1. Product Desc ription
The Filshie Tubal Ligation Syst em consists of:
• the Filshie Clips, and
• the Sterishot II Applicator.
Sterishot II Applicator for Dual Incision Laparoscop y
The Sterishot II Applicator
is intended for dual incision
laparoscopy. The applic ator consists
of a plastic handle and metal shaf t.
The applicator is approximate ly 365mm in length with
a working length of approximately 24 0mm and an approximate diameter
of 7mm. The applicator is designe d for introduction and use through a laparos copic
cannula. The internal diameter of th e cannula needs to be 7.5mm or greater.
The Sterishot II Applicator c an only apply one Filshie Clip at a time and can be rel oaded to
enable more Filshie Clips to be ap plied in the same patient.
The Sterishot II Applicator is de signed for use by both left and right h anded operators.
The Filshie C lip
The Filshie Clip is manufact ured from titanium and is lined on the inner
surface with silicone ru bber (both materials are implantable gr ade). At
one end there is a hinge and at the other a latch . The Filshie Clip is applied
across the entire diameter of the is thmic segment of the Fallopian tube.
When the Clip is fully closed by t he Sterishot II applicator, the upper jaw is
flattened and is sec urely latched under the front end of the lower jaw. This
acts as a clasp, securin g the upper jaw of the Clip. The silicone rubb er is in
direct contact with the t issues and both are compress ed under the force applied by the
titanium. When avascular ne crosis of the Fallopian tube occurs , the compressed silicon e
expands to maintain compl ete occlusion of the lumen. This prevent s re-canalization and
destroys approximately 4mm of the Fallopian tube.
The dimensions of a closed F ilshie Clip are approximately 14mm x 3.5mm x 4mm.
2. Indications
The Filshie Tubal Ligation Syst em is a contraceptive tubal occlus ion device indicated for
permanent female sterilization by occlusion of the Fallopian tubes.
3. Contraindicat ions, Warnings and Pr ecautions
3.1 Contraindicati ons
The Filshie Tubal Ligation System mus t not be applied if any of the following conditions are
present in the patie nt:
• Existing (current) or suspected pregnancy.
• Significant peritubular a dhesions obscuring the portio n of the Fallopian tube to be
occluded.
• Acute pelvic inflammato ry disease (PID) .
• Salpingitis isthmica nodo sa or chronic isthmic induration.
• Hemoperitoneum or suspicion of ectopic pregnancy.
• Any conditions contrain dicating the use of surgery, or local or gen eral anaesthetic.
3.2 Warnin gs
a) Pregnancy
Pregnancy, although infrequent , may occur after placement of the F ilshie Clip1. Women
with pre-existing p elvic inflammatory disease or o besity may be at increased ris k of
sterilization failur e.
Women sterilized postpar tum or postabortion may b e at increased risk of pregnancy. The
pregnancy rate following tub al sterilization of postpartum pat ients is higher than that
reported in interv al patients. After two (2) y ears the annual pregnancy rate for pati ents
sterilized with the Filshie Clip was 1.7% f or postpartum patients .
Pregnancy following occ lusion of the Fallopian tubes using Filshi e Clips may be associated
with applications in which the Filshie C lip has not completely captured the F allopian tube2
or applications which have inadv ertently been placed on the wron g anatomical structure,
such as the round or ovarian ligament s.
b) Ectopic Pregnancy
Rare instances of ectop ic pregnancy (0.016% of subj ects in clinical study) subs equent to
application of the Filshie Clip hav e been reported3. The possibility of e ctopic implantation
must be considered in any patie nt becoming pregnant after sterilizat ion using the Filshie
Tubal Ligation System.
Special attention should b e directed to patients with delayed m enstruation, metrorrhagia
and/or unilateral pel vic pain to determine whether an ectopic pr egnancy has occurred.
c) Unintended Major Surger y (Laparotomy)
Trauma may occur infrequently to pel vic organs during laparoscopic applic ation of
the Filshie Clip4. This trauma may result in the ne ed for major surgical intervention for
the purpose of repair. The nee d to proceed to unintended major surger y also has been
reported in some wome n with pre-existing intra-abd ominal adhesions, obesity o r history
of pelvic inflammatory dis ease (PID).
d) Trauma/Bleeding
The normal closure of the F ilshie Clip may cause immediate transec tion with bleeding in a
small number of cases. A s econd clip may be applied on the proximal ( uterine) side of the
lesion, but with a much slower clos ing action to ameliorate the bleeding. Trans ection of
the tube may lead to unintended m ajor surgery.
Injuries to the Fallopian tube , mesosalpinx or cornua, thou gh infrequent, may result from
Filshie Clip application. Me sosalpingeal or tubal injury is mor e likely among women with
pre-existing p eritubular adhesions, or thick or edemat ous tubes. The incidence of tr auma/
bleeding injuries decreas e with physician experience and c areful patient selection.
Transection of the Fallopian t ube, 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 r equired.
e) Technical Failures
There may rarely be a nee d to change to an alternative procedure or aban don the
sterilization procedure alt ogether during application of the Filshie Clip5. Technical failures
have been reporte d in women with enlarged uteri and other pre-ex isting patient factors
such as peritubular adhesio ns or obesity.
Technical failures have been as sociated with equipment malfunction . Both the operator
and support perso nnel should be familiar with the operation of the F ilshie Clips and the
Sterishot II applicator prior to use .
f) Infection
Infection at the site of the incisio n may rarely follow tubal sterilization (1.3 %)5.
Urinary tract infec tions may follow tubal sterilization (1.0 %)5.
Infections of the pelvic c avity may follow tubal sterilizatio n (0.1%)5. This can lead to
tuboovarian absc esses, endometritis or s alpingitis. Take appropriate diagnostic actio n
when pelvic infection is suspected.
g) Clip Expulsion, For eign Body Reactions, and As ymptomatic Migration
Instances of clip expuls ion per urethra, vaginal cuff and bowel , as well as foreign body
reactions have been rep orted (3 expulsions and 2 for eign body reactions were repor ted
in 5,326 women). T hree instances of apparently as ymptomatic migration of the clip were
observed as incid ental findings, but the frequenc y of this event is not known.
3.3 Precaut ions
a) Patient Evaluatio n
A complete medical histor y should be obtained to determine c onditions that might
influence the selec tion of the procedure, or are absolute or r elative contraindications
to surgery. A routine physic al examination should be perform ed noting the integrity
of the pelvic organs and, if indic ated, a pregnancy test undert aken to determine an
existing pregnancy. T he patient should be evaluated for pel vic inflammatory disease,
cardiovascular diseas e, severe ileus, acute peritonitis , previous pelvic surgery, signif icant
hemoperitoneum and other conditions which contraindicate surgery or the use of
anaesthesia.
b) Patient Counselling
Prior to any sterilization proc edure being performed, the p atient should be fully informed
about alternative method s of contraception, the possibl e side effects of the proc edure,
any complications which may arise dur ing and following the procedure and the risk s and
benefits asso ciated with sterilization in general and the F ilshie Tubal Ligation System
procedure in particular. Th e patient should be encouraged to discus s openly and fully any
questions she may have co ncerning the Filshie Tubal Ligation System .
The patient should be advi sed that if any post-operative sy mptoms are severe or
persistent, she should s ee her physician.
The patient should be informe d that sterilization will not prevent sexuall y transmitted
diseases (ST Ds). Additional prec autions against STDs must still be taken af ter sterilization.
c) Clinical Usage
For each procedure , use only Clips enclosed in the seal ed, sterile package.
Check the operation of th e applicator prior to use (see Dire ctions for Use section) .
Physicians should be thoro ughly familiar with the Filshie Tubal Ligation Syste m, tubal
sterilization procedure s, and management of tubal sterilization c omplications before
attempting its use.
Physicians are cautioned t hat they should confirm the locat ion of the pelvic organs before
and after Filshie Clip applic ation to prevent inadvertent applicatio n to an inappropriate
anatomical structure such as t he round or ovarian ligament.
Improper loading and testin g of the applicator may result in Filshie Clips bein g either
inadvertently discharg ed into the peritoneal cavity or inc orrectly placed. Refer to th e
Directions For Use s ection for the proper method f or inserting the Filshie Clips into the
applicator, and the recommende d course of action for an incorrec tly placed Filshie Clip.
The safety and ef fectiveness of the Fils hie Tubal Ligation System for permanent
sterilization has only been t ested and clinically evaluated using th e Femcare-Nikomed
Filshie Clips and Applicato rs. Applicators from other manuf acturers must not be used for
Filshie Clip application, and oth er manufacturer’s clips must not be use d with the Sterishot
II applicator.
Before endoscopi c instruments and accessori es from different manufacturer s are used
together in a procedure, v erify compatibility prior to st arting the procedure.
d) Long Term Implantation and Sequelae
The silicone and titanium use d in the manufacture of the Filshie Clip are gener ally
regarded as safe materials f or human implantation. Although no adver se toxic or
tumorigenic effec ts due to the device or its materials h ave been reported, the ef fects of
long term implantation are unknown .
The long term effe cts of tubal sterilization on women are uncl ear. Several uncontrolled
studies suggest that wo men undergoing tubal sterilization may be pr one to gynecological
problems. More rec ent controlled studies report that s terilization does not cause any long
term effects . The rates of hospital referr al for gynecological or psy chiatric conditions
appear to be similar for women under going tubal sterilization and women whose
husbands underwent vase ctomy.
In the event of a subsequent hy sterectomy, it has been recommende d that the Filshie Clips
be removed, as leaving th em in may predispose the patient to a later e xpulsion.
4. Adverse E vents
The following adverse e ffects have been repo rted with the use of the Filshie Tubal Ligatio n
System. The eff ects are not listed in order of frequenc y or severity. Reported ad verse
effects include:
• pregnancy, either uterine ( 0.46%)
1
or ectopic (0. 016%)
1
• Clip migration or expulsio n (0.13%)
1
• misapplication to ovaria n ligament, broad ligament, omentum, bowel, t ubal serosa,
cornual or broad ligament ( 0.05%).
1
• pain and cramping (35 .7%)
Other adverse ex periences reported fro m surgical procedures to implant the Filshie C lip
include the following (refe r to Table 10.1 for a complete list of adverse experien ces and
frequencies):
• musculoskeletal pain ( 6.0%)
• adnexal pain, enlargement o r infection (5.0% )
• incisional inflammation, ble eding, abscess, or pain ( 4.4%)
• nausea/vomit ing (4.3%)
• keloids (3.9%)
• headaches (3.0%)
• serous discharge (2. 8%)
• vaginitis (1.1%)
• urinary tract infec tion (1.0%)
• hematoma (1.0%).
Menstruation pattern ch anges, involving the amount of blood f low, duration of flow, cycle
regularity and cycle le ngth, and dysmenorrhea, may oc cur following tubal sterilization.
Menstrual disturbance s not present at baseline in women who receiv ed the Filshie Clip
were reported as follows :
• excessive f low (6.9%)
• menorrhagia (0.7%)
• vaginal bleeding (1.4% )
• severe dysmenorrhea (2.6% )
• severe intermenstrual p elvic pain (0.6% ).
These effe cts have been reported to b e associated with other methods of tu bal
sterilization, and they of ten disappear within a year following steriliz ation.
5. Clinical St udies
For the 5,754 women who were enrolle d in the eleven prospective clinic al trials reported in
the pre-market approval app lication (PMA) and who were ster ilized using the Filshie Tubal
Ligation System, only 22 p regnancies were reported. Onl y one ectopic pregnancy was
reported. A list of the ad verse events that were repor ted in the clinical studies is provided
in Table 10.1.
Four of the clinical studies wer e designated “pivotal studies”. The se studies are
prospective, ran domized, controlled clinical studie s comparing the Filshie Tubal Ligation
System to the Hulka Clip or the F alope-Ring. The method of applic ation was either
laparoscopy or minilaparotomy. T he 12-month follow-up results are shown in Table 5.1.
There was no statistic ally significant difference bet ween the failure rates for the Filshie
Tubal Ligation System as compare d to the Hulka Clip or Falope-Ring.
Table 5.1. Filshie Tubal Ligation System - Gross Cumulativ e Live-Table
Pregnancy Rates
Pool Pivotal Studies Months of
Follow Up
12-Month Pregnancy Rate (Standard Error)
Per 100 Women
Filshie vs. Hulka C lipa12
0.1 (0.1), N=1,06 3
% completing = 68 .7%
0.7 (0.3) , N=1,062
% completing = 67%
Filshie vs. Fal ope-Ringb12
0.2 (0.1), N =1,378
% completing = 81.9 %
0.2 (0.1), N =1,355
% completing = 82.4 %
a The Hulka Clip™ is also known as the Wolf Clip™*
b The Falope-Ring™ is also known as t he Tubal Ring and the Yoon Ring**
Results from a single stud y suggest that the Filshie Tubal Ligation Sy stem may be less
effective than t he Pomeroy method in postpart um women. Of 1,400 women who were
enrolled in a 24 month study, nine (9) r eported pregnancies in the Fils hie 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 suppli ed as a sterile, disposable applicato r in a Tyvek-sealed
tray. A pair of sterile Filshie Clips is pro vided in a single, peelable pouch. T he pair of clips
are provided within the Sterishot II outer p ackaging (but separate from th e Sterishot II
tray), and may als o be obtained separately.
Filshie Clips included with the Ster ishot II applicator are supplied with patient trac eability
(lot) labels for inclusion in t he patient record and a patient MRI information c ard.
7. Directions for Use
7.1 Filshie Clip Sta ges of Operat ion
Shown below is the appearanc e of the Filshie Clip at different stages of o peration:
Clip fully open from the
pack with the ‘No Touch’
loading handle fitte d.
Clip open, as it sits in the
loaded applicator.
Clip half closed, as it goes
down the cannula.
Clip half closed, giving a temp orary grip
on the tube, re-openable at this stage.
Clip permanently secure d after force has
been applied to the applic ator. Latching
has occurred and the Clip c annot be
opened.
7.2 Loadi ng the Filshie Clip
Carefully remove the Sterish ot II Filshie Clip Applicator from its pack aging. Check the
operation of the applicator p rior to use. Users must be able to easil y and fully compress
the Sterishot II trigger to its stop .
7.2.1 Using the ‘No Touch’ Technique
As pictured, pick up th e Filshie Clip using the blue plastic ‘No
Touch’ handle already fitted .
Using a ‘No Touch’ technique, slide the b ottom of the Filshie Clip
along the floor of the applic ator ‘Clip tray’ until it is within the
‘side guides’ and against the ‘ Clip stop’.
Detach the ‘No Touch’ handle by le vering it backwards and then
discard the handle. Ensure the C lip is correctly loaded.
Warning: To maintain sterility, never touch the Filshie Clip.
7.2.2 Check Loading of th e Clip in the Applicator Jaws
1. Check that the bottom p ortion of the Filshie Clip lies perf ectly flat on the floor of the
applicator ‘Clip tray’, not rising up at t he back or the front.
Warning: Filshie Clips are to be applied using only Femcare-Nikomed
applicators.
A ContrACeptive DeviCe for
permAnent femAle SterilizAtion
Single Patient Use
Filshie® Clip Applicator
Instructions For Use
™
®
AVM - 9 51
2. Check that the front end of the F ilshie Clip
lies directly behind the ‘C lip stop’ of the
applicator’ s lower jaw.
3. Check that the upper por tion of the Filshie
Clip is located betwe en the ‘side guides’ of
the applicator’s moveable jaw.
4. Gently tap the applicator agains t 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 Ab domen
The Sterishot II Applicator is de signed for introduction and use through a c annula of
greater than 7.5mm internal diameter.
In order to pass the loade d Sterishot II Applicator through the cannula it must b e in a ‘half
closed’ position:
This is achieved by gently squ eezing
the trigger until the movable jaw is in
the half-closed position. The trigger
should be squeezed ju st enough
to allow smooth passage of th e
applicator through the cannula .
Maintain gentle pressur e to keep
the Clip ‘half closed’ until visu alized
through the laparoscop e. Slowly
release the trigger and the Clip will
open ready for applicat ion.
Important: Obtaining th e ‘half closed’ position should be pr acticed several times be fore
clinical use.
Polished Trigger
Section
White Visual Gui de
Trigger Housing
A feature of the Sterishot II Applic ator is a
white visual guide located within th e trigger
housing, designed to help indic ate the “half
closed” position and h ence avoid over-shooting
the Filshie Clip. To ensure the “half clos ed”
position is not excee ded, the edge of the black
polished section of th e trigger should not pass
beyond the white visual guide lo cated inside
the black trigger housing. It is al so important
that the surgeon visually co nfirms the “half
closed” position in ord er to ensure that overshooting has not occurred p rior to entering the
cannula.
7.4 Applic ation of the Filshie Cl ip
7.4.1 Identifying and M anipulating the Fallopian Tube
It is possible to manipulate the F allopian tube for identification p urposes by gently using
the loaded applicator as a p air of soft forceps being careful not to t ake the trigger past the
‘half closed’ position . Only use the applicator as a manipulator in the ‘half c losed’ position
to avoid the possibilit y of dislodging the Filshie Clip from the applic ator jaw. Heavy
handed manipulation must be avoi ded as this could result in the Clip being dislodg ed from
the applicator. The use of a uterine manip ulator may be helpful in exposing the tub e,
particularly in the cas e of retroverted uteri. To identify the F allopian tube, pick the tube up
with the applicator and track alo ng towards the fimbria at the distal end. Onc e the fimbria
is visualized, track back tow ards the cornu to locate the application s ite of the Filshie Clip
at the isthmus, 1-2cm from the cornu.
Important: The Fils hie Clip is not designed to be removed once it is in p lace. The physician
should be certain of the e xact placement prior to closing th e Filshie Clip.
Note: Digital photography an d video recording of the closure proc ess are encouraged to
support the patient rec ord case file.
• Identify and inspec t the Fallopian tube thoroughly.
• Ensure that the Filshie Clip can
accommodate the whole diameter of
the Fallopian tube.
• Locate the Filshie C lip 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 ad vanced a few
millimeters to move the Fallopian tube
gently to the back of the Filshie C lip,
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 p osition by
applying firm, but gentle p ressure on
the trigger in a smooth action until the
trigger reaches its me chanical stop.
• When the Filshie Clip is secur ed in
position, gently release the trigger and
the Filshie Clip will automatically fr ee
itself from the applicato r.
• Do not use an abrupt action or t he
tube may be transec ted. Should this
occur, apply a second Fil shie Clip on the
proximal (uterine) sid e of the transection.
• If there is any doubt about the pla cement or performance of the Fils hie Clip, it is
strongly recommende d that a second Filshie Clip is applied co rrectly, immediately
adjacent to the first on the uterine side.
ALWAYS CHECK THAT THE FIL SHIE CLIP HAS BEEN PLAC ED ON THE RIGHT STRUCTU RE
AND IN THE CORRECT P OSITION.
Important: It is quite notice able, but quite normal, for the muscle of the t ube to ‘give’
during Filshie Clip application.
Important: For your c onvenience, enclosed within each b ox of Filshie Clips is a Patient LOT
Label to be incorpo rated in the patient’s records as requir ed for traceability purpos es.
7.4.2 Inspection of a Clo sed Clip
Inspect the secure d Filshie Clip both front and
back to confirm that:
• The entire Fallopian tub e has been
captured (upper imag e, right).
• The upper jaw has been c ompressed and
is securely latched under th e nose of the
lower jaw:
• The Filshie Clip is in the corr ect position
on the Fallopian tube (isthmic portion,
1-2cm from the cornu) (lower image,
right).
• The Fallopian tube ha s not been partially
or fully transected.
Once the first clip is pla ced correctly in position with draw the applicator, load a second
Filshie Clip and repeat the pro cedure on the other Fallopian tube. O nce both clips have
been applied, ALWAYS check that t hey have both been placed on the is thmic portion
(1-2cm from the cornu) of each Fallopian tub e and not on either the round or ovarian
ligaments, or a fold in the me sosalpinx.
Retrieval of a Dropped Clip
• If t his should occur the Filshie Clip should be imme diately identified, grasped with
the applicator and removed . The Filshie Clip should be grasped f irmly (preferably near
the hinge) and pulled to the mo uth of the cannula. The applicator holding th e Filshie
Clip firmly, together with the c annula, should then be withdrawn from the abdo men
simultaneously.
• N OTE: If you are unable to find a dropped F ilshie Clip, the decision to leave in the clip
or to perform a laparotomy is at th e discretion of the physician. The F ilshie Clip is
intended for implantation; how ever rare cases of migration and inflammat ion have
been reported.
7.5 Removal of the A pplicator / Desuf flation
7.5.1 Removal of the Applic ator from the Abdomen
Before the Sterishot II Applic ator can be withdrawn from
the abdomen it must be return ed to the ‘half closed’
position so it can pas s through the cannula.
7.5.2 Desufflation
When both Fallopian tube s have been clipped, carefully insp ected and the applicator
withdrawn, desuffl ation of the pneumoperitoneum is neces sary.
The applicator must then be dis carded following appropriate hospit al protocol.
8. MRI Safet y Informat ion
MR CONDITIONAL
Non-clinical testing ha s demonstrated that the Filshie Clip is MR Con ditional7. A patient
with this device can be sc anned safely in an MR system mee ting the following conditions:
• Static magnetic field le ss than or equal to 3.0 T
• Maximum spatial field gr adient of 4,000 Gauss/ cm (40 T/m) or les s
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 rep orted, whole body averag ed specific absorption rate ( SAR)
of 2 W/kg (Normal Op erating Mode).
Under the scan condition s defined above, the Filshie Clip is e xpected to produce a
maximum temperature rise of le ss than 1.3°C after 15 minutes of continuous sc anning.
In non-clinical testing , the image artifact caused by t he Filshie Clip extends approximatel y
10mm from the implant when imaged with a gr adient 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 Expe riences Ever Occ urring in >0.5% of all Patients PostSurgery
Adverse Events by Body
System
Filshie Tubal Ligation
System
Other Tubal Occlusion
Devices/Methods
N=5,454 % N=3,845 %
Digestive
Nausea/Vomi ting 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 15 2 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 conditio n not present at baseli ne)
51 0.9 29 0.8
Excessive Flow 379 6.9 209 5.4
Severe Dysmenorrhea 144 2.6 57 1. 5
Severe Intermen strual Pelvic Pain 35 0.6 16 0.4
Menorrhagia 37 0.7 7 0.2
Vaginal Bleeding 79 1.4 65 1.7
Infection in Adne xa 24 0.4 24 0.6
Tender/Enlarged Adnexa 143 2.6 13 9 3.6
Pelvic Pain 1,9 49 35.7 1,65 2 43.0
Adnexal Pain 109 2.0 91 2.4
Urinary Tract Inf ection 57 1.0 29 0.8
Note: Multiple event s may be reported per wom an.
Expiry Dat e
YYYY-MM-DD
Sterilization using
Ethylene Oxide gas
Manufacturer
Refer to Instru ctions
for Use
Caution: Fed eral (USA)
Law restric ts this device
to sale by, or on the
order of, a physician .
Caution: Cons ult
Accompanying Documents
Do Not Reuse
Catalog Number
Batch Code
Quantity
Product is not m anufactured
with natural rubb er latex
Do not use if packag e
is damaged
MR Conditional
Table 10.2. Birth Control Meth od Pregnancy Rat es - Summary of Contra ceptive
Efficacy
8
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 Use
A
(2)
Perfect UseB
(3)
No Method
D
85 85 —
Spermicides
E
28 18 42
Withdrawal 22 4 46
Fertility awareness-based methods
F
24 — 47
Standard Days Me thod 5
TwoDay Method 4
Ovulation Method 3
Symptothermal method 0.4
Sponge
Parous Women 24 20
Nulliparous Women 12 9
Diaphragm
G
16 6 57
Condom
H
Female (fc) 21 5 41
Male 18 2 43
Combined Pill and Pr ogestin-Only Pill 9 0.3 67
Evra Patch 9 0.3 67
Nuvaring 9 0.3 67
Depo-Provera 6 0.2 56
IUD
ParaGard (C opper 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 10 0
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.
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IFU-0082 A (03/17)
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