MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON, INC. ETHICON PROLENE MESH; MESH, SURGICAL, POLYMERIC

Device Problem Nonstandard Device (1420)

Patient Problems Autoimmune Disorder (1732); Pain (1994); Burning Sensation (2146)

Event Date 03/03/2017

Event Type  Injury  

Event Description

I am on disability due to chronic pain problems that originate from the prolene / goretex mesh system placed in my body for the repair of inguinal hernia bilaterally.I have had no problems before the mesh was put into my body with my legs or arms.After the mesh, i had constant pain where it was placed.My bowels began to slow down.I developed worsening pain syndromes like thoracic outlet syndrome.Piriformis syndrome, cubital tunnel syndrome, orchialgia, si joint pain, and autoimmune problems such as pots.As i write this, the mesh is burning, my left testicle is in pain traveling up into my stomach.This is all the result of mesh interacting with my body in an unnatural and unpredictable fashion.I will have to have repeated spermatic cord denervations to treat pain from testicles.In addition, i may have to remove testicle all together.I cannot flex my stomach, twist, or even use proper posture without intense pain in my stomach, sides, and hip.The chronic pain is not relieved by high doses of lyrica or nsaids.I believe these health conditions may have existed should i have never gotten mesh placed inside me, but the mesh has made them so bad, they all required surgery and/or have little to no treatment like piriformis syndrome and si joint pain.In addition, i have to take 600 mg of lyrica and muscle relaxers daily just to try and cope with the pain.I would also like to point out that during common radiology procedures such as ct scan, it has been proven mesh will contract which can open up new hernias or pull on embedded nerves.I believe strongly that medical sales should not dictate what surgeons can offer or what training they are provided.I cannot believe how much work is required to obtain mesh repair for those who need it.My only thought is that surgeons are all trained in the same way that mesh reduces recurrence rates and complications are kept to a minimum.I am here to tell you that complications are very seriously disabling, chronic, and it is possible that you may have to live with the implanted mesh the rest of your life.When no disclosure is ever made that the mesh is not safe to remove and/or due diligence is not performed by mfr.I would also like to ask the fda to no longer allow piggy backing of medical device approvals on top of other devices that have come before them.Every device is unique and should be treated as such when implanted in the body.I have had three hernia mesh placements with none of them reducing pain and/or preventing recurrent hernia for more than 6 months.I also had a recalled mesh implanted into me 5 months after it was recalled.Who is responsible for pulling recalled items off the shelves? does it even matter if other mesh lacks appropriate testing? i believe hernia mesh is just the tip of the ice berg and ask that more reporting is done to inform surgeons of the reality of mesh complications and the true rate of complications is reported by many to be as high as 25%.Remember, it could be your son or daughter who is the one suffering in chronic pain.Sin syndrome is real and we just don't know who will have problems from these implants.I am going to make an effort to have surgeon saw mesh so that it can be studied when it is removed.Please let me know where to send mesh sample for testing.Fda safety report id# (b)(4).

• Brand Name: ETHICON PROLENE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON, INC.
• MDR Report Key: 8699821
• MDR Text Key: 148402172
• Report Number: MW5087355
• Device Sequence Number: 2
• 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: 06/11/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 39 YR
• Patient Weight: 73