MAUDE Adverse Event Report: ETHICON INC. PROCEED HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Hematoma (1884); Itching Sensation (1943); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Seroma (2069); Tissue Damage (2104); Vomiting (2144); Impaired Healing (2378); Sleep Dysfunction (2517); Bowel Perforation (2668)

Event Date 01/13/2012

Event Type  Injury  

Event Description

I am so pissed off about this hernia mesh that was implanted in me by laparoscopic surgery on (b)(6) 2011.Thought i would get better.Had to stop exercising.Was having all kinds of problems that got really bad last year.Couldn't hold anything down on stomach.I am constantly nauseated, vomiting almost everything i eat back up.Have to take pills for it daily.Wake up in pain, pain all day.Sometimes it wakes me up.Medication doesn't help.No doctors want to touch me.Doctor that put it in is no longer in the (b)(6) network, so if no special approval he wants all of his fees upfront.I'm on a fixed income.So they tell me they can only go back in and remove the scar tissue and adhesions.Barely made it out of (b)(6) 2016 surgery.Got a severe bacterial infection that was melting my skin on vagina and left arm area.Itching like some dog with flees.Had to have a 3pt blood transfusion.Got a hematoma and an abscess.Then read on the (b)(6) law firms website where the fda continues to approve untested hernia mesh products, which benefits the medical device mfrs and hurts the general public.Their investigation has revealed that the hernia mesh mfrs know of the life-threatening complications their products can cause but they don't adequately warn the public or surgeons.It adheres to abdominal tissue and muscles that have to be removed with it.I have to hold on to my vanity every time i have a bowel movement loose or not.More than sure the uncontrollable muscle spasms that i have (that my doctor have to grab and hold sometimes to do my trigger point injections) are coming from the coating(s) the mfrs coat the polypropylene with.This coating was intended to be absorbed by the body over a period of months to yrs, but due to the complications that polypropylene was causing when it came in direct contact with the bowel.The demand for composite hernia mesh skyrocketed, selling for 15-20 times more than an uncoated polypropylene mesh.When one type of mesh caused too many side effects, the company would simply quit mfg that particular mesh.I have most and sometimes all of the complications being investigated.Infection, adhesions, seroma and abscess development, fistulas, protrusion, non-healing wounds, and bowel perforation.Most of these complications can be life threatening or lead to permanent disability.New info shows that chronic infection from hernia mesh may cause dental infections which in turn leads to crumbling and breaking of the teeth which i have now.I just can't believe that you allow something this dangerous to get loose on the unk public.My infection was so bad that they wanted to insert a tube to drain it.The infectious disease doctor said putting the tube in would cause the infection to spread and i would have been dead within 2 wks.I would have let them insert it if my doctor had said i needed it but thank god he fixed it so he was out of town on vacation.My pain is so bad that i'm not even able to have intercourse any more can't let my grandson run into my arms.Have to stand back from sink to wash my dishes, can't participate in many physical activities me and my grandsons used to do."what kind of quality of life have been left within what if i need long term care who will pay for that.What are a few dollars compared to what has been taken from me." it's not right nor fair and i'm not going to be quiet until this travesty has been corrected and everyone knows about it.

• Brand Name: PROCEED HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.
• MDR Report Key: 6879574
• MDR Text Key: 87048811
• Report Number: MW5072246
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Weight: 71