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

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

Patient Problems Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: int urogynecol j (2020); 31:1423¿1433.Doi: https://doi.Org/10.1007/s00192-019-03990-1.  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 (ethibond extra & excel polyester suture & prolene polypropylene mesh) 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 74-year-old female patient with ethibond suture reported via mw # 2210968-2021-08700.Events related to 74-year-old female patient with prolene mesh reported via mw # 2210968-2021-08701.Events related to 77-year-old female patient with prolene mesh reported via mw # 2210968-2021-08702.Events related to 77-year-old female patient with ethibond suture reported via mw # 2210968-2021-08703.Events related to 50-year-old female patient with prolene mesh reported via mw # 2210968-2021-08704.Events related to 50-year-old female patient with ethibond suture reported via mw # 2210968-2021-08705.All other events related to patients with prolene mesh reported via mw # 2210968-2021-08706.All other events related to patients with ethibond suture reported via mw # 2210968-2021-08707.

Event Description

It was reported in a journal article with title: long-term mesh erosion rate following abdominal robotic reconstructive pelvic floor surgery: a prospective study and overview of the literature.The aim of this prospective observational cohort study is to evaluate the long-term mesh erosion rate following robot-assisted laparoscopic sacrocolpopexy (rsc) and robot-assisted laparoscopic sacrocolporectopexy (rscr), and to perform a literature review on mesh erosion after minimally invasive sacrocolpopexy with a minimum follow-up duration of 12 months.Between 2011 to 2012, a total of 96 female patients (mean age = 62.3±10.4 years; mean bmi = 26.1±4.2 kg/m2) who underwent rsc or rscr for pelvic floor disorders were included in the study.50 women (52.1%) underwent an rsc and 46 women (47.9%) an rscr.Surgery was performed using meshes (type 1, macroporous polypropylene, prolene, ethicon inc., johnson & johnson, hamburg, germany, weight 80¿85 g/m2) that were distally attached using non-absorbable sutures (ethibond; ethicon, johnson & johnson, hamburg, germany) and anchored proximally to the sacral promontory using a competitor device.The median follow-up time was 48.1 months (range 36.0¿62.1).Reported complications included intraoperative small bladder perforations in the bladder dome (n=2); intraoperative minor serosal small bowel lesion (n=1); clavien-dindo grade = 2 complication (n=2); clavien-dindo grade = 3 complication (n=1); perforating suture (n=1) found during the intraoperative vaginal examination and was removed; vaginal discomfort (n=4) treated with vaginal estrogen therapy in 2 patients; postoperative new-onset dyspareunia (n=1); and mesh erosion in a 50-year-old (n=1), 77-year-old (n=1), and 74-year-old (n=1) female patients.A 50-year-old female patient presented with pain, dysfunctional voiding, and recurrent urinary tract infections, cystoscopy revealed a small defect of the posterior wall of the bladder with mesh erosion and underwent mesh removal and an omental patch interposition.A 77-year-old female patient had asymptomatic mesh erosion found in the posterior wall of the vagina for which vaginal estrogen was prescribed.A 74-year-old female patient had asymptomatic mesh erosion found in the posterior wall of the vagina, since the mesh exposure was so small, expectant management was chosen.In conclusion, the long-term rate of mesh erosion following an abdominally placed synthetic graft is low.This is an encouraging finding for patients, doctors, and governmental institutions, in a field marked by a lack of knowledge about the use of mesh.Surgeons using synthetic mesh for pelvic floor repair are encouraged to perform focused and meticulous examinations looking for mesh erosion in the long-term to confirm these results.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12509427
• MDR Text Key: 273091581
• Report Number: 2210968-2021-08706
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K962530
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: 08/23/2021
• 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