Align® S Suprapubic Urethral Support System BRD200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741016189), received between Jan 4, 2013 and Dec 22, 2023 — classified as 122 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Adverse 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. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED BOWEL PROBLEMS, ORGAN PERFORATION, UNSPECIFIED NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING, OVARIAN CYST, RECTOCELE (PROLAPSE), WEAK RECTOCERVICAL FASCIA, ADNEXAL TENDERNESS, RIGHT SIDED ABDOMINAL PAIN, DYSPAREUNIA, DECREASED SPHINCTER TONE, INCOMPLETE DEFECATION/BLADDER EMPTYING, URGE URINARY INCONTINENCE, SPONTANEOUS LOSS OF URINE, NEED TO CHANGE POSITION OR REDUCE PROLAPSE TO URINATE/DEFECATE, HEAVINESS/LOWER PELVIC PRESSURE, LOWER BACK PAIN, CONSTIPATION, AND REQUIRED ADDITIONAL SURGICAL AND NON SURGICAL INTERVENTIONS. PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 12/12/2017, THE PATIENT HAS EXPERIENCED PAINFUL SEX, CONSTANT BLADDER LEAKAGE/BLADDER LEAKS, DIFFICULTY URINATING, VAGINAL VAULT PROLAPSE, RECTOCELE, INCONTINENCE, ADHESIONS, BOWEL OBSTRUCTIONS, CHRONIC CONSTIPATION, COLLAGEN DISORDER, IRRITABLE BOWEL SYNDROME, DYSPAREUNIA, RECTOCELE (PROLAPSE), RECURRENT URINARY TRACT INFECTIO

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Constipation; Cyst(s); Hemorrhage/Blood Loss/Bleeding; Incontinence; Inflammation; Internal Organ Perforation; Muscle Weakness/Atrophy; Nausea; Obstruction/Occlusion; Pain; Prolapse; Scar Tissue; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 18382660 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DURING SURGERY PROLAPSED BLADDER SLING. PATIENT WAS COMPLETELY UNAWARE THAT THEY HAD ANY TYPE OF SLING OTHER THAN THE FIRST ONE THEY HAD EVER HAD, WHICH WAS FROM THE THIGH OF THE CADAVER USING THE MUSCLE OF A CADAVER THIS SURGERY WAS IN 2013 IN SURGERY CENTER. PATIENT DID NOT KNOW THEY HAD A MESH SLING INSIDE OF THEM UNTIL THEY SAW THE UROLOGIST IN 2019. IN 2013, PATIENT SAW DOCTOR AS THEY WERE EXPERIENCED STOMACH ISSUES, HORRIFIC PAINS, AND UNEXPLAINED PAIN IN THEIR RIGHT LOWER BACK. PATIENT HAD NOT HURT THEMSELF, ANYTHING. PATIENT HAD TERRIBLE UNEXPLAINED GAGGING AT TIMES, VOMITING IF THEY EVEN TOOK A DRINK OF WATER, CHOKING, AND WOULD HAVE TO RUN TO THE SINK WHEN THEY LAID DOWN. AFTER A FEW TESTS, DOCTOR INFORMED PATIENT THAT THEIR GALLBLADDER HAD RUPTURED. DOCTOR ASKED PATIENT IF THEY HAD ANY SIGNS, AND PATIENT EXPLAINED THE CHOKING, VOMITING, AND OTHER THINGS. THE START OF MANY ILLNESSES, HOSPITAL VISITS, AND THEIR BODY SLOWLY DETERIORATING OVER THESE PAST YEARS. FINDING THE MESH ON 2019 WAS THE LAST PUZZLE PIECE. PATIENT NEVER FELT THE SAME AFTER RECOVERING FROM THE SECOND SLING FOR THEIR PROLAPSED BLADDER. APPROXIMATELY SIX MONTHS LATER, PATIENT

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cognitive Changes; Emotional Changes; Fungal Infection; Malaise

  MAUDE report 17633795 ↗
• InjuryFeb 22, 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: Emotional Changes; Erosion; Incontinence; Pain

  MAUDE report 13576552 ↗
• InjuryDec 8, 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 22NOV2021, THE PATIENT HAS EXPERIENCED ABDOMINAL PAIN, REDNESS OF THE WOUND, TENDERNESS TO TOUCH, LOW GRADE TEMPERATURE, DISCOMFORT, SWELLING, ACUTE SINUSITIS, ACUTE UPPER RESPIRATORY INFECTION, ARTHRITIS, CHRONIC BACK PAIN, BRONCHITIS, CHRONIC CYSTITIS, CYSTOURETHROCELE, DEPRESSION WITH ANXIETY, DIABETES MELLITUS, DIZZINESS, DYSURIA, EDEMA, FATIGUE, GAIT DISTURBANCE, GASTROESOPHAGEAL REFLUX DISEASE, HEADACHE, HYPERLIPIDEMIA, ESSENTIAL HYPERTENSION, ASTHMA, JOINT AND HIP PAIN, MENOPAUSAL SYMPTOMS, MIDLINE CYSTOCELE, OSTEOARTHRITIS, POSTMENOPAUSAL ATROPHIC VAGINITIS, RECTOCELE, SEPSIS, SHORTNESS OF BREATH, SKIN DISORDER, WOUND INFECTION, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINITIS DUE TO CANDIDA ALBICANS, URINARY FREQUENCY AND URGENCY, NOCTURIA, BILATERAL LOWER PELVIC PAIN, SMELLY URINE, COUGH, OBESITY, PROCTOCELE WITHOUT UTERINE PROLAPSE, URINARY RETENTION, INCOMPLETE EMPTYING OF BLADDER, WEAKNESS IN EXTREMITIES, DIFFICULTY WHILE URINATION, MUSCLE ACHES, ARTHRALGIAS, IRON DEFICIENCY ANEMIA, ARTHROPATHY,

  Patient problems: Abdominal Pain; Alteration in Body Temperature; Anemia; Anxiety; Arthralgia; Arthritis; Asthma; Biliary Cirrhosis; Bronchitis; Cancer; Constipation; Cyst(s); Depression; Discomfort; Dizziness; Dyspnea; Dysuria; Fatigue; Headache; High Blood Pressure/ Hypertension; Micturition Urgency; Muscle Weakness/Atrophy; Obstruction/Occlusion; Pain; Post Operative Wound Infection; Respiratory Tract Infection; Sepsis; Sleep Dysfunction; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 12959351 ↗
• InjuryAug 9, 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 HAS EXPERIENCED INJURY, PAIN, DISABILITY AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED ON 21JUL2021, THE PATIENT HAS EXPERIENCED DYSPAREUNIA, DISCOMFORT, MESH EXPOSURE TO VAGINAL MUCOSA, POKING SENSATION WHILE SITTING, VAGINAL PAIN, PAIN DURING SEXUAL INTERCOURSE, SEXUAL FRUSTRATION, EMOTIONAL DISTRESS, DEPRESSION, FREQUENT YEAST INFECTIONS, URINARY LEAKAGE, INFECTIONS, CHRONIC CONSTIPATION, HERNIA, URINARY INCONTINENCE, ANXIETY, ACID REFLUX, RESTLESS LEG SYNDROME, TROUBLE IN SLEEPING, ABDOMINAL PAIN, URINARY HESITANCY, ABNORMAL PAP SMEAR, HEADACHE, PALPITATIONS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Anxiety; Constipation; Depression; Discomfort; Distress; Dyspareunia; Fungal Infection; Headache; Hernia; Pain; Sleep Dysfunction; Urinary Incontinence

  MAUDE report 12293806 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS ON 30MAR2022, THE PATIENT HAS EXPERIENCED PAIN, CHRONIC PELVIC PAIN, URINARY PROBLEMS, URGENCY AND PAINFUL URINATION, MESH MIGRATION, STRESS URINARY INCONTINENCE, CHRONIC CONSTIPATION, HERNIAS, HYPERTENSION, HYPOTENSION, VAGINAL PAIN, INFECTIONS, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, OBSTRUCTIVE VOIDING AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Constipation; Hernia; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Micturition Urgency; Pain; Prolapse; Urinary Incontinence

  MAUDE report 12272124 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BARD ALIGN MESH SLING INSERTED FOR BLADDER ISSUES. PATIENT WENT BACK TO THE DOCTOR A MONTH LATER COMPLAINING OF PROBLEMS AND THEN SEVERAL TIMES OVER THE YEARS. DOCTORS ALL SAID THAT THIS WAS NOT RELATED TO THE SLING. UPON VISITING DOCTOR, HE TOLD NOT TO WORRY ABOUT THIS AS SLING WAS NOT RECALLED BUT HE DID NOT TELL PATIENT THAT THERE WERE INCREASED WARNINGS ABOUT THE PRODUCT INSERTED INSIDE.

  Patient problems: Pain

  MAUDE report 12217737 ↗
• 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 VIA MEDICAL RECORDS ON 12APR2021, THE PATIENT EXPERIENCED CHRONIC PAIN IN THE LOWER ABDOMEN, UTERUS PROLAPSE, INCREASES FREQUENCY OF URINATION, HURTS TO URINATE, URINARY TRACT INFECTIONS, VAGINAL BLEEDING AFTER SEXUAL INTERCOURSE, VAGINAL ATROPHY, DYSURIA, CYSTITIS WHICH REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Dysuria; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 11706001 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED THE PATIENT HAS EXPERIENCED URINARY TRACT INFECTIONS AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Constipation; Dyspareunia; Erosion; Foreign Body In Patient; Incontinence; Pain; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 11706000 ↗
• InjuryNov 19, 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 SLING EROSION, AND UNDERWENT SURGICAL, AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury

  MAUDE report 10868074 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH PENETRATING IN THE POSTERIOR/DOME OF RIGHT SIDE OF BLADDER WITH INFLAMMATION, PELVIC PRESSURE, URINARY TRACT INFECTION, SQUEEZING/SPASMING, DYSURIA, PAIN, BLADDER PAIN, FISTULA, BLADDER INFLAMMATION, FOREIGN BODY REACTION, LOW BACK PIAN, EDEMA, ERYTHEMA, CALCIFICATION, INCONTINENCE, WORSENING ABDOMINAL PAIN, BLADDER STONE, BLADDER SPASMS, LOWER ABDOMINAL PRESSURE, DIFFICULTY WALKING DUE TO DISCOMFORT, BURNING SENSATION WHEN URINATING AND SUFFERED EMOTIONAL AND MENTAL DISTRESS, RECURRENT VAGINAL PAIN, URINARY INCONTINENCE, PELVIC PRESSURE, URINARY TRACT INFECTION, ABDOMEN FEELS TIGHT WITH PASSING GAS AND CANNOT STRAIN, CHRONIC INFLAMMATION, MESH EXPOSURE, AND URINARY FREQUENCY. ADDITIONALLY, THE PATIENT REQUIRED SURGICAL AND NON-SURGICAL INTERVENTIONS.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Calcium Deposits/Calcification; Constipation; Cramp(s) /Muscle Spasm(s); Disability; Discomfort; Distress; Dysuria; Erosion; Erythema; Fistula; Flatus; Foreign Body Reaction; High Blood Pressure/ Hypertension; Incontinence; Inflammation; Injury; Numbness; Pain; Pelvic Inflammatory Disease; Stomach Ulceration; Swelling/ Edema; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 10513795 ↗
• 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, THE PATIENT HAS EXPERIENCED BLADDER SPASMS, URGENCY, URGE INCONTINENCE, DYSPAREUNIA, FREQUENCY, OVERACTIVE BLADDER SYMPTOMS, STRESS INCONTINENCE, HEMATURIA, POSITIVE URINE CULTURE, LEFT SIDED ABDOMINAL PAIN, CONSTIPATION, MESH EROSION/EXTRUSION IN RIGHT DOME OF BLADDER REQUIRING REMOVAL, WOUND GRANULARITY, WOUND DRAINAGE, WOUND INFECTION, POSITIVE TRIGONITIS, BOTOX INJECTIONS, RECURRENT URINARY TRACT INFECTIONS, HEMATURIA, ANEMIA AND REQUIRED SURGICAL AND NONSURGICAL INTERVENTIONS.

  Patient problems: Incontinence; Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 9787062 ↗
• InjuryFeb 27, 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 BLEEDING AT THE ANTERIOR INCISION, VAGINAL SPOTTING, PERSISTENT LEAKAGE REQUIRING SEVERAL PADS PER DAY, URINE LOSS WITH WALKING, HYPERTONICITY OF THE BLADDER, MARKED STRESS INCONTINENCE WITH COUGH, UNSTABLE OR UNINHIBITED BLADDER CONTRACTIONS, PERINEAL DISCOMFORT, RESECTION OF PERINEAL SCAR BAND AND PLACEMENT OF TRANS-OBTURATOR SLING. SHE REQUIRED NONSURGICAL INTERVENTIONS AND SURGICAL INTERVENTIONS.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9764497 ↗
• InjuryFeb 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, URINARY LEAKAGE, RIGHT PELVIC MASS LOCATED ADJACENT TO THE BLADDER, OBTURATOR CANAL WHICH APPEARED TO BE COMPRESSING THE BLADDER, PELVIC ADHESIONS, CYSTOSCOPY WITH INSERTION OF BILATERAL ILLUMINATED URETERAL CATHETERS, FOLLOWED BY DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPIC RETROPERITONEAL DISSECTION, LAPAROSCOPIC PELVIC ADHESIOLYSIS, URINARY FREQUENCY, SUPRAPUBIC DISCOMFORT, FECAL INCONTINENCE, A BIOPSY OF THE RIGHT OBTURATOR WHICH SHOWED FRAGMENTS OF DENSE FIBROCONNECTIVE TISSUE, OLD HEMORRHAGE CONSISTENT WITH A HEMATOMA, URINARY TRACT INFECTIONS, PELVIC PAIN, URGENCY, DYSURIA, HEMATURIA, ABDOMINAL BLOATING, FEELING OF SOMETHING IRRITATING HER WITH INTERCOURSE, VAGINAL MESH EXPOSURE, ATROPHIC VAGINITIS, CHRONIC CYSTITIS, URGE INCONTINENCE, STRESS INCONTINENCE, ISSUES WITH STARTING AND STOPPING URINARY STREAM, ANXIETY, DEPRESSION, CHANGE IN BOWEL HABITS, RECTAL PROLAPSE, RECTOCELE, RIGHT FLANK PAIN, DIARRHEA, BLADDER TRABECULATIONS, CHRONIC CYSTITIS CYSTICA, GLANDULARIS, NOCTURIA, LOWER ABDOMINAL PRESSURE, PERSISTENT BACTERURIA, ADD

  Patient problems: Disability; Injury; Pain

  MAUDE report 9746613 ↗
• InjuryJan 23, 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, NONSURGICAL INTERVENTION AND IMPAIRMENT. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT EXPERIENCED VAGINAL MESH EXPOSURE REQUIRING EXCISION OF EXPOSED MESH.

  Patient problems: Disability; Injury; Pain

  MAUDE report 9622502 ↗
• InjuryJan 23, 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 EXPERIENCE MORE THAN AVERAGE BLEEDING, RIGHT SIDE OF THE PERIURETHRAL SPACE A SIGNIFICANT BLEEDER, BLOOD LOSS, VAGINAL VAULT PROLAPSE, CYSTOCELE, RECTOCELE, APICAL VAULT PROLAPSE, ENTEROCELE (PROLAPSE), EXTENSIVE ADHESIONS OF SMALL INTESTINE TO ANTERIOR ABDOMINAL WALL AND RIGHT ADNEXAL ADHESIONS TO APEX OF VAGINA, LOOPS OF ADHERENT BOWEL WITH DOUBLE-STRAND OF PERMANENT PROLENE SUTURE, CAPTURED A PORTION OF BOWEL, SUTURE MATERIAL IN FIBROUS TISSUE, STALK (FOREIGN BODY IN PATIENT), ADHERENCE OF RIGHT TUBE, RIGHT OVARY TO THE ANTERIOR VAGINAL WALL, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

  Patient problems: Blood Loss; Injury; Prolapse

  MAUDE report 9622090 ↗
• InjuryDec 20, 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: Abdominal Cramps; Abnormal Vaginal Discharge; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Autoimmune Disorder; Constipation; Diarrhea; Dyspareunia; Hernia; Incontinence; Injury; Pain; Swelling/ Edema

  MAUDE report 9507251 ↗
• 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PELVIC PAIN, STRESS URINARY INCONTINENCE, URGE INCONTINENCE, NOCTURIA, URINARY FREQUENCY, URGENCY, DYSURIA, INCOMPLETE EMPTYING, FECAL URGENCY, DYSPAREUNIA, PELVIC PRESSURE, CONSTANT PELVIC PAIN, VAGINAL BLEEDING, MESH EXPOSURE, MIXED INCONTINENCE, VOIDING DYSFUNCTION, POSTMENOPAUSAL ATROPHIC VAGINITIS, PELVIC MUSCLE WEAKNESS, ATROPHY, URETHRAL SCARRING, SURGICAL INTERVENTION, INFECTION, ORGAN PERFORATION AND MESH EROSION.

  Patient problems: Incontinence; Micturition Urgency; Pain

  MAUDE report 9297361 ↗
• 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Injury

  MAUDE report 9296920 ↗
• InjuryOct 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 PELVIC ORGAN PROLAPSE, VAGINAL CUFF PROLAPSE, EROSION, PAIN, EXTRUSION, INFECTION, UNSPECIFIED URINARY PROBLEMS, RECURRENCE, UNSPECIFIED BOWEL PROBLEMS, BLOOD LOSS, DYSPAREUNIA, UNSPECIFIED NEUROMUSCULAR PROBLEMS, VAGINAL SCARRING (SCAR TISSUE), NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

  Patient problems: Erosion; Injury; Prolapse

  MAUDE report 9249570 ↗
• InjuryOct 28, 2019Adverse 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 URINARY RETENTION, INCOMPLETE BLADDER EMPTYING REQUIRING INTERMITTENT SELF CATHETERIZATIONS, STRESS URINARY INCONTINENCE, NOCTURNAL ENURESIS, HESITANCY, PAIN IN THE RIGHT LOWER QUADRANT AND VAGINAL AREA, MESH EROSION, NEUROGENIC BLADDER, URINARY TRACT INFECTION AND URETHROVESICAL HYPOMOBILITY, S PERSISTENT PAIN IN VAGINA AND LOWER ABDOMEN, PELVIC TENDERNESS, PELVIC SIDEWALL LESION, CYSTOCELE, RECTOCELE, ENTEROCELE (PROLAPSE), PELVIC ORGAN PROLAPSE, PAINFUL INTERCOURSE, LOWER ABDOMINAL PAIN, INFLAMMATION, URINARY PROBLEMS, DYSURIA, URINARY URGENCY, UNSPECIFIED BOWEL PROBLEMS, CONSTIPATION, IRRITABLE BOWEL SYNDROME, PAIN, ADHESIONS, LOSS OF ENERGY, LIMITED ACTIVITY, INABILITY TO SIT OR STAND FOR LONG PERIODS, DYSPAREUNIA, HYPERTENSION/HIGH BLOOD PRESSURE, VAGINAL INFECTION, DEPRESSION, NONSURGICAL, ADDITIONAL SURGICAL INTERVENTIONS, PERSISTENT LOWER ABDOMINAL, VAGINAL PAIN, PELVIC TENDERNESS AND DISCHARGE.

  Patient problems: Incontinence; Injury; Urinary Retention

  MAUDE report 9244414 ↗
• InjuryOct 21, 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; Unspecified Infection

  MAUDE report 9214225 ↗
• InjuryOct 21, 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; Unspecified Infection

  MAUDE report 9214213 ↗
• InjuryOct 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. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED A URINARY TRACT INFECTION AND HAS REQUIRED NONSURGICAL INTERVENTION.

  Patient problems: Injury; Urinary Tract Infection

  MAUDE report 9167168 ↗
• InjuryOct 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 9161879 ↗