Supris 93-4450Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05708932490016), received between Mar 5, 2021 and Jan 5, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Malposition of Device

  AS ADDITIONALLY REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT ALSO EXPERIENCED URINARY URGENCY/FREQUENCY, NOCTURIA, FEELING OF INCOMPLETE BLADDER EMPTYING, RANDOM BLOOD IN TOILET AFTER SEX, DYSURIA AFTER SEX, URINARY TRACT INFECTIONS RESISTANT TO ANTIBIOTICS, DYSPAREUNIA, PERSISTENT URETHRAL BURNING (WORSE IN AM THEN IMPROVES), RECURRENT STRESS URINARY INCONTINENCE WITH FULL BLADDER, LEFT HIP PAIN AND MUSCLE SPASM/ HIGH-TONE PELVIC FLOOR DYSFUNCTION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; Erosion; Hematuria; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 23962253 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: A SUPRIS WAS IMPLANTED IN (B)(6) 2014. FROM 2021, THE PATIENT REPORTEDLY EXPERIENCED LOW BACK PAIN, PELVIC PAIN, STRESS URINARY INCONTINENCE, INFECTION REQUIRING MEDICATION, FOUL SMELLING DISCHARGE, BACTERIAL VAGINOSIS, SUBURETHRAL MESH ON PHYSICAL EXAM, LEUKORRHEA, URINARY URGE INCONTINENCE, MESH EROSION, HEMATURIA, BURING WITH URINATION, SEVERE TENDERNESS IN THE INTRAVAGINAL LEFT LEVATOR ANI AREA. TRANSVAGINAL REMOVAL OF SUPRIS VAGINAL MESH WITH CYSTOSCOPY WAS PERFORMED. INTRAOPERATIVE FINDINGS INCLUDED ADHESIONS AND SCARRING ALONG THE URETHRA. MESH WAS NOTED IN THE MIDLINE. THE PATHOLOGY REPORT INDICATED: CHRONICALLY INFLAMED CONNECTIVE TISSUE WITH FOREIGN BODY CONSISTENT WITH MESH. 2.0 X 1.6 X 0.1 CM. THE PATIENT REPORTEDLY CONTINUED TO EXPERIENCE INCOMPLETE BLADDER EMPTYING REQUIRING INTERMITTENT CATHETERIZATION AND LEFT SIDED PELVIC PAIN.

  Patient problems: Abnormal Vaginal Discharge; Abnormal scarring; Adhesion(s); Dysuria; Erosion; Hematuria; Inflammation; Micturition Urgency; Pain; Pelvic Pain; Unspecified Infection; Urinary Incontinence; Urinary Retention

  MAUDE report 22689238 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION WHILE THE SUPRIS SLING WAS BEING PLACED BY THE PHYSICIAN AND DURING IMPLANTATION, THE BLADDER WAS PERFORATED. AFTER PLACEMENT THE PERFORATION WAS DISCOVERED DURING CYSTOSCOPY. THE PHYSICIAN DID NOT FEEL COMFORTABLE LEAVING THE SLING IN PLACE AND REMOVED IT.

  Patient problems: Perforation

  MAUDE report 22297294 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED THE FOLLOWING: PAIN [BACK AND PELVIC], URINARY ANALYSIS WITH TRACE BLOOD, INCONTINENCE, VAGINAL DISCHARGE, BLEEDING, URGE INCONTINENCE AND DYSPAREUNIA. A 1 CM EXPOSURE OF IMPLANTED VAGINAL MESH IN THE ANTERIOR COMPARTMENT WAS NOTED. THE PATIENT UNDERWENT REVISION OF THE SLING WITH ADJACENT TISSUE TRANSFER, LEFT PERIANAL LESION EXCISION AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. PATHOLOGY SHOWED A FRAGMENT OF WHITE INTERWOVEN SYNTHETIC MATERIAL MEASURING 1.2 X 0.5 X 0.1 CM. POST REVISION PATIENT EXPERIENCED TRACE BLOOD IN URINE.

  Patient problems: Abnormal Vaginal Discharge; Dyspareunia; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Incontinence; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain

  MAUDE report 22019620 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A SUPRIS SLING AND A RESTORELLE MESH IMPLANTED. REPORTEDLY, THE PATIENT EXPERIENCED MESH EXPOSURE AND EXCISION OF VAGINAL MESH UNDER GENERAL ANESTHESIA.

  Patient problems: Erosion

  MAUDE report 21756927 ↗
• InjuryFeb 11, 2025Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED LETHARGY, LOWER ABDOMINAL PAIN, KIDNEY/RENAL PAIN, SIGNS OF SYSTEMIC INFECTION, URINARY TRACT INFECTION, ACUTE PYELONEPHRITIS, MESH EXTRUSION, PAIN WITH INTERCOURSE AND TAMPON INSERTION.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Cramp(s) /Muscle Spasm(s); Dyspareunia; Dysuria; Erosion; Fistula; Hematuria; Kidney Infection; Lethargy; Pain; Pelvic Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 21357270 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT HAD A SUPRIS IMPLANTED IN (B)(6) 2017. REPORTEDLY IN (B)(6) 2018 THE MID URETHRAL SLING INCISION HAD NOT HEALED. A 0.5CM PORTION OF THE INCISION WAS STILL OPEN WITH EXPOSED SLING. IN (B)(6) 2018 ADVANCEMENT OF THE VAGINAL FLAP TO COVER EXPOSED SUPRIS MESH WAS PERFORMED UNDER GENERAL ANESTHESIA. INTRAOPERATIVE FINDINGS: 1 CM SLING EXPOSED THROUGH MIDLINE OF THE ANTERIOR VAGINAL WALL.

  Patient problems: Erosion; Impaired Healing

  MAUDE report 20568780 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT HAD A SUPRIS RETROPUBIC SLING IMPLANTED IN (B)(6) 2014. FROM 2019, THE PATIENT REPORTEDLY HAD INCONTINENCE (URGE AND MIXED), HEMATURIA AND AN OVERACTIVE BLADDER. FROM 2022 THE PATIENT REPORTEDLY HAD: VAGINAL MESH EROSION, MESH EXCISION, URETHROLYSIS, URETHRAL RECONSTRUCTION AND CYSTOSCOPY UNDER ANESTHESIA. URETHRAL EROSION, URINARY INCONTINENCE WITHOUT SENSORY AWARENESS, INFECTED SYNTHETIC MESH, URETHRAL VAGINAL FISTULA, ANTERIOR VAGINAL WALL SCARRING, DENERVATED URETHRAL RECONSTRUCTION, CADAVER SLING-FASCIA SLING SUSPEND/COLOPLAST, LEFT MARTIUS FAT PAD TRANSPOSITION, AND USE OF GENTRIX SURGICAL MATRIX/ACELL VIA GENERAL ANESTHESIA. STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY, LOW PELVIC PAIN, BLADDER SPASMS, BURNING, IRRITATION, UTI-LIKE SYMPTOMS. CYSTOSCOPY AND BULKAMID INJECTION VIA LOCAL ANESTHESIA WERE GIVEN. TRANSVAGINAL URETHROLYSIS WAS PERFORMED, CATEGORY FASCIA LATA SUBURETHRAL SLING, ANTERIOR REPAIR WITH VAGINAL PARAVAGINAL REPAIR AND SKIN TISSUE REARRANGEMENT VAGINAL ADVANCEMENT OF APPROXIMATELY 2 CM. FROM 2023, THE PATIENT REPORTEDLY HAD INCISION DRAINAGE AND FURTHER CYSTOURETHROSCOPY, BLADDER BOT

  Patient problems: Abnormal Vaginal Discharge; Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Drug Resistant Bacterial Infection; Dyspareunia; Erosion; Fever; Fistula; Genital Bleeding; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Interstitial Cystitis; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Pelvic Pain; Scar Tissue; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection; Wound Dehiscence

  MAUDE report 20270598 ↗
• MalfunctionSep 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THE SUPRIS SLING/MESH TORE UPON INSERTION OF THE TROCAR; THEREFORE, UNABLE TO TENSION. THE SLING WAS MOSTLY EXPLANTED AND THE REMAINING PORTION WAS DEEMED TO BE SAFE BY SURGEON. ANOTHER SLING WAS OPENED AND THEN IMPLANTED SUCCESSFULLY. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152374 ↗
• MalfunctionSep 4, 2024Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE SUPRIS SLING BROKE IN HALF WHEN IT WAS BEING PULLED UP THROUGH THE PELVIC INCISIONS. IT WAS EASILY REMOVED FROM THE PATIENT. THE SURGEON REPEATED THE PROCEDURE WITH ANOTHER SUPRIS SLING AND THE PROCEDURE WENT FINE. THE PATIENT DID NOT APPEAR HARMED IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135253 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: FOLLOWING A SUPRIS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAD RECURRENT STRESS URINARY INCONTINENCE, MESH EROSION REQUIRING TRIMMING UNDER LOCAL ANESTHESIA AND A HISTORY OR URETHRAL FISTULA REPAIR.

  Patient problems: Abdominal Cramps; Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Erosion; Fistula; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Inflammation; Micturition Urgency; Neuralgia; Neuropathy; Pain; Pelvic Pain; Scar Tissue; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 20128480 ↗
• InjuryJan 21, 2023Migration; Migration

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED LOWER LEFT QUADRANT PAIN, PAIN WORSE WITH MOVEMENT AND CYCLE, FREQUENT URINARY TRACT INFECTIONS, DYSPAREUNIA, URINARY URGENCY, URINARY FREQUENCY, PELVIC PRESSURE, A CYSTOSCOPY NOTED A 5 MM EROSION ENCRUSTED WITH STONE AT 7 O¿CLOCK AT THE DISTAL THIRD END OF THE URETHRA. PATIENT HAD PARTIAL EXPLANTATION OF THE DEVICE. INTRAOPERATIVE FINDINGS NOTED A SUBURETHRAL PORTION OF THE MIDURETHRAL DEVICE WAS REMOVED WITH URETHRAL EROSION IDENTIFIED AND INCLUDED IN THE REMOVAL. MULTILAYER CLOSURE OF URETHROTOMY, WITH MULTIPLE TESTS OF THE URETHROPLASTY REVEALING A WATERTIGHT CLOSURE. PATHOLOGY NOTED A SECTION OF MESH MATERIAL MEASURING 3X2 X 1.1 X 0.4 CM WITH ATTACHED SOFT TISSUE SHOWING SQUAMOUS MUCOSA WITH EROSION OR ULCER, UNDERLYING MARKED ACUTE AND CHRONIC INFLAMMATION, FOREIGN MATERIAL, HEMORRHAGE AND VASCULAR PROLIFERATION. GROSS EXAMINATION ONLY FOR MESH MATERIAL.

  Patient problems: Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Micturition Urgency; Pain; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 16221505 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 03/02/2023 AS FOLLOWS: BETWEEN (B)(6) 2016 AND (B)(6) 2017 THE PATIENT HAD A HISTORY OF MESH EROSION, VAGINAL AND ABDOMINAL PAIN, DYSPAREUNIA, AND RECURRENT SUI AFTER RETROPUBIC SLING FOR INCONTINENCE. SUPRAPUBIC EXPLORATION FOR SLING ARMS, REMOVAL OF VAGINAL SLING, URETHROLYSIS, CYSTOSCOPY UNDER GENERAL ANESTHESIA.

  Patient problems: Abdominal Pain; Dyspareunia; Erosion; Pain; Urinary Incontinence

  MAUDE report 16158747 ↗
• InjuryOct 13, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DYSPAREUNIA, PAIN, FELT EROSION LATERALLY, PATIENT'S PARTNER FELT SHARP FOREIGN BODY DURING INTERCOURSE, DYSURIA, SMALL AMOUNTS OF YELLOW DISCHARGE, VAGINAL TENDERNESS, VAGINAL DISCOMFORT, MILD SPOTTING, VULVODYNIA, URINARY URGENCY, URGE INCONTINENCE, URINARY FREQUENCY, STRESS URINARY INCONTINENCE CONFIRMED WITH URODYNAMICS, VAGINITIS, MENORRHAGIA, INTRINSIC SPHINCTER DEFICIENCY. PATIENT HAD IMPLANTATION OF AN UNKNOWN DEVICE UNDER GENERAL ANESTHESIA. PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY FOR MARKEDLY ENLARGED FIBROID UTERUS, BILATERAL SALPINGECTOMY, LEFT OVARIAN CYSTECTOMY, UTEROSACRAL LIGAMENT VAULT COLPOPEXY, URETEROLYSIS (UNKNOWN DEVICE REMOVAL), DEVICE URETHROPEXY, AND CYSTOSCOPY UNDER GENERAL ANESTHESIA. INTRAOPERATIVE FINDINGS NOTED THE PREVIOUSLY PLACED DEVICE WAS VERY DISTALLY DISPLACED AND BANDED, AND AN ESTIMATED BLOOD LOSS OF 150 ML. PATHOLOGY REPORT FOR PREVIOUS UNKNOWN DEVICE NOTED EXPLANTATION OF VAGINAL WALL DEVICE, FIBROSIS AND FOREIGN BODY TYPE REACTION TO BIREFRINGENT FOREIGN DEBRIS, GROSS EXAMINATION OF FOREIGN BODY, VAGINAL WALL DEVIC

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Dysuria; Erosion; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 15601370 ↗
• InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, BETWEEN (B)(6) 2018-(B)(6) 2019: UTI. URINE CULTURE SHOWED 1,000-10,000 CFU/ML ENTEROCOCCUS FAECALIS AND COAGULASE NEGATIVE STAPHYLOCOCCUS. BLOOD IN URINE. URINE CULTURE SHOWS 10,000-50,000 CFU/ML COAGULASE NEGATIVE STAPHYLOCOCCUS AND (B)(6). URINALYSIS SHOWED MODERATE LEUKOCYTE ESTERASE, 25-50 WBC AND SLIGHT BACTERIA. URINE CULTURE SHOWED >100,000 CFU/ML STAPHYLOCOCCUS AUREUS. URINALYSIS SHOWED LARGE LEUKOCYTES. UNSPECIFIED MECHANICAL COMPLICATION OF GENITOURINARY DEVICE, IMPLANT AND/OR GRAFT. CHRONIC UTIS, DYSURIA, SUI, URGENCY, URGE INCONTINENCE, FREQUENCY, NOCTURIA, INCOMPLETE BLADDER EMPTYING, LOWER PELVIC/VAGINAL PRESSURE, INCONTINENT OF STOOL, MESH EROSION-BLADDER AND ABDOMINAL WALL, PAIN. ON (B)(6) 2018- SUPRIS SLING REMOVAL, URETHRAL LYSIS, ANTERIOR COLPORRHAPHY, ABDOMINAL PARAVAGINAL, REMOVAL OF ABDOMINAL MESH, REMOVAL OF MESH FROM THE BLADDER, REPAIR OF BLADDER FROM MESH EROSION, REINFORCEMENT OF THE BLADDER AND URETHRAL TISSUES WITH DERMAPURE VIA GENERAL ANESTHESIA FOR VAGINAL PAIN, BLADDER PAIN, ABDOMINAL PAIN, SCARRING, AND MESH EROSION. PATHOLOGY SHOWED REACTIVE FIBROSIS, CHRONIC INFLAMMATION, AND FOREIGN BODY GIANT CELL

  Patient problems: Bacterial Infection; Fecal Incontinence; Foreign Body Reaction; Genital Bleeding; Inflammation; Pain; Scar Tissue; Skin Erosion; Urinary Incontinence

  MAUDE report 13005241 ↗
• InjuryMar 5, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED URINARY INCONTINENCE, PHYSICAL DEFORMITY AND LOSS OF THE ABILITY TO PERFORM SEXUALLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Sexual Dysfunction; Urinary Incontinence

  MAUDE report 11423561 ↗