2. Check that the front end of the Filshie Clip
lies directly behind the ‘Clip stop’ of the
applicator’s lower jaw.
3. Check that the upper portion of the Filshie
Clip is located between the ‘side guides’ of
the applicator’s moveable jaw.
4. Gently tap the applicator against the palm
of the hand to ensure the Filshie Clip is
securely loaded.
Warning: Either of the two incorrect loadings pictured above (marked
with “X”) may produce distorted Filshie Clips, which may lead to
pregnancy.
7.3. Entering the Abdomen
The Sterishot II Applicator is designed for introduction and use through a cannula of
greater than 7.5mm internal diameter.
In order to pass the loaded Sterishot II Applicator through the cannula it must be in a ‘half
closed’ position:
This is achieved by gently squeezing
the trigger until the movable jaw is in
the half-closed position. The trigger
should be squeezed just enough
to allow smooth passage of the
applicator through the cannula.
Maintain gentle pressure to keep
the Clip ‘half closed’ until visualized
through the laparoscope. Slowly
release the trigger and the Clip will
open ready for application.
Important: Obtaining the ‘half closed’ position should be practiced several times before
clinical use.
Polished Trigger
Section
White Visual Guide
Trigger Housing
A feature of the Sterishot II Applicator is a
white visual guide located within the trigger
housing, designed to help indicate the “half
closed” position and hence avoid over-shooting
the Filshie Clip. To ensure the “half closed”
position is not exceeded, the edge of the black
polished section of the trigger should not pass
beyond the white visual guide located inside
the black trigger housing. It is also important
that the surgeon visually confirms the “half
closed” position in order to ensure that over-
shooting has not occurred prior to entering the
cannula.
7.4 Application of the Filshie Clip
7.4.1 Identifying and Manipulating the Fallopian Tube
It is possible to manipulate the Fallopian tube for identification purposes by gently using
the loaded applicator as a pair of soft forceps being careful not to take the trigger past the
‘half closed’ position. Only use the applicator as a manipulator in the ‘half closed’ position
to avoid the possibility of dislodging the Filshie Clip from the applicator jaw. Heavy
handed manipulation must be avoided as this could result in the Clip being dislodged from
the applicator. The use of a uterine manipulator may be helpful in exposing the tube,
particularly in the case of retroverted uteri. To identify the Fallopian tube, pick the tube up
with the applicator and track along towards the fimbria at the distal end. Once the fimbria
is visualized, track back towards the cornu to locate the application site of the Filshie Clip
at the isthmus, 1-2cm from the cornu.
Important: The Filshie Clip is not designed to be removed once it is in place. The physician
should be certain of the exact placement prior to closing the Filshie Clip.
Note: Digital photography and video recording of the closure process are encouraged to
support the patient record case file.
• Identify and inspect the Fallopian tube thoroughly.
• Ensure that the Filshie Clip can
accommodate the whole diameter of
the Fallopian tube.
• Locate the Filshie Clip over the isthmic
portion of the Fallopian tube, 1-2cm
from the cornu.
• Having established the best location for
the Filshie Clip, the applicator should
be re-opened and advanced a few
millimeters to move the Fallopian tube
gently to the back of the Filshie Clip,
close to the hinge.
Important: Follow the manufacturers Instructions For Use relevant to
the trocar and cannula being used.
Warning: Do not squeeze the applicator handle too tightly or past the
‘half closed’ position as this may cause the Clip to close prematurely
or to become distorted so that it may fail to close properly. If this
should occur remove the loaded applicator, dispose of the distorted
Clip and load a replacement Clip.
• Close the Filshie Clip into position by
applying firm, but gentle pressure on
the trigger in a smooth action until the
trigger reaches its mechanical stop.
• When the Filshie Clip is secured in
position, gently release the trigger and
the Filshie Clip will automatically free
itself from the applicator.
• Do not use an abrupt action or the
tube may be transected. Should this
occur, apply a second Filshie Clip on the
proximal (uterine) side of the transection.
• If there is any doubt about the placement or performance of the Filshie Clip, it is
strongly recommended that a second Filshie Clip is applied correctly, immediately
adjacent to the first on the uterine side.
ALWAYS CHECK THAT THE FILSHIE CLIP HAS BEEN PLACED ON THE RIGHT STRUCTURE
AND IN THE CORRECT POSITION.
Important: It is quite noticeable, but quite normal, for the muscle of the tube to ‘give’
during Filshie Clip application.
Important: For your convenience, enclosed within each box of Filshie Clips is a Patient LOT
Label to be incorporated in the patient’s records as required for traceability purposes.
7.4.2 Inspection of a Closed Clip
Inspect the secured Filshie Clip both front and
back to confirm that:
• The entire Fallopian tube has been
captured (upper image, right).
• The upper jaw has been compressed and
is securely latched under the nose of the
lower jaw:
• The Filshie Clip is in the correct position
on the Fallopian tube (isthmic portion,
1-2cm from the cornu) (lower image,
right).
• The Fallopian tube has not been partially
or fully transected.
Once the first clip is placed correctly in position withdraw the applicator, load a second
Filshie Clip and repeat the procedure on the other Fallopian tube. Once both clips have
been applied, ALWAYS check that they have both been placed on the isthmic portion
(1-2cm from the cornu) of each Fallopian tube and not on either the round or ovarian
ligaments, or a fold in the mesosalpinx.
Retrieval of a Dropped Clip
• If this should occur the Filshie Clip should be immediately identified, grasped with
the applicator and removed. The Filshie Clip should be grasped firmly (preferably near
the hinge) and pulled to the mouth of the cannula. The applicator holding the Filshie
Clip firmly, together with the cannula, should then be withdrawn from the abdomen
simultaneously.
• NOTE: If you are unable to find a dropped Filshie Clip, the decision to leave in the clip
or to perform a laparotomy is at the discretion of the physician. The Filshie Clip is
intended for implantation; however rare cases of migration and inflammation have
been reported.
7.5 Removal of the Applicator / Desufflation
7.5.1 Removal of the Applicator from the Abdomen
Before the Sterishot II Applicator can be withdrawn from
the abdomen it must be returned to the ‘half closed’
position so it can pass through the cannula.
7.5.2 Desufflation
When both Fallopian tubes have been clipped, carefully inspected and the applicator
withdrawn, desufflation of the pneumoperitoneum is necessary.
The applicator must then be discarded following appropriate hospital protocol.
8. MRI Safety Information
MR CONDITIONAL
Non-clinical testing has demonstrated that the Filshie Clip is MR Conditional7. A patient
with this device can be scanned safely in an MR system meeting the following conditions:
• Static magnetic field less than or equal to 3.0 T
• Maximum spatial field gradient of 4,000 Gauss/cm (40 T/m) or less
Warning: In the unlikely event of the tube being too large for the
Filshie Clip, use an alternative method of tubal occlusion.
Warning: When placing the Filshie Clip on a larger tube this should
be done very slowly to allow oedema to be milked away. Once the
Filshie Clip has been closed, check to ensure the whole Fallopian tube
has been encapsulated. If the surgeon is unsure, a second Filshie Clip
should be placed.
• Maximum MR system reported, whole body averaged specific absorption rate (SAR)
of 2 W/kg (Normal Operating Mode).
Under the scan conditions defined above, the Filshie Clip is expected to produce a
maximum temperature rise of less than 1.3°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the Filshie Clip extends approximately
10mm from the implant when imaged with a gradient echo pulse sequence and a 3.0 T
MRI system.
9. Symbols and Graphics
10. References and Tables
1. PMA Vol 6B Protocols 6249, 6265, 6267, 6240, 6260, 6269.
2. PMA Vol 6B Protocol 6249.
3. PMA Vol 6B Protocol 6269.
4. PMA Vol 6B Protocols 6249, 6264, 6265, 6267.
5. PMA Vol 6B All Protocols.
6. PMA Vol 6B Protocols 6264, 6265, 6269.
7. Data on file at Femcare-Nikomed Ltd.
8. Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell, J, Nelson AL, Cates W, Stewart
FH, Kowal D, Policar M, Contraceptive Technology: Twentieth Revised Edition, New York
NY. Ardent Media, 2011.
Table 10.1. Adverse Experiences Ever Occurring in >0.5% of all Patients Post-
Surgery
Adverse Events by Body
System
Filshie Tubal Ligation
System
Other Tubal Occlusion
Devices/Methods
N=5,454 %N=3,845 %
Digestive
Nausea/Vomiting 235 4.3 155 4.0
Musculoskeletal
Back Pain 32 0.6 23 0.6
Shoulder Pain 295 5.4 212 5.5
Nervous/Psychiatric
Headache 164 3.0 89 2.3
Skin
Keloid 214 3.9 196 5 .1
Serous Discharge 152 2.8 121 3.1
Primal Incision Inflammation 138 2.5 96 2.5
Wound Abscess 29 0.5 36 0.9
Wound Bleeding 23 0.4 21 0.5
Hematoma 55 1.0 35 0.9
Incomplete Dehiscence 24 0.4 30 0.8
Incision Pain 81 1.5 93 2.4
Urogenital
Vaginitis 62 1.1 53 1.4
Vaginal Abnormality 29 0.5 25 0.7
Dysplasia 32 0.6 17 0.4
Uterine Abnormality Menses
(for condition not present at baseline)
51 0.9 29 0.8
Excessive Flow 379 6.9 209 5.4
Severe Dysmenorrhea 144 2.6 57 1.5
Severe Intermenstrual Pelvic Pain 35 0.6 16 0.4
Menorrhagia 37 0.7 70.2
Vaginal Bleeding 79 1.4 65 1.7
Infection in Adnexa 24 0.4 24 0.6
Tender/Enlarged Adnexa 143 2.6 139 3.6
Pelvic Pain 1,949 35.7 1,652 43.0
Adnexal Pain 109 2.0 91 2.4
Urinary Tract Infection 57 1.0 29 0.8
Note: Multiple events may be reported per woman.
Expiry Date
YYYY-MM-DD
Sterilization using
Ethylene Oxide gas
Manufacturer
Refer to Instructions
for Use
Caution: Federal (USA)
Law restricts this device
to sale by, or on the
order of, a physician.
Caution: Consult
Accompanying Documents
Do Not Reuse
Catalog Number
Batch Code
Quantity
Product is not manufactured
with natural rubber latex
Do not use if package
is damaged
MR Conditional
Table 10.2. Birth Control Method Pregnancy Rates - Summary of Contraceptive
Efficacy8
Percentage of women experiencing an unintended pregnancy during the first year
of typical use and the first year of perfect use of contraception and the percentage
continuiung use at the end of the first year in the United States.
Method
(1)
% of Women Experiencing an
Unintended Pregnancy within
the First Year of Use
% of Women
Continuing
Use at One
Year
C
(4)
Typical UseA
(2)
Perfect UseB
(3)
No MethodD85 85 —
SpermicidesE28 18 42
Withdrawal 22 446
Fertility awareness-based methodsF24 —47
Standard Days Method 5
TwoDay Method 4
Ovulation Method 3
Symptothermal method 0.4
Sponge
Parous Women 24 20
Nulliparous Women 12 9
DiaphragmG16 657
CondomH
Female (fc) 21 541
Male 18 243
Combined Pill and Progestin-Only Pill 90.3 67
Evra Patch 90.3 67
Nuvaring 90.3 67
Depo-Provera 60.2 56
IUD
ParaGard (Copper T) 0.8 0.6 78
Mirena (LNG) 0.2 0.2 80
Implanon 0.05 0.05 84
Female Sterilization 0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraception: Emergency contraceptive pills or insertion of a copper intrauterine
contraceptive after unprotected intercourse substantially reduces the risk of pregnancy.
K
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.L
A Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who
experience an accidental pregnancy during the first year if they do not stop use for any other reason. Estimates
of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility
awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are
taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for
the derivation of estimates for the other methods.
B Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both
consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they
do not stop use for any other reason. See the text for the derivation of the estimate for each method.
C Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.
D The percentages becoming pregnant in columns (2) and (3) are based on data from populations where
contraception is not used and from women who cease using contraception in order to become pregnant. Among
such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to
represent the percentage who would become pregnant within 1 year among women now relying on reversible
methods of contraception if they abandoned contraception altogether.
E Foams, creams, gels, vaginal suppositories, and vaginal film.
F The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method
avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on
evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature
to determine the last fertile day.
G With spermicidal cream or jelly.
H Without spermicides.
K ella, Plan B One-Step and Next Choice are the only dedicated products specifically marketed for emergency
contraception. The label for Plan B One-Step (one dose is 1 white pill) says to take the pill within 72 hours after
unprotected intercourse. Research has shown that all of the brands listed here are effective when used within
120 hours after unprotected sex. The label for Next Choice (one dose is 1 peach pill) says to take 1 pill within
72 hours after unprotected intercourse and another pill 12 hours later. Research has shown that both pills can
be taken at the same time with no decrease in efficacy or increase in side effects and that they are effective
when used within 120 hours after unprotected sex. The Food and Drug Administration has in addition declared
the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel
(1 dose is 2 white pills), Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or
Quasence (1 dose is 4 white pills), Jolessa, Portia, Seasonale or Trivora (1 dose is 4 pink pills), Seasonique (1
dose is 4 light-blue-green pills), Enpresse (one dose is 4 orange pills), Lessina (1 dose is 5 pink pills), Aviane or
LoSeasonique (one dose is 5 orange pills), Lutera or Sronyx (one dose is 5 white pills), and Lybrel (one dose is 6
yellow pills).
L However, to maintain effective protection against pregnancy, another method of contraception must be used as
soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced,
or the baby reaches 6 months of age.
Distributed by:
95 Corporate Drive
Trumbull, CT 06611
Toll Free: 800-243-2974
www.coopersurgical.com
Femcare-Nikomed Limited
Stuart Court, Spursholt Place, Salisbury Road, Romsey, Hampshire, SO51 6DJ, UK
Femcare®, Filshie®, Sterishot™ and associated logos are trademarks of Femcare-Nikomed Limited
IFU-0082 A (03/17)
