MAUDE Adverse Event Report: ETHICON INC. VYPRO MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(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 regarding the additional events.Citation: international urogynecology journal (2021);32:955¿960.Https://doi.Org/10.1007/s00192-020-04503-1 attempts are being made to obtain 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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (vypro mesh and prolene polypropylene suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? patient demographics? events related to prolene suture device reported via mw # 2210968-2021-09890.Events related to vypro mesh device reported via this report.

Event Description

It was reported in a journal article with title: preoperative ultrasound findings as risk factors of recurrence of pelvic organ prolapse after laparoscopic sacrocolpopexy.The objective of this retrospective cohort study is to evaluate levator ani muscle avulsion (lama) and ballooning as risk factors for recurrence of pelvic organ prolapse (pop) after laparoscopic sacrocolpopexy (scp).From january 2015 to december 2018, a total of 134 women [mean age of 60 (range 36-75); mean bmi of 30 ± 4.1] who underwent laparoscopic sacrocolpopexy for prolapse repair were included in the study.Two pieces of a polypropylene plus polyglactin mesh (vypro ii; ethicon, somerville, nj, usa), the latter of which had a self-styled y shape, were bilaterally sutured to the anterior and posterior vagina or anterior and posterior cervix (when supracervical hysterectomy was also performed) and promontory with several polypropylene sutures (prolene; ethicon).The number of sutures depended on the length of the vagina.In general, four sutures were used to attach the anterior mesh arm and four sutures to attach the posterior mesh arm.Finally, the meshes were covered by closing the peritoneum with a 2¿0 absorbable running suture (vicryl; ethicon).The mean follow-up time was 16 months.Reported complications include anatomic recurrence (n=13.4%), symptomatic recurrence (n=5) requiring reoperation in 2 patients; de novo stress urinary incontinence (n=6.7%), de novo dyspareunia (n=10), and mesh erosion (n=3).In conclusion, lama and ballooning on pelvic floor us are not significant risk factors for anatomic pop recurrence after laparoscopic scp.Laparoscopic scp has a 13.4% and 3.4% anatomic and symptomatic recurrence rate, respectively, and the majority of patients reported significant improvement in quality of life.

• Brand Name: VYPRO MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12656076
• MDR Text Key: 282226481
• Report Number: 2210968-2021-09891
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K002672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 09/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention