Intended Use; Contraindications; Warnings And Precautions - Promedon Splentis Gebrauchsanweisung

INSTRUCTIONS FOR USE
DESCRIPTION
Splentis is a permanent implant composed of biocompatible, type 1
(monofilamentous and macroporous (117 – 861 µm) according Amid-
1
classification ), lightweight (55 – 69 g/m
mesh arms.
The mesh kit contains:
• 1 reinforcement implant (Ref: MSAP)
• 1 Dispenser Unit with
• 3 Tissue Anchoring Systems (Ref: TAS) attached with polypropylene
sutures
• 1 Retractable insertion guide (Ref: DPN-MNL), disposable, designed for the
placement of the Tissue Anchoring System and provided with a tube in order
to protect surrounding tissues during the surgical procedure
• 1 Knot Pusher (Ref: KP), disposable, provided with a protective tube,
designed to be used during the surgical procedure if necessary.
All components are supplied sterile and ready to use.

INTENDED USE

Splentis is intended for transvaginal reestablishment and reinforcement of
the physiologic anatomy of the female pelvic floor in the defined patient
population.
INDICATIONS
Splentis is indicated for the transvaginal repair of apical pelvic organ
prolapse in non-fertile women
• decent of the uterus
• decent of the uterine cervix after subtotal (supracervical) hysterectomy

CONTRAINDICATIONS

Splentis must not be used in:
• Fertile women
• Women with post-total hysterectomy vaginal vault prolapse
• Patients with active or latent infection of the vagina, cervix or uterus
• Patients with previous or current vaginal, cervical or uterine cancer
• Previous, current or planned pelvic radiation therapy
• Known allergy to polypropylene.

WARNINGS AND PRECAUTIONS

The implantation of Splentis should be based on a thorough patient
assessment as well as the patient's individual characteristics and preferences.
Please consider the following warnings and precautions in the decision for
surgery, clinical aspects, during the surgical procedure or handling of the
device to avoid complications:
• Splentis must ONLY be used by surgeons experienced in transvaginal pelvic
floor reconstruction.
• The surgical technique brochure (B-90-53)
PRIOR to first implantation of Splentis.
Clinical aspects and decision for surgery
• Tobacco use, poorly controlled diabetes mellitus, genital atrophy,
Body-Mass-Index > 30, and concomitant hysterectomy increases the risk of
impaired wound healing and mesh exposure.
• Splentis must be used with care in patients with:
• immunodeficiency
• autoimmune disorders
• Risks can be minimized by utilization of imaging methods before the
procedure if appropriate and by inserting the retractable insertion guide
correctly.
• DO NOT use Splentis simultaneously with any other transvaginal mesh
for pelvic organ prolapse repair because this may increase the risk for mesh
exposure or extrusion.
• Polypropylene mesh integrates with patient's tissue, hence complete
removal may be difficult or unfeasible. The risk for organ injury caused by
mesh removal may be higher than the benefits resulting from this removal.
Adverse events (e.g. pain) may be persistent even after successful removal
of the mesh. Therefore, each case should be decided individually at the
surgeon's discretion.
1
PK Amid. "Classification of biomaterials and their related complications in
abdominal wall hernia surgery". Hernia (1997). 1: 15 - 21.
2
Coda A, Lamberti R, Martorana S. "Classification of prosthetics used in hernia
repair based on weight and biomaterial." Hernia (2012). 16(1):9 - 20.
3
Non-fertile women are defined as women in menopause (def: absence of
menstruation for at least one year) or iatrogenic causes (e.g. subtotal hysterectomy,
sterilization) which exclude women permanently from becoming pregnant.
4
Surgical Technique Brochure is available at
http://www.promedon-urologypf.com/
and is supplied by the distributor to hospitals/health institutions.
2
2 2
) , polypropylene mesh with two
3
with
4
must be read and understood
ENGLISH