MAUDE Adverse Event Report: ETHICON PROLENE MESH (PMH); MESH, SURGICAL, POLYMERIC

Lot Number XJP231

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Emotional Changes (1831); Itching Sensation (1943); Pain (1994); Swelling (2091); Tissue Damage (2104); Ambulation Difficulties (2544)

Event Date 10/11/2007

Event Type  Injury  

Event Description

On (b)(6) 2007, prolene mesh was initially used in my son's urgent bilateral inguinal hernia repair at (b)(6).Thereafter, 2 more surgeries were done on the left in an attempt to correct several resulting problems including extreme pain, itching and limited mobility.In the second surgery, done at community hospital on (b)(6) 2008.A limited probe was made and protacs were removed that had been placed in nerves.It was believed that another surgery might be needed to dissect the nerve and probe further.My son had no relief.In the third surgery, the mesh had migrated to the upper left quadrant of the abdomen and more protacs were found in nerves and removed.An attempt was made to remove the mesh and damage to the area was becoming a problem, so that was abandoned and another mesh was placed.Meanwhile a nerve was dissected.The third surgery was a benevolent procedure and the "phs" mesh was donated.No label was recorded.We assume that this is an acronym for the same type of prolene mesh he had originally received.The final result was that the third mesh did not work.My son now has problems with protrusions that throw him on the floor leaving him in severe pain, as if he is racked, until ice can be applied and the swelling goes down.He is then able to push everything back in.He is a wreck and in bed for the next several days.The un-removed mesh cuts into him with movement and is dangerously close to vital structures.His left side is deteriorating, electing his ability to function.His abdomen, neck, back.Shoulders, legs.Immune system, mind, sleep, etc.Are all effected.He is a mess.The doctor tells him that another surgery could be performed, but there is a 50 percent chance that he won't be able to walk again.We have tried to get 2nd opinions, but no one is willing to touch him.He is now permanently disabled according to social security, angry and suffering from mental anguish, immense pain and limited motion.He needs lots of help everyday.He is tormented by the fact that this could be the day he dies.His family is suffering almost as much as he is.He is scared to death of doctors now and it is only by the grâce of god that he still exists.He has tried to avoid taking adequate pain pills so that he won't become addicted, struggled with the fact that they were causing him trouble, and finally while knuckled it and gave up on them.He also couldn't get rides to the doctor's office on time.They were 40 miles away and he could not drive himself every other week and they didn't have the money for the trip.We are still concerned that there are more protacs through nerves that were not removed.As a result, my son will not submit to scans for fear of burning his insides.I have all the records of his admissions, doctor visits and procedures.The lab data involves pathology for the identification of the nerves.The eval of the pain and localization for the 2nd surgery is largely part of the doctors and surgical records.The typical preliminary blood tests were done and show little reason for concern.His trip to urgent care shows symptoms common to others having mesh issues, but does not tie them to the event (of course).Trips to the er after protrusion experiences were assumed to be solely for gaining access to pain meds.We were appalled.I don't have those records.He went to a neurologist a pain specialist and a general surgeon.

• Brand Name: PROLENE MESH (PMH)
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6399121
• MDR Text Key: 69905395
• Report Number: MW5068408
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/09/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: XJP231
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADVIL PM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 27 YR
• Patient Weight: 82