Project Description

InGYNious

  • an ultra-lightweight mesh (21 g/m²)
  • total implant weight of just 150 mg (standard size)
  • a single-incision procedure
  • 3-level support

Just one incision and an ultralight mesh enable a total pelvic floor reconstruction with 3-level support in the gentlest possible way.

Where’s the genius in it?

A.M.I. has combined the ideal material with an innovative form of 6-point suture fixation (3-level support) to allow the effective repair of various pelvic floor defects through one single incision.

The material

  • Largest pores ≥ 1,9 mm
  • Highest porosity: 93 %

The mesh of monofilament polypropylene is ultralight in weight (21 g/m2), with a wide-pore, hexagonal structure that lends the material a high degree of isoelasticity. Together, these features theoretically promote rapid tissue integration and reduce foreign body reaction in the very elastic vaginal tissue, as well as inducing the formation of mature collagen.1,2  Thus the defect is provided with a natural, very gentle means of support.

– InGYNious can successfully cure pelvic organ prolapse in more than 90% of patients (in 36 months follow-up)3
– InGYNious (Transvaginal mesh) is very safe with low rates of erosion (<2% in 36 months follow-up)
– InGYNious (Transvaginal mesh) significantly improves quality of life in a 36 months follow-up

The suture fixation

Fixation to the sacrospinous ligament and suspension of the mesh is performed with the i-stitch, an instrument for the safe, fast and minimally-invasive placement of sutures in hard-to-reach areas. The i-stitch is designed for easy operation with just one hand.

Example: i-stitch for transvaginal sacrospinous fixation

Using the forefinger, the surgeon guides the i-Stitch into the desired position. The tip of the instrument is then pushed into the ligament. By applying gentle pressure with the thumb, the tip of the loading unit is pushed all the way through until a click can be heard. With the suture firmly attached to the tissue, the loading unit is drawn back and the instrument tip pulled away from the site. The suture stays in position.

Together with the i-stitch, three different shapes and two sizes of mesh allow treatment of a wide range of pelvic floor defects. Level 1 support is created by a suspension suture connecting the apex of the InGYNious mesh – and therefore the apex of the vagina – with the sacrospinous ligament. For level 2 and level 3 support, labelled suture guides indicate at which points the mesh should be attached to the tendinous arch of pelvic fascia or muscular tissue. The correct fixation points vary, depending on which compartment is treated and which shape of mesh is being used.

To secure the mesh, the i-stitch is inserted through the vagina – thus eliminating the need for “blind” tunnelling. This reduces the risk of intraoperative bleeding and trauma, and increases the patient’s chance of a speedy recovery. i-stitch is available in two different models – one for penetration from above and the other with the tip rotated 180° to allow a comfortable approach from underneath.

Product brochure
Product Brochure Urogynaecology

1 Amid, P. K. (1997). Classification of biomaterials and their related complications in abdominal wall hernia surgery. Hernia, 1(1), 15-21. https://doi.org/10.1007/BF02426382

2 Ugianskiene, A., Davila, G. W., & Su, T. (2019). FIGO review of statements on use of synthetic mesh for pelvic organ prolapse and stress urinary incontinence.
International Journal of Gynecology & Obstetrics, 147(2), 147-155. https://doi.org/10.1002/ijgo.12932

3 Kuszka, A., Brandt, A., Niesel, A., Lutz, H., Mengel, M., Ulrich, D., & Fünfgeld, C. (2020). Year outcome after treatment of uterovaginal prolapse with a 6-point fixation mesh. European Journal of Obstetrics & Gynecology and Reproductive Biology, 255, 160-164. https://doi.org/10.1016/j.ejogrb.2020.10.030