PRODUCT CODE OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Monitor reported device problems. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
18Prior 90 days: 52Injury reports
14Source-classified event typeDeath reports
0Reported relationship is unverifiedReporting change
-65.4%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 3. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
Lynx System
Read FDA report 50526939 ↗Received 2026-08-31 · Injury
Patient problems: Pain; Deformity/ Disfigurement; Unspecified Mental, Emotional or Behavioral Problem
Device problems: Adverse Event Without Identified Device or Use Problem
Lynx¿ System
Read FDA report 50507215 ↗Received 2026-08-28 · Injury
Patient problems: Erosion; Nerve Damage; Pain; Deformity/ Disfigurement; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury
Device problems: Material Integrity Problem
BLADDER SLING
Read FDA report 50258810 ↗Received 2026-08-14 · Other
Patient problems: Insufficient Information
Device problems: No Apparent Adverse Event
Advantage System
Read FDA report 50148827 ↗Received 2026-08-05 · Injury
Patient problems: Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury
Device problems: Adverse Event Without Identified Device or Use Problem
Aris transobturator System
Read FDA report 50099164 ↗Received 2026-07-31 · Injury
Patient problems: Erosion; Micturition Urgency; Inflammation; Pain; Urinary Retention; Urinary Tract Infection; Abnormal Vaginal Discharge; Urinary Frequency / Polyuria; Fungal Infection; Dyspareunia; Urinary Incontinence; Pelvic Pain
Device problems: Adverse Event Without Identified Device or Use Problem
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.