Align® RS Retropubic/Suprapubic Urethral Support System BRD300RSRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741016196), received between Apr 10, 2013 and Dec 14, 2022 — classified as 30 injuries.

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 30 reports, in the reporter's own words as published by the FDA.

• 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 ORGAN, TISSUE, AND NERVE DAMAGE, URINARY INCONTINENCE, MESH EROSION, PAIN, INJURY, AND HAS REQUIRED ADDITIONAL SURGERY. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON (B)(6) 2022, THE PATIENT HAS EXPERIENCED URINARY TRACT INFECTION, PELVIC PAIN, PELVIC FLOOR WEAKNESS, SPASM OF MUSCLE, DEPRESSION, RECTOVAGINAL INCOMPETENCE, RECTOCELE, VAGINAL FOREIGN BODY, PELVIC ORGAN PROLAPSES, URGE AND STRESS INCONTINENCE, URGENCY, NOCTURIA, CYSTOCELE, DYSURIA, VAGINAL MESH EROSION, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Depression; Dysuria; Erosion; Foreign Body In Patient; Incontinence; Nerve Damage; Pain; Prolapse; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 15983991 ↗
• InjuryJul 20, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bowel Perforation; Constipation; Discomfort; Erosion; Fistula; Hernia; Incontinence; Pain; Prolapse; Rectovaginal Fistula; Urinary Tract Infection

  MAUDE report 15066680 ↗
• InjuryOct 29, 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 ON 15OCT2021, THE PATIENT HAS EXPERIENCED PERSISTENT MESH EROSION, URINARY URGENCY, PAIN DURING SEXUAL INTERCOURSE, DISCOMFORT, DYSPAREUNIA AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Discomfort; Dyspareunia; Erosion; Micturition Urgency; Pain

  MAUDE report 12721305 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 11APR2022, THE PATIENT HAS EXPERIENCED VAGINAL MESH EROSION, VAGINAL INFECTION, PAIN, ABDOMINAL PAIN, PELVIC PAIN, RECURRENCE OF PROLAPSE, RECURRENCE OF INCONTINENCE, URINARY PROBLEMS, PAIN DURING INTERCOURSE TO THE POINT OF ABSTAINING, EMBARRASSMENT, FREQUENT URINARY TRACT INFECTIONS, PAIN DURING INTERCOURSE DUE TO VAGINAL SHORTENING FROM REMOVAL, ADHESIONS, CYSTOCELE, ENTEROCELE, HERNIAS, RECTOCELE, RECURRENT OR CHRONIC VAGINAL OR BLADDER INFECTIONS, RECURRENT VAGINAL PAIN, URINARY INCONTINENCE, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, ANY OTHER DISEASE OF THE GUT, INTESTINES OR BOWEL AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Adhesion(s); Anxiety; Apnea; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Asthma; Blurred Vision; Bronchitis; Cellulitis; Chills; Cyst(s); Depression; Discomfort; Distress; Dyspareunia; Dysuria; Erosion; Fatigue; Fever; Gastritis; Headache; Hematuria; Hernia; Intermenstrual Bleeding; Micturition Urgency; Nasal Obstruction; Nausea; Neck Pain; Numbness; Pain; Prolapse; Sleep Dysfunction; Sore Throat; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection; Vomiting

  MAUDE report 11706646 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED THE PATIENT HAS EXPERIENCED EROSION, DYSPAREUNIA, PAIN, INABILITY TO EMPTY BLADDER/CONTROL URINATION, URGENCY, PRESSURE SENSATION, NOCTURIA, HIGH BLOOD PRESSURE, BACK PAIN, URINE RETENTION, NUMBNESS/TINGLING, TOO HOT/COLD, TIREDNESS, SLUGGISHNESS, INDIGESTION/HEARTBURN, RECTOCELE (PROLAPSE), TENDERNESS, FOREIGN BODY IN PATIENT, STRESS URINARY INCONTINENCE, MESH EXPOSURE, BLOOD LOSS, BLOOD/BACTERIA/CRYSTALS/MUCOUS IN URINE, INFLAMMATION, CRAMPS, PELVIC PAIN, ABDOMINAL PAIN, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION, THE PATIENT HAS EXPERIENCED VAGINAL AND ANAL SPASMS, HUSBAND COMPLAINTS OF SOMETHING SCRATCHING HIM DURING INTERCOURSE, AN IN OFFICE EXCISION OF ANTERIOR VAGINAL MESH, RECURRENT URINARY INCONTINENCE, HEMATURIA, CHRONIC PAIN DISORDER, PELVIC ORGAN PROLAPSE, CONSTIPATION, A SMALL ANTERIOR VAGINAL WALL ULCERATION, ENTEROCELE, RECTOCELE, ACUTE CYSTITIS, DYSURIA, FREQUENCY, VAGINAL ATROPHY, CONTINUED PAIN WITH INTERCOURSE, AND SEVERAL AREAS OF MESH FIBER THAT WERE VISIBLE AND REQUIRED SURGICAL EXCISION, PARTIAL VAG

  Patient problems: Abdominal Pain; Erosion; Injury

  MAUDE report 10896389 ↗
• InjuryMar 24, 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, IMPAIRMENT, STRESS URINARY INCONTINENCE, ADDITIONAL NON-SURGICAL AND SURGICAL INTERVENTION, A PALPABLE SLING AND SUTURES, SLING MESH EROSION, VAGINAL EROSION OF MIDURETHRAL SLING, MIDLINE CYSTOCELE, URGENCY OF URINATION, UTERINE PROLAPSE, RECURRENT SLING EXPOSURE, ATROPHY, POOR HEALING, MESH CONTRACTURE, INTERSTITIAL CYSTITIS, PUDENDAL NEURALGIA, DYSPAREUNIA, MESH REJECTION, PELVIC PAIN, TRIGGER POINT INJECTIONS, AND PLACEMENT OF RECTUS FASCIA AUTOLOGOUS SLING.

  Patient problems: Incontinence; Injury; Pain

  MAUDE report 9871192 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, INJURY, DISABILITY, AND IMPAIRMENT.

  Patient problems: Abdominal Pain; Adhesion(s); Deformity/ Disfigurement; Diarrhea; Disability; Dyspareunia; Dysuria; Incontinence; Injury; Obstruction/Occlusion; Pain; Skin Tears; Urinary Retention; Urinary Tract Infection

  MAUDE report 9309432 ↗
• InjuryNov 8, 2019Adverse 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.

  Patient problems: Injury

  MAUDE report 9296925 ↗
• InjuryOct 3, 2019Adverse 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 9151552 ↗
• InjurySep 26, 2019Adverse 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 9124079 ↗
• InjurySep 24, 2019Adverse 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 INTRAOPERATIVE BLADDER PERFORATION, PELVIC RELAXATION, PELVIC PRESSURE, UTERINE PROLAPSE AND FEELING A BULGE IN VAGINA, PAIN, PULLING, LIMITED MOVEMENT, RECURRENT THIRD DEGREE UTERINE PROLAPSE, HYPERTROPHY OF THE UTERUS, LEIOMYOMA OF THE UTERUS, CHRONIC CERVICITIS AND ONE SURGICAL INTERVENTION.

  Patient problems: Injury; Perforation; Prolapse

  MAUDE report 9110815 ↗
• InjurySep 12, 2019Adverse 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 9007922 ↗
• InjuryAug 29, 2019Adverse 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 POSITIVE URINE CULTURES, PELVIC PAIN, MESH EROSION, DYSPAREUNIA FROM A PREVIOUS MESH PROCEDURE, NONFUNCTIONING PREVIOUS URETHRAL SLING, RECTOCELE WITH WEAKNESS AND ABSENCE OF THE RECTOVAGINAL FASCIA, VAGINAL PROLAPSE, URINARY INCONTINENCE, AND AN EXTREMELY TIGHT BAND OF MESH. SHE HAS REQUIRED ONE SURGICAL INTERVENTION.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 8945686 ↗
• InjuryAug 22, 2019Adverse 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 STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, COITAL PAIN, CYSTOCELE, RECTOCELE, URETHRAL HYPERMOBILITY, LABIAL HYPERTROPHY WITH REDUCTION AND REQUIRED ONE SURGICAL INTERVENTION.

  Patient problems: Incontinence; Injury; Prolapse

  MAUDE report 8921757 ↗
• InjuryAug 9, 2019Adverse 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 8878524 ↗
• InjuryAug 7, 2019Adverse 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 8870138 ↗
• InjuryJul 26, 2019Adverse 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 8833562 ↗
• InjuryJul 24, 2019Adverse 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 8822407 ↗
• InjuryJul 3, 2019Adverse 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 A SLOW URINE STREAM, HUSBAND FEELING SCRAPING DURING INTERCOURSE, EXPOSED AND ERODED VAGINAL SLING MESH, VAGINAL BLEEDING, CONSTIPATION, URINARY URGENCY, VAGINAL DEFECT WITH UNDERLYING SLING EDGE WITH IN OFFICE REMOVAL, VAGINAL SPOTTING, VAGINAL PRESSURE, MASS COMING OUT OF VAGINA, SECOND DEGREE CYSTOCELE, URINARY TRACT INFECTION, SILVER NITRATE APPLICATION TO GRANULATION TISSUE OF MIDURETERAL WOUND, PESSARY TRIAL WITH REMOVAL THE FOLLOWING DAY DUE TO ACUTE PELVIC PAIN, PELVIC PRESSURE, CHRONIC INFECTION, VAGINAL DISCHARGE, URINARY FREQUENCY, EXCISION OF VAGINAL MESH, REPAIR OF VAGINAL WALL, LOWER RIGHT BACK PAIN, ABDOMINAL PAIN, REQUIRED SURGICAL AND NONSURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Intermenstrual Bleeding

  MAUDE report 8757735 ↗
• InjuryJul 2, 2019Adverse 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 8753007 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUGUST 2017 QUARTERLY ASR REPORT.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 6829665 ↗
• InjurySep 19, 2013Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Constipation; Cyst(s); Erosion; Injury; Pain; Prolapse; Urinary Retention

  MAUDE report 3366375 ↗
• InjurySep 18, 2013Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Erosion; Incontinence; Injury; Pain; Scarring; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 3370123 ↗
• InjuryAug 29, 2013Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Erosion; Hematuria; Incontinence; Inflammation; Injury; Urinary Retention; Urinary Tract Infection

  MAUDE report 3327005 ↗
• InjuryJun 18, 2013Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02451 AND 1018233-2013-02452.

  Patient problems: Adhesion(s); Bacterial Infection; Bowel Perforation; Erosion; Foreign Body In Patient; Incontinence; Injury; Muscle Weakness/Atrophy; Pain; Thrombus; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 3184416 ↗