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

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: int urogynecol j (2009) 20:523¿531; doi 10.1007/s00192-009-0818-9.(b)(4).

Event Description

It was reported via journal article: "title : complications from vaginally placed mesh in pelvic reconstructive surgery." author: roberta e.Blandon & john b.Gebhart & emanuel c.Trabuco & christopher j.Klingele.Citation: int urogynecol j (2009) 20:523¿531; doi 10.1007/s00192-009-0818-9.This retrospective study aimed to describe complications associated with the use of transvaginal mesh for the treatment of pelvic organ prolapse.From jan2003 to sep2007, 21 female patients (mean age of 61 [sd of 11]) presented complications after pelvic reconstruction surgical procedures for the treatment of symptomatic pelvic organ prolapse were included.Of these patients, meshes used were gynemesh, prolene mesh and prolift mesh.In some patients, prolene sutures were used to fix the mesh.Presenting symptoms included dyspareunia (n=10) for which one patient opted to try vaginal dilators, chronic vaginal drainage (n=9), pain not related to intercourse (n=7) for which one who had persistent pelvic pain underwent reoperation, pelvic organ prolapse symptoms (n=7), stress urinary incontinence (n=6) of which 3 had repeat surgeries, urinary urgency (n=6), urge incontinence (n=4), constipation (n=4), vaginal bleeding/spotting (n=3), urinary retention (n=3) and fecal urgency (n=2).Mesh erosion was observed in 12 patients of which four had erosions at more than one site treated with complete vaginal mesh excision and additional excision of eroded mesh from bladder/urethra (n=2).Other surgical interventions (n=16) included anterior colporrhaphy (n=5), posterior colporrhaphy (n=7), vaginal vault prolapse repair (n=5), abdominal sacrocolpopexy with mesh (n=3), autologous rectus fascia sling (n=4), and synthetic midurethral sling (n=1).Five patients opted for a conservative non-surgical approach.In this study, the surgical technique may contribute to the development of these complications and emphasizes the need for specialized training.Use of vaginal mesh for pelvic reconstruction can produce complications.Multiple interventions may be necessary, and bothersome symptoms may persist.Per table 2 (pelvic floor surgeries before referral): patient #1: procedure: lavh, gynemesh bilateral ssl fixation, gynemesh a&p repair; gynemesh bilateral pvdr, tvt sling, cystoscopy.Patient underwent procedure for composite cystocele/rectocele/enterocele repair and bilateral mesh repair and division of gynemesh; underwent procedure for division of painful left uterosacral band (gynemesh).

• 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7754717
• MDR Text Key: 116216987
• Report Number: 2210968-2018-74942
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• 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