 25175552 ↗
• InjuryMay 14, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "THE HERNIA SAC WAS IDENTIFIED, AND THE INCARCERATED FAT WAS DISSECTED OUT AND REDUCED. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SECURED USING SUTURES." ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "THE HERNIA DEFECT WAS IDENTIFIED. THE DEFECT WAS PRESENT IN THE ORIGINAL MESH (DEVICE 1) AND THE UPPER LEFT WALL OF THE ORIGINAL DEFECT. THE OLD MESH (DEVICE 1) WAS TAKEN OUT AND REMOVED. THE HERNIA SAC WAS REMOVED. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SECURED USING SUTURES." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "THE HERNIA DEFECT WITH INCARCERATED OMENTUM WERE NOTED. THE OMENTUM WAS REDUCED. THE HERNIA SAC WAS EXCISED. OLD MESH (DEVICE 2) WAS EXCISED. A SYNTHETIC MESH WAS PLACED AND SECURED USING SU

  Patient problems: Hernia

  MAUDE report 25175537 ↗
• InjuryApr 29, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA (X2) THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, "TWO VENTRALEX MESH (DEVICE 1 AND 2) WERE PLACED POSTERIOR TO THE FASCIA AT THE PERIUMBILICAL SITE USING PROLENE SUTURES." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF PREVIOUS MESH (DEVICE 1 AND 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, "THE MESH WAS CURLED UP, AND THE MESH (DEVICE 1 AND 2) WERE REMOVED. ADHESIONS WERE TAKEN DOWN. A VENTRIO ST MESH (DEVICE 3) WAS PLACED TO THE PERITONEAL POCKET USING PROLENE SUTURES."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25026806 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008: PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, UMBILICAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESHES (DEVICE 1 AND 2). PER OP NOTES, "THE HERNIA SAC WAS IDENTIFIED IN UMBILICAL REGION AND WAS DISSECTED. THE FASCIA SUPERIOR TO THIS DEFECT WAS NOTED AND A FASCIAL DEFECT BENEATH THE UMBILICUS WAS ALSO NOTED. THE UMBILICAL HERNIA WAS REPAIRED BY PLACING A VENTRALEX MESH (DEVICE 1) THROUGH THE DEFECT AND SUTURED AGAINST THE ANTERIOR ABDOMINAL WALL. THEN THE SUPERIOR FASCIAL DEFECT WAS REPAIRED BY PLACING VENTRALEX MESH (DEVICE 2) AND SUTURED AGAINST THE ANTERIOR ABDOMINAL WALL." ON (B)(6) 2009: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 3), VENTRALEX MESH (DEVICE 4). PER OP NOTES, "THE PREVIOUS MESHES (DEVICE 1 AND 2) WAS IN OVERLAP AND THE HERNIA FOUND PROTRUDING THROUGH THE MESHES (DEVICE 1 AND 2) WITH BOTH BOWEL AND OMENTUM WHICH WAS FOUND ADHERENT TO THE FREE EDGE OF THE MESH. ADHESIOLYSIS WERE PERFORMED. THE PREVIOUS DEFECT WAS NOT COVERED ENTIRELY AND THEREFORE A LARGE COMPOSIX L/P (DEVICE 3) WAS PLACED COVERING THE PREVIOUSLY P

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25026477 ↗
• InjuryMar 26, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿A VERTICAL SUPRAUMBILICAL INCISION WAS MADE. THE DEFECT WAS PALPATED AND THE PERITONEUM WAS OPENED. A VENTRALEX MESH (DEVICE 1) WAS PLACED IN THE INTRA-ABDOMINAL LOCATION AND SECURED WITH SUTURES.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿A VERTICAL INCISION THROUGH THE PREVIOUS SUPRAUMBILICAL MIDLINE INCISION EXTENDING AROUND THE RIGHT SIDE OF THE UMBILICUS WAS MADE. THE HERNIA SAC WAS IDENTIFIED TO THE RIGHT SIDE AWAY FROM MIDLINE INCISION WHERE THE CLINICAL HERNIA WAS LOCATED JUST ABOVE THE UMBILICUS REGION. THE HERNIA SAC WAS REDUCED AND EXCISED. THE MESH (DEVICE 1) WAS PALPATED TO THE LEFT SIDE OF THE HERNIA DEFECT AND NOTED TO BE INTACT. THE HERNIA DEFECT WAS MEASURED, AND A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE INTRAABDOMINAL POSITION AND SECURED WITH SUTURES.¿ ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR W

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24695687 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006: PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE SUPRAUMBILICAL MIDLINE POSITION. THE HERNIA SAC WAS DISSECTED OUT. A 6.4 CM VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2017: PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INFRAUMBILICAL CURVED INCISION WAS MADE AROUND THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 2) WAS PLACED INTO THE UMBILICAL REGION AND SECURE IT WITH SUTURES.¿ (B)(6) 2018: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION; PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE THROUGH THE SITE WHERE PREVIOUS VENTRAL HERNIA REPAIR WAS DONE. PREVIOUSLY PLACED (DEVICE 2) MESH WAS ENCAPSULATED IN THE SUBCUTANEOUS TISSUE AND WAS DISSECTED FREE FROM FASCIA. THERE WAS BOWEL OBSTRUCTION WHICH WERE TAKEN DOWN. A SYNTHETIC MES

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 24454599 ↗
• InjuryJan 2, 2026Material Deformation; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC REDUCIBLE RIGHT INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX PATCH (DEVICE 1) ON RIGHT INGUINAL AND OPEN REPAIR WITH THE IMPLANT OF VENTRALEX PATCH (DEVICE 2) ON UMBILICUS. PER OP NOTES, ¿A REDUCIBLE FASCIAL DEFECT IN THE RIGHT INGUINAL REGION WAS NOTED. THE DEFECT WAS REPAIRED WITH A VENTRALEX PATCH (DEVICE 1) AND SECURED USING THE TACKS. ATTENTION TO THE UMBILICUS HERNIA, A MEDIUM VENTRALEX PATCH (DEVICE 2) WAS SECURED IN SUBFASCIAL FASHION USING SUTURES.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 3). PER OP NOTES, ¿THE RIGHT INGUINAL HERNIA HAD SOME OMENTAL ADHESIONS TO MESH WAS TAKEN DOWN. THE MESH TO BE HIGH ON THE ABDOMINAL WALL AND WITH INCOMPLETE CLOSURE OVER THE DEFECT. THE MESH BEING EASILY LIFTED UP TO SHOW THE HERNIA AND COOPER'S LIGAMENT DOWN BELOW THE AREA WHERE THE MESH (DEVICE 1) WAS PRESENT. ATTEMPTED TO DO A PREPERITONEAL REPAIR WITH PLACEMENT OF A BALLOON IN THE PREPERITONEAL SPACE BUT UPON TRYING TO DISSECT OU

  Patient problems: Pain

  MAUDE report 23943284 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH FOUR INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 ¿ RIGHT AND DEVICE 2 ¿ LEFT). PER OPERATIVE NOTES, ¿THE TWO AREAS OF PALPABLE HERNIAS WHICH WERE AT THE COLOSTOMY SITE ON THE LEFT AND ON THE RIGHT SIDE ON THE MIDLINE HERNIA. A VERTICAL INCISION WAS MADE SHARPLY THROUGH THE OLD SCAR. ON THE LEFT SIDE WAS A VERY LARGE, INCARCERATED HERNIA WHICH WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE LEFT ABDOMINAL WALL AND SECURE IT WITH SUTURES. ON THE RIGHT SIDE THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX MESH (DEVICE 2) WAS PLACED INTO RIGHT ABDOMINAL WALL AND SECURE IT WITH SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ADHESION, PAIN, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 3) AND EXPLANT OF VENTRALEX MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿PRIOR SURGICAL INCISION WAS EXCISED. THE HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE TAKEN DOWN. PRIOR PLACED VENTRALEX MESH (DEVICE 1 ¿ RIGHT AND DEVICE 2 ¿ LEFT) WAS EXCISED TOTALLY. A LARGE SEPRAMESH IP (DEVICE 3) WAS PLACED INTO ANTE

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 23941988 ↗
• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED AND EXCISED. A BARD FLAT MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED AND REDUCED. A PERFIX PLUG WAS PLACED WITH ONLAY PATCH AND SUTURED.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 3). (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE) (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 4). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED AND DISSECTED FREE. THE CONTENTS OF HERNIA SAC WERE REDUCED. THE PRIOR MESHES (DEVICE 1 AND 3) WERE NOTED TO ROLLED UNDERNEATH TO PERMIT THE NEW HERNIA. A VENTRALEX MESH (DEVICE 4) WAS PLACED AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND RIGHT FEMORAL HERNIA THE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23531426 ↗
• DeathJul 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA ABOVE UMBILICUS THEREBY UNDERWENT OPEN REPAIR WITH VENTRALEX MESH (DEVICE #1, #2). PER OP NOTES, ¿A VENTRALEX PATCH (DEVICE #1) WAS PLACED INTO PREPERITONEAL POCKET AND SUTURED. THEN, PRUDENT TROCAR SITE WAS REPAIRED USING VENTRALEX PATCH (DEVICE #2) PLACED BETWEEN THE FASCIA AND THE PERITONEUM AND SECURED USING SUTURES CATCHING A PORTION OF UNDERLYING MESH (DEVICE #1).¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH CELLULITIS AND ABSCESS THEREBY UNDERWENT INCISION & DRAINAGE OF ABSCESS. PER NOTES, ¿A SMALL AMOUNT OF SEROUS FLUID WAS OBTAINED, AND ANTIBIOTICS WERE PROVIDED.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INFECTED UMBILICAL MESH WITH CUTANEOUS FISTULA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2). PER OP NOTES, ¿A OLD CUTANEOUS DEFECTS ERODED THROUGH THE ABDOMINAL WALL AND MESH (DEVICE#1, #2) WERE NOTED. THE MESH (DEVICE #1, #2) IMBEDDED INTO FASCIA WAS REMOVED COMPLETELY. PERITONEUM HAD CHRONIC GRANULATION TISSUE WAS EXCISED.¿ ATTORNEY ALLEGES THAT THE PATIENT PASSED AWAY ON (B)(6) 2017.

  Patient problems: Abscess; Bacterial Infection; Fistula

  MAUDE report 22466860 ↗
• InjuryJul 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED PER ANSM REPORT (B)(4) IN SUMMARY: ON (B)(6) 2017 ¿ PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR BY LAPAROSCOPY WITH THE INSERTION OF A 3D PROSTHESIS (BD/BARD 3DMAX MESH DEVICE #1 AND DEVICE #2) AND RESORBABLE STAPLES. PATIENT HAD PERSISTENT LEFT GROIN AND UMBILICAL PAIN, SWELLING AND CONSTIPATION. ON (B)(6) 2017 - ULTRASOUND SHOWED PERSISTENCE OF A SMALL, VAGUELY INFLAMED SCAR IN THE PERIUMBILICAL REGION, IT APPEARS THAT THE LEFT INGUINAL MESH HAS BEEN DISPLACED AND IS NOW IN A VERTICAL OBLIQUE POSITION WITH FLUID COLLECTION AROUND IT, CAUSING THE CLINICAL IMPRESSION OF A PAINFUL SWELLING. ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA BECAUSE HYPER-PRESSURE MOBILIZED THE PREVIOUS PROSTHESES, RESULTING IN AN EXTERNAL OBLIQUE RECURRENCE. FOLLOWING DISSECTION OF THE HERNIA SAC AND EPIGASTRIC VESSELS, THE ORIGINAL PROSTHESIS (3D) WAS REINSERTED AND VENTRALEX MESH WAS IMPLANTED AROUND THE RECURRENCE SAC AND SUTURED. THE SAME PROCEDURE WAS PERFORMED ON THE BOTH SIDES (BD/BARD VENTRALEX MESH DEVICE #3 AND DEVICE #4). ON (B)(6) 2017 - CORTISONE INJECTION PROVIDED TO MANAGE CHRONIC PAIN. ON (B)(6) 2017 - CT - SMALL, ASYMPTOMATIC UMBILICAL

  Patient problems: Pain

  MAUDE report 22440574 ↗
• InjuryJul 8, 2025Material Deformation; Material Deformation

  AS REPORTED PER ANSM REPORT (B)(4) IN SUMMARY: ON (B)(6) 2017: PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR BY LAPAROSCOPY WITH THE INSERTION OF A 3D PROSTHESIS (BD/BARD 3DMAX MESH DEVICE #1 AND DEVICE #2) AND RESORBABLE STAPLES. PATIENT HAD PERSISTENT LEFT GROIN AND UMBILICAL PAIN, SWELLING AND CONSTIPATION. ON (B)(6) 2017: ULTRASOUND SHOWED PERSISTENCE OF A SMALL, VAGUELY INFLAMED SCAR IN THE PERIUMBILICAL REGION, IT APPEARS THAT THE LEFT INGUINAL MESH HAS BEEN DISPLACED AND IS NOW IN A VERTICAL OBLIQUE POSITION WITH FLUID COLLECTION AROUND IT, CAUSING THE CLINICAL IMPRESSION OF A PAINFUL SWELLING. ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT BILATERAL INGUINAL HERNIA BECAUSE HYPER-PRESSURE MOBILIZED THE PREVIOUS PROSTHESES, RESULTING IN AN EXTERNAL OBLIQUE RECURRENCE. FOLLOWING DISSECTION OF THE HERNIA SAC AND EPIGASTRIC VESSELS, THE ORIGINAL PROSTHESIS (3D) WAS REINSERTED AND VENTRALEX MESH WAS IMPLANTED AROUND THE RECURRENCE SAC AND SUTURED. THE SAME PROCEDURE WAS PERFORMED ON THE BOTH SIDES (BD/BARD VENTRALEX MESH DEVICE #3 AND DEVICE #4). ON (B)(6) 2017: CORTISONE INJECTION PROVIDED TO MANAGE CHRONIC PAIN. ON (B)(6) 2017: CT - SMALL, ASYMPTOMATIC UMBILICAL HERN

  Patient problems: Pain

  MAUDE report 22440572 ↗
• InjuryJun 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES PATIENT HE REPRESENTS HAS EXPERIENCE UNSPECIFIED INJURY. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A VENTRALEX MESH. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Bowel Perforation; Fistula; Hernia; Insufficient Information

  MAUDE report 22306674 ↗
• InjuryJun 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE # 1) AND COMPOSIX KUGEL MESH (DEVICE # 2). PER OPERATIVE NOTES, "THE TOTAL DEFECT WAS NOTED AND THE HERNIA HAD EXTRUDED AND THE CONTENTS WERE REDUCED. A VENTRALEX MESH (DEVICE # 1) WAS PLACED AND SUTURED. A COMPOSIX KUGEL MESH (DEVICE # 2) WAS PLACED AGAINST ANTERIOR ABDOMINAL WALL WAS SEWN IN PLACE AND SUTURED." ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH EXTENSIVE ADHESIONS THEREBY UNDERWENT LYSIS OF ADHESIONS AND RE-TACK IN ONE CORNER OF PREVIOUS MESH. ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, RIGHT INDIRECT INGUINAL HERNIA AND RIGHT LOWER QUADRANT PAIN THEREBY UNDERWENT REMOVAL OF MESH. PER OPERATIVE NOTES, "THE SCAR WAS EXCISED. THE UNDERLYING VENTRAL HERNIA MESH (DEVICE #1) WAS REMOVED. THE VENTRAL HERNIA MESH (DEVICE # 2) IN LOWER MIDLINE WAS FOLDED ON LEFT SIDE INFERIORLY. MOST OF THE MESH WAS REMOVED. THE UPPER ONE-THIRD OF MESH WAS LEFT IN PLACE. ADHESIONS WERE TAKEN DOWN. THE RIGHT INDIRECT INGUINAL HERNIA WAS REPAIRED USING SUTURES." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22196596 ↗
• InjuryJun 12, 2025Material Deformation; Material Deformation

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LARGE UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿HERNIA WAS IDENTIFIED. A VENTRALEX MESH (DEVICE #1 & #2) WAS USED FOR REPAIR AND SECURED BY SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AND LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #3) AND BARD FLAT MESH (DEVICE #4) AND EXPLANT OF VENTRALEX MESH (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1 & #2) WERE NOTED TO BE CURLED UPON ITSELF SUPERIORLY WHERE THE HERNIATION HAD RECURRED AND THESE MESHES WERE REMOVED. THE INCARCERATED OMENTUM WAS REDUCED, AND HERNIA SAC WAS EXCISED. THEN A VENTRALEX ST (DEVICE #3) WAS PLACED IN THE ABDOMINAL CAVITY AND SECURED BY SUTURES. THEN THE ATTENTION TURNED TO THE LEFT INGUINAL REGION, ONCE THE EXTERNAL RING WAS IDENTIFIED, THE CORD STRUCTURES WERE DISSECTED OUT. THEN A BARD FLAT MESH (DEVICE #4) WAS PLACED AROUND THE SPERMATIC CORD WITH THE APEX AT THE PUBIC TUBERCLE USING SUTURES.¿

  Patient problems: Hernia

  MAUDE report 22193150 ↗
• InjuryMay 2, 2025Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE # 1). PER OPERATIVE NOTES, ¿THE SAC WAS EXCISED. A BARD VENTRALEX MESH (DEVICE #1) WAS INSERTED AND PLACED THROUGH THE STRAPPED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF PREVIOUS MESH VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE SCAR TISSUE WAS THERE ABOUT THE UMBILICUS. THE VENTRALEX MESH HAD RELEASED ITSELF FROM THE ATTACHMENT. THE MESH WAS THEN REMOVED CAREFULLY. THE HERNIA WAS THEN EASILY EXTRACTED. ADHESION WAS TAKEN DOWN. A ROUND VENTRIO ST MESH (DEVICE # 2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRIO ST MESH (DEVICE # 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿SOME OMENTUM WAS DISSECTED. PREVIOUSLY PLACED VENTRIO ST MESH (DEVICE # 2) WAS FULLY REMOVED. A VENTRIO ST MESH (DEVICE # 3) WAS PLACED AND TACKED.¿

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 21949683 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX MESH ON (B)(6) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX MESH. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain; Scar Tissue

  MAUDE report 21718120 ↗
• InjuryMar 20, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH AND PARTIAL OMENTECTOMY. PER OPERATIVE NOTES, "THE UMBILICAL HERNIA SAC WAS DISSECTED FREE FROM SUBCUTANEOUS TISSUE OF THE INFERIOR ASPECT OF UMBILICUS. THE ENTIRE HERNIA SAC WAS EXCISED, AND THE INCARCERATED HERNIA SAC WAS FREED. THE REMAINDER OMENTUM AND PREPERITONEAL FAT WERE REDUCED. A VENTRALEX MESH WAS PLACED INTO THE FASCIAL DEFECT AND SUTURED." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION. ATTORNEY ALLEGES THAT THE PATIENT HAD BOWEL OBSTRUCTION, HERNIA RECURRENCE AND PAIN.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 21652365 ↗
• InjuryFeb 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT HAD UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). (NOTE: NO OP NOTES WERE PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS AND THERE IS NO INFORMATION REGARDING VENTRALEX MESH (DEVICE #1) IN PPF). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT COMPLEX UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE UNDERLYING HERNIA DEFECT CONTAINED PREPERITONEAL FAT WAS EXCISED. THE DEFECT WAS IDENTIFIED, AND HERNIA SAC WAS REMOVED FROM SURROUNDING TISSUES. A LARGE SHEET OF VENTRALEX MESH (DEVICE #2) WAS PLACED INTO THE PERITONEAL CAVITY AND CLOSED WITH SUTURE.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF VENTRALEX MESHES (DEVICE #1, #2). PER OPERATIVE NOTES, ¿THE OMENTUM AND ISCHEMIC SMALL BOWEL WITHIN THE HERNIA SAC WAS NOTED. THE LARGER HERNIA DEFECT AND THE SMALL BOWEL WERE REDUCED. THERE WERE OMENTAL ADHESIONS TO THE SMALL BOWEL INCLUDING THE VENTRALEX MESH (DEVICE #1, #2) WHICH WERE ON ONE SIDE OF THE HERNIA DEFE

  Patient problems: Adhesion(s); Fibrosis; Hernia; Inflammation; Ischemia; Obstruction/Occlusion

  MAUDE report 21455748 ↗