Original Article

Caution “FDA 2011”: A modern pelvic floor mesh with a new form of cranial fixation. An observational study with 6-month follow-up on the A.M.I.® CR-Mesh and i-Stitch

  • FRIEDER RETZKE
  • ACHIM NIESEL
  • STEFAN ZACHMANN
  • ANGELA SCHEURER
  • ION ANDREI MUELLER FUNOGEA
  • ULRICH BAUMGARTNER
  • CHRISTIAN FUENFGELD

Pelviperineology 2013;32(2):59-63

Mesh-augmented pelvic floor surgery, which continues to be the subject of considerable discussion and attention, has not (yet) reached the surgical gold standard. The 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 Farnsworth was designed to offer full, 3-level support, while allowing individual adjustment of the mesh size and customised cranial fixation. Preliminary results also promised low erosion rates. During April 2008 and March 2010, we carried out an observational study in seven different clinics to evaluate this technique with respect to selected parameters. The study comprised 186 patients with an average age of 65.8 years, who underwent anterior, posterior or total repair with the A.M.I. CR-Mesh. At a follow-up time of 3-6 months, 92.5% of patients were satisfied with the procedure. The most frequent complications were post-operative de novo stress urinary incontinence (SUI) (7.5%) and cystitis (3.7%). Erosion occurred in 3.2% of patients. The authors found the method and materials to be a significant and valuable addition to the range of treatments in mesh-augmented pelvic floor surgery.

Keywords: FDA updates; Pelvic floor repair; Prolapse surgery; Urogynecology; Vaginal meshes.