Upsylon™ M0068318200Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 08714729839217), received between Dec 5, 2017 and Jun 22, 2026 — classified as 116 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPYSLON Y-MESH WAS IMPLANTED INTO THE PATIENT DURING A ROBOTIC-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY AND LABIOPLASTY PROCEDURES ON (B)(6) 2023, FOR THE TREATMENT OF VAGINAL VAULT PROLAPSE. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED DEVICE MALFUNCTION OR COMPLICATIONS, AND NO MESH EXPOSURE WAS NOTED AT THAT TIME. ON (B)(6) 2025, THE PATIENT PRESENTED WITH VAGINAL PAIN AND COMPLICATIONS RELATED TO THE IMPLANTED DEVICE, SPECIFICALLY EXPOSURE OF THE URETHRAL MESH. INTRAOPERATIVE FINDINGS REVEALED THAT THE ANTERIOR ARM OF THE SACROCOLPOPEXY MESH HAD RETRACTED AT THE APEX, AND THE EXPOSED MESH WAS SUBSEQUENTLY EXCISED AND REMOVED DURING A ROBOTIC-ASSISTED LAPAROSCOPIC PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION WAS STABLE, AND SHE WAS TRANSPORTED TO THE RECOVERY ROOM HAVING TOLERATED THE PROCEDURE WELL.

  Patient problems: Erosion; Pain

  MAUDE report 25588487 ↗
• MalfunctionJun 12, 2026Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A SACROCOLPOPEXY PROCEDURE USING AN UPSYLON DEVICE, THE MESH WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491492 ↗
• MalfunctionJun 11, 2026Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT UPON OPENING THE DEVICE PRIOR TO A ROBOTIC SACROCOLPOPEXY PROCEDURE, THE SHIPPING BOX OF AN UPSYLON DEVICE APPEARED TO HAVE BEEN DAMAGED DURING TRANSIT. DUE TO CONCERNS THAT THE DAMAGE MAY HAVE COMPROMISED THE STERILITY OF THE DEVICE, A NEW DEVICE WAS OPENED AND USED, WHICH WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477428 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THE TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH AND LYNX SYSTEM DEVICES WERE IMPLANTED IN THE PATIENT DURING ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH CYSTOSCOPY, SACROCOLPOPEXY, PERINEORRHAPHY, AND A TENSION-FREE MID-URETHRAL SLING; THERE WERE NO INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. FOLLOWING THE PROCEDURE, THE PATIENT HAD A URETHRAL MESH EROSION WITH SCARRING AND URETHRAL STRICTURE, WHICH PRESENTED AS DYSURIA, HEMATURIA, AND RECURRENT URINARY TRACT INFECTIONS. THE PATIENT SUBSEQUENTLY UNDERWENT A REMOVAL OR REVISION OF VAGINAL MESH, CYSTOSCOPY AND COMPLEX URETHROPLASTY ON (B)(6) 2025. THERE WAS NO BLADDER PERFORATION OR INTRAVESICAL MESH MIGRATION, ESTIMATED BLOOD LOSS WAS 400 ML, NO INTRAOPERATIVE COMPLICATIONS OCCURRED, THE PATIENT TOLERATED THE PROCEDURE WELL, AND POSTOPERATIVE STATUS INCLUDED AN INDWELLING 18F FOLEY CATHETER WITH PLANNED REMOVAL AFTER 14 DAYS AND ROUTINE FOLLOW-UP.

  Patient problems: Dysuria; Erosion; Hematuria; Scar Tissue; Urethral Stenosis/Stricture; Urinary Tract Infection

  MAUDE report 24337569 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN OBTRYX - CURVE AND UPSYLON Y-MESH FOR THE TREATMENT OF PROLAPSE AND STRESS URINARY INCONTINENCE ON A TRANSOBTURATOR TAPE SLING PROCEDURE PERFORMED ON (b)(6) 2023. DURING THE SAME PROCEDURE, PERINEORRHAPHY AND CYSTOSCOPY WERE ALSO PERFORMED.ON(b)(6) 2024, SIGMOID COLON PATHOLOGY WAS PERFORMED AND DEMONSTRATED NO SIGNIFICANT ABNORMALITY, WITH MULTIPLE DEEPER TISSUE LEVELS EXAMINED. ON (b)(6)2024, ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE WAS IDENTIFIED. ON (b)(6) 2025, THE PATIENT UNDERWENT BILATERAL SCREENING MAMMOGRAPHY, WHICH REVEALED ASYMMETRY IN THE LEFT BREAST WITH EQUIVOCAL DISTORTION AND AN ADJACENT POTENTIAL MASS. A LEFT 3-D MAMMOGRAM AND ULTRASOUND WERE RECOMMENDED FOR FURTHER EVALUATION, WHILE THE RIGHT BREAST MAMMOGRAM WAS NEGATIVE. ADDITIONAL IMAGING FINDINGS CLASSIFIED THE BREAST TISSUE AS DENSITY CATEGORY B, WITH SCATTERED FIBROGLANDULAR DENSITY. THE ASYMMETRY WITH EQUIVOCAL DISTORTION WAS NOTED IN THE MIDDLE TO POSTERIOR THIRD OF THE LEFT OUTER BREAST, LIKELY CORRESPONDING SUPERIORLY ON THE MEDIOLATERAL OBLIQUE (MLO) VIEW, AND A 5-MM POTENTIAL MASS WAS IDENTIFIED LATERAL AND SUPERIOR TO THE ASYMMETRY.ON

  Patient problems: Abdominal Pain; Constipation; Electrolyte Imbalance; Fall; High White Blood Cell Count; Inflammation; Insufficient Information; Nausea; Necrosis; Obstruction/Occlusion; Pain; Prolapse; Unspecified Infection; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Vomiting

  MAUDE report 24325160 ↗
• InjuryDec 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SACROCOLPOPEXY PROCEDURE USING A Y-MESH DEVICE, THE MESH TORE, RESULTING IN A PORTION DETACHING AND FALLING INTO THE PATIENT. IT WAS SUBSEQUENTLY RETRIEVED USING A GRASPER. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914209 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UPSYLON Y-MESH IMPLANTED ON (B)(6) 2019, DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, ROBOTIC SACRAL COLPOPEXY, POSTERIOR REPAIR, CYSTOSCOPY, AND SUTURE RECTOPEXY FOR STAGE II PELVIC ORGAN PROLAPSE. FOLLOWING SURGERY, THE PATIENT DEVELOPED COMPLICATIONS, INCLUDING SEVERE PAIN AND RECURRENT BLADDER PRESSURE SYMPTOMS THAT WORSENED OVER FIVE YEARS. ON (B)(6) 2024, DIAGNOSTIC IMAGING AND CYSTOSCOPY REVEALED MESH EROSION INTO THE BLADDER WALL. THIS REQUIRED MAJOR REVISION SURGERY ON (B)(6) 2025, INVOLVING COMPLETE MESH REMOVAL, ROBOTIC LEFT URETEROLYSIS, AND TRACHELECTOMY. ACCORDING TO THE PATIENT'S ATTORNEY, THE PATIENT HAS SUSTAINED PERMANENT AND SERIOUS INJURIES.

  Patient problems: Erosion; Insufficient Information; Pain; Unspecified Tissue Injury

  MAUDE report 23724726 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UPSYLON Y-MESH IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE INCLUDE MIXED URINARY INCONTINENCE, EROSION OF THE IMPLANTED MESH INTO SURROUNDING TISSUES AND ORGANS, GRANULATION TISSUE, POST-COITAL BLEEDING, AND PELVIC PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT A PARTIAL VAGINAL MESH EXCISION SURGERY ON (B)(6) 2024, FOLLOWED BY ANOTHER MESH EXCISION SURGERY ON (B)(6) 2024. THE PATIENT ALSO CLAIMED TO HAVE SUFFERED SEVERE PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM AS A RESULT OF THE IMPLANTATION. ADDITIONALLY, SHE STATED THAT SHE MAY NEED TO UNDERGO FURTHER SURGERY AND COULD, IN THE FUTURE, EXPERIENCE DAMAGES SUCH AS SIGNIFICANT PAIN, SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND ONGOING MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement; Erosion; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 22815928 ↗
• InjuryAug 8, 2025Adverse 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 USED DURING THE SAME PROCEDURE. PLEASE REFER TO MANUFACTURER REPORT 2124215-2025-54036 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD BOTH A LYNX BLUE SYSTEM AND UPSYLONY-MESH SYSTEM DEVICES IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS. THESE INCLUDE SMALL BOWEL OBSTRUCTION, INTERNAL HERNIA, ADHESIONS, SCARRING, PAIN INCLUDING DYSPAREUNIA, AND A LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS TO HAVE SUFFERED, OR MAY SUFFER IN THE FUTURE DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Adhesion(s); Dyspareunia; Hernia; Obstruction/Occlusion; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 22747094 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UPSYLON Y-MESH IMPLANTED DURING ROBOTIC SACROCOLPOPEXY, PERINEORRHAPHY, AND CYSTOURETHROSCOPY PROCEDURES. FOLLOWING THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING COMPLICATIONS SUCH AS ABDOMINAL PAIN, NAUSEA, AND VOMITING. A CT SCAN REVEALED A PARTIAL SMALL BOWEL OBSTRUCTION. THE PATIENT THEN UNDERWENT A DIAGNOSTIC TEST USING GASTROGRAFIN, WHICH SHOWED THAT THE CONTRAST HAD REACHED THE RIGHT COLON. LAB TESTS INDICATED SIGNIFICANT LEUKOCYTOSIS AND ELEVATED LACTATE LEVELS, SUGGESTING INFECTION OR REDUCED BLOOD FLOW TO THE BOWEL. A REPEAT CT SCAN RAISED CONCERNS FOR A BOWEL MICROPERFORATION OR ISCHEMIA. AS A RESULT, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, RELEASE OF SMALL BOWEL OBSTRUCTION, SMALL BOWEL RESECTION WITH SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS, AND MESH RESECTION PROCEDURES. DURING THE SURGERY, THE SMALL BOWEL OBSTRUCTION WAS RELIEVED, AND A SECTION OF THE BOWEL WAS REMOVED. A SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS WAS PERFORMED TO RECONNECT THE HEALTHY ENDS OF THE INTESTINE. THE SURGEON ALSO REMOVED THE IMPLANTED MESH BY MAKING A MIDLINE INCISION AND CUTTING THROUGH MULTIPLE ADHESIONS BETWEEN THE MESH AND SMA

  Patient problems: Abdominal Pain; Adhesion(s); Bowel Perforation; Erosion; Ischemia; Nausea; Obstruction/Occlusion; Unspecified Infection; Vomiting

  MAUDE report 22009907 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UPSYLON Y-MESH DEVICE IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL, PELVIC, PERINEAL, ABDOMINAL AND GROIN PAIN, DYSPAREUNIA, URINARY TRACT INFECTIONS, FURTHER OR WORSENING URINARY TRACT PROBLEMS, DEPRESSION, SEVERE SCARRING AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 21MAY2025. ON (B)(6) 2023, THE PATIENT UNDERWENT A COMPLEX SURGICAL PROCEDURE FOR THE REMOVAL OF DA VINCI-PLACED ABDOMINAL SACROCOLPOPEXY MESH. THE SURGERY WAS PARTICULARLY DIFFICULT DUE TO EXTENSIVE SCARRING AND DENSE ADHESION OF THE MESH TO THE RIGHT PELVIC SIDEWALL AND NARROW PELVIS. DISSECTION FOCUSED ON CAREFULLY FREEING THE RIGHT MESH ARM FROM THE PELVIC SIDEWALL AND THE CUL-DE-SAC-AN AREA OF SIGNIFICANT DIFFICULTY. THE REMAINING MESH ATTACHED TO THE SACRUM WAS DISSECTED AND REMOVED. INTRAOPERATIVE CYSTOSCOPY CONFIRMED THE INTEGRITY OF THE BLADDER, SHOWING BILATERAL URETERAL JETS. THE VAGINAL CANAL WA

  Patient problems: Abdominal Pain; Depression; Dyspareunia; Pain; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Tract Infection

  MAUDE report 21938000 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UPSYLON Y-MESH SYSTEM IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. CYSTOSCOPY REVEALED NORMAL BLADDER MUCOSA AND BILATERAL URETERAL ORIFICES POSITIONED MORE DISTALLY AND MIDLINE THAN EXPECTED; EFFLUX WAS CONFIRMED FROM BOTH ORIFICES, WITH NO ADDITIONAL ABNORMALITIES OBSERVED. SHE HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING PAIN INCLUDING VAGINAL PAIN, CHRONIC PELVIC PAIN, LEVATOR SPASMS, AND NERVE PAIN, DYSPAREUNIA, MESH EROSION, ADHESIONS, SCARRING, FURTHER OR WORSENING URINARY PROBLEMS, RECURRENCE, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. ON HER PREVIOUS VISIT ON (B)(6) 2023, EXAMINATION FINDINGS WERE CONSISTENT WITH PELVIC FLOOR MUSCLE SPASM AND TENDERNESS. TREATMENT OPTIONS DISCUSSED INCLUDED PELVIC FLOOR PHYSICAL THERAPY WITH BIOFEEDBACK, VAGINAL VALIUM SUPPOSITORIES, ORAL MEDICATIONS (AMITRIPTYLINE, GABAPENTIN), TRIGGER POINT INJECTIONS, AND BOTOX INJECTIONS. SYMPTOMS WERE PREVIOUSLY REFRACTORY TO PELVIC FLOOR PHYSICAL THERA

  Patient problems: Adhesion(s); Cough; Cramp(s) /Muscle Spasm(s); Dyspareunia; Erosion; Inflammation; Micturition Urgency; Movement Disorder; Neuropathy; Pain; Respiratory Tract Infection; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 21937835 ↗
• InjuryApr 22, 2025Adverse 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 USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 2124215-2025-25183 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD A SOLYX SIS SYSTEM AND UPSYLON Y-MESH SYSTEM DEVICE IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION, VAGINAL DISCHARGE, FREQUENT URINARY TRACT INFECTION, MIXED INCONTINENCE, VAGINAL ATROPHY, RECURRENT RECTOCELE, VAGINAL PROLPASE, PERINEOCELE, PELVIC PAIN, FURTHER OR WORSENING URINARY PROBLEMS, DEPRESSION, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

  Patient problems: Abnormal Vaginal Discharge; Depression; Erosion; Incontinence; Pain; Prolapse; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 21882444 ↗
• MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING A SACROCOLPOPEXY PROCEDURE, AN UPSYLON Y-MESH WAS USED. WHEN THE MESH WAS GRASPED WITH THE NEEDLE DRIVER AND INSERTED INTO THE PATIENT, IT TORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21530644 ↗
• InjuryFeb 28, 2025Adverse 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 IMPLANTED ON THE SAME PATIENT. PLEASE REFER TO MFR REPORT 2124215-2025-12236 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THE ADVANTAGE FIT SYSTEM AND UPSYLON Y-MESH UNDERWENT ROBOTIC-ASSISTED SACROCOLPOPEXY WITH Y-MESH AND MIDURETHRAL SLING INSERTION ON (B)(6) 2020, TO TREAT VAGINAL VAULT PROLAPSE AND STRESS INCONTINENCE. THE UPSYLON Y-MESH WAS ANCHORED TO THE ANTERIOR AND POSTERIOR VAGINAL WALLS AND SECURED TO THE SACRAL PROMONTORY, WHILE THE ADVANTAGE FIT SUBURETHRAL SLING WAS PLACED IN A TENSION-FREE POSITION UNDER THE MID-URETHRA VIA SUPRAPUBIC INCISIONS. CYSTOSCOPY CONFIRMED NO INJURY TO THE BLADDER OR URETERS, AND THE PATIENT WAS TRANSFERRED TO THE POSTANESTHESIA CARE UNIT IN STABLE CONDITION WITH NO INTRAOPERATIVE COMPLICATIONS REPORTED. FOLLOWING THE IMPLANTATION, THE PATIENT REPORTED EXPERIENCING INJURIES INCLUDING PELVIC AND BLADDER PAIN, FISSURES, DYSPAREUNIA, CONSTIPATION, FURTHER OR WORSENING URINARY PROBLEMS, DEPRESSION, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MEN

  Patient problems: Constipation; Depression; Dyspareunia; Pain; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 21499481 ↗
• InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WHO WAS IMPLANTED WITH THIS UPSYLON Y-MESH EXPERIENCED INJURIES INCLUDING: ABSCESS, ABNORMAL BLEEDING, DISCHARGE, DYSPAREUNIA, CHRONIC, SEVERE, AND PERSISTENT PELVIC PAIN, PRESSURE, AND BURNING SENSATION, LOWER ABDOMINAL PAIN AND PRESSURE, RECURRENT URINARY TRACT INFECTIONS, CONSTIPATION, FURTHER URINARY PROBLEMS, SCARRING, FEAR OF CANCER, AND LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED, OR MAY IN THE FUTURE SUFFER, DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON MAY 21, 2025: ON (B)(6) 2023, THE PATIENT PRESENTED WITH A 5 CM PELVIC MASS WITH BOTH CYSTIC AND SOLID COMPONENTS. SHE UNDERWENT ROBOTIC EXCISION OF A RETROPERITONEAL MASS, ROBOTIC EXCISION OF PELVIC MESH, AND VAGINAL BIOPSIES. INTRAOPERATIVELY, A RETROPERITONEAL MASS WAS LOCATED AT THE 4-5 O'CLOCK POSITION ADJACENT TO THE VAGINAL CUFF, BLADDER, AND RECTUM, WITH MESH FROM THE PRIOR SACROCOLPOPEXY FOUND EXTENDING INTO AND INTIMATELY ASSOCIATED WITH THE MASS. THE MESH WAS FULLY EXCISED ALONG WITH THE MASS, WHICH RUPTURED DURING DISSECTION AND

  Patient problems: Abnormal Vaginal Discharge; Abscess; Burning Sensation; Constipation; Discomfort; Dyspareunia; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Tract Infection

  MAUDE report 21496771 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE DURING WHICH AN ADVANTAGE SYSTEM SLING AND AN UPSYLON Y-MESH WERE IMPLANTED. THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF PELVIC ORGAN PROLAPSE WITH CYSTOCELE, RECTOCELE, PARAVAGINAL DEFECT, STRESS URINARY INCONTINENCE, ENTEROCELE, AND INCOMPLETE UTEROVAGINAL PROLAPSE. AFTER A CONCOMITANT HYSTERECTOMY, THE PATIENT UNDERWENT ROBOTIC ABDOMINAL SACROCOLPOPEXY WITH THE REPAIR OF THE AFOREMENTIONED DEFECTS, TENSION-FREE VAGINAL TAPE (TVT) SUB-URETHRAL SLING AND CYSTOSCOPY, AND VAGINAL APPROACH TO A POSTERIOR REPAIR. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH URETROVAGINAL FISTULA, VAGINAL EXPOSURE AND EROSION INTO THE URETHRA AND EXPOSED AT THE VAGINAL WALL, AND URINARY INCONTINENCE. SHE HAD UNDERGONE EXCISION OF URETHROVAGINAL FISTULA WITH REPAIR, PARTIAL MESH REMOVAL OF EXPOSED ERODED POLYPROPYLENE MESH, REMOVAL AND REPLACEMENT OF SUPRAPUBIC CYSTOSTOMY TUBE, AND CYSTOSCOPY. DURING THE PROCEDURE, THE ERODED MESH WAS SEEN AT THE URETHRAL MEATUS-- ERODING INTO THE FULL-THICKNESS URETHRA AND EXPOSED AT THE VAGINAL WALL AT THE SAME TIME, THE REMAINING POR

  Patient problems: Erosion; Fistula; Urinary Incontinence

  MAUDE report 20698867 ↗
• InjuryOct 16, 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 UPSYLON DEVICE, AND SHE CLAIMED TO HAVE EXPERIENCED ANTERIOR AND POSTERIOR VAGINAL PROLAPSE, MESH MIGRATION, AND PAIN AS A RESULT OF THE IMPLANTATION, WHICH REQUIRED HER TO UNDERGO SURGICAL REVISION/REMOVAL PROCEDURE. FURTHERMORE, THE PATIENT CLAIMS TO HAVE SUFFERED, OR MAY SUSTAIN IN THE FUTURE, THE FOLLOWING DAMAGES AS A RESULT OF THE IMPLANTATION OF THE UPSYLON DEVICE: PHYSICAL IMPAIRMENT, PHYSICAL DISFIGUREMENT, IMPAIRMENT OF RELATIONSHIPS AND EARNING CAPACITY, EMOTIONAL DISTRESS, PAIN AND SUFFERING, OUT OF POCKET COST, AND LOSS OF CONSORTIUM.

  Patient problems: Erosion; Inflammation; Pain; Prolapse; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 20466730 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC MESH WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Adhesion(s); Bowel Perforation; Erosion; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hernia; Inflammation; Insufficient Information; Ischemia; Necrosis; Obstruction/Occlusion; Ulcer

  MAUDE report 20433301 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UPSYLON DEVICE WAS IMPLANTED DURING A ROBOTIC ABDOMINAL SACRAL COLPOPEXY, ROBOTIC RIGHT INGUINAL HERNIA REPAIR PERFORMED ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT PRESENTED DIFFERENT KINDS OF PAIN, DYSPAREUNIA, FREQUENCY OF URINATION, SEVERE PELVIC SCAR TISSUE, AND A HISTORY OF RIGHT INGUINAL HERNIA. DURING THE PROCEDURE, AN OPEN LAPAROSCOPY WAS PERFORMED, AND THREE OTHER PORTS WERE PLACED UNDER DIRECT VISUALIZATION. ADHESIONS HAVE BEEN TAKEN DOWN TO THE ANTERIOR ABDOMINAL WALL, AND ATTENTION HAS BEEN TURNED TO THE SACRO COLPOPEXY MESH. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: LAPAROSCOPIC SACRAL COLPOPEXY MESH SKELETIZATION, RIGHT LAPAROSCOPIC RIGHT URETEROLYSIS, LAPAROSCOPIC MESH REMOVAL FROM THE VAGINA, FROM THE BLADDER, FROM THE ANTERIOR VAGINAL WALL, FROM THE SIGMOID COLON AND RECTUM, LAPAROSCOPIC POSTERIOR VAGINAL WALL MESH REMOVAL, LAPAROSCOPIC INGUINAL HERNIA MESH REMOVAL, AND LAPAROSCOPIC INGUINAL HERNIA MESH REMOVAL FROM THE ILIOPECTINEAL LINE. THE MESH WAS FOUND TO BE ROCK HARD AS A RESULT OF AN EXAM DURING SURGERY. THE MESH FROM THE VAGINA WAS CERTAINLY SCARRED. HOWEVER, IT CANNOT BE REMOVED SINCE THE MESH FROM THE ABDOMINAL WALL AND THE

  Patient problems: Abdominal Pain; Adhesion(s); Cognitive Changes; Discomfort; Dizziness; Dyspareunia; Fecal Incontinence; Hernia; Inflammation; Movement Disorder; Pain; Paresthesia; Scar Tissue; Seroma; Unspecified Mental, Emotional or Behavioral Problem; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 19825617 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVANTAGE FIT BLUE SYSTEM AND UPSYLON DEVICE WERE IMPLANTED DURING A ROBOTIC SACRO COLPOPEXY, ADVANTAGE FIT SUB URETHRAL SLING, SUPRAPUBIC BONANNO CATHETER PLACEMENT, CYSTOSCOPY, AND ROBOTIC LYSIS OF ADHESIONS PROCEDURE PERFORMED ON (B)(6) 2022, FOR THE TREATMENT OF CYSTOCELE, RECTOCELE, ENTEROCELE, AND STRESS INCONTINENCE. DUE TO URINARY TRACT INFECTION, CHRONIC CYSTITIS, AND PELVIC FLOOR DYSFUNCTION, THE PATIENT WAS SCHEDULED FOR A CYSTOSCOPY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, A FLEXIBLE CYSTOSCOPE WAS PASSED PER URETHRA. CHRONIC CYSTITIS WAS SEEN OVER THE BLADDER NECK AND TRIGONE CONSISTENT WITH CHRONIC INFLAMMATION. THE PATIENT HAS HAD A BLADDER LIFT AND SLING WITH MESH. ADDITIONALLY, PELVIC EXAMS CONSISTENTLY FOUND PELVIC FLOOR DYSFUNCTION AND DYSPAREUNIA. NOTE: THIS REPORT IS THE SECOND OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2023-05465 AND MFR. REPORT #2124215-2024-27942).

  Patient problems: Dyspareunia; Inflammation; Unspecified Kidney or Urinary Problem; Urinary Tract Infection

  MAUDE report 19378242 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UPSYLON WAS IMPLANTED DURING A SACROCOLPOPEXY PROCEDURE PERFORMED DURING AN UNSPECIFIED DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED MESH EROSION AT THE APEX, AND AN INFECTION IN THE SACRUM. THE INFECTION WAS SUCCESSFULLY MANAGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19075598 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLONY MESH DEVICE WAS IMPLANTED DURING A ROBOTIC-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY WITH ANTERIOR, POSTERIOR REPAIR AND ENTEROCELE REPAIR AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016. ON (B)(6) 2021, THE PATIENT WAS TAKEN TO THE OPERATING ROOM URGENTLY FOR EXPLORATORY LAPAROTOMY AS THE PATIENT HAD CRAMPY ABDOMINAL PAIN AND ACUTE SURGICAL ABDOMEN. IT WAS FOUND OUT THAT THE PATIENT HAD A CLOSED LOOP BOWEL OBSTRUCTION WHICH WAS CAUSED BY MESH PLACED FOR A SACRO COLPOPEXY AND THE LOOP OF BOWEL GOT CAUGHT UNDERNEATH THE MESH. SPECIFICALLY, IT WAS THE SMALL BOWEL (ILEUM) THAT WAS OBSTRUCTED. THERE WAS ALSO A GANGRENE OF THE ILEUM RESULTING IN THE NEED FOR BOWEL RESECTION (APPROX. 30 CM OF SMALL BOWEL REMOVED). THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

  Patient problems: Ischemia; Necrosis; Obstruction/Occlusion; Pain

  MAUDE report 19071729 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DUE TO THE IMPLANTATION, THE PATIENT SUSTAINED INJURIES SUCH AS PAIN, DYSPAREUNIA, URINARY INFECTIONS, VAGINAL VAULT PROLAPSE, DIVERTICULUM OF THE BLADDER, AND ADDITIONAL MEDICAL TREATMENT AND PROCEDURES INCLUDING REPAIR AND REMOVAL. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Dyspareunia; Pain; Prolapse; Urinary Tract Infection

  MAUDE report 19071401 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON DEVICE WAS USED DURING A TOTAL VAGINAL HYSTERECTOMY WITH RIGHT SALPINGECTOMY, ROBOTIC-ASSISTED SACRO COLPOPEXY, RECTOCELE REPAIR, AND LYNX SUB URETHRAL SLING, AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE AND URETHRAL HYPERMOBILITY. ON (B)(6) 2022, THE PATIENT UNDERWENT A SERIES OF PROCEDURES DUE TO VAGINAL APICAL MESH EROSION, DYSPAREUNIA AND PELVIC PAIN, AND RECURRENT ANTERIOR VAGINAL VAULT PROLAPSE. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WERE DENSE ADHESIONS OF THE SMALL BOWEL AND COLON TO THE LEFT LATERAL PELVIC SIDEWALL AND THE POSTERIOR CUL-DE-SAC. APPROXIMATELY 25-30 MINUTES OF LYSIS OF ADHESIONS AND ENTEROLYSIS WERE PERFORMED TO SAFELY MOBILIZE THE BOWEL OUT OF THE PELVIS SO THAT THE MESH EXCISION COULD BE PERFORMED. ONCE THE BOWEL WAS MOBILIZED, THE MESH WAS IDENTIFIED AND TRACKED DOWN TO THE VAGINA. MUCUS DISCHARGE WAS NOTED TOWARD THE LEFT APICAL ASPECT OF THE VAGINA, CONSISTENT WITH THE AREA OF MESH EROSION. MULTIPLE GORE-TEX STITCHES AND MESH WERE FOUND TO BE ERODED THROUGH THE APEX OF THE VAGINA. DURING DISSECTION OF THE

  Patient problems: Dyspareunia; Erosion; Pain; Prolapse

  MAUDE report 19040895 ↗