MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Abscess (1690); Hematoma (1884); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Blood Loss (2597); 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.Citation: am j obstet gynecol 2012;207:301.E1-7; doi: http://dx.Doi.Org/10.1016/j.Ajog.2012.08.016.(b)(4).

Event Description

It was reported via journal article "title: a multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse".Author(s): michael halaska, md, phd; katerina maxova, md; oldrich sottner, md; kamil svabik, md, phd; michal mlcoch, md; dusan kolarik, md; ivana mala, phd; ladislav krofta, md, phd; michael j.Halaska, md, phd.Citation: am j obstet gynecol 2012;207:301.E1-7; doi: http://dx.Doi.Org/10.1016/j.Ajog.2012.08.016.The objective of this multicenter, prospective, randomized, comparative study study was to compare recurrence and complication rates for sacrospinous fixation (ssf) and prolene mesh techniques for the primary treatment of posthysterectomy vaginal vault prolapse.A total of 168 patients with central posthysterectomy vaginal vault prolapse were randomized into 2 groups: ssf group (n=83) and mesh group (n=85).In ssf group, 2 nurolon stitches were anchored in the sacrospinous ligament and fixed to the vaginal cuff apex.In mesh group, prolift cannulas (gynecare, ethicon) was inserted with retrieval loops.Then, totatl prolift mesh was attached to the pubocervical fascia and vaginal wall using pds 2-0 sutures.At 3 months follow-up, complications included severe bleeding (n=6 ssf group; n=10 mesh group), hematoma (n=1 mesh group), bladder injury (n=1 ssf group; n=3 mesh group), abscess (n=1 mesh group), lower urinary tract (lut) infection (n=5 ssf group; n=1 mesh group), mesh exposure (n=12 mesh group), prolapse recurrence (n=13 ssf group; n=6 mesh group), de novo stress urinary incontinence (n=18 ssf group; n=21 mesh group), de novo overactive bladder (n=9 ssf group; n=7 mesh group), dyspareunia (n=2 ssf group; n=7 mesh group) and pelvic pain (n=3 ssf group; n=8 mesh group).At 12 months follow-up, complications included lower urinary tract (lut) infection (n=5 ssf group; n=3 mesh group), mesh exposure (n=16 mesh group), prolapse recurrence (n=28 ssf group; n=13 mesh group), de novo stress urinary incontinence (n=18 ssf group; n=27 mesh group), de novo overactive bladder (n=8 ssf group; n=8 mesh group), dyspareunia (n=2 ssf group; n=6 mesh group) and pelvic pain (n=3 ssf group; n=6 mesh group).In ssf group, out of 28 cases of prolapse recurrences, 3 patients underwent reoperations: anterior prolift (n=1), total prolift (n=1) and colpocleisis (n=1).While in mesh group, only one patient underwent reoperation by abdominal sacralcolpopexy.Of the vaginal mesh exposures, 10 were treated successfully by surgical resection of the protruded mesh and 6 cases resolved with local estrogen therapy.The high incidence of de novo sui in the ssf (25.4%) and mesh (35.1%) groups in our study is likely related to the correction of anterior prolapse because the successful correction of a cystocoele with or without meshes can unmask so-called potential sui.Mesh exposure occurrence was balanced against a lower prolapse recurrence rate in the patients undergoing mesh surgery compared with those undergoing ssf.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8001992
• MDR Text Key: 124962171
• Report Number: 2210968-2018-76758
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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?: Yes
• Date Manufacturer Received: 10/11/2018
• 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