MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE SYNECOR PREPERITONEAL HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Purulent Discharge (1812); Fistula (1862); Seroma (2069); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 02/07/2019

Event Type  Injury  

Event Description

Gore synecor preperitoneal abdominal mesh used in the repair of a large ventral hernia.Started experiencing problems on day 1.Had purulent drainage in my drain that did not clear up.Drain was pulled about 3 weeks post op.Developed a seroma that burst through an older incision line in abdomen below navel.The date the seroma burst, imaging was done which stated findings were "highly suspicious" for a chronic mesh infection.Was started on antibiotics (doxycycline.) the wound still did not close.Experienced chronic drainage for over 2 years despite antibiotics and proper wound care.I have experienced chronic abdominal pain that has nearly destroyed my livelihood.Developed a fistula that was surgically excised in (b)(6) 2021, however the infection spread.I developed two additional seromas that burst through my navel and again through the incision below my navel.Insisted on infectious disease referral.Was started on rifampin which did not help the wound.Tried wound vac therapy which did not help.Eventually the mesh became visible to the naked eye.Sought other expert opinions who recommended the mesh be removed.Most of the gore synecor mesh was removed.Some remnants remain in my abdominal wall.Phasix was used in its place.Fda safety report id# (b)(4).

• Brand Name: GORE SYNECOR PREPERITONEAL HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 12407038
• MDR Text Key: 269658264
• Report Number: MW5103647
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 82