Adverse Events; How Supplied; Operational Instructions; Prior To Use - Boston Scientific Solyx Mode D'emploi

• Do not use any mechanical means of contact with the mesh
(such as clips, staples, etc.) within the urethral support region
of the mesh as mechanical damage to the mesh may occur.
• Avoid excessive tension on the mesh during handling.

aDVeRse eVenTs

The following adverse events have been reported due to
suburethral sling placement, but are not limited to:
• As with all implants, local irritation at the wound site and/or
a foreign body response may occur.
• Tissue responses to the mesh implant could include:
• erosion/exposure/extrusion of the mesh through the
vaginal or urethral mucosa, bladder wall or other
surrounding tissue
• scarring/scar contracture
• device migration
• fistula formation and inflammation
The occurrences of these events may require surgical
intervention and possible removal of the entire mesh.
• Like all foreign bodies, the mesh may potentiate an
existing infection.
• Excess tension may cause temporary or permanent lower
urinary tract obstruction and retention.
• Allergic reaction has been reported.
• Known risks of surgical procedures for the treatment of
incontinence include:
• pain, ongoing pain (pelvic, vaginal, groin/thigh,
dyspareunia)
• infection
• detrusor instability
• complete failure of the procedure
• voiding dysfunction (incontinence, mild to moderate
incontinence due to incomplete urethral support or due
to overactive bladder)
• bruising, bleeding (vaginal, hematoma formation)
• abscess
• vaginal discharge
• dehiscence of vaginal incision
• edema and erythema at the wound site
• Perforation or laceration of vessels, nerves, bladder or
urethra may occur during placement.
The occurrence of these events may require surgical
intervention. In some instances the response to these events
may persist as a permanent condition after the intervention.

HoW sUPPlIeD

The Solyx™ and Solyx Blue SIS Systems are sterile, single use
systems each consisting of one (1) delivery device and one (1)
mesh assembly. Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Store in a cool, dry, dark place. Rotate inventory so that devices
are used prior to the expiration date displayed on package label.

oPeRaTIonal InsTRUCTIons

Prior to Use

The Solyx and Solyx Blue SIS Systems are supplied sterile and are
intended for single patient use only. Carefully examine the system
to verify that neither the contents nor the sterilized package has
been damaged in shipment. DO NOT USE if the sterile barrier or
product is damaged. Immediately return damaged product to
Boston Scientific. The design of both systems allows the operator
a transvaginal route of delivery. see figure 1 for parts description.
5
Black (K) ∆E ≤5.0