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 Erosion (1750); Incontinence (1928); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/03/2018.(b)(4).Citation: arch gynecol obstet (2013) 287:1159¿1165; doi 10.1007/s00404-012-2685-8 -[(b)(4)].

Event Description

It was reported via journal article: "title : risk factors of surgical failure following sacrospinous colpopexy for the treatment of uterovaginal prolapse." author: ayman qatawneh, fida thekrallah, majed bata, fawaz al-kazaleh, mahmoud almustafa, ilham abu-kader.Citation: arch gynecol obstet (2013) 287:1159¿1165; doi 10.1007/s00404-012-2685-8.The purpose of this retrospective study was to analyse the potential risk factors of surgical failure following sacrospinous colpopexy.From jan2005 to jan2008, 114 female patients (mean age of 56±8.9 years) with varying degrees of vaginal vault and uterovaginal prolapse underwent unilateral sacrospinous colpopexy.In the procedure, the anterior vaginal wall was sharply dissected from the underlying pubocervical fascia, which was plicated in the midline with a delayed absorbable 2-0 polydioxanone suture (ethicon).In some women, the retropubic space was widened using sharp and blunt dissection, and gynemesh ps was designed and tailored, leaving two tabs on each side, which were placed into the retropubic space in a tension-free fashion without sutures.The mesh was loosely fixed at four point using 3-0 vicryl sutures.Vaginal incision was closed with 0 vicryl suture.A triple n0.0 delayed absorbable polydioxanone suture (ethicon) was inserted into the right sacrospinous ligament 2 cm medial to the ischial spine.Fifty three of these patients had mesh augmentation of the anterior vaginal wall.Two patients had mesh erosion which failed to respond to conservative management.Thus, the patient had reoperation during the follow-up period.Three patients had de novo stress urinary incontinence treated with sub-urethral tapes on reoperation.In conclusion, the presence of advanced anterior vaginal wall prolapse, prior vaginal repair and a lack of mesh augmentation of the anterior compartment are significant risk factors for the surgical failure of sacrospinous suspension.

Manufacturer Narrative

Pc-000234470 date sent to the fda: 08/03/2018 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.Does the surgeon believe the cases of sub-urethral tapes for the de novo stress urinary incontinence were related to any ethicon products? does the surgeon believe that ethicon products 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 (gynemesh, pds suture or vicryl suture) used in this procedure?.

• 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: 7746476
• MDR Text Key: 115912304
• Report Number: 2210968-2018-74873
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2018
• 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