MAUDE Adverse Event Report: SAFYRE SLING; STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR

Device Problems Material Twisted/Bent (2981); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/09/2014

Event Type  Injury  

Event Description

On this date, i had a hysterectomy and safyre sling inserted to treat stress incontinence.Which i was told was a simple surgery with less than 3/4% of complications.After the surgery, i was unable to empty my bladder and i had a catheter for a week.The sling was too tight the dr said.I started getting infections and suffering from intense pain in urethra.I was unable to empty my bladder.I was self catheterising.Four weeks later i had surgery to loosen sling.I no longer needed to set catheterize but the pain and infection problems remained.Surgery again this time they cut the sling on the other side.This helped reduce the pain.I continue to get infections every 4/5 weeks.Pain started worsening.After seeing a urologist and having her clean out my bladder (it was covered in blister like skin, another surgery) the infections eased off but the pain remained.I went back to gynecologist who did original surgery.He felt inside my vagina after i told him my symptoms.His face dropped as he realized the right hand side of the sling had come loose and the plastic anchor was sitting bunched up my urethra.He scheduled me for another surgery and removed this part of the sling.It is now almost 4 yrs since implantation and i still suffer from pain in the urethral area and infection symptoms.Which i believed are caused by the mesh the dr implanted.

• Brand Name: SAFYRE SLING
• Type of Device: STRESS URINARY INCONTINENCE, RETROPUBIC OR TRANSOBTURATOR
• MDR Report Key: 7813350
• MDR Text Key: 118389082
• Report Number: MW5079386
• Device Sequence Number: 1
• Product Code: PWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 68