A new form of cranial fixation observational study with 6 month follow-up on the A.M.I. CR MESH and I- Stich

Objective

Mesh –augmented pelvic floor surgery, which continue to be the subject of considerable discussion and attention, has not (yet) reached the surgical gold standard (1, 2). Than last 15 years have seen the development of an extensive range of materials and instruments, with the introduction of several revolutionary new methods. However while many of these concepts are a step in the right direction, they are not yet free of risks and complications. A reconstructive technique first demonstrated by Faarnsworth was designed to offer full, 3 level support, while allowing individual adjustment of the mesh size and customized cranial fixation (3). Preliminary results also promise low erosion rates (ultra light 21gr/m2 mesh) (4).

Methods and results

During the last year we carried out an observational study to evaluate this technique with respect to selected parameters. The study comprised 14 patients with an average age of 61, 4 years (46 – 73), who underwent anterior repair with the A.M.I. CR-Mesh. All patients presented a 3rd or 4th stage prolapse according POPQ classification and were studied by urodynamics and cystografy; in 3 cases there was a stress urinary incontinence and was positionated a sling under the median urethra ( TOT )
The surgical procedure consist of
1)Preparation of the surgical site in the traditional manner for anterior repair
2)Placement using I Stich instrument of the PP O suture of both sides of the sacrospinous ligament ,as high as medial as possible, for level I suspension. This eliminates the need for extensive dissection
3) Suspension of the lateral, sleeved mesh arms to the side pelvic wall to provide support at level II
4) Individual customization of the mesh by cutting the arms that are placed at the bladder neck for level III stabilization
In this way we have a stable, individually -customized cranial suspension at level I , firm but springy muscular suspension and stabilization at level II and wide stable connection at level III.
All patients underwent a general or spinal anesthesia and the median operating time was 52 min. The only in surgery complication was bleeding during and after surgery (20% more than 300 cc). No vascular or visceral complications occurred. All patients had a vesical catheter and vaginal medication for 48 hours and left the hospital in 3 (9) or 4 (5) days after surgery. All patients received cortisone and antibiotics ( bentelan 4 mg x 3 x 3 gg e ciproxin 200 x 2 e deflamon 1 x 3 per 5 gg) . In 3 cases a mild perineal hematoma occurred.

Median follow up was 4 months and urogynaecological evaluation was performed after 1, 3, 6 months from surgery. All of patients were satisfied with this procedure. The most frequent complications were post operative de novo stress urinary incontinence (SUI) 7% and 6 %Cystitis. No erosion or extrusion of mesh was observed, no prolapsed recurrence was recorded and no dyspareunia was collected

Discussion

Mesh –augmented pelvic floor surgery continue to be the subject of considerable discussion and attention. Till now it has not (yet) reached the surgical gold standard for these pelvic floor diseases (1, 2) even if the development of new matherials has been increasing through the last twenty years as much as the related complications and risks. First of all, whoever faces to this surgery must consider the risk of erosions and be able to manage it. According to our experience, mostly about the erosions, we found this method and these materials to be significant and valuable addition to the range of treatment in mesh augmented pelvic floor surgery. It’s necessary, anyway, a longer follow up and a larger number of cases to assess its long term efficacy and safety.

References

1)HTPP://www.fda.gov /medicaldevices/safety/ alertsandnotices / ucm262435.htm
2)Bader W., Baessler K. FDA Sicherheitswarnung zum alloplastichenmaterials in de rag urogynaekologie und plastische Fraunarzt 2011, 52 865-867
3)Farnsworth B Development of the third generation surgical technique for mesch repair for pelvic organ prolapsed using a light weight monofilament polypropylene mesh. Apreliminary report of efficacy and safety .PELVIPERINEOLOGY 2010 ,Issue 4 art n CD004014
4)Katakam N, De VitaD., Chia P, Safe and effective intervention surgery for pelvic prolapsed with CR –Mesh kit: a comparative study from United Kingdom and Italy, Pelviperineology 2010, 29 .116 122