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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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: european journal of obstetrics & gynecology and reproductive biology.2008; 139: 245 251.Doi: 10.1016/j.Ejogrb.2008.01.013 (b)(4).

Event Description

Journal article title : vaginal reconstructive surgery for severe pelvic organ prolapses: a ¿uterine-sparing¿ technique using polypropylene prostheses.The ulmsten¿s ¿¿integral theory¿¿ for pelvic floor dysfunctions is based on the need to reinforce fascias and ligaments with prostheses to obtain a reconstitution of the pelvic floor¿s anatomy.In september 2004, the authors developed a ¿¿uterine-sparing¿¿ surgical technique to correct such pathologies.The primary outcome of the study was to evaluate the technique¿s efficacy and the secondary outcome was the resolution of stress urinary incontinence, postoperative pain, safety and complications.This prospective study included 80 patients (age range: 38 to 74 years old) affected by stage 3 and 4 uterine-vaginal prolapse who wished to conserve their uterus.The authors performed an anterior-central vaginal reconstruction in 35 patients (group 1), central-posterior in 25 patients (group 2), and total reconstruction in 20 patients (group 3).During the surgical procedure in all groups, the gynecare gynemesh-soft ps mesh (ethicon) were used to reconstruct the pubo-cervix and the recto-vaginal fascia.They were prepared cutting four ¿¿arms¿¿ from the initial mesh and were subsequently washed in a cephalosporin solution prior to insertion.The authors used 1 mesh to repair the anterior-central compartment, 1 for the central-posterior compartment, and 2 for the total prolapse repair (both compartments).For group 1, the authors inserted and fixed the prosthesis to the sacrospinosus ligament (ssl) with polyester 1-0 (ethicon) using an endostitch device.This represents the first level of suspension for the vaginal apex.For group 3, both techniques from groups 1 and 2 were combined and applied in this study group.In group 1, reported complications included vaginal erosion (n-1) which required local excisions of the visible graft and suturing of the vagina.In group 3, reported complications included vaginal erosion (n-2) which required local excisions of the visible graft and suturing of the vagina and post-operative dyspareunia (n-1) which was successfully resolved with the prosthesis removal.It was reported that prostheses were intentionally created with 4 arms in order to fix them deep inside pelvic structures.These multiple lateral attachments could explain the absence of recurrences.This pilot study suggests that the technique can efficiently repair severe pelvic organ prolapses, restore a normal horizontal axis of the vagina, and a normal sexual life without removing the uterus, without recurrences and with a low rate of vaginal erosions.

• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7745671
• MDR Text Key: 115890435
• Report Number: 2210968-2018-74864
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 07/18/2018
• 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