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

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Uterine Perforation (2121); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: int urogynecol j.2008; 19: 473¿479.Doi: 10.1007/s00192-007-0476-8.[(b)(4)].

Event Description

It was reported via journal article: "title: risk evaluation of smoking and age on the occurrence of postoperative erosions after transvaginal mesh repair for pelvic organ prolapses".Author: francesco araco & gianpiero gravante & roberto sorge & davide de vita & emilio piccione.Citation: int urogynecol j.2008; 19: 473¿479.Doi: 10.1007/s00192-007-0476-8.This study evaluated the influence of age and smoking on the occurrence of vaginal erosions after transvaginal mesh repair of pelvic organ prolapses (pop).The study began in january 2002 and ended in december 2006 with the recruitment of the last patient.The authors evaluated a total of 325 patients (age range: 45 to 75 years old; bmi: 29 ± 4) who underwent mesh correction of pop.During the procedure, the prostheses were introduced via the anterior or posterior approach.For the anterior repair, 2 tiny skin incisions were made on the genitorfemoralis fold, near the hymen, and 2 other incisions more caudally and laterally.A tunneller, with the gynecare gynemesh-soft ps mesh prosthesis (ethicon) included, was introduced in the obturator foramen and passed through the obturator membrane and obturator internal muscle until it reached the vagina.At this point, the prosthesis was anchored and the arms distended.For the posterior repair, a tunneller was introduced, with the gynecare gynemesh-soft ps mesh prosthesis, and passed through the ischiatic fossa and exited on the para-rectal space.The posterior colpotomy was closed with absorbable suture.Reported complications included superficial vaginal erosion (n-13) which were treated by resuturing the vaginal mucosa in local anesthesia and, when mesh was exposed, the authors resected a small piece of it, deep vaginal erosion with evident signs of infection (n-6) in which the patients were readmitted to the hospital and the mesh was removed in general anesthesia, dyspareunia (n-18), vaginal perforation (n-4), recurrence (n-9), and bacterial colonization of (b)(6).The results of this study suggests that patients prone to develop erosions could be easily identified preoperatively by the class of age and the smoking status.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7769851
• MDR Text Key: 116702278
• Report Number: 2210968-2018-75050
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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: 07/19/2018
• 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