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261 - EARLY COMPLICATIONS OF AN ULTRA LIGHT WEIGHT TRANSVAGINAL MESH

261

EARLY COMPLICATIONS OF AN ULTRA LIGHT WEIGHT TRANSVAGINAL MESH

FERRY1, P. BERTHERAT 1, H. FERNANDEZ 2, P. DEBODINANCE 3, R. DE TAYRAC 4;
1Gynecology, La Rochelle Hosp., La Rochelle, France, 2Gynecology, Kremlin Bicetre Hosp., Le Kremlin-Bicetre, France, 3Gynecology, Dunkerque Hosp., Dunkerque, France, 4Caremeau Univ. Hosp., Nîmes, France.

Introduction: The safety information of a vaginal mesh upon introduction to teaching urogynecology centers is limited. We used in this study a single incision mesh which allows an anterior sacrospinous ligament (SSL) approach, using a pre-cut macroporous Ultra lightweight polypropylene (19 g/m2) and a single-use, disposable device intended to deliver a suture to the operative site without direct visualization . The proximal arms of the mesh are sutured to the SSL and the distal arms of the mesh are sutured bilaterally in the obturator internus at the level of the arcus tendineus fascia pelvis with the same device. This procedure appears to offer a durable success (1).
Objective: To determine the frequency of intraoperative and perioperative complications associated with the use of Restorelle® DirectFix™ for a combined treatment of pelvic organ prolapse (POP) of anterior and medium compartments.
Methods: A longitudinal case series of the first 74 consecutive patients operated between January 2013 and December 2016 in four tertiary centres by 4 surgeons. Primary outcome was any deviation from a normal intraoperative or perioperative course using the Clavien-Dindo classification. At the time of surgery all the patients had a stage 2 or greater (POP-Q) symptomatic cystocele and/or uterine prolapse. All patients underwent a Restorelle DirectFix® procedure (Porges Coloplast) with concurrent procedures that included posterior fascial repair, posterior mesh reinforcement, hysterectomy and sling procedures for symptomatic stress urinary incontinence (SUI).
Results: Demographic characteristics of the subjects are: Mean age 68 years; BMI: 26, 6; Previous hysterectomy 19%, previous surgery for pelvic organ prolapse: 23%. Median follow up: 4, 5 months (2 to 18 months). Intraoperative and early complications are listed in Table 1 and 2. The vast majority of perioperative complications were related to the need for assisted bladder drainage on discharge (11%) and urinary tract infection. One subject required blood transfusion. 4 Dindo’s grade III complication (re-intervention) occurred (6%):2 for ureteral injury, 2 for hematoma and 1 mesh exposure (1, 3%). The rate of major post-operative complications is concordant with previous reports using the same bilateral anterior sacrospinous ligament fixation with anterior mesh repair (2), with a very low exposure rate.
Conclusions: It has been shown (2) that the risk of major complications was reduced by approximately 30% every ten procedures. A good training, awareness of anatomical landmarks, and routine cystoscopy are necessary to achieve Restorelle® DirectFix™ procedure for prolapse repair with few perioperative complications
References:

  1. Int Urogynecol J .2012; 23 (Suppl 2):S43-S244
  2. Eur J Obstet Gynecol Reprod Biol. 2012 Dec;165(2):361-5.

 

Description, management, and outcome of patients with grade I, II, and III complications

Grade (modified Clavien-Dindo)

Description

Number

Management

Outcome

I

Urinary retention

8 (4 urinary retention among 22 concomitant miduretral sling procedure)

Bladder catheterization up to 8 days

Recovery

I

Para-vesical hematoma

1

Conservative

Recovery

I

Mesh retraction

3

Conservative

No sexual activity since surgery but not related to pain according to the patient

II

Local pain (SSL )

1

Outpatient local infiltration with lidocaine

Improvement No reoperation

II

Urinary infection

2

Oral treatment

Recovery

II

Bladder injury

1

Foley catheter 7 days

Uneventful

IIIb

Ureteral kinking diagnosed at day 3 post op

1

Re-intervention by vaginal approach Section of the arm

Recovery

IIIb

Ureteral injury

1

Nephrostomy and ureteral reimplantation

Recovery

IIIb

Para-vesical hematoma

1

Embolization

Normal healing.

IIIb

Para-vesical hematoma

1

Blood transfusion and surgical drainage at day 8 through vaginal route under general anesthesia

Normal healing.

IIIb

Vaginal mesh exposure diagnosed at 6 weeks

1

Partial removal of the mesh by vaginal route under general anesthesia at 4 months

Normal healing.

 

De novo SIU

Complication

Number

Management

Outcome

De novo stress urinary incontinence

7

1 sling,1 Bulking agent

Recovery