Solyx™ SIS System M0068507000Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 08714729774044), received between Dec 29, 2016 and Feb 4, 2026 — classified as 184 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2018. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY. ADDITIONAL DETAILS REGARDING THIS EVENT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24259768 ↗
• MalfunctionSep 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE USING A SOLYX? SIS SYSTEM DEVICE, THE NEEDLE TIP BECAME BENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SOLYX? SIS SYSTEM DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935056 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO PATIENTS WERE IMPLANTED WITH SOLYX? SIS SYSTEM ON THE SAME DATE. WITHIN 24 HOURS POSTOPERATIVELY, THE PATIENTS EXPERIENCED REDNESS, SWELLING AND ITCHING ACROSS THE BODY AND FACE, SIMILAR TO AN ALLERGIC REACTION TO ANTIBIOTICS. THE PHYSICIAN IS UNCERTAIN WHETHER THE OBSERVED REACTIONS WERE RELATED TO THE USE OF SOLYX OR ATTRIBUTABLE TO ANOTHER CAUSE. BOTH PATIENTS RECEIVED MEDICAL TREATMENT FOR THE ALLERGIC REACTIONS AND HAVE FULLY RECOVERED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND PATIENT IMPLANTED WITH A SOLYX DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22511251 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO PATIENTS WERE IMPLANTED WITH SOLYX? SIS SYSTEM ON THE SAME DATE. WITHIN 24 HOURS POSTOPERATIVELY, THE PATIENTS EXPERIENCED REDNESS, SWELLING AND ITCHING ACROSS THE BODY AND FACE, SIMILAR TO AN ALLERGIC REACTION TO ANTIBIOTICS. THE PHYSICIAN IS UNCERTAIN WHETHER THE OBSERVED REACTIONS WERE RELATED TO THE USE OF SOLYX OR ATTRIBUTABLE TO ANOTHER CAUSE. BOTH PATIENTS RECEIVED MEDICAL TREATMENT FOR THE ALLERGIC REACTIONS AND HAVE FULLY RECOVERED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST PATIENT IMPLANTED WITH A SOLYX DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22511248 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN SOLYX SIS SYSTEM DEVICE IMPLANT PROCEDURE ON (B)(6) 2019. DURING THE SAME SURGERY, ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, ANTERIOR COLPORRHAPHY, UTEROSACRAL PLICATION, AND CYSTOSCOPY PROCEDURES WERE ALSO PERFORMED. ON (B)(6) 2020, THE PATIENT WAS DIAGNOSED WITH SEVERE VOIDING DYSFUNCTION, PELVIC PAIN, AND DYSPAREUNIA, AND UNDERWENT MESH REMOVAL. DURING THE PROCEDURE, SHARP DISSECTION WAS USED TO SEPARATE THE VAGINAL EPITHELIUM FROM THE PERIURETHRAL FASCIA BILATERALLY TO THE LEVEL OF THE INFERIOR PUBIC RAMUS. THE SLING WAS IDENTIFIED AT THE MID-URETHRA, LOCATED DEEP TO THE PERIURETHRAL FASCIA. IT WAS CIRCUMFERENTIALLY DISSECTED, TRANSECTED AT THE MIDLINE, AND REMOVED BILATERALLY UP TO ITS INSERTION INTO THE OBTURATOR INTERNUS MUSCLE. THE SLING WAS EXCISED AND SENT FOR PATHOLOGICAL ANALYSIS. THE URETHRA WAS INSPECTED AND FOUND TO BE INTACT. COPIOUS ANTIBIOTIC IRRIGATION WAS PERFORMED. VAGINAL PACKING AND A FOLEY CATHETER WERE PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Dyspareunia; Pain; Urinary Retention

  MAUDE report 22211453 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY PROCEDURE WHERE A SOLYX SIS SYSTEM WAS IMPLANTED. DURING THE SAME PROCEDURE, ANTERIOR COLPORRHAPHY, SOLYX SLING PLACEMENT, POSTERIOR COLPORRHAPHY, RIGHT SACROSPINOUS LIGAMENT FIXATION, PERINEORRHAPHY, AND CYSTOSCOPY WERE ALSO PERFORMED. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH SEVERE VOIDING DYSFUNCTION AND PELVIC PAIN, FOR WHICH SHE UNDERWENT SLING INCISION AND REMOVAL. OPERATIVE FINDINGS REVEALED THE SLING LOCATED AT THE MID-URETHRA, DEEP TO THE PERIURETHRAL FASCIA. SHARP DISSECTION WAS USED TO SEPARATE THE VAGINAL EPITHELIUM FROM THE PERIURETHRAL FASCIA BILATERALLY TO THE LEVEL OF THE INFERIOR PUBIC RAMUS. THE SLING WAS DISSECTED CIRCUMFERENTIALLY, CUT AT THE MID-URETHRA, AND REMOVED UP TO ITS INSERTION INTO THE OBTURATOR INTERNUS MUSCLE BILATERALLY. THE EXCISED SLING WAS SENT FOR PATHOLOGICAL ANALYSIS. THE URETHRA WAS INSPECTED AND FOUND TO BE INTACT. VAGINAL PACKING AND A FOLEY CATHETER WERE PLACED POSTOPERATIVELY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 22203757 ↗
• InjuryMay 30, 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 2124215-2025-31154 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX SYSTEM - HALO IMPLANTED DURING A PROCEDURE ON (B)(6) 2019, AND A SOLYX SIS SYSTEM IMPLANTED ON (B)(6) 2021. DURING THE (B)(6)2019 PROCEDURE, THE OBTRYX SYSTEM - HALO SLING WAS PLACED VIA A TRANSOBTURATOR APPROACH USING HALO NEEDLES. THE SLING WAS POSITIONED AND TENSIONED UNDER DIRECT CYSTOSCOPIC VISUALIZATION, WHICH CONFIRMED A NORMAL BLADDER AND NO UNDUE TENSION AT THE MID-URETHRA. EXCESS SLING MATERIAL WAS EXCISED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. ON (B)(6) 2021, THE PATIENT UNDERWENT MULTIPLE PELVIC RECONSTRUCTIVE PROCEDURES TO ADDRESS SYMPTOMATIC PELVIC FLOOR RELAXATION, PELVIC PAIN, DYSPAREUNIA, AND MIXED URINARY INCONTINENCE, WITH STRESS URINARY INCONTINENCE CONFIRMED BY URODYNAMIC STUDIES. AMONG THE PROCEDURES PERFORMED WAS PLACEMENT OF A SECOND TRANSOBTURATOR TAPE MID-URETHRAL SLING. THE PRIOR SLING WAS REMOVED, AND A NEW SLING WAS INSERTED USING THE OBTRYX HALO NEEDLE TECHNIQUE THROUGH THE LABIAL CRURAL FOLDS TO THE OBTURATOR ME

  Patient problems: Abnormal Vaginal Discharge; Deformity/ Disfigurement; Dyspareunia; Erosion; Insufficient Information; Pain; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 22116749 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SOLYX? SIS SYSTEM DEVICE IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING VAGINAL, PELVIC AND BLADDER PAIN, DYSPAREUNIA, SCARRING, MESH EROSION/EXPOSURE, FURTHER OR WORSENING URINARY PROBLEMS 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: Discomfort; Dyspareunia; Erosion; Pain; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence; Urinary Retention

  MAUDE report 22087612 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN WHICH A SOLYX SIS SYSTEM WAS IMPLANTED. DURING THE SAME PROCEDURE, A ROBOTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY, EXTENSIVE LYSIS OF ADHESIONS, RIGHT OVARIAN CYSTECTOMY, REMOVAL OF A LEFT OVARIAN MASS, CYSTOSCOPY AND ANTERIOR COLPORRHAPHY PROCEDURE WERE ALSO PERFORMED. FOLLOWING THE IMPLANT PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD COMPLAINED OF FREQUENT URINARY TRACT INFECTION (UTI) GROSS HEMATURIA, PASSING OF MULTIPLE BLADDER STONES, AND SIGNIFICANT PELVIC PAIN. THE PATIENT WAS REFERRED TO CONTINUING TREATMENT WITH ANOTHER PHYSICIAN. A RECENT COMPUTED TOMOGRAPHY (CT) SCAN OF HER ABDOMEN AND PELVIC, WHICH REVEALED EVIDENCE OF LARGE BLADDER STONE AND URETHRAL STONE. THE WEEK FOLLOWING THE REFERRAL, THE PATIENT NOTED AN EXACERBATION OF PELVIC PAIN, INCOMPLETE BLADDER EMPTYING, GROSS HEMATURIA AND CLOT RETENTION. A CYSTOSCOPY WAS PERFORMED, SHOWING EVIDENCE OF LARGE URETHRAL /BLADDER NECK STONE, LARGE BLADDER STONE, AND MULTIPLE, LARGE BLOOD CLOTS. IT WAS NOTED THAT THE PATIENT COULD NOT TOLERATE AN IN-OFFICE PROCEDURE DUE TO SEVERE PAIN. ON (B)(6) 2024, THE PATIENT UNDERWENT CYSTOSCOPY, CYSTOLITHOLAPAXY FOR THE B

  Patient problems: Erosion; Hematuria; Inflammation; Obstruction/Occlusion; Pain; Scar Tissue; Thrombosis/Thrombus; Urinary Incontinence; Urinary Retention; Urinary Tract Infection

  MAUDE report 21997747 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SOLYX SIS SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING ABDOMINAL, PELVIC, PERINEAL, AND BLADDER PAIN, DYSPAREUNIA, SIGNIFICANT PELVIC TENDERNESS, ABNORMAL BLEEDING, FURTHER OR WORSENING URINARY PROBLEMS, 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.

  Patient problems: Abdominal Pain; Discomfort; Dyspareunia; Dysuria; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Pain; Scar Tissue; Skin Inflammation/ Irritation; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21896092 ↗
• 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 FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT 2124215-2025-24083 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED THAT THE PATIENT HAD A SOLYX SIS SYSTEM AND UPSYLON Y-MESH SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING MESH EROSION, VAGINAL DISCHARGE, FREQUENT URINARY TRACT INFECTIONS, MIXED INCONTINENCE, VAGINAL ATROPHY, RECURRENT RECTOCELE, VAGINAL PROLAPSE, PERINEOCELE, PELVIC PAIN, 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 21882437 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A NEW SOLYX SLING, AN ERODED TAPE WAS OBSERVED IN THE PATIENT'S URETHRA. DURING A ROUTINE FOLLOW-UP, THE PATIENT PRESENTED WITH DYSPAREUNIA, A URINARY TRACT INFECTION, AND MESH AT THE URETHRAL LUMEN. THE PATIENT ALSO EXPERIENCED DISCOMFORT AND PAIN. CONSEQUENTLY, THE ENTIRE SLING, INCLUDING THE MESH CARRIERS, WAS REMOVED, AND THE HOLES IN THE URETHRA WERE REPAIRED.

  Patient problems: Discomfort; Dyspareunia; Erosion; Pain; Urinary Tract Infection

  MAUDE report 21774818 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SINGLE INCISION SLING HAS EXPERIENCED COMPLICATIONS, INCLUDING ANTERIOR AND POSTERIOR PROLAPSE AND MESH MIGRATION. SHE SUBSEQUENTLY UNDERWENT A SURGICAL REVISION OR REMOVAL PROCEDURE. ADDITIONALLY, SHE CLAIMS TO HAVE SUFFERED, OR MAY IN THE FUTURE SUFFER, PHYSICAL IMPAIRMENT, DISFIGUREMENT, LOSS OF CONSORTIUM, LOSS OF EARNING CAPACITY, EMOTIONAL DISTRESS, PHYSICAL PAIN, AND MEDICAL EXPENSES DUE TO THE DEVICE'S IMPLANTATION.

  Patient problems: Deformity/ Disfigurement; Erosion; Inflammation; Prolapse; Scar Tissue; Unspecified Kidney or Urinary Problem; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 21436791 ↗
• MalfunctionSep 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE PROCEDURE USING A SOLYX SIS SYSTEM DEVICE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE MESH USING THE DELIVERY DEVICE. ANOTHER DEVICE WAS OPENED, AND A SECOND DELIVERY DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183666 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY AND TRANS OBTURATOR TAPE PROCEDURE PERFORMED ON (B)(6) 2017, A SOLYX SIS SYSTEM DEVICE WAS IMPLANTED. IT WAS NOTED THAT FOLLOWING THIS PROCEDURE, THE PATIENT EXPERIENCED EROSION/EXTRUSION OF THE MESH, DYSPAREUNIA, SCARRING, FURTHER URINARY PROBLEMS, DIFFERENT KINDS OF PAIN SUCH AS CHRONIC, SEVERE PELVIC, ABDOMINAL, LOW BACK PAIN, AND LOSS OF ENJOYMENT OF LIFE. THE PATIENT UNDERWENT EXCISION OF EXTRUDED VAGINAL MESH ON (B)(6) 2022, AS APPROXIMATELY 1 CM SEGMENT OF THE MESH WAS EASILY VISIBLE AS TRAVERSED FROM THE LEFT LATERAL URETHRA TO THE LEFT VAGINAL WALL.

  Patient problems: Abdominal Pain; Dyspareunia; Erosion; Micturition Urgency; Pain; Scar Tissue; Unspecified Mental, Emotional or Behavioral Problem; Urinary Incontinence

  MAUDE report 19774969 ↗
• MalfunctionJun 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SOLYX SIS SYSTEM IMPLANT PROCEDURE, THE DEVICE WAS ADVANCED INTO THE PATIENT, HOWEVER, THE SHAFT TIP WAS OBSERVED TO BE BENT. THE DEVICE WAS REMOVED, AND ANOTHER SOLYX SIS SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575571 ↗
• InjuryJan 25, 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 SOLYX SIS SYSTEM WAS IMPLANTED DURING A MID-URETHRAL SLING PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. AFTER THE PROCEDURE, THE CYSTOSCOPIC EVALUATION SHOWED NO URETHRAL OR BLADDER INJURY. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH MESH EROSION AND STRESS INCONTINENCE AND HAD REMOVAL OF ERODED MESH WITH AUTOLOGOUS PUBOVAGINAL SLING. FINDINGS: THE MESH HAD EXPOSED ITSELF THROUGH THE MIDLINE. CYSTOSCOPY THAT WAS PERFORMED AFTER THE SLING PLACEMENT SHOWED NO URETHRAL OR BLADDER INJURY. DESCRIPTION OF PROCEDURE: THE ERODED SLING WAS NOTED AND DISSECTED FROM SIDEWALL TO SIDEWALL. AFTER REMOVING THE SLING, THE VAGINAL PLANES WERE FURTHER DEVELOPED FOR THE PLACEMENT OF THE PUBOVAGINAL SLING. A 2 CM X 7 CM FACIA WAS HARVESTED FROM THE RECTUS ABDOMINIS. THE FASCIA WAS THEN ATTACHED AND THEN PULLED INTO THE VAGINAL FIELD. AT THIS POINT, CYSTOSCOPY WAS PERFORMED SHOWING NO URETHRAL OR BLADDER INJURY. THE SLING WAS TIED IN THE MIDLINE IN A TENSION-FREE WAY. EACH PORTION OF THE SLING WENT INTO THE SPACE OF RETZIUS. THE WOUND WAS THEN CLOSED IN TWO LAYERS. THERE WERE NO IMMEDIATE COMPLICATIONS.

  Patient problems: Abnormal Vaginal Discharge; Bacterial Infection; Erosion; Incontinence; Inflammation; Pain; Skin Inflammation/ Irritation; Urinary Incontinence

  MAUDE report 18582727 ↗
• InjuryJan 17, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A STRESS URINARY INCONTINENCE PROCEDURE IN THE BLADDER, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO PUSH THE SOLYX ANCHOR INTO THE PERIURETHRAL TISSUE, IT PERFORATED THE BLADDER. THE PHYSICIAN ATTEMPTED TO POP THE ANCHOR INTO THE MUSCLES, HOWEVER, IT WAS NOT ADVANCING, AND WHEN TRIED TO REMOVE, THERE WAS RESISTANCE. WHEN THE PHYSICIAN HAD SUCCESSFULLY REMOVED THE ANCHOR, IT WAS NOTICED THAT THE MESH WAS STRETCHED FROM PULLING THE ANCHOR OUT OF THE BLADDER. ANOTHER SOLYX SIS SYSTEM WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD A LARGE BLOOD CLOT AND A BLADDER PERFORATION WHICH WAS CAUTERIZED USING A BUGBEE DURING CYSTOSCOPY. THE BLEEDING WAS CONTROLLED, AND A CATHETER WAS LEFT IN PLACE. THE DAY AFTER THE PROCEDURE, THE PATIENT HAD A 50% POST-VOID RESIDUAL (PVR), SO SHE WAS TAUGHT SELF-CATHETERIZATION AND SCHEDULED TO FOLLOW UP A WEEK LATER. WHEN THE SURGEON LAST SPOKE TO THE PATIENT ON (B)(6) 2024, SHE DID NOT NEED TO SELF-CATHETERIZE AND WAS ALSO NOT LEAKING; THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation; Urinary Retention

  MAUDE report 18527920 ↗
• MalfunctionOct 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE END BROKE OFF OF THE MESH, WHICH MOST LIKELY SUGGESTS THAT THE MESH CARRIER WAS DETACHED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: THE SHAFT TIP DETACHED AND WAS FOUND STUCK IN ONE OF THE MESH CARRIERS. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003108 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS IMPLANTED DURING A LAPAROSCOPY, LEFT OOPHORECTOMY, BILATERAL TUBAL LIGATION WITH BIPOLAR ELECTROCOAGULATION, HYSTEROSCOPY, DILATATION, AND CURETTAGE AND SOLYX SUB URETHRAL SLING SUSPENSION PROCEDURE PERFORMED ON (B)(6) 2015, FOR THE TREATMENT OF PERSISTENT LEFT ADNEXAL CYST MASS, RULE OUT DERMOID CYST, DESIRES PERMANENT STERILIZATION, LEFT LOWER QUADRANT PELVIC PAIN, MENOMETRORRHAGIA, DYSMENORRHEA AND STRESS URINARY INCONTINENCE WITH URETHRAL HYPERMOBILITY. ON (B)(6) 2023, THE PATIENT UNDERWENT PLACEMENT OF PUBOVAGINAL SUB URETHRAL SLING USING VNEW FASCIA LATA CADAVER ALLOGRAFT, REVISION OF MID-URETHRAL SLING MESH AND CYSTOURETHROSCOPY DUE TO URODYNAMIC STRESS INCONTINENCE AND VAGINAL EXPOSURE OF MID-URETHRAL SLING MESH. THE PRE-EXISTING MID-URETHRAL SLING EXPOSURE WAS APPROXIMATELY 5-8MM IN THE LEFT LATERAL VAGINAL FORNIX. TENOTOMY SCISSORS WERE USED TO EXCISE THE EXPECTED MESH. AN AREA OF NODULARITY DUE TO NEAR MESH EXPOSURE IN THE RIGHT LATERAL VAGINAL FORNIX WAS ADDRESSED WITH A SCALPEL INCISION AROUND THE APPROXIMATELY 3MM AREA AND TENOTOMY EXCISION OF A SMALL SEGMENT OF MESH. A SERIES OF INTER

  Patient problems: Erosion; Urinary Incontinence

  MAUDE report 17969455 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE INCISION SLING DEVICE WAS IMPLANTED INTO THE PATIENT DURING A MID-URETHRAL SLING WITH PROLENE MESH PLACEMENT AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS INCONTINENCE. DURING THE PROCEDURE, A CYSTOSCOPY WAS PERFORMED, AND THERE WAS NO INJURY TO THE BLADDER. THE TRIGONE WAS NORMAL, AND URINE WAS SEEN TO SPILL FROM EACH URETERAL ORIFICE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAD A BLADDER OBSTRUCTION AFTER THE SLING WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT HAD THE VAGINAL MESH REMOVED AND URETHROLYSIS PERFORMED. DURING THE SURGERY, A CYSTOURETHROSCOPY WAS PERFORMED, WHICH INDICATED A NORMAL BLADDER WITH NO SIGNS OF A STONE MASS LESION, CARCINOMA IN SITU, FOREIGN BODY INJURY, OR TRAUMA TO THE BLADDER OR URETHRA. URETERAL ORIFICES WERE IN THEIR NORMAL ANATOMIC LOCATION, EFFLUXING CLEAR URINE BILATERALLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17762510 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS DIAGNOSED WITH CYSTOCELE AND STRESS URINARY INCONTINENCE. ON (B)(6) 2018, A SOLYX SIS SYSTEM WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR COLPORRHAPHY AND PUBOVAGINAL SLING PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH RECTOCELE, STRESS URINARY INCONTINENCE AND SLING EROSION IN THE VAGINAL MUCOSA AND SUBSEQUENTLY UNDERWENT A POSTERIOR COLPORRHAPHY AND A PARTIAL PUBOVAGINAL SLING PARTIAL REMOVAL PROCEDURES ON THE SAME DAY.

  Patient problems: Erosion; Prolapse; Urinary Incontinence

  MAUDE report 17660434 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL SUBURETHRAL SLING + CYSTOURETHROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. FINDINGS INCLUDED A SMALL MILD CYSTOCELE AND HYPERMOBILE URETHRA. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY AREA AWAKE AND IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17549112 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING AN ANTERIOR COLPORRHAPHY + SOLYX SLING WITH CYSTOSCOPY + POSTERIOR COLPORRHAPHY PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF SYMPTOMATIC CYSTOCELE, STRESS URINARY INCONTINENCE AND SYMPTOMATIC RECTOCELE. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT EXPERIENCED AN UNKNOWN INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17466928 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, AND MID-URETHRAL SLING PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016, FOR THE TREATMENT OF ABNORMAL UTERINE BLEEDING, ANEMIA, AND PELVIC PAIN. DURING THE EXAM UNDER ANESTHESIA, IT WAS OBSERVED THAT THE UTERUS WAS SLIGHTLY ENLARGED AND IN A GLOBULAR SHAPE. IT WAS FOUND TO BE MOBILE AND ANTEVERTED. NO MASSES WERE DETECTED IN THE SURROUNDING AREAS. THE LAPAROSCOPIC FINDINGS SHOWED A SIMILAR ENLARGED GLOBULAR UTERUS, BUT BOTH FALLOPIAN TUBES AND OVARIES APPEARED NORMAL. THE LIVER EDGE WAS ALSO NORMAL, BUT THE GALLBLADDER WAS SLIGHTLY ENLARGED. AFTER THE CYSTOSCOPY, IT WAS CONFIRMED THAT BILATERAL URETERAL JETS WERE PRESENT, AND THERE WAS NO DAMAGE OR SUTURE ON THE BLADDER. IN ADDITION, THE PATIENT UNDERWENT THE PROCEDURE WITHOUT ANY ISSUES AND WAS SUCCESSFULLY AWAKENED FROM ANESTHESIA. AFTERWARD, SHE WAS MOVED TO THE RECOVERY AREA AND REMAINED IN STABLE CONDITION. AS REPORTED BY THE PATIENT'S ATTORNEY, THE PATIENT HAS EXPERIENCED AN UNSPECIFIED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17426921 ↗