Upsylon™ Y Mesh Kit M0068318220Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729848103), received between Mar 29, 2018 and Apr 23, 2026 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Apr 15, 2021Open, Classified

   Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection

   Z-1491-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE USING AN UPSYLON Y-MESH KIT, THE MESH TORE. THE MESH WAS CUT ANTERIORLY AND POSTERIORLY AND INSERTED VIA A ROBOTIC ARM. AT THE TIME OF CUTTING, THE MESH DID NOT APPEAR TO BE TORN. DURING ANTERIOR SUTURING, MISSING SUTURES WERE OBSERVED ON THE LEFT SIDE OF THE MESH, WHICH REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967589 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UPSYLON Y MESH WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED. THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 2124215-2024-43324 AND MFR. REPORT # 2124215-2024-44172).

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Discomfort; Dyspareunia; Erosion; Fibrosis; Insufficient Information; Pain; Prolapse; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 19799801 ↗
• InjuryMar 25, 2024Adverse 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 IN SEPARATE PROCEDURES. PLEASE REFERENCE REPORT NUMBER 2124215-2024-17936 FOR THE DETAILS OF THE FIRST PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE (POP). FOLLOWING THE PROCEDURE, THE PATIENT HAD ACUTE PELVIC AND LEG PAIN. THE TENSION OF THE MESH PLACEMENT WAS TOO TIGHT, AND SECOND SURGERY WAS NEEDED TO RELEASE THE MESH. IT WAS NOTED THAT PROLAPSE REOCCURRED WITH TWO MONTHS OF IMPLANT. ON (B)(6) 2020, A SECOND IMPLANT PROCEDURE WAS PERFORMED IN WHICH AN UPSYLON Y-MESH KIT WAS IMPLANTED TO TREAT THE POP; HOWEVER, THE PROLAPSE RE-OCCURRED AGAIN WITHIN THREE WEEKS FROM IMPLANT. THE PATIENT HAD INCONTINENCE AND BOWEL PAIN AS WELL AS CONTINUING CHRONIC PAIN FROM FIRST IMPLANT SURGERY. THE PATIENT HAD BEEN EXPERIENCING WEIGHT GAIN, CIRRHOSIS, CHRONIC GENERAL FATIGUE AND MALAISE, CONSTIPATION, AND THE DECREASED ABILITY TO WALK OR MOBILIZE WITH PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Constipation; Fatigue; Incontinence; Malaise; Pain; Prolapse; Weight Changes

  MAUDE report 18975675 ↗
• InjuryFeb 22, 2023Adverse 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 Y MESH KIT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A LAPAROSCOPIC HYSTERECTOMY + SALPINGECTOMY + CONSERVING OVARIES + ADHESIOLYSIS + LAPAROSCOPIC SACROCOLPOPEXY PROCEDURE PERFORMED ON (B)(6) 2016 FOR THE TREATMENT OF PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16416886 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES IMPLANTED INTO THE SAME PATIENT, THE UPSYLON Y MESH KIT. REFER TO MANUFACTURER REPORT # 3005099803-2022-05481 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y MESH KIT WAS USED DURING AN ABDOMINAL SACROCOLPOPEXY, CYSTOSCOPY, AND INJECTION MACROPLASTIQUE PROCEDURES PERFORMED ON DECEMBER 12, 2017 TO TREAT A PATIENT WITH PROLAPSE. IN THE PHYSICIAN'S ASSESSMENT, THERE WERE STILL CONSIDERABLE ADHESIONS OF OMENTUM TO THE ANTERIOR ABDOMINAL WALL UMBILICALLY AFTER THE PROCEDURE WAS COMPLETED. THE PHYSICIAN ADVISED AGAINST AN UMBILICAL ENTRY SHOULD THE PATIENT REQUIRE LAPAROSCOPY IN THE FUTURE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15583332 ↗
• InjuryAug 24, 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 UPSYLON Y-MESH KIT WAS IMPLANTED DURING A LAPAROSCOPIC SACROCOLPOPEXY AND CYSTOSCOPY PROCEDURES PERFORMED ON (B)(6) 2014 TO TREAT VAULT PROLAPSE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE RIGHT SIDE OF AN ANTERIOR ELEVATE EYELET. THE ANTERIOR EYELET, A NON-BSC MESH DEVICE, HAD BEEN IMPLANTED IN 2012 ON (B)(6) 2017, THE PATIENT SOUGHT CONSULT AS SHE CONTINUED TO EXPERIENCE SYMPTOMS SUCH AS "DISPLACED TAMPON FEELING" AND THE PATIENT ALSO DESCRIBED "A GRATING FEELING." MOREOVER, THE PATIENT ALSO REPORTED TO HAVE SOME RIGHT SIDED DISCOMFORT WITH INTERCOURSE. THESE ISSUES OCCURRED PRIOR TO THE LAPAROSCOPY PROCEDURE SHE UNDERWENT IN 2014. THE PATIENT WAS AWARE OF A VAGINAL BULGE WHICH IS TO THE LEVEL OF THE INTROITUS. WHEN THE PATIENT WAS LYING DOWN, SHE SAID SHE HAD NO FEELING OF A VAGINAL BULGE OR DISCOMFORT. THE PATIENT NOTED THAT THE RIGHT SIDED DISCOMFORT OCCURRED WHEN SHE WAS CROSSING HER RIGHT LEG WHEN SEATED OR STANDING. ON EXAMINATION, THERE WAS AN ANCHOR OR EYELET WHICH WAS TENDER AND DEEP IN THE RIGHT SACROSPINOUS SPACE. THE LEFT WAS ALSO PALPABLE BUT THIS WAS NOT TENDER. THERE WAS NO EVIDENCE OF MESH EXPOS

  Patient problems: Discomfort; Dyspareunia; Insufficient Information; Prolapse

  MAUDE report 15285721 ↗
• InjuryAug 6, 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 UPSYLON Y MESH KIT WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED DURING A PLACEMENT OF SACROCOLPOPEXY MESH BY LAPAROSCOPY PROCEDURE ON (B)(6) 2022. FOUR DAYS AFTER THE MESH WAS PLACED, THE PATIENT WAS SEEN FOR REVIEW FOR BLEEDING. FINDINGS SHOWED PERFORATION IN THE ILIAC ARTERY AND IN HER COLON FOR WHICH SUTURING OF THE ILIAC AND COLON AS WELL AS MESH REMOVAL WERE PERFORMED. THE TEAR IN ILIAC ARTERY WAS CONTROLLED BUT IT BLED AGAIN. THE DOCTORS NOTED THAT THE PATIENT HAS AN UNUSUAL TRANSPOSITION OF A VEIN CLOSE TO THE ILIAC ARTERY. THE PATIENT WAS HOSPITALIZED BUT HER CONDITION HAS REPORTEDLY IMPROVED.

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 15180585 ↗
• InjuryJul 29, 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 UPSYLON Y-MESH KIT WAS IMPLANTED DURING A LAPAROSCOPIC, SACROCOLPOPEXY, POSTERIOR REPAIR AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAD EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15128861 ↗
• InjuryJul 15, 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 UPSYLON Y MESH KIT DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. THE PATIENT CLAIMS THAT SINCE THE SLING PLACEMENT SURGERY, SHE HAS BEEN IN PAIN AND IS UNABLE TO ENGAGE IN INTIMATE ACTIVITIES. SHE ALSO REPORTS HAVING TROUBLE URINATING. ACCORDING TO REPORTS, THE PATIENT HAD UNSPECIFIED INTERVENTION TO TREAT THE SYMPTOMS.

  Patient problems: Discomfort; Dyspareunia; Dysuria; Pain

  MAUDE report 15028163 ↗
• InjuryMay 31, 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 UPSYLON Y MESH KIT WAS IMPLANTED INTO THE PATIENT DURING AN ABDOMINAL SACROCOLPOPEXY PROCEDURE PERFORMED ON (B)(6) 2018. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14547893 ↗
• 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 UPSYLON Y-MESH KIT DEVICE WAS IMPLANTED INTO THE PATIENT DURING ROBOTIC ADHESIOLYSIS, DISTAL LEFT URETEROLYSIS, BILATERAL SALPINGO-OOPHORECTOMY, SACROCOLPOPEXY, CYSTOSCOPY, EXCISE POST VAGINAL FOCAL MESH EXPOSURE, INSERTION OF SURGICAL-PELVIC ORGAN PESSARY (S-POP) PROCEDURE PERFORMED ON (B)(6) 2020 FOR THE TREATMENT OF ENTEROCELE, VAULT EVERSION PROLAPSE AND TRACTION CYSTOCELE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14411901 ↗
• InjuryMay 11, 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 UPSYLON Y MESH DEVICE WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2018 FOR TREATMENT OF PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 14350684 ↗
• 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 UPSYLON Y MESH KIT WAS IMPLANTED DURING A LAPAROSCOPIC, ADHESIOLYSIS, SACROCOLPOPEXY, AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014 TO TREAT PROLAPSE. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14335419 ↗
• InjuryMar 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 UPSYLONY MESH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2006. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13811981 ↗
• InjuryMar 17, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2016. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13794697 ↗
• InjuryDec 31, 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 UPSYLON Y-MESH DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT WAS SENT HOME AFTER THE IMPLANT WITH VARIOUS MEDICATIONS FOR RECOVERY. HOWEVER, IN LATER DAYS THESE MEDICATIONS WERE DISCONTINUED AS THE PATIENT PRESENTED WITH ALLERGIC REACTION AND ITCHING. VIDEOS PROVIDED SHOWED SKIN RASHES ON THE PATIENT'S ARMS AND LEGS. THE DEVICE REMAINED IMPLANTED. THE PATIENT HAD TREATMENT FOR ALLERGY; HOWEVER, THE ISSUE HAS NOT BEEN RESOLVED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 13125350 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH IMPLANT AND A OBTRYX IMPLANT WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2010. THE PATIENT EXPERIENCED COMPLICATIONS. PATIENT SYMPTOMS INCLUDE: VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; PAIN INTER; OFF VAG DIS; DIFF BOWEL; REC INCONT; AGGRAV INCONT;

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

  MAUDE report 12931147 ↗
• InjuryDec 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: TWO BOSTON SCIENTIFIC MESH DEVICES WERE IMPLANTED INTO THE SAME PATIENT. THIS REPORT PERTAINS TO THE UPSYLON Y-MESH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPSYLON Y-MESH AND AN ADVANTAGE SLING WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2009. 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; PAINFUL INTERCOURSE; INABILITY TO HAVE INTERCOURSE; DIFFICULTIES WITH BOWEL MOTIONS; RECURRENT INCONTINENCE . SURGICAL INTERVENTIONS: ON (B)(6) 2009 THE PATIENT UNDERWENT FURTHER SURGERY REGARDING THE UPSYLON Y-MESH IMPLANT UNDER GENERAL ANESTHESIA FOR THE FOLLOWING PURPOSE: SURGERY ON (B)(6) 2009 WAS TO REMOVE THE MESH WHICH HAD DISLODGED AND THIS SURGERY (B)(6) 2009 WAS TO PUT A NEW ONE IN. NONSURGICAL TREATMENTS: ON (B)(6) 2015 THE PATIENT COMMENCED PAIN MEDICATION: PARACETAMOL FOR PURPOSE: TO RELIEVE DISCOMFORT. TREATMENT DURATION: ONGOING. THE PATIENT WAS TREATED WITH TOPICAL TREATMENT (INCLUDING OESTROGEN CREAM): VAGIFEM FOR PURPOSE: TO THICKEN THE VAGINAL WALLS AND TO ASSIST WITH THE PAINFUL INTERCOURSE. TREATMENT DURATION

  Patient problems: Constipation; Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain

  MAUDE report 12931143 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014 AND ADVANTAGE WAS IMPLANTED ON (B)(6) 2014. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP; VAGINAL PAIN; PELVIC PAIN; PAIN INTER; INAB INTER; REC INCONT; NONSURGICAL TREATMENTS: ON (B)(6) 2014 THE PATIENT COMMENCED INCONTINENCE MEDICATION: INCONTINENCE PADS FOR THE TREATMENT OF: LEAKAGE OF URINE. TREATMENT DURATION: 7 YEARS.

  Patient problems: Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain

  MAUDE report 12931140 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED NON-SURGICAL 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; OTHER PAIN: PAIN THAT GOES DOWN LEG THAT STARTS ON HIP/GROIN/SIDE (PELVIC); PAINFUL INTERCOURSE; OFFENSIVE VAGINAL DISCHARGE; DIFFICULTIES WITH BOWEL MOTIONS; RECURRENT INCONTINENCE; AGGRAVATED INCONTINENCE; DAMAGE. NONSURGICAL TREATMENTS: THE PATIENT WAS TREATED WITH PAIN MEDICATION: PA.

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

  MAUDE report 12931131 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; DIFF BOWEL; REC INCONT; AGGRAV INCONT. NONSURGICAL TREATMENTS: THE PATIENT WAS TREATED WITH PAIN MEDICATION: LYRICA FOR THE TREATMENT OF: PAIN REDUCTION. TREATMENT DURATION: 10 YEARS. THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION FOR THE TREATMENT OF: ANXIETY. TREATMENT DURATION: 10 YEARS. THE PATIENT WAS TREATED WITH PHYSIOTHERAPY TREATMENT (INCLUDING PELVIC FLOOR EXERCISES OR TRAINING). TREATMENT DURATION: ONGOING.

  Patient problems: Constipation; Incontinence; Pain

  MAUDE report 12931129 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: EEP (EROSION/EXTRUSION/PROTRUSION OF THE MESH); BACK PAIN; VAGINAL PAIN; PELVIC PAIN; GROIN PAIN; ANAL PAIN; RECTAL PAIN; THIGH PAIN; OTHER PAIN: LOWER STOMACH PAIN AND LEGS; PAINFUL INTERCOURSE; OFFENSIVE VAGINAL DISCHARGE; DIFFICULTIES WITH BOWEL MOTIONS; RECURRENT INCONTINENCE; DAMAGE. NONSURGICAL TREATMENTS: ON (B)(6) 2015 THE PATIENT COMMENCED OTHER MEDICATION (PLEASE SPECIFY): URAL FOR THE TREATMENT OF: UTI'S. TREATMENT DURATION: AS NEEDED. ON (B)(6) 2019 THE PATIENT COMMENCED PAIN MEDICATION: PANADOL/IBUPROFEN FOR THE TREATMENT OF: PAIN RELIEF, AS NEEDED. TREATMENT DURATION: 2 YEARS. ON (B)(6) 2020 THE PATIENT COMMENCED PAIN MEDICATION: PANADEINE FORTE FOR THE TREATMENT OF: PAIN RELIEF, AS NEEDED. TREATMENT DURATION: 1 YEAR. ON (B)(6) THE PATIENT COMMENCED TOPICAL TREATMENT (INCLUDING OESTROGEN CREAM): VOLTARIN FOR THE TREATMENT OF: PAIN RELIEF. TREATMENT DURATION: 6 MONTHS.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Dyspareunia; Erosion; Incontinence; Insufficient Information; Pain; Urinary Tract Infection

  MAUDE report 12931128 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; NONSURGICAL TREATMENTS: THE PATIENT WAS TREATED WITH PAIN MEDICATION. THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION.

  Patient problems: Pain

  MAUDE report 12931125 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS. PATIENT SYMPTOMS INCLUDE: VAGINAL PAIN; PELVIC PAIN; PERINEUM PAIN; PAINFUL INTERCOURSE; OFFENSIVE VAGINAL DISCHARGE; DIFFICULTIES WITH BOWEL MOTIONS; DAMAGE.

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

  MAUDE report 12931124 ↗
• InjuryDec 5, 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 UPSYLON Y-MESH WAS IMPLANTED INTO THE PATIENT ON AN UNSPECIFIED DATE. THE PATIENT EXPERIENCED COMPLICATIONS AND NONSURGICAL TREATMENT. PATIENT SYMPTOMS INCLUDE: BACK PAIN; VAGINAL PAIN; PELVIC PAIN; RECT PAIN; THI PAIN; OFF VAG DIS; DIFF BOWEL; REC INCONT. NONSURGICAL TREATMENTS: THE PATIENT WAS TREATED WITH PAIN MEDICATION. THE PATIENT WAS TREATED WITH PSYCHOLOGICAL MEDICATION.

  Patient problems: Abnormal Vaginal Discharge; Constipation; Incontinence; Pain

  MAUDE report 12931123 ↗