MAUDE Adverse Event Report: JOHNSON AND JOHNSON GYNECARE MESH

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Depression (2361); Disability (2371); Fungal Infection (2419); Weight Changes (2607); Intermenstrual Bleeding (2665); No Code Available (3191); Constipation (3274)

Event Date 02/06/2015

Event Type  Injury  

Event Description

Implanted with gynecare pelvic mesh in 3 places, bladder sling, anterior and posterior in 2006.Protrusion was noticed within 6-8 weeks post op.I now have much worsened gynecare mesh erosion with mesh shrinkage causing bleeding, yeast infections, bladder pain with difficult urination, constipation, pain extending from r side abdomen to ankle.Vaginal burning and inability to have intercourse with spouse.Ongoing orthopedic muscle and leg pain that has required 3 different surgical procedures for overuse issues from tightened pelvic and hip muscles.Additionally a sphincterotomy was performed to allow for regular bowel movements 2 years ago that has now stopped performing well due to newer pelvic symptoms.Have had several rounds of pt, multiple health and orthopedic tests where no diagnosis was found.I was being informed by physician who implanted gynecare mesh for prolapse issues that my mesh was stable for 9 years, telling me other problems must exist not associated with mesh.She maintained my problems must be related to post hyst bladder symptoms.She told me my yellow discharge was from mesh and did not follow up with tests for yeast until i examined myself and found green and white material on my latex glove.She then did yeast test which was positive and has been ongoing with treatment failing to resolve it.When i asked for specific information regarding how to handle my mesh complications, she advised she could cut it in operating room.She also advised me to use vaginal estrogen cream to cover mesh over with tissue, but this has failed to happen.Ongoing pain and disability caused me to seek other medical opinions, both urogyn's who advised the erosion is too advanced for vag cream to help, and should be removed due to the shrinkage.I am having to travel out of state to have the mesh removed with expenses which insurance does not cover.My insurance is out of network as well, and have to be away from my home and family with no guarantee the results will make my poor quality of life at present any better.Other problems have been fatigue, depression over pain and life altering circumstances, marital problems, increased allergies, and bloating, weight gain, financial problems over out of pocket costs for medications for pain control and treatments for orthopedic secondary complications from the mesh eroding and pulling internal pelvic muscles and ligaments.This product needs to be taken off the market and out of the hands of medical personnel.

• Brand Name: GYNECARE MESH
• Type of Device: MESH
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 4516272
• MDR Text Key: 5442751
• Report Number: MW5040706
• Device Sequence Number: 1
• Product Code: OTN
• 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: 02/06/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 65