MAUDE Adverse Event Report: HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pain (1994); Hernia (2240); Ulcer (2274); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Constipation (3274)

Event Date 10/01/2009

Event Type  Injury  

Event Description

Had original hiatal hernia mesh implanted (b)(6) 2009 after 11 years of an internal bleeding.I had been getting it for infusions and blood transfusions.After years of weekly hosp stays medical treatments and medications, i traveled to (b)(6) in (b)(6).I had a paraesophageal hernia with 8 bleeding ulcers and a nissan fundoplication with mesh was preformed.Within 7 months i was in worse pain.I had ibs, hypertension, gerd, depression, anxiety, difficulty swallowing, headaches, eyes issues, fatigue, constipation, diarrhea, flu like symptoms, bloating gas, ingestion, sour stomach, bad breath.All drs felt that the bleeding had stopped with the mesh, so i no longer had any issues with the procedure done to treat the bleed.The pain grew worse year after year, week after week, and day by day, i wanted to die to get rid of all the new symptoms and diagnosis i "had developed." i had egds and colonoscopies done yearly.My gastroenterologist finally decided i needed to consult with a surgeon.I was referred to and consulted with 2-3 before anyone would discuss doing a revision.I had a revision done (b)(6) 2017.The surgeon told my family he did not find any mesh but i was full of adhesions.Adhesion removal took 4-hours of surgery.My liver and stomach had to be removed from the inside of my esophagus and stomach had to be tacked in place.I had developed a new hiatal hernia and new ulcers as well as the old hernia was inside my esophagus.While waiting for a dr to try and find the mesh issues, i also lost (b)(6).I was malnourished, lacked in vitamins.The surgeon in 2017 was only to place a linx but without permission, placed a new mesh and a linx.I am also needing to report i have still been having same problems and cannot swallow.I have developed gastroparesis since that surgery.No one can tell if it is from the mesh or the linx.I need both the previous mesh and the new mesh as well as the linx reviewed by the fda as the original mesh nor the linx were approved.

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 8041984
• MDR Text Key: 126555856
• Report Number: MW5081059
• 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: 10/31/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 50 YR
• Patient Weight: 77