VENTRALEX 0010301Recalls & reported problems

Summary

The FDA's MAUDE database contains 466 adverse event reports that list this exact device (DI 00801741000355), received between Sep 23, 2015 and Sep 29, 2026 — classified as 1 death, 444 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Defective Device” (407 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 466 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Migration

  Patient problems: Adhesion(s)

  MAUDE report 50929896 ↗
• InjurySep 1, 2026Patient-Device Incompatibility

  Patient problems: Abdominal Pain; Adhesion(s); Bowel Perforation; Obstruction/Occlusion

  MAUDE report 50541554 ↗
• InjuryJul 28, 2026Material Deformation

  Per information provided:(b)(6) 2008- Patient was diagnosed with two incisional hernias thereby underwent open repair with implant of Ventralex Mesh (Device 1 and Device 2). Per op notes, "An incision was made through the left lateral scar, approximately two- third of the way between the umbilicus and pubis. Some areas of fat necrosis and a large defect with a loop of bowel adherent to a hernia sac were identified. The bowel was taken down. A Ventralex Mesh (Device 1) was placed in the wound and the wound was partially closed over the mesh and was secured with tacks to the fascia. The umbilicus was opened and below which another transverse incision was made. A large omental fat from the small defect at the base of the umbilicus was identified, the fat was reduced and a Ventralex Mesh (Device 2) was placed and was secured with tacks."(b)(6) 2015- Patient was diagnosed with abdominal pain and incisional hernia, adhesion, obstruction thereby underwent open repair with excision of Ventralex Mesh (Device 1 and Device 2) and implant of XenMatrix graft (Device 3). Per op notes, "A sterile incision was made above the umbilicus down to the pubis. The large amount of calcified mesh that was

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 50052060 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2010 - Patient was diagnosed with epigastric and umbilical hernias thereby underwent open repair with implant of Ventralex Mesh (Device 1 and 2). Per op notes, "Supraumbilical incision was made. Umbilical hernia sac was identified and dissected off. The sac was reduced. A Ventralex Mesh (Device 1) was placed and sutured. Epigastric hernia was identified and dissected out. The hernia sac was reduced. A Ventralex Mesh (Device 2) was placed and sutured."(b)(6)2011 - Patient was diagnosed with infected umbilical and epigastric mesh and abdominal pain thereby underwent open repair with excision of Ventralex Mesh (Device 1 and 2). Per op notes, "Supraumbilical incision was made through the previous incision. The previous mesh (Device 2) was encountered and was removed entirely. There was a pus cavity that was drained. After removal of mesh, the defect was repaired with sutures. Under the umbilicus, there was another piece of mesh (Device 1) was also removed entirely. The fascia was closed with sutures."

  Patient problems: Abdominal Pain; Bacterial Infection

  MAUDE report 50050079 ↗
• InjuryMay 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL INCISIONAL HERNIA, EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE OVER BOTH HERNIAS. THE EPIGASTRIC HERNIA SAC WAS IDENTIFIED JUST ABOVE THE UMBILICUS, AND THIS WAS EXCISED FROM PERITONEAL CAVITY. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURE IT WITH SUTURES. AN UPPER ELLIPTICAL INCISION WAS MADE. RECURRENT INCISIONAL ABDOMINAL WALL HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 2) WAS PLACED INTO THE POSTERIOR PERITONEUM AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2015 ¿ PATIENT HAVE BOWEL OBSTRUCTION AND PAIN. ATTORNEY ALLEGES THAT ¿PATIENT HAD ONGOING PAIN DUE TO FAILED MESH IMPLANTS.¿

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 25147237 ↗
• InjuryMay 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX (DEVICE 1). PER OP NOTES, "A SUB-UMBILICAL INCISION WAS MADE, A VENTRALEX (DEVICE 1) WAS PLACED IN THE RETROPERITONEAL SPACE." (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "THE OLD MESH (DEVICE 1) WAS IDENTIFIED. A VENTRALEX MESH (DEVICE 2) WAS PLACED TO THE ABDOMINAL WALL USING SUTURES." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE 3). PER OP NOTES, "THE OLD TWO MESHES (DEVICE 1 AND 2) WERE IDENTIFIED. A VENTRALEX ST (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY USING PROLENE SUTURES."

  Patient problems: Hernia

  MAUDE report 25077621 ↗
• InjuryApr 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT. THERE WERE 3 SMALL HERNIAS, WHICH WERE TAKEN DOWN. ONE MALL AND ONE MEDIUM VENTRALEX MESH (DEVICE 1 AND 2) WAS PLACED TOGETHER WITH GOOD COVERAGE AND CLOSED THE DEFECT WITH SUTURES.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION HEREBY UNDERWENT LAPAROSCOPIC REPAIR EXPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE JUST ABOVE INTO THE RIGHT OF THE UMBILICUS THROUGH PRIOR VERTICAL INCISION SITE. THE HERNIA SAC WAS DISSECTED OUT. THERE WAS DENSE OMENTUM ADHESION WHICH WAS REMOVED ENTIRELY. PREVIOUSLY PLACED (DEVICE 1 AND 2) WERE EXCISED ENTIRELY FROM ABDOMEN. THE DEFECT WAS CLOSED WITH SUTURES PRIMARILY.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25034183 ↗
• InjuryApr 10, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED TO THE MEDULLARY CAVITY USING PROLENE SUTURES." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "AN INCISION AT THE MIDLINE, A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE PREPERITONEAL SPACE."

  Patient problems: Hernia

  MAUDE report 24844002 ↗
• InjuryMar 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, ¿A VERTICAL INCISION WAS MADE OVER THE PALPABLE MASS IN THE EPIGASTRIUM SUPERIOR TO THE UMBILICUS REGION. THE UNDERLYING PROTUBERANT CYSTIC STRUCTURE WAS IDENTIFIED AND REDUCED. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SECURED ON EITHER SIDE WITH SUTURES. UMBILICUS DEFECT WAS IDENTIFIED AND A CURVILINEAR INCISION WAS MADE. THE HERNIA WAS IDENTIFIED. A VENTRALEX MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ ON (B)(6) 2022, PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR. PER OP NOTES, ¿SMALL BOWEL WAS NOTED BE DISTENDED WITH MULTIPLE LOOPS OF SMALL BOWEL NOTED TO BE HYPEREMIC AND ADHERENT TO A PREVIOUS MESH (DEVICE 1 AND 2) IN THE ANTERIOR ABDOMINAL WALL. COLLAPSED SMALL BOWEL WAS NOTED DISTAL TO ONE OF THESE ADHESION POINTS. THE SMALL BOWEL WAS RELEASED FROM THE MESH AND ANTERIOR ABDOMINAL WALL. TWO POINT SEROSAL INJURIES WERE NOTED AND PRIMARILY REPAIRED WITH SUTURES.¿

  Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion

  MAUDE report 24710043 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH UMBILICAL AND EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). PER OP NOTES, ¿TWO HERNIAS WERE IDENTIFIED, UMBILICAL HERNIA AND EPIGASTRIC HERNIA. THE DEFECT WAS NOTED TO BE ABOVE THE UMBILICUS AND ONE IN THE RIGHT OF UMBILICUS. THE HERNIA SAC AND CONTENTS WERE EXCISED. THE VENTRAL HERNIAL DEFECT WAS REPAIRED WITH VENTRALEX MESH (DEVICE 1) AND EPIGASTRIC HERNIA WAS REPAIRED WITH VENTRALEX MESH (DEVICE 2). THE ORIGINAL DEFECT WAS ALSO CLOSED WITH MAYO TECHNIQUE¿ ON (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH SUPRAPUBIC RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH AND BIOLOGICAL MESH. PER OP NOTES, ¿THE RECURRENT DEFECT WAS NOTED TO BE BULGING. AN ELLIPTICAL INCISION WAS MADE ALONG THE OLD SUPRAPUBIC AND TOWARDS THE RIGHT SIDED INCISION. SCAR TISSUE WAS THEN EXCISED. THE HERNIA WAS IDENTIFIED. A SYNTHETIC MESH WAS PLACED IN THE INTRAPERITONEAL SPACE AND SECURED TO THE ANTERIOR ABDOMINAL WALL WITH SUTURES. A BIOLOGICAL MESH WAS THEN PLACED THROUGH THE TOP OF THE CONNECTIVE TISSUE AND SECURED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED

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

  MAUDE report 24481606 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO VENTRALEX MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿THERE WAS A SMALL DEFECT CAUDAL TO THE UMBILICUS IN THE MIDLINE AND ANOTHER LARGE DEFECT WITH INCARCERATED OMENTUM WAS NOTED AND REDUCED. A SMALL ADHESIONS TO HERNIA SAC WAS REDUCED AND DISSECTED FROM SUBCUTANEOUS TISSUES. THE HERNIA SACS WERE REDUCED AND MEDIUM VENTRALEX MESH (DEVICE 1) WAS PLACED OVER THE LARGE DEFECT AND SMALL VENTRALEX MESH (DEVICE 2) WERE PLACED OVER SMALL DEFECT AND FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENT LARGE VENTRAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESHES (DEVICE 1 AND 2) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿IN THE UPPER MIDLINE TO THE UMBILICUS, A PREVIOUSLY FAILED HERNIA REPAIR WAS ENCOUNTERED. IN THE REGION OF THE UMBILICUS AND INFERIOR TO THE UMBILICUS A RECURRENT HERNIA WAS REDUCED AND OLD MESHES (DEVICE 1 AND 2) WERE REMOVED AND DEFECT WAS CLOSED AND IRRIGATED WITH SUTURES. THE SYNTHETIC MESH WAS PLACED OVER THE FASCIA AND SUTU

  Patient problems: Hernia

  MAUDE report 24457452 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA WITH OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE OVER THE PERIUMBILICAL SITE. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE PERIUMBILICAL REGION AND SECURE IT WITH SUTURES. A VENTRALEX MESH (DEVICE 2) WAS PLACED INTO THE UPPER MIDLINE REGION AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH INCARCERATED BOWEL AND BOWEL OBSTRUCTION, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE 1 AND DEVICE 2) PARTIALLY AND IMPLANT OF VENTRALEX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE TO THE PRIOR INCISIONAL AREA. THE HERNIA SAC WAS DISSECTED OUT. THERE WAS DENSE NUMBER OF ADHESIONS AND OBSTRUCTION WHICH WERE TAKEN DOWN. PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1 AND DEVICE 2) WAS PARTIALLY REMOVED. A MEDIUM VENTRALEX MESH (DEVICE 3) WAS PLACED INTO THE PREPERITONEAL SPACE AND SECURE IT WITH SUTURES.¿

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

  MAUDE report 24337159 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OP NOTES, "A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY THROUGH THE LEFT UPPER QUADRANT INCISION. A SMALL VENTRALEX MESH (DEVICE 2) WAS SUTURED TO THE FASCIA." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND EVENTRATION OF PREVIOUS MESH THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX MESH (DEVICE 3). PER OP NOTES, "THE PREVIOUS HERNIA REPAIR OMENTUM WAS ADHERED TO THE UNDERSURFACE OF THE MESH. ADHESIOLYSIS WAS CARRIED OUT. A COMPOSIX MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL CAVITY USING TACKS." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PERIANAL ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF PERIANAL ABSCESS. PER OP NOTES, "THERE WAS ENTRANCE INTO THE ABSCESS CAVITY, THERE WAS RELEASE OF PURULENT FLUID." (B)(6) 2016 - PATIENT HAD PAIN AND MASS AT PREVIOUS VENTRAL HERNIA SITE THEREBY UNDERWENT REPAIR WITH REMOVAL OF ALL THE MESHES (DEVICE 1, 2 AND 3). PER OP NOTES, "FOUND TO BE DENSE ADHESIONS, SCAR TISSUE

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

  MAUDE report 24321005 ↗
• InjuryFeb 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 1). PER OP NOTES, ¿THE MIDLINE HERNIA WAS IDENTIFIED AND THE OMENTAL ADHESIONS GOING UP INTO THE HERNIA WERE REDUCED. THERE WAS ONE PORTION OF OLD MESH IN THE RIGHT LOWER QUADRANT AND LEFT UNDISSECTED. A SYMPTOMATIC PORTION OF OPEN HERNIA IN UPPER MIDLINE REGION WAS IDENTIFIED. A COMPOSIX L/P MESH (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED¿. (NOTE: THE OLD MESH SEEN DURING THIS PROCEDURE WAS UNKNOWN) (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED¿. (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL CAVITY. THERE WERE ADHESIONS NOTED WITH THE EDGES OF HERNIA AND WAS LYSED. A VENTRALEX ST MESH (DEVICE

  Patient problems: Adhesion(s); Erythema; Fistula; Hernia; Unspecified Infection

  MAUDE report 24267134 ↗
• InjuryJan 29, 2026Material Deformation

  AS PER ANSM REPORT ((B)(4)): DESCRIPTION OF INCIDENT: SINCE (B)(6) 2022, I HAVE BEEN LIVING IN HELL. IT STARTED ON (B)(6) 22 WHEN I HAD SURGERY FOR AN UMBILICAL HERNIA. THE SURGEON INSERTED A VENTRALEX PROSTHESIS, WHICH WAS POORLY FITTED AND BROKE IN MY PERITONEUM, CAUSING ME TO DEVELOP PERITONITIS. I HAVE HAD MULTIPLE OPERATIONS, AND THIS IS STILL THE CASE TODAY, THE LAST ONE BEING ON (B)(6) 25, BUT I AM STILL IN PAIN AND THERE HAS BEEN NO IMPROVEMENT. DATE OF OPERATION: (B)(6) 2025 CLINICAL HISTORY: 45-YEAR-OLD FEMALE PATIENT. SHE PRESENTS WITH A HERNIA THAT HAS BECOME BOTHERSOME. THERE IS A CLEAR INDICATION FOR HERNIA REPAIR. APPROACH: DIRECT APPROACH. LESIONS OBSERVED: A NOTE INDICATES A DOUBLE HERNIA AT THE UPPER PART OF THE SCAR. UPON OPENING THE HERNIAL NECK, AN INCARCERATED OMENTAL FRINGE IS OBSERVED AT THIS LEVEL, WHICH WILL BE RESECTED. THE NECK IS SUPRA-CENTIMETRIC, REQUIRING THE PLACEMENT OF A PROSTHESIS. PROCEDURE PERFORMED: RELEASE OF THE ANTERIOR APONEUROSIS OF THE RECTUS ABDOMINIS MUSCLES. DISSECTION OF THE HERNIAL NECK, WHICH IS OPENED. A FRINGE OF OMENTUM IS RELEASED AT THIS LEVEL, WHICH WILL BE RESECTED BY LIGATION AND SECTIONING WITH VICRYL 2/0 AND SENT FOR HIST

  Patient problems: Pain; Peritonitis

  MAUDE report 24211878 ↗
• InjuryDec 19, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1 AND 2). (NOTE: THERE ARE NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1 AND 2) AND IMPLANT OF PHASIX MESH (DEVICE 3). PER OP NOTES, ¿THE HERNIA SAC WAS ENCOUNTERED AND OPENED. THE INCARCERATED COLON ADHERENT TO SAC WAS REDUCED INTO ABDOMINAL CAVITY. THE HERNIA SAC WAS DISSECTED FREE AND REMOVED. THERE WERE TWO PRIOR MESHES (DEVICE 1 AND 2) NOTED CURLED UP ALMOST INTO BALL WERE EXCISED ENTIRELY. COMPONENT SEPARATION WAS PERFORMED. A PHASIX MESH (DEVICE 3) WAS PLACED AND SUTURED.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23848749 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, "AN INFRAUMBILICAL INCISION WAS MADE, A VENTRALEX ST MESH (DEVICE 1) WAS PLACED TO THE FASCIA USING PROLENE SUTURES." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, "THE MESH (DEVICE 1) HAD BEEN PULLED AWAY FROM THE FASCIA. A VENTRALEX MESH (DEVICE 2) WAS SECURED TO THE EXISTING MESH AS WELL AS THE FASCIA USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH PARTIAL REMOVAL OF MESH (DEVICE 1 AND 2), LYSIS OF ADHESIONS AND SMALL BOWEL RESECTION. PER OP NOTES, "AN INCISION WAS MADE IN THE SUPRAUMBILICAL REGION AND THE OLD SCAR EXCISED. REMOVED A PORTION OF THE MESH (DEVICE 1 AND 2)."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23786748 ↗
• InjuryNov 28, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2008 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISIONAL HERNIA AT THE MID TO UPPER PORTION OF HIS MIDLINE INCISION WAS DISSECTED. SAC WITH ADHESIONS WERE LYSED AND SMALL VENTRALEX MESH (DEVICE 1) WAS PLACED AND SUTURED TO THE FASCIAL DEFECT. ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND MIGRATED MESH THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SMALL VENTRALEX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISIONAL HERNIA JUST ABOVE THE PREVIOUS INCISION AND TWO SMALL INCISIONAL HERNIA JUST BENEATH THE PREVIOUS INCISION WAS NOTED. THE SAC WAS REDUCED, AND PART OF OLD MESH WAS SEEN PULLED AWAY FROM THE FASCIA. THE MESH WAS GRASPED AND SUTURED TO THE FASCIA AND DEFECT WAS CLOSED WITH SUTURES. ANOTHER DEFECT IN THE RIGHT AND LEFT SIDE WAS NOTED. ON THE RIGHT SIDE, THE DEFECT WAS REDUCED AND FASCIA WAS CLOSED WITH SUTURES. IN LEFT SIDE DEFECT, FASCIA WAS REMOVED AND SMALL VENTRALEX MESH (DEVICE 2) WAS SUTURED TO THE FASCIA AND OLD MESH. (DEVICE 1)¿. ON (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23670868 ↗
• InjuryAug 8, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND REDUCED. A SMALL VENTRALEX MESH (DEVICE #2) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED USING SUTURES.¿ ATTORNEY ALLEGES THAT PATIENT HAD NERVE DAMAGE, HERNIA RECURRENCE, ADHESIONS, PAIN, BOWEL REMOVAL, EMOTIONAL INJURIES. IT ALSO ALLEGED THAT THE PATIENT HAD CROHN¿S DISEASE AND MESH MIGRATION. NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THE COMPOSIX E/X (DEVICE #1) IMPLANTED ON (B)(6) 2006 IN PPF AND MEDICAL RECORDS.

  Patient problems: Adhesion(s); Hernia; Nerve Damage

  MAUDE report 22749044 ↗
• InjuryJul 30, 2025Migration; Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2004: PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1) AND VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. A COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED TO COVER THE DEFECT USING SUTURES AND VENTRALEX MESH (DEVICE #2) WAS PLACED TO CLOSE TROCAR INCISION USING SUTURES.¿ ON (B)(6) 2007: PATIENT HAD ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE #1, #2). PER OPERATIVE NOTES, ¿THE SMALL BOWEL ADHESIONS HAD BEEN TAKEN DOWN. THE MESH (DEVICE #1) WAS BENT AND HAD CREVICES. THE COMPOSIX KUGEL MESH (DEVICE #1) AND VENTRALEX MESH (DEVICE #2) ON LOWER QUADRANT WERE REMOVED COMPLETELY WHICH WAS DISTORTED AND PROTRUDING ANTERIORLY. A BIOLOGICAL MESH WAS USED TO REPAIR THE ABDOMINAL WALL.¿

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 22664226 ↗
• InjuryJul 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2002 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #1). PER OP NOTES, ¿THE HERNIA IN MIDLINE AND LOWER STERNOTOMY INCISION WAS NOTED. THE BARD FLAT MESH (DEVICE #1) WAS PLACED ON THE DEFECT AND SECURED USING SUTURES CIRCUMFERENTIALLY.¿ (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #2) AND VENTRALEX PATCH (DEVICE #3). PER OP NOTES, ¿RECURRENT HERNIA WAS JUST INFERIOR TO THE XIPHOID PROCESS WHICH HAD SOME INCARCERATED OMENTUM. A PIECE OF COMPOSIX E/X MESH (DEVICE #2) WAS PLACED WITHIN ABDOMEN AND TACKED. THE VENTRALEX PATCH (DEVICE #3) WAS PLACED THROUGH THE UMBILICAL DEFECT AND SECURED USING SUTURES.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT AND INCARCERATED INCISIONAL HERNIA AT EPIGASTRIUM THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE PARTIAL REMOVAL OF MESHES (DEVICE #1, 2). PER OP NOTES, ¿THE ADHESIONS AROUND UMBILICUS AND EPIGASTRIUM WERE TAKEN DOWN. THE LIVER WAS ALSO ADHERED TO THE PREVIOUS MESH (DEVICE #3) AND WAS FREED FROM

  Patient problems: Adhesion(s)

  MAUDE report 22458271 ↗
• InjuryJun 13, 2025Migration; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR WITH IMPLANT OF VENTRALEX HERNIA PATCH ON (B)(6) 2020. IT WAS ALLEGED THAT THE PATIENT HAD RECURRENT VENTRAL HERNIA AND DISPLACED MESH, THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS WITH REMOVAL OF MESH ON (B)(6) 2025. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS FALCIFORM, FAT AND OLD MESH ENTERING THE HERNIA. DUE TO THE LARGE VOLUME OF FAT, FALCIFORM, AND MESH NEEDED TO BE EXCISED, SURGEON ELECTED TO OPEN DIRECTLY OVER THE HERNIA SAC. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A VENTRALEX ST. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, ADHESION, DISABILITY, RECURRENCE AND CHRONIC PAIN. 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 22200992 ↗
• InjuryJun 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX E/X (DEVICE #1). PER OP NOTES, ¿A COMPOSIX E/X (DEVICE #1) WAS PLACED USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OP NOTES, ¿ADHESIONS TO THE SMALL BOWEL WERE TAKEN DOWN. A SMALL VENTRALEX MESH (DEVICE #2) WAS THEN PLACED TO THE FASCIA USING PROLENE SUTURES.¿ (NOTE: THE PREVIOUSLY PLACED COMPOSIX E/X (DEVICE #1) WAS NOT SEEN DURING THIS PROCEDURE). (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH FISTULA, BOWEL OBSTRUCTION & INFECTED MESH THEREBY UNDERWENT REMOVAL OF MESH (DEVICE #1 & #2). PER OP NOTES, ¿ROTTEN OLD MESH WITH MULTIPLE METALLIC TACKS WERE PRESENT IN THE ABDOMEN. THIS WAS REMOVED. THERE WERE SEVERAL AREAS OF SMALL BOWEL ADHERED TO THE MESH AND FISTULA SECTION OF THE TRANSVERSE COLON. SMALL BOWEL WAS RESECTED.¿

  Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 22160575 ↗
• InjuryApr 25, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS NOTED WITH INCARCERATED AND STRANGULATED OMENTUM, THERE WAS ALSO A KNUCKLE OF SMALL BOWEL THAT WAS OBSTRUCTED. A PIECE OF SMALL BOWEL WAS DUMPED INTO THE ABDOMINAL CAVITY FOR MOBILIZATION AND VENTRALEX MESH (DEVICE #1) WAS PLACED AS AN INLAY UNDERNEATH THE FASCIA AND STAPLED. ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, "A SMALL DEFECT WAS NOTED IN UMBILICUS. THE HERNIA SAC OVERLYING THIS WAS EXCISED AND LOOP OF SMALL BOWEL WAS FREED FROM SURROUNDING THIS AREA. AS THERE WAS NO PREVIOUS MESH IN THAT LOCATION, ANOTHER SMALL VENTRALEX MESH (DEVICE #2) WAS PLACED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #3). PER OPERATIVE NOTES, "MULTIPLE ADHESIONS OF SMALL BOWEL WERE TAKEN DOWN F

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21909108 ↗
• InjuryMar 28, 2025Defective Device; Patient-Device Incompatibility; Migration; Defective Device; Patient-Device Incompatibility; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX. 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); Insufficient Information; Pain

  MAUDE report 21719955 ↗