General Warning; Post Procedural Warning; Precautions - Boston Scientific Solyx Mode D'emploi

GeneRal WaRnInG

The risks and benefits of performing a suburethral sling procedure
in the following patients should be carefully considered:
• Careful consideration should be given to performing this
procedure for patients with untreated coagulopathies
or who are being treated with either anticoagulants or
antiplatelet agents.
• Patients with hypertonic bladders or vesico ureteral reflux
• Take special care in cases of bladder prolapse
because of anatomical distortion. If the patient requires
a cystocele repair, it should be done prior to the
suburethral sling procedure
• Vaginal and urinary tract infection should be treated prior to
a suburethral sling implantation procedure.
• User should be familiar with surgical procedures and
techniques involving nonabsorbable meshes.
• Good surgical practices should be followed for
management of contamination or infected wounds.
• Mesh is considered a permanent implant. Removal of mesh
or correction of mesh related complication may involve
multiple surgeries.
• Complete removal of mesh may not be possible and additional
surgeries may not always fully correct the complications.

PosT PRoCeDURal WaRnInG

• If subsequent infection occurs, follow appropriate medical
intervention practices.
• The patient should be advised that future pregnancies may
negate the effects of this procedure and the patient may
again become incontinent.

PReCaUTIons

• The use of polypropylene mesh in urogynecologic
procedures such as the treatment of stress urinary
incontinence, regardless of the route of delivery
(transvaginal, suprapubic or transobturator), has been
associated with cases of erosion. Erosion has been
reported in bladder, vagina, urethra and ureter, and bowel.
Treatment of the erosion may require surgical removal.
• As with all surgical procedures, certain risk factors are
known to impact patient outcomes in the pelvic floor
which include, but are not limited to, impaired vascularity
(e.g. diabetes, smoking status, estrogen status, pelvic
floor radiation exposure, etc.), age, pelvic floor myalgia,
impaired wound healing (e.g. diabetes, steroid usage,
etc.), or active infection in or near the surgical site. The
above pathophysiologic conditions must be considered
when determining whether the patient is an appropriate
candidate for mesh implantation, either by transvaginal,
suprapubic or transobturator route.
• Standard surgical practices should be followed for the
suburethral sling procedure as well as for the management
of contaminated or infected wounds.
• Bleeding can occur. Check carefully before releasing
patient from the hospital.
• Ensure the mesh is placed tension free under the mid-urethra.
• Use of this device should be done with the understanding
that subsequent infection may require removal of the mesh.
• Physician should determine when it is suitable for each
patient to return to normal activities.
• Patients should be counseled when to resume vigorous
activities (heavy lifting, exercise), and intercourse after
the procedure.
• Should dysuria, bleeding or other problems occur, the patient
should be instructed to immediately contact their physician.
Black (K) ∆E ≤5.0
4