Filshie CooperSurgical Instructions For Use

®
A C D
ontrACeptive eviCe for
For Female Surgical Sterilization
p f S
ermAnent emAle terilizAtion
Instructions For Use
Single Patient Use
™
Filshie ® Clip Applicator
Instructions For Use
AVM-851
AVM-851J
AVM-951
FILSHIE is a registered trademark of Femcare-Nikomed Ltd.
MR
1. Product Description
The Filshie Tubal Ligation System consists of:
•
the Filshie Clips, and
•
the Sterishot II Applicator.
Sterishot II Applicator for Dual Incision Laparoscopy
The Sterishot II Applicator
is intended for dual incision
laparoscopy. The applicator consists
of a plastic handle and metal shaft.
The applicator is approximately 365mm in length with
a working length of approximately 240mm and an approximate diameter
of 7mm. The applicator is designed for introduction and use through a laparoscopic
cannula. The internal diameter of the cannula needs to be 7.5mm or greater.
The Sterishot II Applicator can only apply one Filshie Clip at a time and can be reloaded to
enable more Filshie Clips to be applied in the same patient.
The Sterishot II Applicator is designed for use by both left and right handed operators.
The Filshie Clip
The Filshie Clip is manufactured from titanium and is lined on the inner
surface with silicone rubber (both materials are implantable grade). At
one end there is a hinge and at the other a latch. The Filshie Clip is applied
across the entire diameter of the isthmic segment of the Fallopian tube.
When the Clip is fully closed by the Sterishot II applicator, the upper jaw is
flattened and is securely latched under the front end of the lower jaw. This
acts as a clasp, securing the upper jaw of the Clip. The silicone rubber is in
direct contact with the tissues and both are compressed under the force applied by the
titanium. When avascular necrosis of the Fallopian tube occurs, the compressed silicone
expands to maintain complete occlusion of the lumen. This prevents re-canalization and
destroys approximately 4mm of the Fallopian tube.
The dimensions of a closed Filshie Clip are approximately 14mm x 3.5mm x 4mm.
2. Indications
The Filshie Tubal Ligation System is a contraceptive tubal occlusion device indicated for
permanent female sterilization by occlusion of the Fallopian tubes.
3. Contraindications, Warnings and Precautions
3.1 Contraindications
T he Filshie Tubal Ligation System must not be applied if any of the following conditions are
present in the patient:
•
Existing (current) or suspected pregnancy.
•
Significant peritubular adhesions obscuring the portion of the Fallopian tube to be
occluded.
•
Acute pelvic inflammatory disease (PID).
•
Salpingitis isthmica nodosa or chronic isthmic induration.
•
Hemoperitoneum or suspicion of ectopic pregnancy.
•
Any conditions contraindicating the use of surgery, or local or general anaesthetic.
3.2 Warnings
a) Pregnancy
Pregnancy, although infrequent, may occur after placement of the Filshie Clip
with pre-existing pelvic inflammatory disease or obesity may be at increased risk of
sterilization failure.
Women sterilized postpartum or postabortion may be at increased risk of pregnancy. The
pregnancy rate following tubal sterilization of postpartum patients is higher than that
reported in interval patients. After two (2) years the annual pregnancy rate for patients
sterilized with the Filshie Clip was 1.7% for postpartum patients.
Pregnancy following occlusion of the Fallopian tubes using Filshie Clips may be associated
with applications in which the Filshie Clip has not completely captured the Fallopian tube
or applications which have inadvertently been placed on the wrong anatomical structure,
such as the round or ovarian ligaments.
b) Ectopic Pregnancy
Rare instances of ectopic pregnancy (0.016% of subjects in clinical study) subsequent to
application of the Filshie Clip have been reported 3 . The possibility of ectopic implantation
must be considered in any patient becoming pregnant after sterilization using the Filshie
Tubal Ligation System.
Special attention should be directed to patients with delayed menstruation, metrorrhagia
and/or unilateral pelvic pain to determine whether an ectopic pregnancy has occurred.
c) Unintended Major Surgery (Laparotomy)
Trauma may occur infrequently to pelvic organs during laparoscopic application of
the Filshie Clip . This trauma may result in the need for major surgical intervention for
4
the purpose of repair. The need to proceed to unintended major surgery also has been
reported in some women with pre-existing intra-abdominal adhesions, obesity or history
of pelvic inflammatory disease (PID).
d) Trauma/Bleeding
The normal closure of the Filshie Clip may cause immediate transection with bleeding in a
small number of cases. A second clip may be applied on the proximal (uterine) side of the
lesion, but with a much slower closing action to ameliorate the bleeding. Transection of
the tube may lead to unintended major surgery.
Injuries to the Fallopian tube, mesosalpinx or cornua, though infrequent, may result from
Filshie Clip application. Mesosalpingeal or tubal injury is more likely among women with
pre-existing peritubular adhesions, or thick or edematous tubes. The incidence of trauma/
bleeding injuries decrease with physician experience and careful patient selection.
Transection of the Fallopian tube, mesosalpinx or cornua, though infrequent, may result
in bleeding and hematoma formation. If bleeding is uncontrolled, surgical intervention
and repair or completion of the sterilization procedure using another tubal occlusion
methodology may be required.
e) Technical Failures
There may rarely be a need to change to an alternative procedure or abandon the
sterilization procedure altogether during application of the Filshie Clip
have been reported in women with enlarged uteri and other pre-existing patient factors
such as peritubular adhesions or obesity.
Technical failures have been associated with equipment malfunction. Both the operator
and support personnel should be familiar with the operation of the Filshie Clips and the
Sterishot II applicator prior to use.
Minilap
f) Infection
Infection at the site of the incision may rarely follow tubal sterilization (1.3%)
Urinary tract infections may follow tubal sterilization (1.0%)
Infections of the pelvic cavity may follow tubal sterilization (0.1%)
tuboovarian abscesses, endometritis or salpingitis. Take appropriate diagnostic action
when pelvic infection is suspected.
g) Clip Expulsion, Foreign Body Reactions, and Asymptomatic Migration
Instances of clip expulsion per urethra, vaginal cuff and bowel, as well as foreign body
reactions have been reported (3 expulsions and 2 foreign body reactions were reported
in 5,326 women). Three instances of apparently asymptomatic migration of the clip were
observed as incidental findings, but the frequency of this event is not known.
3.3 Precautions
a) Patient Evaluation
A complete medical history should be obtained to determine conditions that might
influence the selection of the procedure, or are absolute or relative contraindications
to surgery. A routine physical examination should be performed noting the integrity
of the pelvic organs and, if indicated, a pregnancy test undertaken to determine an
existing pregnancy. The patient should be evaluated for pelvic inflammatory disease,
cardiovascular disease, severe ileus, acute peritonitis, previous pelvic surgery, significant
hemoperitoneum and other conditions which contraindicate surgery or the use of
anaesthesia.
b) Patient Counselling
Prior to any sterilization procedure being performed, the patient should be fully informed
about alternative methods of contraception, the possible side effects of the procedure,
any complications which may arise during and following the procedure and the risks and
benefits associated with sterilization in general and the Filshie Tubal Ligation System
procedure in particular. The patient should be encouraged to discuss openly and fully any
questions she may have concerning the Filshie Tubal Ligation System.
The patient should be advised that if any post-operative symptoms are severe or
persistent, she should see her physician.
The patient should be informed that sterilization will not prevent sexually transmitted
diseases (STDs). Additional precautions against STDs must still be taken after sterilization.
c) Clinical Usage
For each procedure, use only Clips enclosed in the sealed, sterile package.
1 . Women Check the operation of the applicator prior to use (see Directions for Use section).
Physicians should be thoroughly familiar with the Filshie Tubal Ligation System, tubal
sterilization procedures, and management of tubal sterilization complications before
attempting its use.
Physicians are cautioned that they should confirm the location of the pelvic organs before
and after Filshie Clip application to prevent inadvertent application to an inappropriate
anatomical structure such as the round or ovarian ligament.
Improper loading and testing of the applicator may result in Filshie Clips being either
2
inadvertently discharged into the peritoneal cavity or incorrectly placed. Refer to the
Directions For Use section for the proper method for inserting the Filshie Clips into the
applicator, and the recommended course of action for an incorrectly placed Filshie Clip.
The safety and effectiveness of the Filshie Tubal Ligation System for permanent
sterilization has only been tested and clinically evaluated using the Femcare-Nikomed
Filshie Clips and Applicators. Applicators from other manufacturers must not be used for
Filshie Clip application, and other manufacturer's clips must not be used with the Sterishot
II applicator.
Before endoscopic instruments and accessories from different manufacturers are used
together in a procedure, verify compatibility prior to starting the procedure.
d) Long Term Implantation and Sequelae
The silicone and titanium used in the manufacture of the Filshie Clip are generally
regarded as safe materials for human implantation. Although no adverse toxic or
tumorigenic effects due to the device or its materials have been reported, the effects of
long term implantation are unknown.
The long term effects of tubal sterilization on women are unclear. Several uncontrolled
studies suggest that women undergoing tubal sterilization may be prone to gynecological
problems. More recent controlled studies report that sterilization does not cause any long
term effects. The rates of hospital referral for gynecological or psychiatric conditions
appear to be similar for women undergoing tubal sterilization and women whose
husbands underwent vasectomy.
In the event of a subsequent hysterectomy, it has been recommended that the Filshie Clips
be removed, as leaving them in may predispose the patient to a later expulsion.
4. Adverse Events
The following adverse effects have been reported with the use of the Filshie Tubal Ligation
System. The effects are not listed in order of frequency or severity. Reported adverse
effects include:
•
pregnancy, either uterine (0.46%)
• Clip migration or expulsion (0.13%)
•
misapplication to ovarian ligament, broad ligament, omentum, bowel, tubal serosa,
cornual or broad ligament (0.05%).
5 . Technical failures
•
pain and cramping (35.7%)
Other adverse experiences reported from surgical procedures to implant the Filshie Clip
include the following (refer to Table 10.1 for a complete list of adverse experiences and
frequencies):
•
musculoskeletal pain (6.0%)
•
adnexal pain, enlargement or infection (5.0%)
•
incisional inflammation, bleeding, abscess, or pain (4.4%)
•
nausea/vomiting (4.3%)
5 .
•
keloids (3.9%)
•
headaches (3.0%)
5 .
•
serous discharge (2.8%)
5 . This can lead to
•
vaginitis (1.1%)
•
urinary tract infection (1.0%)
• hematoma (1.0%).
Menstruation pattern changes, involving the amount of blood flow, duration of flow, cycle
regularity and cycle length, and dysmenorrhea, may occur following tubal sterilization.
Menstrual disturbances not present at baseline in women who received the Filshie Clip
were reported as follows:
• excessive flow (6.9%)
•
menorrhagia (0.7%)
•
vaginal bleeding (1.4%)
•
severe dysmenorrhea (2.6%)
•
severe intermenstrual pelvic pain (0.6%).
These effects have been reported to be associated with other methods of tubal
sterilization, and they often disappear within a year following sterilization.
5. Clinical Studies
For the 5,754 women who were enrolled in the eleven prospective clinical trials reported in
the pre-market approval application (PMA) and who were sterilized using the Filshie Tubal
Ligation System, only 22 pregnancies were reported. Only one ectopic pregnancy was
reported. A list of the adverse events that were reported in the clinical studies is provided
in Table 10.1.
Four of the clinical studies were designated "pivotal studies". These studies are
prospective, randomized, controlled clinical studies comparing the Filshie Tubal Ligation
System to the Hulka Clip or the Falope-Ring. The method of application was either
laparoscopy or minilaparotomy. The 12-month follow-up results are shown in Table 5.1.
There was no statistically significant difference between the failure rates for the Filshie
Tubal Ligation System as compared to the Hulka Clip or Falope-Ring.
Table 5.1. Filshie Tubal Ligation System - Gross Cumulative Live-Table
Pregnancy Rates
Pool Pivotal Studies
Filshie vs. Hulka Clip
Filshie vs. Falope-Ring
a The Hulka Clip™ is also known as the Wolf Clip™*
b The Falope-Ring™ is also known as the Tubal Ring and the Yoon Ring**
Results from a single study suggest that the Filshie Tubal Ligation System may be less
effective than the Pomeroy method in postpartum women. Of 1,400 women who were
enrolled in a 24 month study, nine (9) reported pregnancies in the Filshie group, and two
(2) in the Pomeroy group.
* Hulka Clip™ and Wolf Clip™ are trademarks of Richard Wolf Medical Instruments, Inc.
** Falope-Ring® is a registered trademark of Olympus Corp.
6. How Supplied
The Sterishot II applicator is supplied as a sterile, disposable applicator in a Tyvek-sealed
tray. A pair of sterile Filshie Clips is provided in a single, peelable pouch. The pair of clips
are provided within the Sterishot II outer packaging (but separate from the Sterishot II
tray), and may also be obtained separately.
Filshie Clips included with the Sterishot II applicator are supplied with patient traceability
(lot) labels for inclusion in the patient record and a patient MRI information card.
7. Directions for Use
7.1 Filshie Clip Stages of Operation
Warning: Filshie Clips are to be applied using only Femcare-Nikomed
applicators.
Shown below is the appearance of the Filshie Clip at different stages of operation:
Clip fully open from the
pack with the 'No Touch'
loading handle fitted.
1 or ectopic (0.016%) 1
1
1
Clip half closed, giving a temporary grip
on the tube, re-openable at this stage.
7.2 Loading the Filshie Clip
Carefully remove the Sterishot II Filshie Clip Applicator from its packaging. Check the
operation of the applicator prior to use. Users must be able to easily and fully compress
the Sterishot II trigger to its stop.
7.2.1 Using the 'No Touch' Technique
As pictured, pick up the Filshie Clip using the blue plastic 'No
Touch' handle already fitted.
Using a 'No Touch' technique, slide the bottom of the Filshie Clip
along the floor of the applicator 'Clip tray' until it is within the
'side guides' and against the 'Clip stop'.
Detach the 'No Touch' handle by levering it backwards and then
discard the handle. Ensure the Clip is correctly loaded.
Warning: To maintain sterility, never touch the Filshie Clip.
7.2.2 Check Loading of the Clip in the Applicator Jaws
1. Check that the bottom portion of the Filshie Clip lies perfectly flat on the floor of the
applicator 'Clip tray', not rising up at the back or the front.
Months of 12-Month Pregnancy Rate (Standard Error)
Follow Up Per 100 Women
0.1 (0.1), N=1,063 0.7 (0.3), N=1,062
12
a
% completing = 68.7% % completing = 67%
0.2 (0.1), N=1,378 0.2 (0.1), N=1,355
b 12
% completing = 81.9% % completing = 82.4%
Clip open, as it sits in the Clip half closed, as it goes
loaded applicator. down the cannula.
Clip permanently secured after force has
been applied to the applicator. Latching
has occurred and the Clip cannot be
opened.