MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (prolift mesh, prolene suture, vicryl suture, pds ii suture and monocryl suture ) involved caused and/or contributed to intra-operative complications (bladder injury, rectal injury, ureteral injury and bleeding) described in the article? please specify.Does the surgeon believe that ethicon products (prolift mesh, prolene suture, vicryl suture, pds ii suture and monocryl suture ) involved caused and/or contributed to post-operative complications (vaginal exposure, bladder exposure, fistula formation and prolapse recurrence) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon products (prolift mesh, prolene suture, vicryl suture, pds ii suture and monocryl suture ) used in this procedure/study? if yes, please provide patient demographics for the patients that experienced the intra-operative and post-operative complications and details of events if available.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Please provide, if possible, type, product code or lot number of ethicon products (prolift mesh, prolene suture, vicryl suture, pds ii suture and monocryl suture ) used in this study.Citation: international journal of urology (2020) 27, 996¿1000; doi: 10.1111/iju.14343.Events were submitted via 2210968-2021-04465, 2210968-2021-04466, 2210968-2021-04467, and 2210968-2021-04469.

Event Description

Title: techniques of transvaginal mesh prolapse surgery in japan, and the comparison of complication rates by surgeons¿ specialty and experience this study aims to investigate the practice patterns of prolapse surgery and tvm techniques and compare tvm complication rates by surgeons¿ specialties and tvm experiences.As no mesh prolapse kits had been approved by the japanese government, from 2005, surgeons began to use self-cut mesh and custom-made needles to carry out tvm.Five years later, a questionnaire survey were carried out to investigate the practice patterns of urogynecological surgery, and compared tvm complication rates depending on surgeons¿ specialties and experience.A total of 11 935 prolift-type mesh surgeries (5551 by gynecologists, 6384 by urologists) were carried out within 5 years since its introduction to japan in 2005.84% of the respondents inserted mesh in both the anterior and posterior compartments, 8% restricted tvm to the anterior compartment, and 8% planned to begin mesh surgery.In all cases, was chosen.The mesh was stitched to the uterine cervix by 92% of surgeons (3 points in 51%, 2 points in 22% and 1 point in 15%).The following sutures were used: proline 91%, vicryl 4%, pds 3% and others 2%.The mesh was stitched to the vaginal wall by 90% of surgeons (3 points in 59%, 2 points in 22% and 1 point in 7%), whereas 10% did not use stitches between the vagina and mesh.The following sutures were used: vicryl 58%, proline 15%, pds 21% and others 6%.Reported complications included : intraoperative complications: (n=196) bladder injury,(n=37) rectal injury,(n=13) ureteral injury,(n=25) bleeding requiring blood transfusion,or (n=2) bleeding requiring vascular embolization.Postoperative complications included: (n=335) vaginal exposure ,(n=1) bladder exposure , and (n=3) fistula formation.Prolapse recurrence requiring reoperation (n=135).It was concluded, that this survey showed that >10 000 tvm had been carried out in japan with a relatively low complication rate until 2010.Experienced surgeons showed significantly lower rates of bladder injury, blood transfusion and vaginal exposure.Details relating to surgical techniques, such as the full-thickness dissection layer and avoiding concomitant surgeries, are critical.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11810459
• MDR Text Key: 264606711
• Report Number: 2210968-2021-04468
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention