MAUDE Adverse Event Report: BARD VENTRALEX HERNIA PATCH

Model Number 0010302

Device Problems Entrapment of Device (1212); Folded (2630); Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Disability (2371); Ambulation Difficulties (2544); Claudication (2550); Alteration In Body Temperature (2682); No Code Available (3191)

Event Date 06/25/2009

Event Type  Injury  

Event Description

I was implanted in 2009 with c.R.Bard ventralex mesh patch to repair a hernia and my recovery period lasted between 5-6 months.Between 2010-2011, i was able to resume normal activity.At the end of 2011, i began to experience discomfort at the site of my mesh implant.The site was consistently tender and warm to touch, i experience severe pain when physically active, i would experience muscle spasms attributed to specific movements, and i began to have intestinal problems.I began to decrease normal activity to avoid pain.In 2012, i experienced extreme pain in abdomen and unable to have regular bowel movements due to pain i experienced at the site of implant when attempting bowel movements.I began to lose time at work.In 2012, i saw a physician regarding abdominal pain after x-ray i was prescribed with barium to relieve my body of a large amount of waste.In 2013, i was unable to comfortably extend my arms over my head, legs, twist, push, and pull.This limited by ability to work, shower, drive, exercise, have intercourse, and interact with my children.I began to experience loss of mobility of my right leg.The implant was placed on my right lower abdomen.I was unable to lift my right leg, i was forced to drag my leg after about 10 minutes of walking.In (b)(6) of 2013, i went in for an unrelated umbilical hernia procedure and surgeon found that the ventralex patch that was implanted by a prior surgeon had formed adhesion and had coiled.After repairing the umbilical with mesh i have experienced no complications at that site of repair.The surgeon also cut away the adhesion and adjusted the ventralex mesh patch.My recovery time was close to 6 months.Between (b)(6) 2013, my health spiraled out control.I was unable to work more than 3 days in a row without calling in due to stabbing pain at the site of patch.This pain was severe and would cause me to double over and lay in the fetal position to find relief.I was unable to stand upright.I was being reprimand at work for attendance.I could no longer, stand upright, i walked hunched over, i loss use of right leg, i walked with limp, i could not have regular bowel movements, i'd get sudden stabbing pain at site of implant, could not lift, push or pull anything.I struggled when attempting to sit and stand.This required assistance from family.I became a hermit and rarely left home because all movement was painful.In (b)(6) of 2013, i was at my wits end and went to see a surgeon.After ct scan, it was discovered that the ventralex mesh patch had completely formed into a ball that was connected to muscle and nerves on my right lower region.An ex-plantation was scheduled for (b)(6) 2013.The ventralex mesh was sent to pathology and was found to have transformed into bone in my abdomen, thus the pain that i was enduring.My recovery period lasted about 6 weeks consequently, i returned to work.To present, i have not experienced any of the symptoms that i had over the past few years.I feel 100% cured after the mesh patch was removed.I have lasting emotional scarring.I became disconnected and estranged to my family and friends due to pain and inability to participate as a functional parent, wife, friend.

• Brand Name: VENTRALEX HERNIA PATCH
• Type of Device: VENTRALEX HERNIA PATCH
• Manufacturer (Section D): BARD
• MDR Report Key: 3784067
• MDR Text Key: 15996402
• Report Number: MW5035845
• 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
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 0010302
• Device Lot Number: HUTC1375
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 118