Looking Into Problems With Transvaginal Surgical Mesh
By Nasrin Mirsaidi, RN, CNOR, MSN
(Article reprinted from July Nursing2009, Volume 39, Issue 7)
A PATIENT, 67, had a transvaginal repair with synthetic mesh for pelvic
organ
prolapse. Four weeks later, she reported spotting, discomfort, and
vaginal
irritation. The surgeon found that the surgical mesh had eroded into her
vagina
and prescribed estrogen cream for a month, but it wasn’t effective. The
patient
needed more surgery for resection of the exposed mesh and closure of
eroded
tissue.
Pelvic organ prolapse and stress urinary
incontinence are pelvic disorders affecting millions of women in the
United
States.1
They occur when pelvic floor muscles lose
strength, allowing pelvic organs, including the bladder and uterus, to
descend
from their normal location and bulge through the vaginal wall (pelvic
organ
prolapse), or diminishing bladder control (stress urinary incontinence).1,2
Treatment options for pelvic organ prolapse or
stress urinary incontinence include several surgical and nonsurgical
approaches.
Transvaginal placement of mesh has become increasingly popular in recent
years.3
What’s the problem?
In the last 3 years, the FDA has received over 1,000
adverse event reports about mesh used in transvaginal surgical repair of
pelvic
organ prolapse and stress urinary incontinence. These reports include
problems
such as pain, infection, mesh erosion (into vagina, bowel, and bladder),
and
recurrence of prolapse or incontinence. Some reports involved rare but
serious
intraoperative injuries such as bowel, bladder, or blood vessel
perforation.
Most patients described in the adverse event reports needed medical or
surgical
intervention, and some required hospitalization.4
Although the exact cause of these adverse events hasn’t been identified,
they’re likely to be the result of multiple factors. Further
investigation is
needed.
What precautions can you take?
Although treatment with mesh may have helped many
women, in others it’s caused complications affecting quality of life.3,4
A literature review
demonstrates conflicting information on success rates for transvaginal
mesh
placement, but everyone agrees on the need for controlled trials.5
If you care for a patient undergoing a transvaginal
mesh placement procedure, consider this advice:
- Become familiar with the types of mesh and procedures used for the
repair of
pelvic organ prolapse and treatment of stress urinary incontinence.
- Ensure that your patient has given her informed consent. Make sure
she’s
received appropriate information about her choice of treatment, the
type of
procedure she’s undergoing, and possible adverse events.
- During preoperative teaching sessions, tell your patient about
possible
adverse reactions, the signs and symptoms of infection, and when to
notify her
healthcare provider.
- If you’re an OR nurse, follow your facility’s policies and
procedures for
recording information about implanted materials. Record the name of the
mesh
used and its catalog number, lot number, and size in the patient’s
medical
record.
- Provide your patient with a written copy of the patient labeling
from the
surgical mesh manufacturer, if it’s available.
- If your patient has surgery to remove mesh, follow your facility’s
policies
and procedures for properly handling the explanted mesh. Additionally,
follow
your facility’s policies and procedures for reporting adverse events.
The actual costs of your LAP-BAND® System will depend on your individual situation, including your health plan, the surgeon/hospital you choose, and whether you have an inpatient (overnight) or outpatient (same day) procedure. That said, there may be many ways to cover the costs of your LAP-BAND® System procedure, including insurance, Medicare, or private financing. Once you find a certified LAP-BAND® System surgeon, they, along with the experts at our free reimbursement hotline (1-800-LAP-BAND), can help you understand your insurance coverage and financing options.
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