MAUDE Adverse Event Report: JOHNSON AND JOHNSON TRANSVAGINAL MESH

Device Problems Difficult to Remove (1528); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)

Event Date 02/14/2007

Event Type  Injury  

Event Description

I was implanted with an (b)(4) transvaginal mesh to help stop stress incontinence in (b)(6) 2006.By (b)(6) 2007, the mesh had started to erode into my vagina and my husband felt it during intercourse.The dr.Was unable to fully remove the mesh.I became incontinent worse than i had been before.I have pain and need to wear pads and diapers if i get sick.In (b)(6) 2014, dr.(b)(6) of (b)(6) was able to fully remove the parts that the regular obgyn couldn't.He was the only dr.Trained and willing to do the removal.I remain incontinent but the pain is gone from the mesh.I was never this bad prior to having mesh implanted.My sex life was ruined.Please prevent this type of product from being put into innocent women who, like myself, trust their drs and they in turn trust the mfrs even though thousands of people like me are suffering every day.What has been done to us is criminal, and i wish my government would protect us from it ever happening again.

• Brand Name: TRANSVAGINAL MESH
• Type of Device: TRANSVAGINAL MESH
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 5630028
• MDR Text Key: 44472359
• Report Number: MW5062062
• 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: 05/01/2016

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 45 YR
• Patient Weight: 95