Adverse Events - Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual

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included in their medication regimen in order to avoid the increased
risk of endometrial adenocarcinoma associated with unopposed
estrogen replacement therapy .
• The safety and effectiveness of the NovaSure system has not been
fully evaluated in patients:
- with a uterine sound measurement greater than 10 cm;
- with submucosal fibroids that distort the uterine cavity;
- with bicornuate, septate or sub-septateuteri;
- with medical (e .g ., GnRH agonist) or surgical pretreatment;
- who have undergone a previous endometrial ablation including the
NovaSure endometrial ablation procedure; or,
- who are post-menopausal .
• Do not attempt to repair the controller if problems are suspected .
Call Hologic Technical Support or a Hologic sales representative for
instructions .
• Cables to the disposable device should be positioned such that contact
with patient or other leads is avoided .
• The user should inspect the disposable device for damage prior to use .
• The suction line desiccant is non-sterile, and the packaging should not
be placed in the sterile field .
• If the ARRAY POSITION LED light is illuminated on Models 08-
09, or an Array Position message is displayed on the Model 10
screen, see the Troubleshooting section under "ARRAY POSITION
ALARM"
• Do not use the NovaSure suction line desiccant if desiccant material is
pink in color .
• The disposable device must be external to (outside of) the patient
before connecting the cord to the appropriate port on the front panel of
the controller (step 2 .15) .
• The carbon dioxide canister contains gas under high pressure . In the
event of a breached CO canister or line, allow the canister to exhaust
2
completely, and allow the canister and/or lines to equilibrate to room
temperature prior to handling .
• CO continuously flows from the time that the disposable device is
2
plugged into the controller until the CIA portion of the procedure is
complete . To minimize the duration of CO
embolism, perform the seating procedure immediately after inserting
the disposable device and proceed directly from the seating procedure
to the CIA .
• Electrically conductive objects (e .g ., monitoring electrodes from other
devices) that are in direct contact with the electrode array of the
disposable device or in close proximity to the electrode array may
draw current away from the array . This may result in localized burns
to the patient or physician or in distortion of the electrical field of the
array, which would change the therapeutic effect (under-treatment or
over-treatment) . It may also result in distortion of the current in the
conductive object, e .g ., monitors may display false readings .
• Grounding reliability is only achieved when equipment is connected to
a receptacle marked "hospital grade" .
flow and potential risk of
2
• The cervical collar must be fully retracted to its proximal position in
order to minimize the potential for damage to the sheath when closing
the array .
NovaSure 3-Year Clinical Data

Adverse Events

The NovaSure system was evaluated in a randomized, prospective,
multi-center clinical study of 265 patients with abnormal uterine
bleeding comparing the NovaSure system to a control arm of wire loop
resection of the endometrium followed by rollerball ablation .
Table 1A. Intra-Operative Adverse Events
Adverse Event
Bradycardia
Uterine perforation
Cervical tear
Cervical stenosis
TOTAL
Table 1B. Post-Operative Adverse Events < 24 Hours
Adverse Event
Pelvic pain/cramping
Nausea and/or vomiting
TOTAL
* Nine events reported in 6 (3 .4%) patients
** Five events reported in 4 (4 .4%) patients
Table 1C. Post-Operative Adverse Events > 24 Hours – 2 Weeks
Adverse Event
Hematometra
Urinary tract infection
Vaginal infection
Endometritis
Pelvic inflammatory disease
Hemorrhage
Pelvic pain/cramping
Nausea and/or vomiting
TOTAL
* Five events reported in 4 (2 .3%) patients
** Seven events reported in 6 (6 .7%) patients
5
ENGLISH
NovaSure Loop Resection
Plus Rollerball
n=175 (%) n=90 (%)
1 (0 .6%) 0 (0 .0%)
0 (0 .0% 3 (3 .3%)
0 (0 .0% 2 (2 .2%)
0 (0 .0% 1 (1 .1%)
1 (0 .6%) 6 (6 .7%)
NovaSure Loop Resection
Plus Rollerball
n=175 (%) n=90 (%)
6 (3 .4%) 4 (4 .4%)
3 (1 .7%) 1 (1 .1%)
9 (5 .1%)* 5 (5 .6%)**
NovaSure Loop Resection
Plus Rollerball
n=175 (%) n=90 (%)
1 (0 .6%) 0 (0 .0%
1 (0 .6%) 1 (1 .1%)
1 (0 .6%) 0 (0 .0%
0 (0 .0% 2 (2 .2%)
0 (0 .0% 1 (1 .1%)
0 (0 .0% 1 (1 .1%)
1 (0 .6%) 1 (1 .1%)
1 (0 .6%) 1 (1 .1%)
5 (2 .9%)* 7 (7 .8%)**