VENTRALEX 5950007Recalls & reported problems

Summary

The FDA's MAUDE database contains 245 adverse event reports that list this exact device (DI 00801741031472), received between Apr 2, 2013 and Jul 28, 2026 — classified as 235 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Defective Device” (206 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 245 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:ON (b)(6) 2017 - Patient was diagnosed with incarcerated supraumbilical incisional hernia thereby underwent open repair with implant of Ventra Lex ST Mesh (Device 1). Per op notes, "A longitudinal incision was made in the midline above the umbilicus at the previous incision and palpable bulge. The defect in the fascia was noted with incarcerated fat and contents were reduced. A Ventra Lex ST Mesh (Device 1) was placed in the defect and secured with sutures."ON (b)(6)2019 - Patient was diagnosed with incarcerated upper abdominal incisional hernias and incarcerated umbilical hernia thereby underwent open repair with excision of Ventra Lex ST Mesh (Device 1) and implant of Ventra Lex ST Mesh (Device 3). Per op notes, "A longitudinal laparotomy incision was made in the upper midline abdominal area at the previous scar site. The hernias were identified. Multiple Swiss cheese like hernias were noted in multiple quadrants of the abdomen at-least four to five. The Ventra Lex ST Mesh (Device 1) was excised. The incarcerated fat was also dissected and removed. An incarcerated umbilical hernia was identified and repaired with sutures. A Ventra Lex ST Mesh (Device 3) w

  Patient problems: Hernia

  MAUDE report 50050306 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "INCISION TO THE UMBILICUS, A LARGE PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE DEFECT USING PROLENE SUTURES." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 2). PER OP NOTES, "THE PREVIOUSLY PLACED MESH (DEVICE 1) WAS PALPABLE. IT WAS DISSECTED FREE, EXTRACTED AND DISCARDED. A SMALL COMPOSIX KUGEL MESH (DEVICE 2) WAS PLACED INTO THE SUBFASCIAL POSITION WITH PROLENE SUTURES." (B)(6) 2013 - PATIENT AS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESH (DEVICE 2). PER OP NOTES, "THE PREVIOUSLY PLACED MESH (DEVICE 2) WAS REMOVED. THEN A SYNTHETIC MESH WAS PLACED TO THE ABDOMEN." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO VENTRALEX ST MESHES (DEVICE 3 AND DEVICE 4). PER OP NOTES, "ATTENTION TO THE RIGHT MID ABDOMEN, A MEDIUMVENTRALEX ST MESH (DEVICE 3

  Patient problems: Hernia

  MAUDE report 25364462 ↗
• InjuryJun 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, "DIRECT RIGHT INGUINAL HERNIA WAS NOTED. A BARD FLAT MESH (DEVICE 1) WAS PLACED INTO THE FLOOR OF CANAL OF INGUINAL CANAL SUPERIOR TO EPIGASTRIC VESSELS AND PUBIC TUBERCLE USING SUTURES." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, "A LARGE DEFECT WAS NOTED JUST MEDIAL TO THE INTERNAL RING. A BARD FLAT MESH (DEVICE 2) WAS PLACED OVER THE FLOOR OF INGUINAL CANAL AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE BARD FLAT MESH (DEVICE 3). PER OP NOTES, "THE RIGHT-SIDED LAPAROSCOPIC INGUINAL HERNIA REPAIR WAS INTACT. ON LEFT, DIRECT INGUINAL HERNIA WAS IDENTIFIED. A BARD FLAT MESH (DEVICE 3) WAS PLACED IN THE ABDOMEN WITHIN THE PREPERITONEAL SPACE. A SYNTHETIC MESH WAS SITUATED IN PLACE AND PERITONEUM AND CLOSED OVERUSING TACKS." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT LE

  Patient problems: Hernia

  MAUDE report 25359367 ↗
• InjuryMay 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE OVER THE DEFECT IN THE UPPER ABDOMEN. THE VENTRAL HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO POSTERIOR TO THE FASCIA. THE FASCIA WAS CLOSED WITH SUTURES. A TRANSVERSE INCISION WAS MADE JUST INFERIOR TO THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED AROUND THE UMBILICUS AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC WOUND UPPER ABDOMEN WITH INFECTED SUTURES AND MESH; INFLAMMATION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 1 AND DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE AROUND THE PRIOR WOUND. ALL INFLAMMATORY TISSUES WERE TAKEN DOWN. PREVIOUSLY PLACED INFECTED MESH (DEVICE 1 AND 2) WAS EXCISED ENTIRELY. THE DEFECT WAS CLOSED WITH SUTURES PRIMARILY.¿

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25154242 ↗
• MalfunctionMay 8, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING INSPECTION, IT WAS DISCOVERED THAT A FOREIGN MATERIAL (HAIR) WAS PRESENT IN THE OUTER PACKAGING OF THE VENTRALEX ST MESH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121941 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility

  PER LEGAL COMPLAINT: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR WITH IMPLANT OF VENTRALEX ST MESH ON (B)(6) 2022. IT WAS ALLEGED THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL INTERVENTION FOR ABDOMINAL PAIN, DURING WHICH AN OPEN INCARCERATED RECURRENT VENTRAL HERNIA REPAIR WAS PERFORMED. THE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE VENTRALEX ST MESH AND IMPLANTATION OF PHASIX MESH ON (B)(6) 2024. ATTORNEYS ALLEGES THAT THE PATIENT EXPERIENCING ADDITIONAL SURGICAL INTERVENTION, RECURRENCE, PAIN WHICH HAVE IMPAIRED DAILY ACTIVITIES. 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: Abdominal Pain; Hernia

  MAUDE report 24567901 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012: PATIENT WAS DIAGNOSED WITH 2 VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 1). PER OP NOTES, ¿PREVIOUS INCISION WAS REOPENED IN UMBILICUS. THE HERNIA SAC WAS OPENED AND ADHESIONS WERE TAKEN DOWN. THE DEFECT WAS REPAIRED WITH SUTURES. ANOTHER HERNIA DEFECT WAS NOTED ON LEFT LOWER QUADRANT. THE SAC WAS OPENED AND ADHESIONS WERE LYSED. A VENTRALEX ST (DEVICE 1) WAS PLACED ON LLQ AND SUTURED.¿ (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT TWO VENTRAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 2 AND 3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND FREED BACK AT THE LEVEL OF FASCIA. EXCESS SAC WAS EXCISED. ADHESIONS OF BOTH PRIOR INCISION SITES WERE LYSED. BOTH DEFECTS WERE NOTED. TWO VENTRALEX ST (DEVICE 2 AND 3) NEAR UMBILICUS AND LLQ WERE PLACED ON BOTH DEFECTS INTRAPERITONEALLY AND SUTURED.¿ (B)(6) 2014: PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE VENTRAL INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE 1,2 AND 3) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿SIGNIFICANT ADHESIONS WERE NOTED IN ABDOMINAL WALL WAS LYSED. SW

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24483442 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016- PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA, LEFT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1), 3DMAX MESH (DEVICE 2). PER OP NOTES, ¿A VENTRAL HERNIA IN ABDOMINAL REGION WAS IDENTIFIED AND DISSECTED. A VENTRALIGHT ST USING ECHO PS (DEVICE 1) WAS PLACED INTRA-ABDOMINALLY WAS PLACED IN DOUBLE CROWN TECHNIQUE. THE HERNIA SAC IN LEFT INGUINAL REGION WAS REPAIRED BY PLACING A 3DMAX MESH (DEVICE 2) AND SUTURED¿. (B)(6) 2016- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿OMENTUM IN THE LEFT UPPER QUADRANT WAS REDUCED. THERE WAS NO EVIDENCE OF ADHESION OR OBSTRUCTION. A SMALL VENTRALEX ST MESH WAS PLACED AND TACKED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE 1), VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿THE ADHESIONS IN THE ABDOMINAL REGION WAS TAKEN DOWN ALONG WITH THE PORTION OF MESH (DEVICE 1 AND 3)¿.

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

  MAUDE report 24469190 ↗
• InjuryFeb 12, 2026Migration

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA (X3) THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALEX ST MESH (DEVICE 1 AND 2) AND VENTRIO ST MESH (DEVICE 3). PER OP NOTES, "A VENTRALEX ST PATCH (DEVICE 1) WAS PLACED WITHIN THE ABDOMINAL CAVITY. ATTENTION ON THE UMBILICAL HERNIA, A VENTRALEX ST MESH (DEVICE 2) AND VENTRIO ST MESH (DEVICE 3) BOTH WERE PLACED THROUGH THE UMBILICAL INCISION." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD PIECE OF MESH (DEVICE 1, 2 AND 3). PER OP NOTES, "ENCOUNTERED A SAC WHICH WAS DISSECTED FREE BACK TO THE AREA OF THE MESH THAT HAD PULLED AWAY FROM THE FASCIA. TAKEN DOWN THE ADHESIONS FROM THE UNDERSURFACE OF THE MESH AND THEN REMOVE THIS OLD PIECE OF MESH (DEVICE 1, 2 AND 3). THEN PLACED AN UNKNOWN ONLAY MESH OF MARLEX." ON (B)(6) 2013 - PATIENT HAD HEMATOMA THEREBY UNDERWENT EVACUATION OF ABDOMINAL WALL HEMATOMA. PER OP NOTES, "PATIENT HAD A HEMATOMA OVERLYING THE MESH, EVACUATED THE HEMATOMA."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24321412 ↗
• InjuryDec 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LOWER ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3) AND EXPLANT OF SYNTHETIC MESH AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE THROUGH THE PREVIOUSLY MARKED AREA. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED SYNTHETIC MESH AND VENTRALEX ST MESH (DEVICE 2) WAS REMOVED ENTIRELY. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE PREPERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 3) AND PRIMARY CLOSER OF ABDOMINAL WALL

  Patient problems: Hernia; Pain

  MAUDE report 23901566 ↗
• InjuryDec 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LOWER ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT ABDOMINAL WALL HERNIA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3) AND EXPLANT OF SYNTHETIC MESH AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE THROUGH THE PREVIOUSLY MARKED AREA. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED SYNTHETIC MESH AND VENTRALEX ST MESH (DEVICE 2) WAS REMOVED ENTIRELY. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE PREPERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 3) AND PRIMARY CLOSER OF ABDOMINAL WALL

  Patient problems: Pain

  MAUDE report 23897317 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL, VENTRAL HERNIA, LARGE RIGHT INGUINAL HERNIA AND SMALL LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL PATCH (RIGHT - DEVICE 1), KUGEL PATCH (LEFT ¿ DEVICE 2) AND VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿ON THE RIGHT SIDE, POSTERIOR FASCIA WAS OPENED, AND A MODERATE-SIZED DIRECT HERNIA MASS WAS REDUCED. A SMALL OVAL KUGEL PATCH (RIGHT ¿ DEVICE 1) WAS CONTOURED TO THE ABDOMINAL CONTENT. ON THE LEFT SIDE, A DIRECT HERNIA WAS IDENTIFIED. A SMALL OVAL KUGEL PATCH (LEFT - DEVICE 2) WAS CONTOURED TO THE ABDOMINAL CONTENT. THE WOUND WAS CLOSED. ON THE VENTRAL UMBILICAL HERNIA, A VENTRALEX ST MESH (DEVICE 3) WAS PLACED POSTERIORLY, AND THE FASCIA WAS CLOSED USING SUTURES." ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH PERFORATED DIVERTICULITIS THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THERE WAS AN EXTREMELY LARGE MESENTERIC ABSCESS NOTED. IN THE MIDLINE, WHERE THE ANTERIOR ABDOMINAL WALL MESH WAS SEEN. THE VENTRALEX ST MESH (DEVICE 3) WAS IDENTIFIED AND REMOVED.¿ ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH BIL

  Patient problems: Abscess

  MAUDE report 23788636 ↗
• InjuryOct 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALEX ST MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿A PALPABLE HERNIA IN THE SUPERIOR ASPECT OF THE ABDOMEN WAS REDUCED AND VENTRALEX ST MESH (DEVICE 1) WAS PLACED. SEVERAL SMALL ADHESIONS TO EDGE OF HERNIA WAS LYSED. A SEPARATE INFERIOR VENTRAL HERNIA WITH SAC WAS REDUCED AND SMALL VENTRALEX ST (DEVICE 2) WAS PLACED AND SUTURED IN PLACE.¿ 2017- PRESENT ¿ PATIENT HAD SEVERE PAIN DUE TO MESH AND HAD TO UNDERGO ADDITIONAL SURGERY DUE TO MESH DEFECT AND FAILURE ALSO ATTORNEY ALLEGED THAT PATIENT HAD HERNIA RECURRENCE, ADHESION, PAIN.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 23366112 ↗
• InjuryAug 5, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. THE SAC WAS OPENED, AND THE OMENTUM WAS REDUCED. THE SAC WAS REDUCED. THE OLD MESH WAS IDENTIFIED NEAR OMENTUM. A VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED.¿ (NOTE: THE OLD MESH MENTIONED IN THIS PROCEDURE WAS UNKNOWN) ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #2). PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1) WAS FINE AND INTACT. THE HERNIA SAC WAS IDENTIFIED LATERAL LEFT SIDE OF PRIOR MESH. THE SAC CONTAINS PERITONEAL FAT. THE FAT AND HERNIA SAC WERE REDUCED. A VENTRALEX ST (DEVICE #2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA WITH PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE #3). PER OP NOTES, ¿THE OMENTAL ADHESIONS WERE TAKEN DOWN. THE TWO PIECES OF MESH (DEVICE #1 AND #2) WERE IDENTIFIED AND APPEARED TO BE WADDED. BOTH MESHES (DEVICE #1 AND #2) ADHERENT TO OMENTUM W

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 22713666 ↗
• InjuryJun 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OP NOTES, "A VENTRALEX MESH (DEVICE #1) WAS PLACED AND SUTURED." ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH ADHESIONS, RIGHT ADNEXAL PAIN THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS. ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT PERIUMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OP NOTES, "A VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SUTURED." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH SIGMOID DIVERTICULITIS WITH MICRO PERFORATION THEREBY UNDERWENT REMOVAL OF OLD MESH (DEVICE #1 & #2). PER OP NOTES, "ADHESIONS WERE TAKEN DOWN. THE FOLDED MESHES (DEVICE #1 & #2) WERE REMOVED." ON (B)(6) 2019 - PATIENT DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #3). PER OP NOTES, "LYSIS OF ADHESIONS WAS PREFORMED AND A VENTRALIGHT ST MESH (DEVICE #3) WAS PLACED AND SUTURED

  Patient problems: Adhesion(s); Bowel Perforation

  MAUDE report 22338375 ↗
• InjuryJun 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH IMPLANT OF VENTRALEX ST ON (B)(6) 2022. IT WAS ALLEGED THAT THE PATIENT HAD CLINICAL SIGNS OF INFECTION INCLUDING A NON-HEALING UMBILICAL WOUND, PERSISTENT YELLOW/GREEN DRAINAGE, MALODOROUS DRAINAGE, IMAGING WITH PHLEGMON/ ABSCESS, EXPOSED MESH FROM UMBILICAL INCISION SITE AND REMOVAL OF MESH ON (B)(6) 2022. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH A VENTRALIGHT ST MESH. DUE TO THE MESH BEING IMPROPERLY PLACED IN A CONTAMINATED FIELD, THIS REVISION SURGERY WAS FURTHER COMPLICATED BY NONHEALING, DRAINING WOUND, POST OPERATIVE ABSCESS WITH MYOSITIS NECESSITATING DRAIN PLACEMENT, CULTURES WITH STAPH, DIPHTHEROID NECESSITATING ANTIBIOTIC THERAPY AND REMOVAL OF MESH ON (B)(6) 2023. DUE TO UNINCORPORATED MESH AND MESH INFECTION WITH MYCOBACTERIUM FORTUITUM MAKING FURTHER ANTIBIOTIC THERAPY NECESSARY. 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

  Patient problems: Abscess; Impaired Healing; Unspecified Infection

  MAUDE report 22209722 ↗
• InjuryMar 11, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  PER LEGAL CLAIM: CASE # (B)(4). ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALEX ST MESH ON (B)(6)2019. ALLEGED, THAT THE PATIENT DEVELOPED RECURRENT INCARCERATED PERIUMBILICAL HERNIA AND THEREBY UNDERWENT ADDITIONAL SURGICAL INTERVENTION ON (B)(6)2023. IT WAS ALLEGED THAT THE OMENTUM ADHERENT TO THE PRIOR PLACED PIECE OF MESH WAS NOTED, ADHESIONS WERE TAKEN DOWN USING SHARP DISSECTION AND THE MESH WAS EXPLANTED. 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 ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 21571789 ↗
• MalfunctionFeb 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE PROCEDURE CONDUCTED WAS AN OPEN UMBILICAL HERNIA REPAIR, DURING WHICH THE MESH WAS HYDRATED FOR A DURATION OF 5 TO 15 SECONDS. FOLLOWING HYDRATION, THE SURGEON ATTEMPTED TO POSITION THE SUTURES AFTER THE MESH HAD BEEN INSERTED THROUGH THE DEFECT INTO THE ABDOMINAL CAVITY, THE MESH TORE WHILE PLACING THE SUTURE AND COULD NOT BE FIXATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461325 ↗
• InjuryJun 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH A VENTRALEX ST MESH ON (B)(6) 2019. ABOUT A YEAR POST IMPLANT THE PATIENT STARTED TO EXPERIENCED PAIN, PULLING SENSATION AND SWELLING. THE PAIN IS REPORTED TO BE PRESENT WHILE LEANING FORWARD, GETTING IN BATH, PUTTING SOCKS ON, LAYING DOWN, GOING TO TOILET, PAIN IN AREA ALL THE TIME, AND SWELLING AROUND THE AREA WHERE THE MESH WAS IMPLANTED. REPORTEDLY THE PATIENT WAS REFERRED FOR SURGERY AND IS CURRENTLY ON A WAITING LIST TO HAVE THE SURGERY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19632142 ↗
• MalfunctionJun 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR ON (B)(6) 2024, WHILE OPENING THE STERILE PACKAGING, SURGICAL TECHNOLOGIST NOTED THAT INSIDE THE FOLDS OF THE WHITE WRAP (OVER THE MESH) HAD A SMALL HAIR. IT WAS REPORTED THAT THE MESH WAS NOT IMPLANTED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527304 ↗
• MalfunctionMay 22, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A PROCEDURE, A HAIR WAS FOUND INSIDE THE VENTRALEX ST MESH UPON OPENING THE STERILE PACKAGING. NO DAMAGE ON THE OUTER PACKAGE WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A NEW MESH AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373764 ↗
• InjuryMay 9, 2024Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX AND BARD SOFT MESH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALEX WHICH WAS IMPLANTED ON (B)(6) 2020. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. 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: Hernia; Insufficient Information; Pain

  MAUDE report 19276480 ↗
• InjuryApr 30, 2024Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A VENTRALEX MESH. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿A SUPRAUMBILICAL CURVILINEAR INCISION WAS MADE ABOVE THE TRUE UMBILICAL HERNIA, THE HERNIA SAC WAS REDUCED. A VENTRALEX ST MESH WAS INSERTED TO A 2 CM DEFECT AND SUTURED.¿ (B)(6) 2021 - PATIENT VISITED HOSPITAL FOR MESH PROTRUDING ON ONE SIDE OF HIS ABDOMEN TO THE EXTENT THAT HAS TO CUT OFF THE EDGES. THERE ARE NO BOWEL SYMPTOMS, LUMPS OR SWELLING. (B)(6) 2021 - PATIENT VISITED HOSPITAL WITH MESH PROTRUSION. THERE IS NO EVIDENCE OF RECURRENCE BUT CAN FEEL BITS OF THE MESH COMING OUT OF HIS SCAR AND REMAINS SYMPTOMATIC.

  Patient problems: Erosion; Insufficient Information; Scar Tissue

  MAUDE report 19211385 ↗
• InjuryApr 3, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ST PATCH ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX ST PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Pain; Unspecified Infection

  MAUDE report 19030031 ↗
• InjuryMar 6, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ST PATCH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALEX ST PATCH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 18846110 ↗