Alyte™ Y-Mesh Graft Y100Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00801741016158), received between Jun 14, 2013 and Jul 17, 2026 — classified as 1 death, 82 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, EROSION OF IMPLANTED VAGINAL MESH AND PROSTHETIC MATERIALS, OVERACTIVE BLADDER, MIXED STRESS AND URGE URINARY INCONTINENCE, URINARY TRACT INFECTION, DETRUSOR DYSFUNCTION. PER MEDICAL RECORDS WERE RECEIVED ON 23JUN2026, THE PATIENT HAS EXPERIENCED SEVERE BOWEL ADHESIONS TO THE VAGINAL CUFF, SEVERE BOWEL ADHESIONS TO THE PELVIC SIDEWALL, SEVERE BOWEL ADHESIONS TO THE PELVIS POSTERIOR CUL-DE-SAC, URINARY INCONTINENCE, NARROWED VAGINAL INTROITUS, VAGINAL MESH EROSION AT THE APEX, BLEEDING, VAGINAL PROLAPSE, HEMORRHAGE, EDEMA, ANEMIA, OVERACTIVE BLADDER, URINARY RETENTION, E COLI URINARY TRACT INFECTION, STRESS, LOWER BACK PAIN, DYSURIA, FREQUENCY, FEVER, VAGINAL WOUND, URETHRAL WOUND, OVERACTIVE GENITOURINARY, PAIN, INCOMPLETE EMPTYING OF BLADDER, DETRUSOR DYSFUNCTION, URGENCY, ANXIETY, MESH EXPOSURE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Adhesion(s); Anemia; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dysuria; Erosion; Fever; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Prolapse; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 25856899 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED CONTINUOUS FOUL SMELLING AND FECULENT VAGINAL DISCHARGE, RECURRENT E. COLI URINARY TRACT INFECTIONS, PASSAGE OF GAS THROUGH VAGINA, YELLOW OR BROWN DISCHARGE WITH BLOOD MIXED, FOUL SMELLING DISCHARGE, RECTOVAGINAL FISTULA, MESH EROSION, COMPLICATED AND PROLONGED EXTENSIVE SURGERY, PAIN, MILD ILEUS, CHRONIC PAIN, SEXUAL DYSFUNCTION, MULTIPLE REVISION SURGERIES, COLOVAGINAL FISTULA, DENSE ADHESIONS OF THE COLON TO THE POSTERIOR VAGINA AND ADHESIONS OF THE ASCENDING AND DESCENDING COLON TO THE PELVIC SIDEWALLS, PROLONGED POST OPERATIVE COMPLICATIONS.

  Patient problems: Abnormal Vaginal Discharge; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Fistula; Pain; Urinary Tract Infection

  MAUDE report 25854752 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 09-SEP-2024, THE PATIENT HAD EXPERIENCED PELVIC PAIN, DYSPAREUNIA, VAGINAL MESH EXPOSURE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 20360578 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 24-JUL-2024, THE PATIENT HAD EXPERIENCED VAGINAL PAIN, MESH EROSION, CHRONIC INFLAMMATION, VAGINAL PROLAPSE, PERSISTENT ATRIAL FIBRILLATION, HEAT INTOLERANCE, MASS ON RIGHT SIDE OF NECK, SHORTNESS OF BREATH, FEVER AND CHILLS, INSOMNIA, DYSPHAGIA, HEMORRHOIDS, CONSTIPATION, PEDAL EDEMA, MODERATE EPISODE OF RECURRENT MAJOR DEPRESSIVE DISORDER, PERIPHERAL NEUROPATHY, POSTMENOPAUSAL SYMPTOMS, ANORECTAL SPASM, SIGMOID DIVERTICULOSIS, STRESS INCONTINENCE, SYMPTOMATIC CHOLELITHIASIS, VAGINAL ATROPHY, SPINAL STENOSIS, SPONDYLOLISTHESIS, MYOFASCIAL PAIN, BACK PAIN, ANOREXIA, NAUSEA, VOMITING, PELVIC ABSCESS, COLO-VESICAL FISTULA, ACUTE CYSTITIS, DYSURIA, BOIL OF BUTTOCK, PRURITIC RASH, BURNING SENSATION, LOWER ABDOMINAL PAIN, BOWEL LEAKAGE AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Abscess; Anemia; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Burning Sensation; Chills; Constipation; Cramp(s) /Muscle Spasm(s); Depression; Diarrhea; Dysphagia/ Odynophagia; Dysuria; Erosion; Fatigue; Fever; Headache; Hematuria; Incontinence; Inflammation; Muscle Weakness/Atrophy; Nausea; Neuropathy; Pain; Prolapse; Rash; Stenosis; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Tract Infection; Vomiting

  MAUDE report 20008746 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE LITIGATION DOES NOT SPECIFICALLY STATE WHICH PRODUCT WAS USED ON THE PATIENT THEREFORE AN UNKNOWN COMPLAINT IS BEING ENTERED. AS PER MEDICAL RECORD REVIEW OF DOCUMENTS RECEIVED ON (B)(6) 2024, THE PATIENT HAD EXPERIENCED INCONTINENCE, PROLAPSE, RECTOCELE, INTERNAL COMPLETE RECTAL PROLAPSE WITH INTUSSUSCEPTION OF RECTOSIGMOID, EROSION OF IMPLANTED VAGINAL AND URETHRAL MESH, DYSPAREUNIA, TIGHTNESS, PRESSURE, NAUSEA, VOMITING, PAIN, URINARY OBSTRUCTION, ABNORMAL HEART RHYTHM, ATRIAL FIBRILLATION, SHORTNESS OF BREATH, OSTEOARTHRITIS, INFECTION, PELVIC PAIN, ABDOMINAL PAIN, CONSTIPATION, BLADDER IRRITATION, BLADDER PAIN, FACE REDNESS, BURNING, RAPID HEART RATE DUE TO BARIUM ALLERGY, ANORECTAL PAIN AND BLEEDING, ASYMPTOMATIC INTERNAL HEMORRHOIDS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Atrial Fibrillation; Constipation; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Incontinence; Nausea; Obstruction/Occlusion; Pain; Prolapse; Skin Inflammation/ Irritation; Tachycardia; Unspecified Infection

  MAUDE report 19499667 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED CHRONIC PAINFUL INFECTIONS, PELVIC AND PERINEAL PAIN, LOWER BACK AND BILATERAL FLANK PAIN, DYSURIA, SCARRING, RECURRENT PROLAPSE, AND MESH EROSION. AS PER MEDICAL RECORD REVIEW OF DOCUMENT RECEIVED ON 03-MAY-2024, THE PATIENT EXPERIENCED CHRONIC PAINFUL INFECTIONS, PELVIC AND PERINEAL PAIN, LOWER BACK AND BILATERAL FLANK PAIN, DYSURIA, SCARRING AND MESH EROSION, CYSTOCELE, RECTOCELE, UTERINE BLEEDING, PELVIC ORGAN PROLAPSE, VAGINAL INFECTION, URINARY LEAKAGE, URGENCY, FREQUENCY, URGE INCONTINENCE, STRESS INCONTINENCE, ATROPHY, FLATUS INCONTINENCE, CHRONIC URINARY TRACT INFECTIONS, CONSTIPATION, CYSTITIS AND REQUIRED ADDITIONAL SURGICAL AND NON - SURGICAL TREATMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Dysuria; Erosion; Flatus; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Muscle Weakness/Atrophy; Pain; Prolapse; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 19393019 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT. AS PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 15NOV2023 THE PATIENT HAD EXPERIENCED INCREASED ABDOMINAL PAIN POST-SURGICAL COMPLICATIONS FOLLOWING VAGINAL PROLAPSE REPAIR, ACUTE VAGINITIS, ATROPHY OF THE VAGINA, SEPTIC SHOCK, VAGINAL BLEEDING, SEVERE GENERAL PAIN, MIGRAINES, ODOROUS DARK-BROWN DISCHARGE, DEPRESSION, BACK PAIN, FREQUENT URGE TO URINATE, ABNORMAL DISCHARGE, BACTERIAL INFECTION, VISION ISSUES, SEPSIS, HEADACHE, TERRIBLE LEFT EYE GLARE, STROKE, DEVELOPS EPISODES OF TREMORS AND LIGHTHEADEDNESS, SHORTNESS OF BREATH SYNCOPE, DIZZINESS, URINARY TRACT INFECTION, TRANSIENT ISCHEMIC ATTACK TIA. CHRONIC THORACIC COMPRESSION DEFORMITIES, DYSLIPIDEMIA, OSTEOPOROSIS, TRICUSPID VALVE REGURGITATION, PALPITATIONS, CHEST PRESSURE, WHEEZES, ANEMIA, VERTIGO, ATAXIA, AGE RELATED OSTEOPOROSIS, ANEURYSM, GASTROESOPHAGEAL REFLEX DISEASE, CHRONIC BILATERAL LOW BACK PAIN, POLYURIA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL TREATMENTS.

  Patient problems: Abdominal Distention; Abdominal Pain; Abnormal Vaginal Discharge; Anemia; Aneurysm; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Bacterial Infection; Depression; Diarrhea; Discomfort; Dizziness; Dysuria; Erosion; Fatigue; Gastrointestinal Regurgitation; Genital Bleeding; Headache; Hemorrhage/Blood Loss/Bleeding; Hernia; Micturition Urgency; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Osteopenia/ Osteoporosis; Pain; Peritonitis; Prolapse; Sepsis; Septic Shock; Shaking/Tremors; Stroke/CVA; Syncope/Fainting; Transient Ischemic Attack; Tricuspid Valve Insufficiency/ Regurgitation; Urinary Frequency / Polyuria; Urinary Tract Infection; Vertebral Fracture; Vertigo; Visual Impairment

  MAUDE report 17624121 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY, IMPAIRMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 16895208 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED CHRONIC PAIN IN HER BACK AND CONTINUED TO SUFFER WITH INCONTINENCE. PATIENT UNDERWENT LAPAROSCOPY SUB-TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY AND SACROCOLPOPEXY USING A WIRE MESH IMPLANT AND LAPAROSCOPY COLPUSUSPENSION ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Diarrhea; Dysuria; Micturition Urgency; Nausea; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 15975624 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED VAGINAL ITCHING, VAGINAL SMELL, PELVIC PAIN, VAGINAL DISCHARGE, ABDOMINAL PAIN, DIARRHEA, CONSTIPATION, URGENCY, PAIN WHEN OPENING HER BOWELS, LEG PAIN, BOWEL LEAKAGE, URINARY FREQUENCY, ANAL PAIN, ANAL ITCHING AND ANAL TENDERNESS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Diarrhea; Micturition Urgency; Pain; Urinary Frequency / Polyuria

  MAUDE report 15923768 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Discomfort; Pain

  MAUDE report 15292913 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAD EXPERIENCED CHRONIC BACK PAIN, PROLAPSE BUT THAT THERE WAS NO VISIBLE OR PALPABLE ERODED MESH. PATIENT WAS ALSO SUFFERING FROM PAIN IN THE LOWER BACK AND SHOOTING PAIN TOWARDS THE UMBILICUS. PATIENT WAS SUFFERING FROM SEVERE BACK PAIN AND GENERALIZED PELVIC PAIN SINCE SURGERY. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING POSTMENOPAUSAL BLEEDING AND SOME POSTCOITAL BLEEDING, VAGINAL BLEEDING, DIFFICULTY FULLY EVACUATING HER BOWELS, AND SYMPTOMS OF URGENCY AND STRESS INCONTINENCE.IT WAS CONCLUDED THAT THE MESH IMPLANTED WITHIN THE PATIENT HAD BUNCHED UP BEHIND HER BLADDER AND THAT THE END OF A CONNECTING SUTURE HAD PERFORATED THE BLADDER JUST ABOVE THE TRIGONE. PATIENT HAD DEVELOPED MARKED FIBROSIS AND TETHERING OF THE VAGINA, BLADDER AND RIGHT PELVIC SIDE BONE. THE PATIENT ELECTED TO PROCEED WITH MINIMAL ACCESS SURGERY AND LASER TREATMENT OF THE BLADDER. OWING TO THE ONSET OF THE COVID-19 PANDEMIC, THE PATIENT HAD NOT YET UNDERGONE THIS PROCEDURE. THE PATIENT CONTINUED TO ENDURE PAIN AND SUFFERING AS A RESULT OF THE IMPLANTATION OF THE MESH DEVICE MANUFACTURED AND SUPPLI

  Patient problems: Fibrosis; Incontinence; Pain; Perforation of Vessels; Prolapse

  MAUDE report 12353454 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECTOCELE WITH PERINEAL DEFECT RIGHT AT THE INTROITUS (PROLAPSE), STRESS INCONTINENCE, INCONTINENCE, MECHANICAL COMPLICATION WITH PREVIOUSLY PLACED GENITOURINARY GRAFT, PAIN WITH INTERCOURSE, VAGINAL DISCOMFORT, HYPERMOBILE URETHRA, "SHOOTING, PENETRATING PAIN", DYSPAREUNIA, ATROPHY, REDDENED VULVA (IRRITATION), DISCOMFORT IN ABDOMEN (DISCOMFORT), LEAKING WITH SNEEZING/COUGHING, FATIGUE, BLOOD LOSS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT STRESS INCONTINENCE, SUPRAPUBIC AND GROIN PAIN, DYSPAREUNIA, PELVIC PAIN, PERIURETHRAL BANDING OF TOT SLING WITH TENDERNESS TO PALPATION, RECURRENT RECTOCELE, HYPERMOBILE URETHRA, REMOVAL OF TOT SLING, MILD VAGINAL DISCHARGE, RECURRENT URINARY TRACT INFECTIONS, LOW BACK PAIN, PERINEOCELE, POSTMENOPAUSAL ATROPHIC VAGINITIS, MESH IMBEDDED IN BLADDER WALL, (BARD) ANTERIOR MESH EROSION AND REMOVAL, IATROGENIC CYSTOTOMY AND CLOSURE, VAGINAL RECONSTRUCTION, ENTEROCE

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Deformity/ Disfigurement; Discomfort; Dysuria; Erosion; Fatigue; Fistula; Foreign Body In Patient; Incontinence; Inflammation; Irritability; Itching Sensation; Micturition Urgency; Obstruction/Occlusion; Pain; Scar Tissue; Stenosis; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 11706006 ↗
• InjuryDec 30, 2020Defective Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT¿S POST IMPLANTATION SYMPTOMS ARE UNKNOWN.

  Patient problems: Injury

  MAUDE report 11096491 ↗
• InjuryDec 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAINFUL INTERCOURSE, BLEEDING FOLLOWING INTERCOURSE, DYSPAREUNIA, VAGINA ATROPHIC, NON-FRIABLE EXCORIATION AT VAGINAL CUFF, DISCHARGE- THIN WHITE, MESH EXPOSURE AT 2 LOCATIONS- ANTERIOR WALL. 0.5 CM, EXPOSURE OF VAGINAL MESH THROUGH VAGINAL WALL, MESH EROSION AT APPROXIMATELY 3 TO 5:00 NEAR THE APEX, RECURRENT CYSTOCELE, URINARY TRACT INFECTION, DYSURIA, CRAMPING, AND CYSTITIS. THE PATIENT ADDITIONALLY REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 11073809 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED ON 15NOV2021, THE PATIENT HAS EXPERIENCED PAIN FROM GENITOURINARY PROSTHETIC GRAFT, CHRONIC PELVIC PAIN, RECTOCELE, ENTEROCELE, URINARY RETENTION, PELVIC ORGAN PROLAPSE, MIXED URINARY INCONTINENCE, URINARY URGENCY, URINARY FREQUENCY, NOCTURIA, RIGHT HIP PAIN, EXQUISITE PAIN WITH GENTLE PALPITATION OF VAGINAL CUFF AND RIGHT ADNEXA, SACRAL OR BUTTOCK PAIN AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Micturition Urgency; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention

  MAUDE report 11028326 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED CHEST TIGHTNESS, ABDOMINAL/INCISIONAL PAIN (ABDOMINAL PAIN), BLOOD LOSS, AND TENDERNESS. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, IMPAIRMENT, LIMITED ENJOYMENT, LIMITED ACTIVATES, TENDERNESS, SPOTTING, BLOOD LOSS, DISCOMFORT, NAUSEA, ABDOMINAL DISTENTION, ANEMIA, INABILITY TO VOID, ABDOMINAL PAIN AND NONSURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EXPOSURE AT VAGINAL APEX AND PATIENT REQUIRED ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Abdominal Distention; Abdominal Pain; Abnormal Vaginal Discharge; Anemia; Asthma; Chest Pain; Chest Tightness/Pressure; Constipation; Cramp(s) /Muscle Spasm(s); Discomfort; Injury; Intermenstrual Bleeding; Nausea; Pain; Unspecified Blood or Lymphatic problem; Urinary Tract Infection

  MAUDE report 10986705 ↗
• InjuryOct 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, THE PATIENT HAS EXPERIENCED MESH EROSION, CHRONIC PELVIC PAIN, DYSPAREUNIA, DIFFICULTY IN DEFECATION, LOWER URINARY TRACT SYMPTOMS, RECURRENCE OF THE PROLAPSE, LOWER ABDOMINAL, GROIN, AND THIGH PAIN, VAGINAL PAIN, URGE INCONTINENCE, RECURRENT CYSTOCELE, VAGINAL WALL PROLAPSE, CYSTOCELE, HERNIA, SMALL BOWEL ADHESIONS, OSTEOARTHRITIS RIGHT HIP, BUTTOCK PAIN, BLADDER PROLAPSE, SENSATION OF FOREIGN BODY, PRICKLING SENSATION, PROBLEM IN VOIDING, BOWEL OPENING, VAGINAL DISCOMFORT, VAGINAL ATROPHY, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Anxiety; Bronchitis; Chest Pain; Discomfort; Distress; Dyspareunia; Dysuria; Erosion; Failure of Implant; Fatigue; Foreign Body In Patient; Headache; Hernia; Incontinence; Injury; Micturition Urgency; Pain; Prolapse; Sore Throat; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 10767308 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS A RESULT OF HAVING ALYTE Y MESH IMPLANTED IN 2016, THE PATIENT EXPERIENCED VARIOUS AUTOIMMUNE SYNDROME INDUCED BY ADJUVANTS SYMPTOMS LIKE AILMENTS SINCE 2017, WHICH INCLUDES CHRONIC FATIGUE, MUSCLE PAIN/STIFFNESS, CONSTANT THROAT INFLAMMATION, AUTO IMMUNITY, BRAIN FOG, FORGETFULNESS, DYSPAREUNIA, PROBLEMS TO DEFECATE ETC. IT WAS FURTHER REPORTED THAT SINCE NOVEMBER 2019, THE PATIENT WAS UNABLE TO DO ANY JOB AND PAIN HAS INCREASED.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Autoimmune Disorder; Blurred Vision; Cramp(s) /Muscle Spasm(s); Cyst(s); Discomfort; Dry Eye(s); Dyspnea; Dysuria; Erosion; Extreme Exhaustion; Eye Burn; Fasciitis; Fatigue; Fever; Headache; Hypersensitivity/Allergic reaction; Inflammation; Injury; Irritability; Itching Sensation; Loss of consciousness; Memory Loss/Impairment; Muscle Weakness/Atrophy; Neck Pain; Neck Stiffness; Pain; Prolapse; Sneezing; Sore Throat; Swelling/ Edema; Swollen Lymph Nodes/Glands; Urinary Frequency / Polyuria; Vomiting; Weight Changes

  MAUDE report 10317051 ↗
• DeathJun 26, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT HAD AN ALYTE Y MESH DEVICE IMPLANTED ON (B)(6) 2013 DURING AN ABDOMINAL COLPOSACROPEXY PROCEDURE FOR VAGINAL VAULT PROLAPSE. FOLLOWING SURGERY IN (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND URINARY INCONTINENCE. BEGINNING IN (B)(6) 2017, THE PATIENT EXPERIENCED URINARY LEAKAGE AND CONTACTED GENERAL PHYSICIAN WHO REFERRED THE PATIENT TO A UROGYNAECOLOGIST. IN (B)(6) 2017, A CYSTOSCOPE REVEALED THAT THE MESH HAD ERODED INTO THE PATIENT¿S VAGINA AND DEVELOPED A VESICOVAGINAL FISTULA. IN (B)(6) 2018, THE PATIENT UNDERWENT A LASER PROCEDURE TO REMOVE THE MESH THAT HAD PERFORATED THE PATIENT'S BOWEL. THE PROCEDURE DID NOT REMOVE ALL OF THE ERODED MESH FROM THE PATIENT. THE PATIENT EXPERIENCED PAIN, DISCOMFORT, AND CHRONIC INFLAMMATION OF THE PELVIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2018. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE WAS MULTIPLE ORGAN FAILURE, ANTERIOR RECTAL PERFORATION, CHRONIC PELVIC INFLAMMATION WITH POSSIBLE SEPSIS, AND SACROCOLPOPEXY MESH REPAIR.

  Patient problems: Abdominal Pain; Death; Injury

  MAUDE report 10200037 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 10178990 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT VAGINITIS, VULVOVAGINITIS, CANDIDIASIS, VAGINAL VAULT PROLAPSE, CONTINUED PESSARY USE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, FREQUENCY, URGENCY, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL DISCHARGE, DEPRESSION, PROLAPSED OMENTUM SECONDARY TO VAGINAL WALL DEFECT (VAGINAL CUFF DEHISCENCE WITH OMENTUM IN THE VAGINA), OMENTECTOMY, PAIN AND PRESSURE WITH BLOATING IN THE UPPER ABDOMINAL AREA, CYSTOCELE, RECTOCELE, APICAL PROLAPSE, DEHISCENCE OF INTERNAL SURGICAL WOUND, INCOMPETENCE OF PUBOCERVICAL TISSUE, FEMALE PROCTOCELE, MIXED INCONTINENCE, ADHESIONS, EXPOSURE OF VAGINAL MESH, VAGINAL BULGING, PAIN AND PRESSURE IN VAGINAL/RECTAL AREA, INABILITY TO AMBULATE FOR MORE THAN A FEW MINUTES DUE TO WEAKNESS AND DISCOMFORT, PULLING SENSATION BACK OF VAGINA/RECTUM, DYSPAREUNIA, EXPOSURE OF PROLENE SUTURE, AND REMOVAL OF EXPOSED SUTURE. SHE HAS REQUIRED MULTIPLE SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Injury; Prolapse; Urinary Tract Infection

  MAUDE report 9788425 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED RECURRENT PROLAPSE, RECURRENT STRESS URINARY INCONTINENCE, MESH EROSION, CYSTOCELE, PELVIC PAIN, ADHESIONS OF THE SIGMOID COLON, THE MESH WAS FOUND TO BE ROLLED/ CURLED AND FRAYED, MESH WAS EMBEDDED IN DENSE SCAR TISSUE WITH SIGNIFICANT SCAR PLATING AND BRIDGING FIBROSIS, SIGNIFICANT SCARIFICATION OF ALL ADJACENT TISSUE THAT THE MESH WAS ATTACHED TO, AND NO ATTEMPT COULD BE MADE TO REMOVE THE MESH FROM THE VAGINA AS IT HAD ERODED THROUGH THE VAGINA SO SUBSTANTIALLY THAT THE ANTERIOR VAGINAL WALL AT THE LOCATION OF THE MESH COULD NOT BE SALVAGED AND ONE SURGICAL INTERVENTION.

  Patient problems: Erosion; Incontinence; Injury

  MAUDE report 9787117 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SYMPTOMATIC RECURRENT PELVIC PROLAPSE, PELVIC PRESSURE, A FEELING OF SOMETHING IRRITATING AND BULGING FROM HER VAGINA, CRAMPY PAIN DURING THE END OF HER URINATION (DYSURIA), CERVICAL STUMP PROLAPSE, GRANULATION TISSUE POSTERIORLY NEAR THE APEX, SUTURE EXPOSURE, URINARY FREQUENCY, MODERATE BLOOD IN URINE (HEMATURIA), URINARY TRACT INFECTION, CERVICAL SUTURE EROSION, INCOMPLETE BLADDER EMPTYING, SOMETIMES HAS TO SPLINT TO REDUCE PROLAPSE TO VOID, MESH EROSION CAUSING VAGINAL DISCHARGE, POSTERIOR VAGINAL MESH EXPOSURE, GRANULATION TISSUE AT THE VAGINAL VAULT, SMALL BOWEL ADHESIONS TO VAGINAL MESH, INTERMITTENT LOWER ABDOMINAL PAIN/CRAMPING, CONSTIPATION, DIARRHEA, REQUIRED ONE SURGICAL INTERVENTION AND MULTIPLE NONSURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9787111 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT PELVIC PAIN, BACK PAIN, PRESSURE WITH URINATION, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VAGINAL DISCHARGE, SUPRAPUBIC PAIN, SEXUAL DYSFUNCTION, DECREASED LIBIDO, DYSPAREUNIA SINCE HYSTERECTOMY WAS PERFORMED, PAIN COMING FROM CERVICAL STUMP WITH ASSOCIATED GRAFT MATERIAL, OVARIAN CYST, ISSUES CONCERNING VAGINAL MESH, FREE FLUID IN THE PELVIS, ABDOMINAL/PELVIC PAIN WITH SNEEZING, COUGHING, AND PASSING GAS X PAST 3 DAYS, CONSTIPATION, URINARY URGENCY, URINARY FREQUENCY, URINARY URGE INCONTINENCE, OVERACTIVE BLADDER, SMALL AMOUNT WHITE DISCHARGE IN VAULT, MICROABRASIONS/PETECHIAE BUT NO ACTIVE BLEEDING, MILD TO MODERATE CERVICAL MOTION TENDERNESS, MILD BLADDER WALL TENDERNESS, MILD SUPRAPUBIC TENDERNESS, AND MINIMAL ADNEXAL TENDERNESS BILATERALLY. SHE HAS REQUIRED NONSURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9770465 ↗