Promedon EXIA Mode D'emploi page 2

INSTRUCTIONS FOR USE
DESCRIPTION
EXIA is a knitted ultra-lightweight
monofilament polypropylene mesh. It is a permanent implant designed for the
surgical treatment of vaginal vault prolapse and uterine prolapse by abdominal
(open, laparoscopic or aided by a robot) sacrocolpopexy and sacrohysteropexy.
It is offered as single-use sterile product.
The mesh is provided flat in several sizes or in Y-shaped mesh. The dimensions
of the rectangular meshes are (in cm):
• 24x8
• 20x12
• 10x15
The Y-shaped mesh is presented:
(Figure 1). To join the 2 arms of the Y-shaped mesh, a polypropylene thread
is used and stitched. A line painted with a silicone ink is only included in the
Y-shaped mesh.
HOW SUPPLIED
EXIA is supplied as follows:
• KIT containing 1 unit of Straight "Y" implant
• KIT containing 1 unit of flat mesh 10 x 15 cm
• KIT containing 1 unit of flat mesh 8 x 24 cm
• KIT containing 1 unit of flat mesh 20 x 12 cm
The following codes are used:
Product Code
EX – Y MESH 1
EXIA FLAT 10x15cm
EXIA FLAT 8x24cm
EXIA FLAT 20x12cm
INDICATION
EXIA is indicated for the surgical treatment of vaginal vault prolapse in women
who have had a previous hysterectomy (sacrocolpopexy) and for uterine
prolapse (sacrohysteropexy).
CONTRAINDICATIONS
EXIA is contraindicated in patients who:
• are pregnant,
• have potential for further growth (e.g. adolescents),
• are sensitive or allergic to polypropylene products,
• have pre-existing local or systemic infection,
• have soft tissues pathologies in the site intended for implant placement,
• have pathologies or other conditions that compromise wound healing, or
• have pre-existing pathologies or conditions posing an unacceptable surgical
risk.
WARNINGS
EXIA must be used only by properly trained surgeons with experience in the
surgical treatment of pelvic floor disorders involving non-absorbable mesh and
in management of complications resulting from these procedures
Careful patient selection and complete diagnostic evaluation are essential prior
to surgery to determine the suitability of a synthetic mesh procedure.
The surgical procedure must be carried out carefully, avoiding damage to large
blood vessels, nerves, and organs. Risks can be minimized by closely observing
the local anatomy. In the event of perforations or injuries to blood vessels,
Coda, A & Lamberti, R & Martorana, S. (2011). Classification of prosthetics
1
used in hernia repair based on weight and biomaterial. Hernia : the journal
of hernias and abdominal wall surgery. 16. 9-20. 10.1007/s10029-011-0868-z.
2
non-absorbable biocompatible
1
Figure 1- Y-Shaped implant
Content
- 1 Mesh Straight "Y" implant
- 1 mesh 10 x 15 cm
- 1 mesh 8 x 24 cm
- 1 mesh 20 x 12 cm
ENGLISH