UPSYLON
Report
- Report Number
- 2124215-2025-40182
- Event Type
- Injury
- Date Received
- June 27, 2025
- Date of Event
- January 1, 2019
- Report Date
- August 1, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLOCK A2: AGE AT THE TIME OF EVENT. PATIENTS OVER THE AGE OF 18 WHO UNDERWENT ABDOMINAL SCP BETWEEN 2019 AND 2023 WERE INCLUDED. BLOCK B3 DATE OF EVENT: THE EXACT ONSET DATE OF THE EVENT IS UNKNOWN. THE PROVIDED DATE OF JANUARY 1, 2019, WAS SELECTED AS THE BEST ESTIMATE BASED ON THE STUDY PERIOD BETWEEN 2019 AND 2023. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK D4 UNIQUE IDENTIFIER (UDI) #: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E1310 - CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. E2319 - CAPTURES THE REPORTABLE EVENT OF HERNIA. E1309 - CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: F1901 - CAPTURES THE REPORTABLE EVENT OF PATIENT UNDERWENT A REOPERATION DUE TO PORT HERNIA. LITERATURE SOURCE HENRY H. CHILL, M.D., ALIREZA HADIZADEH, M.D., CALUDIA PAYA-TEN, M.D., ANGELA LEFFELMAN, M.D., CECILIA CHANG, M.D., NANI P. MOSS, M.D., AND ROGER P. GOLDBERG, M.D., POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS FOLLOWING MINI-LAPAROTOMY VS. LAPAROSCOPIC/ROBOTIC-ASSISTED SACROCOLPOPEXY: A COMPARATIVE RETROSPECTIVE STUDY. BMC WOMEN'S HEALTH VOLUME 24, NUMBER 24:173.
BLOCK H2 CORRECTION: - BLOCK D2B PRO CODE HAS BEEN UPDATED. BLOCK A2: AGE AT THE TIME OF EVENT. PATIENTS OVER THE AGE OF 18 WHO UNDERWENT ABDOMINAL SCP BETWEEN 2019 AND 2023 WERE INCLUDED. BLOCK B3 DATE OF EVENT: THE EXACT ONSET DATE OF THE EVENT IS UNKNOWN. THE PROVIDED DATE OF JANUARY 1, 2019, WAS SELECTED AS THE BEST ESTIMATE BASED ON THE STUDY PERIOD BETWEEN 2019 AND 2023. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK D4 UNIQUE IDENTIFIER (UDI) #: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E1310 - CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. E2319 - CAPTURES THE REPORTABLE EVENT OF HERNIA. E1309 - CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. THE IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: F1901 - CAPTURES THE REPORTABLE EVENT OF PATIENT UNDERWENT A REOPERATION DUE TO PORT HERNIA. LITERATURE SOURCE HENRY H. CHILL, M.D., ALIREZA HADIZADEH, M.D., CALUDIA PAYA-TEN, M.D., ANGELA LEFFELMAN, M.D., CECILIA CHANG, M.D., NANI P. MOSS, M.D., AND ROGER P. GOLDBERG, M.D., POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS FOLLOWING MINI-LAPAROTOMY VS. LAPAROSCOPIC/ROBOTIC-ASSISTED SACROCOLPOPEXY: A COMPARATIVE RETROSPECTIVE STUDY. BMC WOMEN'S HEALTH VOLUME 24, NUMBER 24:173.
BOSTON SCIENTIFIC BECAME AWARE OF AN INCIDENT INVOLVING THE UPSYLON Y-MESH THROUGH AN ARTICLE TITLED "POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS FOLLOWING MINI-LAPAROTOMY VS. LAPAROSCOPIC/ROBOTIC-ASSISTED SACROCOLPOPEXY" EXPLORES THE COMPARATIVE SAFETY AND EFFECTIVENESS OF TWO SURGICAL APPROACHES FOR TREATING APICAL PELVIC ORGAN PROLAPSE (POP): MINI-LAPAROTOMY AND LAPAROSCOPIC OR ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP). POP IS A CONDITION WHERE PELVIC ORGANS DESCEND DUE TO WEAKENED SUPPORT STRUCTURES, AND SCP IS A WELL-ESTABLISHED SURGICAL METHOD FOR RESTORING APICAL SUPPORT. IN THIS STUDY, BOTH SURGICAL TECHNIQUES UTILIZED SYNTHETIC MESH, SPECIFICALLY THE UPSYLON Y-MESH TO REINFORCE THE VAGINAL WALLS AND SECURE THEM TO THE SACRAL PROMONTORY, THEREBY PROVIDING DURABLE ANATOMICAL SUPPORT. ADDITIONALLY, SOME PATIENTS RECEIVED MID-URETHRAL SLINGS TO ADDRESS COEXISTING STRESS URINARY INCONTINENCE THE RESEARCHERS CONDUCTED A RETROSPECTIVE COHORT STUDY INVOLVING 116 WOMEN TREATED BETWEEN 2019 AND 2023. PATIENTS WERE DIVIDED INTO TWO GROUP: 26 UNDERWENT SCP VIA A MINI-LAPAROTOMY APPROACH, AND 90 UNDERWENT EITHER LAPAROSCOPIC OR ROBOTIC-ASSISTED SCP. ALL SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA BY EXPERIENCED UROGYNECOLOGIC SURGEONS. THE STUDY AIMED TO COMPARE SHORT-TERM POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS BETWEEN THE TWO GROUPS. THE FINDINGS REVEALED THAT INTRAOPERATIVE COMPLICATIONS WERE RARE IN BOTH GROUPS. POSTOPERATIVELY, BOTH GROUPS DEMONSTRATED LOW COMPLICATION RATES. IN THE MINI-LAPAROTOMY GROUP, NO COMPLICATIONS WERE REPORTED WITHIN THE FIRST 30 DAYS. IN CONTRAST, THE LAPAROSCOPIC/ROBOTIC GROUP EXPERIENCED TWO CASES OF URINARY TRACT INFECTIONS AND ONE CASE OF PORT SITE HERNIA, WHICH REQUIRED SURGICAL REPAIR. MINOR POSTOPERATIVE SYMPTOMS SUCH AS NAUSEA, DIZZINESS, AND URINARY RETENTION WERE OBSERVED BUT MANAGED CONSERVATIVELY AND DID NOT NECESSITATE FURTHER INTERVENTION. UNANTICIPATED HEALTHCARE ENCOUNTERS, INCLUDING PHONE CALLS, CLINIC VISITS, EMERGENCY DEPARTMENT VISITS, AND READMISSIONS, WERE SIMILAR BETWEEN THE TWO GROUPS. ONLY ONE PATIENT IN THE LAPAROSCOPIC/ROBOTIC GROUP REQUIRED REOPERATION. IMPORTANTLY, THE STUDY FOUND THAT THE MINI-LAPAROTOMY APPROACH RESULTED IN SIGNIFICANTLY SHORTER OPERATIVE TIMES BY OVER TWO HOURS ON AVERAGE COMPARED TO THE LAPAROSCOPIC/ROBOTIC METHOD, WITHOUT COMPROMISING SAFETY OR INCREASING COMPLICATION RATES. IN CONCLUSION, THE STUDY SUPPORTS THE MINI-LAPAROTOMY APPROACH AS A VIABLE AND EFFICIENT ALTERNATIVE TO LAPAROSCOPIC OR ROBOTIC-ASSISTED SCP. IT OFFERS COMPARABLE SAFETY IN TERMS OF INTRA AND POSTOPERATIVE COMPLICATIONS AND HEALTHCARE UTILIZATION, WHILE ALSO REDUCING OPERATIVE TIME. THESE FINDINGS SUGGEST THAT MINI-LAPAROTOMY SCP MAY BE PARTICULARLY ADVANTAGEOUS IN CLINICAL SETTINGS WHERE SURGICAL EFFICIENCY AND RESOURCE OPTIMIZATION ARE PRIORITIES.
BOSTON SCIENTIFIC BECAME AWARE OF AN INCIDENT INVOLVING THE UPSYLON Y-MESH THROUGH AN ARTICLE TITLED "POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS FOLLOWING MINI-LAPAROTOMY VS. LAPAROSCOPIC/ROBOTIC-ASSISTED SACROCOLPOPEXY" EXPLORES THE COMPARATIVE SAFETY AND EFFECTIVENESS OF TWO SURGICAL APPROACHES FOR TREATING APICAL PELVIC ORGAN PROLAPSE (POP): MINI-LAPAROTOMY AND LAPAROSCOPIC OR ROBOTIC-ASSISTED SACROCOLPOPEXY (SCP). POP IS A CONDITION WHERE PELVIC ORGANS DESCEND DUE TO WEAKENED SUPPORT STRUCTURES, AND SCP IS A WELL-ESTABLISHED SURGICAL METHOD FOR RESTORING APICAL SUPPORT. IN THIS STUDY, BOTH SURGICAL TECHNIQUES UTILIZED SYNTHETIC MESH, SPECIFICALLY THE UPSYLON Y-MESH TO REINFORCE THE VAGINAL WALLS AND SECURE THEM TO THE SACRAL PROMONTORY, THEREBY PROVIDING DURABLE ANATOMICAL SUPPORT. ADDITIONALLY, SOME PATIENTS RECEIVED MID-URETHRAL SLINGS TO ADDRESS COEXISTING STRESS URINARY INCONTINENCE THE RESEARCHERS CONDUCTED A RETROSPECTIVE COHORT STUDY INVOLVING 116 WOMEN TREATED BETWEEN 2019 AND 2023. PATIENTS WERE DIVIDED INTO TWO GROUP: 26 UNDERWENT SCP VIA A MINI-LAPAROTOMY APPROACH, AND 90 UNDERWENT EITHER LAPAROSCOPIC OR ROBOTIC-ASSISTED SCP. ALL SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA BY EXPERIENCED UROGYNECOLOGIC SURGEONS. THE STUDY AIMED TO COMPARE SHORT-TERM POSTOPERATIVE COMPLICATIONS AND UNANTICIPATED HEALTHCARE ENCOUNTERS BETWEEN THE TWO GROUPS. THE FINDINGS REVEALED THAT INTRAOPERATIVE COMPLICATIONS WERE RARE IN BOTH GROUPS. POSTOPERATIVELY, BOTH GROUPS DEMONSTRATED LOW COMPLICATION RATES. IN THE MINI-LAPAROTOMY GROUP, NO COMPLICATIONS WERE REPORTED WITHIN THE FIRST 30 DAYS. IN CONTRAST, THE LAPAROSCOPIC/ROBOTIC GROUP EXPERIENCED TWO CASES OF URINARY TRACT INFECTIONS AND ONE CASE OF PORT SITE HERNIA, WHICH REQUIRED SURGICAL REPAIR. MINOR POSTOPERATIVE SYMPTOMS SUCH AS NAUSEA, DIZZINESS, AND URINARY RETENTION WERE OBSERVED BUT MANAGED CONSERVATIVELY AND DID NOT NECESSITATE FURTHER INTERVENTION. UNANTICIPATED HEALTHCARE ENCOUNTERS, INCLUDING PHONE CALLS, CLINIC VISITS, EMERGENCY DEPARTMENT VISITS, AND READMISSIONS, WERE SIMILAR BETWEEN THE TWO GROUPS. ONLY ONE PATIENT IN THE LAPAROSCOPIC/ROBOTIC GROUP REQUIRED REOPERATION. IMPORTANTLY, THE STUDY FOUND THAT THE MINI-LAPAROTOMY APPROACH RESULTED IN SIGNIFICANTLY SHORTER OPERATIVE TIMES BY OVER TWO HOURS ON AVERAGE COMPARED TO THE LAPAROSCOPIC/ROBOTIC METHOD, WITHOUT COMPROMISING SAFETY OR INCREASING COMPLICATION RATES. IN CONCLUSION, THE STUDY SUPPORTS THE MINI-LAPAROTOMY APPROACH AS A VIABLE AND EFFICIENT ALTERNATIVE TO LAPAROSCOPIC OR ROBOTIC-ASSISTED SCP. IT OFFERS COMPARABLE SAFETY IN TERMS OF INTRA AND POSTOPERATIVE COMPLICATIONS AND HEALTHCARE UTILIZATION, WHILE ALSO REDUCING OPERATIVE TIME. THESE FINDINGS SUGGEST THAT MINI-LAPAROTOMY SCP MAY BE PARTICULARLY ADVANTAGEOUS IN CLINICAL SETTINGS WHERE SURGICAL EFFICIENCY AND RESOURCE OPTIMIZATION ARE PRIORITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939913 | UPSYLON | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP | OTO | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |