T-SLING 5194001400Recalls & reported problems
Herniamesh Srl · The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for the treatment of stress urinary incontinence (SUI). · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This HerniaMesh T-Sling mesh, used for stress urinary incontinence, has 168 reports, with no deaths and 168 injuries. Many reports describe pain, bleeding, infections, and mesh erosion or protruding through tissue, and some say the mesh had to be surgically removed. Many reports come from patients' legal representatives, who allege complications. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 168
- Deaths reported
- 0
- Injuries reported
- 168
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 28032919892120), received between Aug 8, 2016 and Jul 16, 2025 — classified as 168 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (50 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information50
- Material Erosion31
- Adverse Event Without Identified Device or Use Problem23
- Extrusion21
- Patient-Device Incompatibility19
- Appropriate Device Problem Term/Code Not Available13
- Migration or Expulsion of Device9
- Device Operates Differently Than Expected7
Patient problems
- Pain71
- Incontinence60
- Unspecified Infection37
- Hemorrhage/Blood Loss/Bleeding31
- No Code Available30
- Urinary Retention28
- Urinary Tract Infection26
- Erosion23
Recent adverse event reports
The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT'S LEGAL REPRESENTATIVE STATED THE PATIENT SUFFERED COMPLICATIONS INCLUDING BUT NOT LIMITED TO, PELVIC PAIN, PROTRUSION, EXTRUSION, EROSION, URINARY ISSUES, RECURRENCE, BLEEDING, DYSPAREUNIA, HEAVY DISCHARGE, VAGINAL SCARRING, PERMANENT DISFIGUREMENT, AND DIFFICULTY WITH DAILY ACTIVITIES, WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH: ON (B)(6) 2023 LIGHT PINK COLORED DISCHARGE AFTER INTERCOURSE, PALPABLE ROUGH TEXTURED AREA IN ANTERIOR VAGINA (~3 MM) IN DIAMETER ~3 CM FROM VAGINAL OPENING, HOWEVER UNABLE TO VISUALIZE THIS AREA WITH SPECULUM EXAM, (+) BACTERIAL VAGINOSIS. ON (B)(6) 2023 CONSULTATION - PALPABLE ANTERIOR VAGINAL WALL ROUGH/IRREGULAR RIDGE JUST INSIDE INTROITUS, AREA NOT VISIBLE, AREA IS MOST LIKELY MESH FROM BLADDER REPAIR, NO EROSION THROUGH VAGINAL MUCOSA. ON (B)(6) 2023 PINK COLORED DISCHARGE AFTER INTERCOURSE, (+) BACTERIAL VAGINOSIS, (+) VAGINAL CANDIDIASIS. ON (B)(6) 2023 URINARY FREQUENCY/DYSURIA, BLADDER PRESSURE, UTI WITH HEMATURIA (+) E COLI. ON (B)(6) 2024 UTI. ON (B)(6) 2024 VAGINAL ITCHING AND DISCHARGE, INTERMITTENT VAGINAL SPOTTING, EROSION OF MESH FROM PRIOR BLADDER REPAIR THAT IS ERODED THROUGH VAGINAL WALL, (+) VAGINAL C
Patient problems: Dyspareunia; Erosion; Intermenstrual Bleeding; Pelvic Pain; Urinary Incontinence
MAUDE report 22520616 ↗InjuryDec 2, 2020Material Erosion; Material Protrusion/Extrusion
LEGAL REPRESENTATIVE STATED SEVERE AND DEBILITATING ABDOMINAL PAIN, VAGINAL BLEEDING, CHRONIC URINARY TRACT INFECTIONS, URINARY INCONTINENCE, DYSPAREUNIA, DYSURIA, HEMATURIA, URINARY FREQUENCY, LETHARGY, AND MESH EROSION SOME TIME AFTER IMPLANT, EROSION OF MESH, SERIOUS BODILY INJURY AND HARM, LETHARGY, UNDERGONE MEDICAL TREATMENT, INCLUDING MULTIPLE PROCEDURES TO CORRECT HER INJURIES, AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES, EXPOSURE/EXTRUSION/PROTRUSION, INFECTIONS, BLADDER PROBLEMS. ON (B)(6) 2020, REVISION SURGERY TO REMOVE SLING. PARTIAL EXCISION/REVISION OF ERODED SLING ON (B)(6) 2020. INTRAOPERATIVE FINDING: 1X1CM T-SLING EROSION IN MID-VAGINA ABOUT 2CM FROM EXTERNAL URETHRAL MEATUS. EXCISION SIZE: 2CM.
Patient problems: Abdominal Pain; Dyspareunia; Dysuria; Genital Bleeding; Hematuria; Lethargy; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection
MAUDE report 10934138 ↗InjuryNov 15, 2018Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, CHRONIC URINARY TRACT INFECTIONS, AS WELL AS VAGINAL BLEEDING, REOCCURRING STRESS "INCONTINECE", AND URGE INCONTINENCE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Incontinence; No Code Available; Pain; Patient Problem/Medical Problem; Urinary Tract Infection
MAUDE report 8073210 ↗InjurySep 17, 2018Material Erosion
PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, CHRONIC URINARY TRACT INFECTIONS AS WELL AS VAGINAL BLEEDING AND REOCCURRING STRESS INCONTINENCE, PELVIC PAIN AND MESH EROSION.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Incontinence; Pain; Urinary Tract Infection
MAUDE report 7880529 ↗InjurySep 17, 2018Material Protrusion/Extrusion
PATIENT LEGAL REPRESENTATIVE STATED EXTRUSION OF VAGINAL MESH, RECURRENT UTI'S, MUSCLE CRAMPS.
Patient problems: Muscle Spasm(s); Urinary Tract Infection
MAUDE report 7880520 ↗InjuryMay 11, 2018Material Erosion; Defective Device
PATIENT'S LEGAL REPRESENTATIVE STATED CHRONIC AND RECURRENT UTI'S, MESH EROSION, URGENCY, WORSENED URINARY LEAKAGE, PAIN AND E-COLI COLONIZED IN THE BLADDER FROM THE DEFECTIVE MESH REQUIRING ADDITIONAL MEDICAL CARE AND TREATMENT AND ULTIMATELY SURGICAL INTERVENTION.
Patient problems: Micturition Urgency; No Code Available; Pain; Urinary Tract Infection
MAUDE report 7506710 ↗InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem
PATIENT'S LEGAL REPRESENTATIVE STATED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES, LOSS OF CONSORTIUM.
Patient problems: Injury; No Code Available; Pain
MAUDE report 7506651 ↗InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem
PATIENT'S LEGAL REPRESENTATIVE STATED INCOMPLETE BLADDER EMPTYING, PAIN, FREQUENT URINATION AND STRAIN WHEN URINATING. PHYSICIAN NOTED BLADDER NECK OBSTRUCTION DURING EXPLANT SURGERY. DURING PROCEDURE SLING APPEARED IN NORMAL POSITION. PHYSICIAN PLACED BEHIND SLING AND SLING WAS CUT WITH SMALL SEGMENT REMOVED. PATHOLOGICAL REPORT: SLING SPECIMEN SHOWED SCAR TISSUE AND MILD CHRONIC INFLAMMATION.
Patient problems: Urinary Frequency / Polyuria; Urinary Retention
MAUDE report 7506558 ↗InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem
PATIENT'S LEGAL REPRESENTATIVE STATED DYSPAREUNIA, OVERACTIVE BLADDER, BILATERAL TENDERNESS AT THE SLING ARMS.
Patient problems: Incontinence
MAUDE report 7506452 ↗InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem
PATIENT'S LEGAL REPRESENTATIVE STATED SEVERE PAIN WITH DAILY ACTIVITIES AND INTERCOURSE, CHRONIC URINARY TRACT INFECTIONS, INCONTINENCE AND PELVIC ORGAN PROLAPSE.
Patient problems: Incontinence; Pain; Prolapse; Urinary Tract Infection
MAUDE report 7506217 ↗InjuryFeb 20, 2017Device Dislodged or Dislocated
PLAINTIFF IMPLANTED WITH T-SLING (B)(4) ON (B)(6) 2015. MESH REMOVAL OCCURRED ON (B)(6) 2016. PATIENT'S LEGAL REPRESENTATIVE STATED HEMATURIA, PELVIC PAIN, UTI, DYSPAREUNIA, URGE URINARY INCONTINENCE, URGENCY/FREQUENCY, PALPABLE MESH, EXPOSED SLING, PAIN.
Patient problems: Hematuria; Incontinence; Pain; Urinary Tract Infection
MAUDE report 6342747 ↗InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem
PLAINTIFF IMPLANTED WITH T-SLING (B)(4) ON (B)(6) 2011. MESH REMOVAL OCCURRED ON (B)(6) 2011. PATIENT'S LEGAL REPRESENTATIVE STATED SLING REVISION FOR URINARY RETENTION, BACK PAIN, INTERMITTENT PELVIC PAIN/PRESSURE AND OCCASIONAL FREQUENCY, INFECTION
Patient problems: Incontinence; Pain; Unspecified Infection
MAUDE report 6342746 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED URINARY INCONTINENCE, PHYSICAL DEFORMITY AND LOSS OF THE ABILITY TO ENJOY LIFE AND PERFORM SEXUALLY.
Patient problems: Incontinence
MAUDE report 6215307 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED RECURRENT SUI.
Patient problems: Incontinence
MAUDE report 6215306 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED VAGINAL MESH EXPOSURE, RIGHT LOWER QUADRANT PAIN.
Patient problems: Pain
MAUDE report 6215305 ↗InjuryDec 30, 2016Appropriate Device Problem Term/Code Not Available
PATIENT'S LEGAL REPRESENTATIVE STATED DIFFICULTY EMPTYING BLADDER, SMALL AMOUNT OF LEAKAGE, RIGHT LOWER QUADRANT PAIN, URGENCY, DIFFICULTY VOIDING, AND ATYPICAL LESION ON THE LEFT HEMITRIGONE OF THE BLADDER.
Patient problems: Incontinence; Micturition Urgency; Pain; Urinary Retention
MAUDE report 6215304 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED POST-OPERATIVE URINARY RETENTION.
Patient problems: Urinary Retention
MAUDE report 6215303 ↗InjuryDec 30, 2016Appropriate Device Problem Term/Code Not Available
PATIENT'S LEGAL REPRESENTATIVE STATED RECURRENT PROLAPSE, INCOMPLETE EMPTYING, AND VAGINAL PAIN.
Patient problems: Pain; Prolapse; Urinary Retention
MAUDE report 6215302 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED PROLAPSE AND CYSTOCELE.
Patient problems: Prolapse
MAUDE report 6215299 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED URETHRAL OBSTRUCTION.
Patient problems: Obstruction/Occlusion
MAUDE report 6215298 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED MID-SUBURETHRAL SLING MESH EXPOSURE IN MIDLINE, AND EXCISION.
Patient problems: No Information
MAUDE report 6215297 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED EROSION, WOUND SEPARATION, EXPOSURE OF MESH, SCAR TISSUE, UTI, DYSPAREUNIA, EXCISION OF VAGINAL FOREIGN BODY.
Patient problems: Erosion; Pain; Scarring; Urinary Tract Infection; Wound Dehiscence
MAUDE report 6215296 ↗InjuryDec 30, 2016Appropriate Device Problem Term/Code Not Available
PATIENT'S LEGAL REPRESENTATIVE STATED DYSPAREUNIA, MESH EXPOSURE, SUI, AND SCARRING.
Patient problems: Incontinence; Scarring
MAUDE report 6215295 ↗InjuryDec 30, 2016Device Operates Differently Than Expected
PATIENT'S LEGAL REPRESENTATIVE STATED STRESS INCONTINENCE, NOCTURIA, INCOMPLETE BLADDER EMPTYING, DECREASED FORCE OF STREAM, STRAINING TO VOID, POST-VOID URINARY INCONTINENCE, LEAKAGE WITH STANDING AFTER VOIDING, URGENCY, FREQUENCY, URGE AND MIXED URINARY INCONTINENCE, VAGINAL VAULT PROLAPSE, FAILED PUBOVAGINAL SLING, GREENISH/BROWN DRAINAGE FROM VAGINA, WEAKNESS, RIGHT SIDE AND TAILBONE PAIN, URINARY RETENTION.
Patient problems: Abnormal Vaginal Discharge; Complaint, Ill-Defined; Incontinence; Micturition Urgency; Pain; Patient Problem/Medical Problem; Prolapse; Urinary Frequency / Polyuria; Urinary Retention; Weakness
MAUDE report 6215294 ↗InjuryDec 30, 2016Insufficient Device Problem Information
PATIENT'S LEGAL REPRESENTATIVE STATED VAGINAL WALL EROSION, MESH EXPOSURE, UTI, PAIN, INCONTINENCE, BLEEDING, MODERATE STREAM, DYSPAREUNIA, URINARY FREQUENCY, DISCHARGE.
Patient problems: Discharge; Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Pain; Urinary Tract Infection
MAUDE report 6215293 ↗
Other Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling devices
- Altis 519650Coloplast A/S · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling540 reports
- Solyx™ SIS System M0068507000Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling248 reports
- Solyx™ Blue M0068507010Boston Scientific Corporation · mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling55 reports
- Desara One CAL-DS2111Caldera Medical, Inc. · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling15 reports
- Desara One CAL-DS2113Caldera Medical, Inc. · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling14 reports
- Needleless Sling NL-01Desarrollo E Investigacion Medica Aragonesa Sl · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page