Hologic NovaSure Advanced, Instructions For Use And Controller Operator'S Manual

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Secondary endpoint: anesthesia regimen
Anesthesia was left to the discretion of each patient, clinical investigator
and attending anesthesiologist . For the NovaSure patients, 27 .0%
(47/174) had the procedure performed under general anesthesia or
epidural and 73 .0% (127/174) under local and/or IV sedation . One
patient did not have a reported anesthesia regimen in this group . In
the rollerball group, 82 .2% (74/90) of the patients were treated under
general anesthesia or epidural and 17 .8% (16/90) under local and/or IV
sedation (Table 6) .
Table 6. Anesthesia Regimen
NovaSure
n=175*
Wire Loop Resection
Plus Rollerball
n=90
General or epidural 27 .0% 82 .2%
Local and/or IV sedation 73 .0% 17 .8%
* One patient did not have a reported anesthesia regimen .
Clinical observations
Hysterectomy
Fifteen women had a hysterectomy within the three years following the
ablation procedure . Table 7 lists the reasons for hysterectomy .
Table 7. Hysterectomy
Reason For Hysterectomy
NovaSure
n=175
Wire Loop Resection
Plus Rollerball
n=90
Adenocarcinoma diagnosed at
time of ablation procedure
1 1
Fibroids 2 0
Pelvic abscess 1 1
Endometriosis 3 0
Adenomyosis 4 0
Hematometra 0 1
Menorrhagia 0 1
TOTAL 11 (6 .3%) 4 (4 .4%)
7 Hysterectomies were in patients <40 years (7 NovaSure ) and 8 hysterectomies were in patients >40 years
(4 NovaSure ; 4 Rollerball) .
Patient Selection
Menorrhagia can be caused by a variety of underlying problems,
including, but not limited to; endometrial cancer, myomas, polyps, drugs
and dysfunctional uterine bleeding (anovulatory bleeding) . Patients
always should be screened and evaluated to determine the cause of
excessive uterine bleeding before any treatment option is initiated .
Consult medical literature relative to various endometrial ablation
techniques, indications, contraindications, complications and hazards
prior to the performance of any endometrial ablation procedure .
Patient Counseling
As with any procedure, the physician needs to discuss risks, benefits
and alternatives with the patient prior to performing endometrial
ablation . Patient’s expectations should be set in a way that the patient
understands that the aim of the treatment is the reduction in bleeding to
normal levels .
The disposable device is intended for use only in women who do
not desire to bear children because the likelihood of pregnancy is
significantly decreased following the procedure . Patients of childbearing
capacity should be cautioned of potential complications, which may
ensue if they should become pregnant . This counseling should include
the need for post-procedure contraception where indicated . This
procedure is not a sterilization procedure and subsequent pregnancies
may be dangerous for the mother and fetus .
Vaginal discharge is typically experienced during the first few weeks
following ablation and may last as long as a month . Generally,
the discharge is described as bloody during the first few days;
serosanguineous by approximately one week; then profuse and watery
thereafter . Any unusual or foul-smelling discharge should be reported to
the physician immediately . Other common post-procedural complications
include cramping/pelvic pain, nausea and vomiting .
Uterine perforation should be considered in the differential diagnosis of
any post-operative patient complaining of acute abdominal pain, fever,
shortness of breath, dizziness, hypotension or any other symptom that
may be associated with uterine perforation with or without damage
to the adjacent organs of the abdominal cavity . Patients should be
counseled that any such symptoms should be immediately reported to
their physician .
Pretreatment Preparation of Patient
The NovaSure impedance controlled endometrial ablation system
successfully treats a uterine cavity over a range of endometrium
thickness . The lining of the uterus does not have to be thinned prior to
the procedure, and the procedure may be performed during either the
proliferative or the secretory phase of the cycle . Although the safety and
effectiveness of the NovaSure system has not been fully-evaluated in
patients with medical or surgical pretreatment, it has been evaluated in a
limited number of patients who had been pretreated with GnRH agonists
with no complications or adverse events .
Active bleeding was not found to be a limiting factor when using
the NovaSure system . It is recommended that a nonsteroidal anti-
inflammatory drug (NSAID) be given at least one hour prior to treatment
and continued postoperatively to reduce intraoperative and postoperative
uterine cramping .
NovaSure Impedance Controlled Endometrial Ablation System
Instructions For Use
Please read all instructions, cautions and warnings prior to use .