MAUDE Adverse Event Report: ETHICON, INC. MESH ULTRAPRO 3X6 UMR3; MESH, SURGICAL,POLYMERIC

Lot Number JB8BJWA0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Hair Loss (1877); Inflammation (1932); Neuropathy (1983); Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Date 09/21/2016

Event Type  Injury  

Event Description

I ((b)(6)) had left inguinal hernia repair surgery on (b)(6) 2016 at (b)(6) hospital in (b)(6).The surgeon implanted a surgical mesh to repair it, and i have had health complications ever since.I have been, and currently are under the care of a neurologist at (b)(6).Ever since the surgery and recovery period of the surgery, i have had chromic pain throughout my entire pelvis, groin, and genital area.During the recovery process, i thought this was normal, until (b)(6) when all of the hair on my legs (from the knees to feet) fell out.At this same time is when i began feeling intense burning pain in both of my calves and forearms, (the hair did not fall out of my forearms).I went back to the surgeon's office ((b)(6)) and the surgeon told me the pain in the pelvis was a normal part of recovery, but did not have an answer of the symptoms in my legs and arms.The surgeon then gave me a steroid injection in my pelvis which seemed to numb my pelvis for the rest of the day, but the pelvic pain returned that night.It was perhaps a week or so later that the burning pain in my legs and arms became so intense that i went to my gp who gave me a script (lyrica, gabapentin) and sent me to a rheumatologist, who did some blood test (with no findings) and sent me to an endocrinologist, who did more blood work (with no findings) and they sent me to the specialist/neurologist at (b)(6).After explaining the surgery and my symptoms to him, he changed my medication to alleviate the burning pain and ordered multiple blood test (no findings) and then after examining my legs and arms a skin biopsy which revealed i had small fiber neuropathy (idiopathic) which was causing all the burning pain.At that point, and over the next several months he continued to order more test which produced no results or indications on what was causing this idiopathic small fiber neuropathy, he ordered genetic testing done, but again the genetic testing offered no answers.During the past two years while under his care i have additionally developed painful autoimmune symptoms throughout my entire body (all joints, inflamed, minor swelling, etc.) these new symptoms were only successfully controlled with large doses of prednisone.My neurologist has sent me to two different rheumatologist since the onset of the new symptoms, but they could not find any positive indication on their blood work, that would suggest i have any of the common autoimmune diseases.All through my care with (b)(6), i kept on asking if all of these symptoms could be related to the hernia mesh that was implanted, and the answer was "probably not " and "it would be very hard to prove".It wasn¿t until just recently that i re-asked the question to my neurologist (because we have no more tests to conduct) that he said the possibility exists that all of this is related to the surgical mesh, my neurologist has since sent me to a surgeon about replacing the mesh, and the surgeon told me that i would most likely be worse off to have it replaced and that he would not perform the surgery.So, now i am trying to symptomatically treat everything and live a semi-normal life.

• Brand Name: MESH ULTRAPRO 3X6 UMR3
• Type of Device: MESH, SURGICAL,POLYMERIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 8252878
• MDR Text Key: 133374753
• Report Number: MW5083121
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Lot Number: JB8BJWA0
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 93