MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX BLADDER SLING; SURGICAL MESH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Edema (1820); Fatigue (1849); Hair Loss (1877); Incontinence (1928); Nausea (1970); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Weakness (2145); Arthralgia (2355); Choking (2464); Confusion/ Disorientation (2553); Test Result (2695); Constipation (3274)

Event Date 06/18/2008

Event Type  Injury  

Event Description

Obtryx bladder sling and avaulta posterior mesh placed in 2008.Symptoms post mesh implant include initial frequent uti's, painful sexual intercourse, brain fog, fatigue, joint pain, difficulty swallowing, choking on liquids and thin foods, pain around my ribs wrapping right around my chest, pelvic pain and pelvic floor congestion syndrome (abdomen swelling to 8-9 months pregnant in under 10 minutes - time lapse video available), hair loss, urinary leaking but not stress incontinence.It was post void residual, rectal pressure, stool leakage, constipation, vaginal odor, 30 pounds of excess fluid in body 1+ pitting edema to legs, feet, body, left sacro iliac pain and throbbing, elevated autoimmune lab results, elevated calcium, low vitamin d, constant nausea, loss of appetite, weakness, gum retraction to expose nerves, renal cell carcinoma.On (b)(6) 2018 partial removal of bladder sling and pelvic mesh, mesh is being saved at (b)(6) pathology dept of my attorney.The mesh had shrunk, hardened and curved into an arc causing my pelvic pain.I am 3 weeks post removal and pain free and most symptoms are gone.I continue to have fluid retention.I had instant relief post surgery as far as fatigue, nausea, constipation, urinary incontinence, rectal pressure and stool leakage, brain fog improved.

• Brand Name: OBTRYX BLADDER SLING
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7776717
• MDR Text Key: 117025151
• Report Number: MW5079072
• Device Sequence Number: 2
• Product Code: PAH
• Combination Product (y/n): N
• 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: 08/09/2018
• 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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 78