MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEM PERIGEE ; TRANSVAGINAL MESH

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Abrasion (1689); Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Discomfort (2330); Disability (2371)

Event Date 03/03/2010

Event Type  Injury  

Event Description

Initially i was implanted with ams perigee transvaginal mesh, march (b)(6) 2010 for cystocele during hysterectomy and fibroid tumor removal surgery.The next day, following discharge from hospital, i was in unusual pain and the right side of my groin at the surgical incision area had swollen 3 times the size of the left groin incision area and was very tender and warm to the touch.I immediately phoned my surgeon's office, dr.(b)(6) describing my symptoms and was told that dr.(b)(6) would call in a prescription for hormone cream to be inserted vaginally to assist with vaginal wound, healing quickly.I followed the instructions of the prescription but pain and swelling didn't go away, approx 2 days later, i phone dr's office again stating that the pain and swelling remained and told that i am to continue with vaginal hormone until gone.I did but still had reservations about the knot that remained in my right groin area.At my 6 wk f/u dr appointment, i told dr (b)(6) that my partner felt scratching on penis during intercourse and during vaginal check up she said she felt the opening in vaginal wall where the mesh had been placed, and she clipped the access and i left the office bleeding and in pain.Fast forward: i questioned dr.(b)(6) about my concerns and was told that the vaginal wound should close up over sutures, what was later identified as mesh via surgical medical report.I continued to have ripping, pulling pain in groin and lower abdomen so 1 year later, i went to primary doctor, dr (b)(6) and he did a vaginal exam and confirmed that the mesh was exposed on the right side of vaginal wall, and i currently have groin and lower abdominal pain even following 2 excision repair surgeries and mesh sling implant in 2013.I also have boston scientific's vaginal mesh implant called biomedical xenform sling.

• Brand Name: PERIGEE
• Type of Device: TRANSVAGINAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEM
• MDR Report Key: 5327669
• MDR Text Key: 34377782
• Report Number: MW5058745
• Device Sequence Number: 1
• Product Code: OTP
• 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: 12/22/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MULTIVITAMINS
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 42 YR
• Patient Weight: 100