Uphold™ LITE M0068318170Recalls & reported problems

Summary

The FDA's MAUDE database contains 459 adverse event reports that list this exact device (DI 08714729839200), received between Nov 17, 2016 and Nov 28, 2024 — classified as 263 injuries, 196 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (169 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 12, 2018Class IITerminated

   Potential for Capio sutures to break and /or detach.

   Z-1622-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 459 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX SYSTEM - CURVED AND UPHOLD LITE. AS A RESULT OF THE MESH IMPLANT, THE PATIENT EXPERIENCED EROSION OF THE MESH TO THE URETHRA, FREQUENT URINARY TRACT INFECTIONS, PURULENT VAGINAL DISCHARGE, PELVIC PAIN, AND DYSPAREUNIA. ON (B)(6) 2023, THE PATIENT UNDERWENT MESH REVISION SURGERY. SHE CLAIMED TO HAVE SUFFERED SEVERE PAIN, UNNECESSARY EXPENSE, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTATION. ADDITIONALLY, THE PATIENT MAY HAVE TO UNDERGO ADDITIONAL SURGERY IN THE FUTURE AND MAY CONTINUE TO SUFFER SIGNIFICANT PAIN, AND UNNECESSARY MEDICAL EXPENSES FOR MEDICAL CARE, TREATMENT, AND THERAPIES LONG INTO THE FUTURE. FURTHERMORE, SHE SUSTAINED AND WILL CONTINUE TO SUSTAIN IN THE FUTURE, THE FOLLOWING DAMAGES AS A RESULT OF THE IMPLANTATION: SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY INJURY, MENTAL AND PHYSICAL PAIN, AND SUFFERING, AND HAS INCURRED ECONOMIC LOSS. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-74954 FOR THE OBTRYX SYSTEM - CURVED DEVICE, AND 2124215-2024-74964 FOR UPHOLD LITE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Chest Pain; Constipation; Dyspareunia; Dyspnea; Dysuria; Erosion; Fecal Incontinence; Incontinence; Micturition Urgency; Pain; Prolapse; Rash; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 20805516 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD PS 8/14. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE WAS IMPLANTED INTO THE PATIENT DURING ROBOT XI ASSISTED SACROCOLPOPEXY, ROBOT LAPAROSCOPIC SACROCOLPOPEXY, LYSIS OF ADHESIONS, AND CYSTOSCOPY PROCEDURES PERFORMED ON JUNE 12, 2020, FOR THE TREATMENT OF MIDLINE CYSTOCELE. DURING THE SURGICAL INTERVENTION, THE SURGEON NOTED THE PRESENCE OF MAJOR BOWEL AND OMENTAL ADHESIONS IN THE CENTRAL AND LEFT REGIONS OF THE PATIENT'S ABDOMEN. ADDITIONALLY, THE SURGEON OBSERVED THAT THE RECTUS MUSCLES WERE NOT FUSED IN THE CENTER AND THERE WAS A MAJOR DEFECT LOCATED ON THE FRONT OF THE ABDOMEN THAT WAS RELATED TO THE BLADDER. HOWEVER, NO INJURY OR BLEEDING WAS DETECTED DURING CYSTOSCOPY, AND BOTH URETERIC ORIFICES WERE PROPERLY POSITIONED WITH CLEAR URINE DRAINAGE. MOREOVER, THE PATIENT TOLERATED THE PROCEDURE WELL AT THE END OF THE PROCEDURE THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM WITHOUT ANY COMPLICATIONS. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17541086 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 3005099803-2023-00678 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE AND ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2016. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AS A RESULT OF THE IMPLANTATION OF THE PRIOR DESIGNATED PELVIC MESH PRODUCT: DYSPAREUNIA, CHRONIC PAIN, EROSION, EROSION OF THE BLADDER MESH INTO THE BLADDER, INFECTIONS, REVISION SURGERIES, SCARRING AND LOSS OF ENJOYMENT OF LIFE. MOREOVER, THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING DAMAGES AS A RESULT OF THE IMPLANTATION OF THE PRIOR DESIGNATED PELVIC MESH PRODUCT: PHYSICAL PAIN AND MENTAL ANGUISH SUSTAINED IN THE PAST; PHYSICAL PAIN AND MENTAL ANGUISH, THAT IN REASONABLE PROBABILITY, PATIENT WILL SUSTAIN IN THE FUTURE. PHYSICAL IMPAIRMENT SUSTAINED IN THE PAST; PHYSICAL IMPAIRMENT THAT, IN REASONABLE PROBABILITY, PATIENT WILL SUSTAIN IN THE FUTURE MEDICAL CARE EXPENSED INCURRED IN THE PAST; AND MEDICAL CARE EXPENSES THAT, IN REASONABLE PROB

  Patient problems: Abdominal Pain; Anxiety; Diarrhea; Discomfort; Dyspareunia; Dysuria; Erosion; Micturition Urgency; Nausea; Obstruction/Occlusion; Pain; Prolapse; Rash; Scar Tissue; Unspecified Infection; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection; Vomiting

  MAUDE report 16378021 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2022-03673 FOR THE FIRST SOLYX SIS SYSTEM, AND 3005099803-2023-00661 FOR THE SECOND UPHOLD (TM) LITE W/ CAPIO SLIM. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE AND SOLYX SIS SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL VAGINAL HYSTERECTOMY, ANTERIOR REPAIR, UTEROSACRAL COLPOPEXY, POSTERIOR REPAIR AND TENSION-FREE VAGINAL TAPE PROCEDURE PERFORMED ON (B)(6) 2018 FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. AS A DIRECT AND PROXIMATE CAUSE OF HAVING THE SOLYX AND UPHOLD DEVICES IMPLANTED IN THE PATIENT, SHE HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, INCLUDING EROSION INTO THE BLADDER, DYSPAREUNIA, NEUROMUSCULAR PAIN, PELVIC PAIN, ABDOMINAL PAIN, GROIN PAIN, RECURRENCE OF INCONTINENCE, URINARY PROBLEMS, AND VAGINAL SCARRING. THE PATIENT HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES. SHE HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND/OR LOST I

  Patient problems: Abdominal Pain; Anxiety; Calcium Deposits/Calcification; Depression; Dyspareunia; Erosion; Insufficient Information; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 16370895 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR VAGINAL REPAIR + UPHOLD MESH, TVT EXACT RETROPUBIC SLING + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014 FOR THE TREATMENT OF RECURRENT CYSTOCELE AND STRESS INCONTINENCE. ON (B)(6) 2015, THE PATIENT WAS SEEN FOR MESH SURVEILLANCE. AT THAT TIME, THE PATIENT REPORTED SHE HAD BEEN WELL, BUT OVER THE LAST 6 TO 8 WEEKS SHE INTERMITTENTLY FELT SOME SLIGHT PROLAPSE SENSATION AND PERHAPS A SLIGHT INCOMPLETE EMPTYING SENSATION IN HER BLADDER. SHE WAS A LITTLE CONSTIPATED THEN. THERE HAS BEEN NO STRESS INCONTINENCE OTHERWISE. DURING THE DAY, SHE WILL ONLY VOID 6-8 TIMES, AND ONCE TO TWICE OVERNIGHT. HER URINARY FLOW IS GENERALLY GOOD AND DOES NOT STOP STARTING; THERE IS NO CONSISTENT INCOMPLETE BLADDER EMPTYING SENSATION. BOWEL HABITS ARE SOMEWHAT IRREGULAR AS PER USUAL. HAS NO DYSPAREUNIA AND HAS BEEN USING VAGIFEM PESSARIES. A CLINICAL EXAMINATION FOUND NO SIGNIFICANT PROLAPSE APART FROM POSTERIOR VAGINAL WALL LAXITY. THERE WAS NO MESH EXPOSURE OR TENDERNESS. ON (B)(6) 2017, THE PATIENT WAS SEEN FOR ANOTHER MESH SURVEILLANCE REVIEW. THE PATIENT HAD R

  Patient problems: Constipation; Discomfort; Dysuria; Insufficient Information; Micturition Urgency; Pain; Prolapse; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 15392963 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE FOR REPAIR OF ENTEROCELE AND PERINEAL BODY + CYSTOSCOPY PERFORMED ON (B)(6) 2016 FOR TREATMENT OF PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15121211 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAP LSO (LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY) + UPHOLD PROCEDURE + POSTERIOR REPAIR WITH BIOLOGIC GRAFT + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018 FOR THE TREATMENT OF CYSTOCELE, RECTOCELE AND STRESS URINARY INCONTINENCE. AFTER THE IMPLANT, THE PATIENT HAD EXPERIENCED PELVIC PAIN AND LABIAL ADHESIONS. ON (B)(6) 2020, THE PATIENT UNDERWENT A VAGINAL MESH EXCISION, ANTERIOR REPAIR, SEPARATION OF LABIAL ADHESIONS AND CYSTOSCOPY PROCEDURE. ON INITIAL EXAM, THE PATIENT HAD A BANDED APICAL MESH. THE SLING APPEARED TO BE LAYING FLAT AND OFF TENSION. THERE WERE LABIAL AND CLITORAL ADHESIONS CREATING SKIN BANDING. THE MESH WAS SHARPLY DIVIDED IN THE MIDLINE AND SHARP DISSECTION WAS THEN PERFORMED TO THE SACROSPINOUS LIGAMENTS BILATERALLY MOBILIZING THE MESH AND THEN EXCISING THE MESH AT THE BASE. ANTERIOR REPAIR WAS THEN PERFORMED USING 2-0 VICRYL IN AN IMBRICATING MANNER, THE VAGINA CLOSED IN A RUNNING FASHION USING 2-0 VICRYL, AND PERINEUM REPAIRED USING MATTRESS STITCHES OF 2-0 VICRYL. CYSTOSCOPY WAS THEN PERFORMED SHOWING NO EVIDENCE OF BLADDER OR URETHRAL INJURY.

  Patient problems: Adhesion(s); Pain

  MAUDE report 15095205 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS USED DURING AN ANTERIOR REPAIR WITH GRAFT, CUFF SUSPENSION WITH GRAFT, AND POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF RECURRENT PROLAPSE WITH AN ESTIMATED BLOOD LOSS OF 200 ML. ON (B)(6) 2019, THE PATIENT UNDERWENT VAGINAL MESH EXCISION AND A CYSTOSCOPY PROCEDURE FOR THE TREATMENT OF ATROPHIC VAGINITIS AND A SENSATION OF PRESSURE IN THE BLADDER AREA. MOREOVER, THE PATIENT PRESENTED WITH AN EXTENSIVE HISTORY OF RECONSTRUCTIVE PELVIC FLOOR SURGERY, WHO HAD COMPLAINTS OF PELVIC PAIN AND VAGINAL SPOTTING IN THE SETTING OF APICAL MESH EXPOSURE IN THE VAGINA AND DESIRED SURGICAL MANAGEMENT. SHE DOES HAVE A HISTORY OF CHRONIC PAIN, INCLUDING EVIDENCE OF LEVATOR SPASM ON EXAM. SHE ALSO REPORTED THAT SHE EXPERIENCED URINARY URGENCY AND BLADDER DISCOMFORT AT TIMES WITH A VERY FULL BLADDER.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Erosion; Hemorrhage/Blood Loss/Bleeding; Micturition Urgency; Pain; Unspecified Tissue Injury

  MAUDE report 15094304 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED DURING AN ANTERIOR VAGINAL REPAIR USING UPHOLD MESH, POSTERIOR VAGINAL REPAIR AND CYSTOSCOPY PROCEDURES PERFORMED ON (B)(6) 2017. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. THE PATIENT WAS SCHEDULED BY THE PHYSICIAN FOR A FOLLOW-UP AND SURGERY ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 15086256 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS USED DURING AN ANTERIOR REPAIR WITH GRAFT CUFF SUSPENSION WITH GRAFT AND POSTERIOR REPAIR WITH ENTEROCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF VAGINAL PROLAPSE. ON (B)(6) 2020, THE PATIENT UNDERWENT RESECTION AND REMOVAL OF THE VAGINAL CUFF MESH GRAFT BECAUSE SHE HAD VAGINAL MESH GRAFT EXTRUSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM. SHE WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION AFTER GENERAL ENDOTRACHEAL ANESTHESIA HAD BEEN PERFORMED AND PLACED IN THE HIGH LITHOTOMY POSITION. A WEIGHTED SPECULUM WAS PLACED INTO THE VAGINA AND AN UPPER BLADE WAS DONE. THE GRAFT EXTRUSION WAS ISOLATED INTO THE VAGINAL CUFF. AN INCISION WAS MADE AROUND THE VAGINAL CUFF AREA. THE GRAFT WAS THEN DISSECTED OUT USING TENOTOMY SCISSORS WITH PICKUPS UNTIL COMPLETELY MOVING THAT SECTION. ALL AREAS WERE CHECKED AND NOTED TO BE HEMOSTATIC AFTER USE OF BOVIE CAUTERIZATION. THE AREA WAS OVERSEWN WITH 2-0 MONOCRYL SUTURE IN A RUNNING CONTINUOUS FASHION. THE 2ND AREA WAS NOTED WITH SOME GRAFT EROSION ANTERIORLY. THIS WAS OPENED AND ALSO REMOVED AND OVERSEWN WITH 2-0 MONOCRYL

  Patient problems: Abnormal Vaginal Discharge; Discomfort; Erosion; Pain

  MAUDE report 15071768 ↗
• InjuryJun 21, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2011 AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AND UNDERWENT A MESH REMOVAL SURGERY ON (B)(6) 2021.

  Patient problems: Abnormal Vaginal Discharge; Adhesion(s); Dyspareunia; Erosion; Insufficient Information; Micturition Urgency; Obstruction/Occlusion; Pain; Prolapse; Swelling/ Edema; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 14764624 ↗
• InjuryJun 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE AND AN ADVANTAGE SYSTEM WERE USED DURING A TOTAL VAGINAL HYSTERECTOMY, ANTERIOR/POSTERIOR REPAIR, SACROSPINOUS LIGAMENT FIXATION WITH ADVANTAGE MID-URETHRAL SLING RETROPUBIC AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2015, FOR THE TREATMENT OF MENORRHAGIA, UTERINE PROLAPSE, AND STRESS URINARY INCONTINENCE. FINDINGS INCLUDED CYSTOCELE, UTERINE PROLAPSE WITH APICAL PROLAPSE, AND PERINEAL RELAXATION. ON (B)(6) 2018, THE PATIENT UNDERWENT VAGINAL MESH EXCISION. SHE HAD VAGINAL PAIN AND DYSPAREUNIA WITH COMPLICATION OF VAGINAL MESH. DURING THE PROCEDURE, A TRANSVERSE INCISION WAS MADE WITH A SCALPEL AND METZENBAUM USED TO UNDERMINE THE VAGINAL EPITHELIUM. BLUE COLORED MESH WAS ENCOUNTERED IN THE ANTERIOR VAGINAL WALL WITH ARMS EXTENDING IN THE DIRECTION OF THE SACROSPINOUS LIGAMENT. SHARP DISSECTION WAS USED TO DISSECT FREE THE VAGINAL SIDE OF THE MESH. NEXT, AN SHNIDT WAS PASSED UNDERNEATH THE MEDIAL PORTION OF THE MESH, AND CAREFUL SHARP DISSECTION WAS USED TO DISSECT THE MEDIAL PORTION OF THE MESH. THE MESH WA

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Constipation; Cramp(s) /Muscle Spasm(s); Discomfort; Dyspareunia; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Muscle Weakness/Atrophy; Nerve Damage; Obstruction/Occlusion; Pain; Prolapse; Scar Tissue; Urinary Incontinence

  MAUDE report 14672657 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE PELVIC FLOOR REPAIR KIT AND AN UPHOLD LITE WITH CAPIO SLIM DEVICE WERE USED DURING AN ANTERIOR/POSTERIOR REPAIR AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14552511 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WITH CAPIO SLIM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR REPAIR WITH UPHOLD LITE MESH + SACROSPINOUS COLPOPEXY + CYSTOSCOPY CONVENTIONAL POSTERIOR REPAIR (CARDOZO METHOD) PROCEDURE PERFORMED ON (B)(6) 2017 FOR THE TREATMENT OF SYMPTOMATIC CYSTOCELE, URGENCY, PRIOR HYSTERECTOMY AND FAILED CONVENTIONAL SURGERY. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14432126 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD (TM) LITE WITH CAPIO SLIM DEVICE WAS USED DURING A MONARCH, ANTERIOR/POSTERIOR TRANSVAGINAL SACROSPINOUS FIXATION (AP TVSSF), USING UPHOLD-PINNACLE FOR ANTERIOR REPAIR AND NATIVE TISSUE FOR POSTERIOR REPAIR, FOLLOWED BY CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2015 TO TREAT ANTERIOR VAGINAL PROLAPSE, AND STRESS INCONTINENCE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14408853 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE WAS IMPLANTED INTO THE PATIENT DURING ANTERIOR REPAIR WITH UPHOLD, POSTERIOR REPAIR AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14333318 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES IMPLANTED INTO THE PATIENT DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - CURVED AND AN UPHOLD LITE WITH CAPIO SLIM DEVICE WERE IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2018. AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Burning Sensation; Depression; Discomfort; Dyspareunia; Erosion; Insufficient Information; Micturition Urgency; Nerve Damage; Pain; Prolapse; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 13787734 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE DEVICE AND AN OBTRYX II SYSTEM - HALO DEVICE WERE IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2018. AFTER THE PROCEDURE, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY AND UNDERWENT A DEVICE REMOVAL ON (B)(6) 2019.

  Patient problems: Constipation; Dyspareunia; Dysuria; Erosion; Fecal Incontinence; Hematuria; Insufficient Information; Micturition Urgency; Nausea; Pain; Prolapse; Unspecified Tissue Injury; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 13474093 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A CYSTOCELE REPAIR WITH UPHOLD MESH, VESICOURETHROPEXY (WITH NON-BSC SLING), ENTEROCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2019 FOR THE TREATMENT OF CYSTOCELE AND STRESS INCONTINENCE. SHE UNDERWENT CONCOMITANT LAPAROSCOPIC ASSISTED HYSTERECTOMY, BILATERAL SALPINGECTOOPHORECTOMY BY ANOTHER SURGEON PRIOR TO THE MESH PLACEMENT PART OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE SATISFACTORILY AND WAS DISCHARGED ON POST-OPERATIVE DAY 1 TOLERATING A REGULAR DIET, AMBULATING / VOIDING WITHOUT DIFFICULTY, AND WITH PAIN CONTROLLED BY PO MEDS. THE PATIENT WAS SEEN FOR A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2019. AT THAT VISIT THE PATIENT REPORTED SHE WAS STILL HAVING A LOT OF PAIN BUT IT WAS GETTING BETTER EACH DAY. SHE WAS STILL HAVING BROWN COLORED VAGINAL DISCHARGE AND WAS CHANGING HER PAD FREQUENTLY DUE TO THE SMELL. VAGINAL EXAMINATION REVEALED INFECTED UPHOLD MESH WITH GAPING OF THE ANTERIOR VAGINAL WALL, EXPOSED MESH WITH PURULENT BLOODY DISCHARGE. CULTURE AND SENSITIVITY WERE TAKEN AND IT WAS DECIDED THAT THE MESH WOULD BE REMOVED THE

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Necrosis; Pain; Purulent Discharge; Unspecified Infection; Urinary Tract Infection

  MAUDE report 13006449 ↗
• InjuryDec 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WAS IMPLANTED ON (B)(6) 2014. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PERIN PAIN; ANAL PAIN; RECT PAIN; BOTH PAIN (PAIN IN LEFT SIDE OF ABDOMEN (STABBING)); PAIN INTER; DIFF BOWEL; REC INCONT; AGGRAV INCONT; PSYCH. SURGICAL INTERVENTIONS: ON (B)(6) 2017 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPHOLD LITE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: ALLEVIATION OF COMPLICATIONS FROM INITIAL SURGERY . NONSURGICAL TREATMENTS: ON (B)(6) 2014 THE PATIENT COMMENCED PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING) FOR THE TREATMENT OF: RELIEF FROM DISCOMFORT/PAIN . ON (B)(6) 2014 THE PATIENT COMMENCED TOPICAL TREATMENT (INCLUDING OESTROGEN CREAM): LUBRICATION FOR THE TREATMENT OF: NEEDED FOR INTERCOURSE (GM ASSOCIATES WITH IMPLANT). TREATMENT DURATION: 7 YEARS. BOSTON SCIENTIFIC RECEIVED AN ADDITIONAL INFORMATION ON JULY 27, 2022 AS FOLLOWS: IT WAS REPORTED TO BOSTON S

  Patient problems: Constipation; Discomfort; Dyspareunia; Erosion; Incontinence; Inflammation; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 12930729 ↗
• InjuryDec 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WAS IMPLANTED ON FEBRUARY 7, 2017. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP (EROSION/EXTRUSION/PROTRUSION); BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PERINEUM PAIN; ANAL PAIN; RECTAL PAIN; THIGH PAIN; OTHER PAIN (PAIN WHEN I COUGH OR SNEEZE OR IF I GET UP TO FAST OR IF I STAND FOR MANY HOURS AT WORK ); PAINFUL INTERCOURSE; INABILITY TO HAVE INTERCOURSE; OFFENSIVE VAGINAL DISCHARGE; DIFFICULTIES WITH BOWEL MOTIONS; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; AGGRAVATED INCONTINENCE; DAMAGE; PSYCHIATRIC INJURY. SURGICAL INTERVENTIONS: ON (B)(6) 2018 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPHOLD LITE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: HAVING PAIN AND NOT BEING ABLE TO HOLD URINE AND ALWAYS LEAKING. NONSURGICAL TREATMENTS: ON FEBRUARY 7, 2017 THE PATIENT COMMENCED PAIN MEDICATION: NUROFIN, PANADOL, TRAMADOL, FOR: PAIN RELIEF. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 2, 2022: ON (B)(6) 2017, THE UPHOLD LITE WITH CAPIO SLIM DEVICE WAS IMPLANTED AS PART OF A PROCEDURE TO ADDRESS UT

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain; Perforation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 12930694 ↗
• InjuryDec 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UPHOLD LITE IMPLANT WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2017. THE PATIENT EXPERIENCED COMPLICATIONS, FURTHER SURGERY, AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP (EROSION/EXTRUSION/PROTRUSION OF THE MESH); BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PERINEUM PAIN; ANAL PAIN; RECTAL PAIN; THIGH PAIN; PAINFUL INTERCOURSE; OFFENSIVE VAGINAL DISCHARGE; DIFFICULTIES WITH BOWEL MOTIONS; INCONTINENCE NOT PRESENT BEFORE IMPLANT; RECURRENT INCONTINENCE; AGGRAVATED INCONTINENCE; DAMAGE; PSYCHIATRIC INJURY SURGICAL INTERVENTIONS: ON (B)(6) 2021 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPHOLD LITE IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: TO TRY AND FIX EROSION - THIS SURGERY HAD NOT HAPPENED YET AT THE TIME THE INFORMATION WAS PROVIDED TO THE LAW FIRM, BUT WAS SCHEDULED TO OCCUR AS INDICATED.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 12930682 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WAS IMPLANTED INTO THE PATIENT DURING A REPAIR ENTEROCELE AND PERINEAL BODY + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016 FOR PROLAPSE. POSTOPERATIVELY, THE PATIENT EXPERIENCED COMPLICATIONS AND HAD NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE ANAL PAIN, RECTAL PAIN, PAIN DURING INTERCOURSE, DIFFICULTY IN BOWEL MOVEMENT, INCONTINENCE NOT PREVIOUSLY PRESENT, AND PSYCHIATRIC INJURY. ON (B)(6) 2016, THE PATIENT HAD TOPICAL TREATMENT INCLUDING ESTROGEN CREAM TO HEAL AND IMPROVE PHYSICAL FUNCTIONS.

  Patient problems: Constipation; Dyspareunia; Incontinence; Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 12929236 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE WAS IMPLANTED ON (B)(6) 2014. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; ANAL PAIN; THI PAIN; PAIN INTER; INAB INTER; REC INCONT; PSYCH NONSURGICAL TREATMENTS: THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION: PORAXTINE FOR THE TREATMENT OF: ANXIETY. TREATMENT DURATION: 6. ON MARCH 3, 2021 THE PATIENT COMMENCED TOPICAL TREATMENT (INCLUDING OESTROGEN CREAM): ESTRIOL FOR THE TREATMENT OF: IN CONTINENCE . TREATMENT DURATION: ONGOING . ***ADDITIONAL INFORMATION RECEIVED ON AUGUST 24, 2022*** THE PROCEDURES PERFORMED ON (B)(6) 2014 WERE UPHOLD LITE MESH IMPLANT, ANTERIOR AND POSTERIOR REPAIR, CYSTOSCOPY, BILATERAL LABIAPLASTY, REPAIR OF BLADDER INJURY, AND RETROGRADE URETEROGRAM TO TREAT THE PATIENT'S POST HYSTERECTOMY PROLAPSE, VAULT DESCENT TO +1 CM, CYSTOCELE TO +1 CM, RECTOCELE TO +2 CM, ACCIDENTAL BLADDER INJURY LEFT SIDE OF TRIGONE NEAR LEFT URETERIC ORIFICE, PATHOLOGICALLY ENLARGED LABIA MINORA WITH LEFT SIDED TEAR, AND SMALL CIRCULAR "HOLE" RIGHT. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT WILL NEED AN INDWELLING CATHETER

  Patient problems: Dyspareunia; Incontinence; Laceration(s); Pain; Perforation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 12928661 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED WITH THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2021-06803 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UPHOLD LITE IMPLANT AND A OBTRYX II IMPLANT WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2018. THE PATIENT EXPERIENCED COMPLICATIONS AND FURTHER SURGERY. PATIENT SYMPTOMS INCLUDE: EEP; VAGINAL PAIN; PAIN INTER; INAB INTER; OFF VAG DIS; DIFF BOWEL; INCONT NOT PRES; SURGICAL INTERVENTIONS: ON (B)(6) 2021 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE OBTRYX II IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: REMOVAL OF ERODED MESH AND BOTOX PUT INTO MY BLADDER TO HELP WITH INCONTINENCE. ADDITIONAL INFORMATION AS OF 02NOV2022: THE PROCEDURE PERFORMED ON, (B)(6) 2018, WAS ANTERIOR AND POSTERIOR VAGINAL WALL REPAIR, SACROSPINOUS FIXATION, MID-URETHRAL SLING PROCEDURE.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Incontinence; Insufficient Information; Pain

  MAUDE report 12928609 ↗