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A comparative evaluation of intrauterine contraceptive devices
GYNECOLOGY A comparative evaluation of intrauterine contraceptive devices ROBERT E. HALL, M.D.
New York, New York
T H E P u R P o s E of this study is to compare the advantages and disadvantages of the various intrauterine contraceptive devices most widely used in the United States.
Of the 2,375 requests for initial insertion, 71 were refused for the reasons shown in Table II. Insertions were subsequently performed in 26 of these 71 cases. The social composition of the case material is outlined in Table III. Because of the greater incidence of pain and expulsion experienced by nulliparas, insertions are no longer done on these women. The vast majority of initial insertions were
Material
The number of IUCD insertions performed during the past 2 years at the Sloane Hospital for Women is shown in Table I. The coil 5,* loop l,t and loop 2t have been used for 2 years; the bovv 3~ for 19 months; the bow St for 9 months; the steel ring§ for 6 months; and the nylon ring for 2 months. The presentation of data will therefore be largely restricted to those pertaining to coil 5, loop 2, and bows 3 and 5. The type of IUCD reinserted after removal or expulsion was randomly determined.
performed 6 \veeks post partum.
Through the first 23 months of this study, there was a total of 20,444 woman-months of IUCD use. Method The technique of IUCD insertion has been described previously .1 Each patient is given a written list of
Tabie I. IUCD insertions (April i, i963, to March 31, 1965)
From the Department of Obstetrics and Gynecology, Columbia University, College of Physicians and Surgeons. Supported by Grant No. M-6455 from the Population Council. *Gynecoil, Ortho Pharmaceutical
Total insertions Coil 5 Loop 1 Loop 2 Bow 3 Bow 5 Steel ring Nylon ring
Corporation, Raritan:> J.AJew jersey.
tHohabe, Inc., P.O. Box 36, Buffalo, New York. Loops I and 2 are now designa-ted loops A and D J respectively. :j:Marco and Son, 4 Kenneth Avenue, Old Bridge, New Jersey. §Goshen Instrument Corporation, P.O.
Total
Box 102, Goshen, New York.
65
347 51 737 560 325 277 33
16 9 172 74 82 206 17
634 407 483 50
2,330
576
2,906
363 60
909
66 Hall
Am.
Table II. Initial IUCD insertion not performed
Reason
No.
Subsequent insertion
Recent or current pelvic infection Suspected pregnancy Cervical stenosis Fibromyomas of uterus Abnormal uterine bleeding Perforation of uterus on attempt at insertion Hysteria Double uterus Vulvar furunculosis Retained secundines Adenomatous hyperplasia Severe vaginitis and vulvar edema Influenza Condylomata acurninata Appendicitis Ah~ormal cervical cytology Hematoma of episiotomy Incomplete abortion Ovarian cyst Colitis Subinvolution of uterus
18
7
Total
71
7
14 8 7
0 0 5
5 3
2
0 0 1 0
2 I 1
0 1 1
0 1 1 0 0 0 0 0
26
Table III. Case material 2,330
Total patients Private Ward
183 2,147
Nulliparas Gravidas
6 2,324
Catholic Noncatholic
1,026 (44%) 1,304
Unmarried Married
324 2,006
Negro White Puerto Rican Oriental
1,018 (44%) 771 536 5
/1 &.Oi. \
\ .1.& /U
I
instructions. She is requested to return ( 1 ) for evaluation of adverse side effects, ( 2) for annual examination, and ( 3) for removal if she intends to move away. The number and character of patient visits necessitated by this regime are shown in Table IV. Patients more than 3 months overdue for their
J.
Jauuary 1. 19titi Oh:"t. & Gym·c.
annual checkup are regarded as lost to follow-up; 51 have been thus categorized. The monthly rates of complications were computed by dividing the number of individual complications occurring during a given month by the number of patients still at risk during that month-the number of patients at risk having been determined by monthly elimination of patients who became lost to follow-up 15 months later and patients who had experienced removal, expulsion, or pregnancy during the previous month. The cumulative rates of complications were computed by multiplying the difference between a given month's rate and 100 per cent by the difference between the folJowing month's rate and 100 per cent and subtracting the product from 100 per cent.
Side effects 1 he cumulative incidence of initial complaints registered during the first year following initial insertion of the various devices is shown in Table V, together with the nature of these complaints. Note that the incidence of every side effect except the serious complications was highest among coil-\vearers and that t\vo of the complaints ("excess number of beads" and "felt by husband") are peculiar to the coil. During the first year after initial insertions, 90 per cent of the patients with coil 5 returned with some complaint, as opposed to 39 per cent of patients with loop 2 and 40 per cent of patients with bow 3. Fig. 1 illustrates the higher incidence of severe bleeding and pain encountered with the coii, together with the tendency for these difficulties to subside with the passage of time. Table VI shows the number and nature of pelvic infections occurring in IUCDwearers. Although symptoms, physical findings, body temperature, erythrocyte sedimentation rate, and vvhite blood count \vere taken into consideration whenever possible in differentiating between the degrees of severity of the infection, these classifications are admittedly arbitrary. In some
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
67
Table IV. IUCD patient visits Totals
No insertion First insertions Removals after first insertions Expulsions after first insertions Pregnancies after first insertions Minor complaints after first insertions Annual checkups after first insertions Removals after reinsertions Expulsions after reinsertions Pregnancies after reinsertions Minor after reinsertions Annual after reinsertions Totals
10 1
51 25 14 5 15 6 2 6 0 1 0
737 76 60 23 175 150 9 12 3 20 7
560 347 21 67 96 15 35 6 8 16 9
325 25 5 14 54 0 11 0 3 10 0
277 7 27 3 16 1 12 13 4 16 0
33 1 5 0 1 0 1 0 0 0 0
71 2,330 594 199 124 573 322 73 43 19 73 1
926
125
1,272
1,180
447
376
41
4,438
347 113 67 12 216 150 3 6
1
Table V. Cumulative incidences of first complaints following first insertions Nine months Coil 5 !Loop
Severe bleeding Mild bleeding Severe pain Mild pain Excess number of beads Inability to feel tail Felt by husband Miscellaneous Infection Serious complications
38.7% 17.4 14.0 11.2 14.5 4.8 6.5 8.0 5.4 0
21 Bow 31 Bow
8.8% 7.0 5.4 3.8 0 3.5 0 5.5 0.8 1.7
7.8% 3.6 3.2 1.3 0 0 0 9.8 1.6 0.6
Twenty-four months
Twelve months 5
6.7% 3.2 1.0 3.5 0 0 0 5.0 1.0 1.0
Coil 5 43.1% 20.2 15.7 12.9 16.2 4.8 6.5 12.4 6.5 1.1
I Loop 2 I Bow 10.1% 8.3 5.7 5.4 0 3.8 0 5.8 1.4 1.7
3
8.8% 5.6 3.7 2.7 0 0 0 5.3 2.4 1.4
Coil 5 45.4% 28.4 17.1 16.6 17.7 6.3 8.7 24.9 10.9 2.6
I Loop
2
12.0% 13.2 6.7 10.3 0 3.8 0 7.7 1.4 1.7
Table VI. Pelvic infections Total Infections No. of infections Patient hospitalized Antibiotic therapy IUCD removed Previous pelvic infection Severity Questionable Mild Moderate Severe
19 3 13 10 4
3 1 3 1 1
11 2 9 2 0
16 3 10 6 0
5 3 3 1 2
6 1 5 2
6 6 4 3
0 2 1 0
1 5 5 0
1 8 6 1
1 2 1 1
0 5
cases, particularly during the early phase of the study, hospitalization of the patient, administration of antibiotics, and/or removal of the IUCD was done unnecessarily. It is noteworthy that only 5 severe pelvic
1
1
0
1 0 1 0 0
61 13 44 22 8
0 0 1 0
28
9 19 5
infections were seen among 2,330 predominantly ward patients and that 4 of these 5 occurred more than 7 months after insertion of the IUCD. As seen from Table V, pelvic infections
68
.JanuaJy lj 1966 Am. j. Obst. & Gynec.
Hall
'·
BLEEDING
50
£ ,------"
40
/" 30
20
-Cot! 5 2
/'
:
-
~1
~::: 3
Bow5
...
,:r~ ~u ~
%
50
6
12
18
.•
24
PAIN
40
30
20 -
months, 10.2 per cent at 18 months; and bow .5, 4.4 per cent at 9 months. In addition, removals for nonrelevant reasons after first insertions were performed at the following rates: coil 5, 7.8 per cent at 12 months, 12.2 per cent at 24 months; loop 2, 4.2 per cent at 12 months, 6.2 per cent at 24 months; bow 3, 6.2 per cent at 12 months, 11.4 per cent at 18 months; and bow 5, 4.9 per cent at 9 months. Hence, the total removal rates after first insertions were: coil 5, 34.6 per cent at 12 months, 45.5 per cent at 24 months; loop 2, 12.9 per cent at 12 months, 17.2 per cent at 24 months; bow 3, 14.2 per cent at 12 months, 21.6 per cent at 18 months; and bow 5, 9.3 per cent at 9 months. As can be seen from Fig. 2, as is the case with all other IUCD problems, the removal rate decreases with time. Elective removals of loop 1 and bow 3 have been performed routinely since the discovery that they are too small to provide adequate contraception. Expulsions
2
4
6
8
10
12 14 16 18 20 22 24 TIME in MONTHS
Fig. 1. Cumulative incidences of severe bleeding and pain following insertions.
were more common with the coil than with the other devices. Removals
The reasons for IUCD removal following first insertions are cited in Table VII. Bleeding and/or pain accounted for the rP'YY'II"''..,r<:tT'-' ,...._. ......... '-'Y~.L~
{,..,"' .LV.L
-rol.c.,,"::...,.+ .....a..,...,_...,.., ,....f OA _ _ ,.._ ...,...,._,"-
.L1...-.L'-'Va.J.J.L
J.\...Q.iJVJ.liJ
VJ.
U"'T p.:::;1
\..C11l.
The cumulative rates of complete and partial expulsions following first insertions (Fig. 3) were: coil 5, 21.4 per cent at 12 months, 23.0 per cent at 24 months; loop 2, 9.1 per cent at 12 months, 10.7 per cent at 24 months; bow 3, 4.0 per cent at 12 months, 6.4 per cent at 18 months; and bow 5, 1.5 per cent at 9 months. As can be seen from Table VIII, most of the IUCD expulsions \Vere noticed by the patient. Of the 238 expulsions for which this fact was recorded, 86 per cent were observed by the patient. Two pregnancies followed the 34 unnoticed expulsions.
of the coil 5, 94 per cent of the loop 2, 92 per cent of the bow 3, and 100 per cent of the bow 5 devices. The cumulative incidences of removals
Sixty-one per cent of the expulsions occurred during menstruation.
for relevant reasons after first insertions
.1 ne cum mauve inc10ences of pregnancy with the various devices is depicted by Fig. 4. Numerically, these rates were as follows: coil 5, 3.4 per cent at 12 months, 4.5 per cent at 24 months; loop 2, 3.2 per cent at
(Fig. 2) were: coil 5, 26.8 per cent at 12 months, 33.3 per cent at 24 months; loop 2, 8. 7 per cent at 12 months, 11.0 per cent at 24 months; bow 3, 8.0 per cent at 12
Pregnancies
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
69
.,.
:~~ 0
2
4
8
6
10 12 14
16
18 20 22 24
~~L~~~ 0
2
4
B 10. 12 14
6
16
16 20 22 .24
~:~:::J ..... 0
2
4
8
6
10 12 14
~
18 20 22 24
i~l . . =··············· 0
2
4
8
6
10 12 14 16 18 20 22 24
Number of Months
Fig. 2. Cumulative incidences of relevant removals following first insertions.
Table VII. Reasons for removals following first insertions Coil 5
Relevant Bleeding Bleeding and pain Pain Infection IUCD in utero Accidental Terminal bead buried Subtotal N onrelevant Religion Psychological Moving away Desire to conceive Husband's insistence Lack of confidence Separated from husband ll-1 ••
:~
.1..'-'.Lv.u....
48 21
5
8 0
4 2 88 1 6 4 5
5 2 0
. , ___ , "'""5\....J.}'
Suspected pregnancy Subtotal Elective Grand total
1
--25
0
113
Loop I
1 1
I Loop 2 I Bow 3 19 19
15 9
12 1
3
Bow 5
Steel ring
Nylon ring
6 3
4 1
0 0 0 0 0 0 0
1 0
0 0 0
3 0 0 0 0
3
53
39
12
0 0 0
5
1
0 0 0
1
1 1 2 2
2
5 6 3 13 1
0
1
0 3 0
5 0
0
4 0
0 1 0 0 0
1
3
1
1
4 5
---
---
17 25
76
5
23
0
12
6
--36
--13
272 347
25
0
1 0 0 0 0
--6
---
0 0 0 0 0 0
0 0 0 0 1 0 0
0 0
0 0
0
0
1
--1
7
0
1
70
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Am .
J. OOsl.
& G yrH~ C .
.,.
~: ,.:;,,c;~ :;"~ 0
2
6
4
I
I
I
I
I
8
10 12 14 16 18 20 22 24
''''"''';
.. ~ .....
2
4
6
201 10
0
I
. . . :: .........
~:k 0
I
10 '2 14 16 18 20 22 24
8
2
4
6
8
10 12 14 16 18 20 22 24
il . . . . . "''"""""' 0
2
4
6
8
10 12 14 16 18 20 22 24
Number of Months
Fig. 3. Cumulative incidences of expulsions following first insertions.
Table VIII. Number of expulsions noticed by patients Total Expulsion noticed by patient Tail's absence noticed by patient Unnoticed by patient Unknown whether noticed by patient Total
12 months, 3.2 per cent at 24 months; bow 3, 12.4 per cent at 12 months, 14.5 per cent at 18 months; and bow 5, 4.5 per cent at 9 months. The location of the IUCD at the time of conception is shown in Table IX. Although no attention was paid to the time of the menstrual cycle at the time of insertion, only 5 patients were pregnant at this time (including one "pregnancy with I UCD ex utero") . Five other patients were pregnant at the time of elective removal of one device and reinsertion of another. In addition to these 136 proved pregnancies, there were 51 suspected pregnancies which were disproved by pregnancy
Complete
IncomPlete
No.
%
185
14
82 2
4 13 3
1
199 5
21 1
34 4
14 2
205
3i
242
100
tests and 7 suspected early abortions which could be neither proved nor disproved. The outcome of the pregnancies is shown in Table X. Of the 2 premature births with neonatal deaths, one occurred in a patient who conceived after unnoticed expulsion of the device and the other in a patient who had had 3 previous premature deliveries. The maternal death was due to rupture of a congenital cerebral arteriovenous malformation. The fate of the IUCD in these pregnancies is shown in Table XI. There are too few cases to warrant correlation between the fate of the pregnancy and the fate of the device.
Volume 94 Number 1
71
Evaluation of intrauterine contraceptive devices
24.9 per cent at 24 months; bow 3, 24.4 per cent at 12 months, 31.1 per cent at 18 months; and bow 5, 10.4 per cent at 9 months. If the removals for nonrelevant reasons are included, these rates increase to: coil 5, 59.4 per cent at 12 months, 73.0 per cent at 24 months; loop 2, 25.2 per cent at 12 months, 31.1 per cent at 24 months; bow 3, 30.6 per cent at 12 months, 42.5 per cent at 18 months; and bow 5, 15.3 per cent at 9 months.
Removals, expulsions, and pregnancies
Fig. 5 is a composite of Figs. 2, 3, and 4, showing the cumulative rates of relevant removals, expulsions, and pregnancies after first insertions. The totals of these events for the various devices were: coil 5, 51.6 per cent at 12 months, 60.8 per cent at 24 months; loop 2, 21.0 per cent at 12 months,
Table IX. Pregnancies: location of IUCD at time of conception Pregnancies before insertion of IUCD Pregnancies after unnoticed expulsion of IUCD Pregnancies with expulsion of IUCD before or after conception Pregnancies with location of IUCD unknown Pregnancies with IUCD in utero Pregnancies with IUCD ex utero
4 2
Reinsertions
The number of IUCD reinsertions following removals, expulsions, and pregnancies are shown in Table XII. Note that reinsertion was performed following 73 per cent of initial expulsions and following only 23 per cent of initial removals. As can be seen by comparing Figs. 5 and
11 39 76 4 136
Total
Table X. Pregnancy outcome Loop I Still pregnant Spontaneous abortion Induced abortion Therapeutic abortion Ectopic pregnancy Term birth, living child Premature birth, neonatal death Died during pregnancy No follow-up Total
I LooP 2
Total
22
0 0
11 5 3 0 0
1 0 0
0 0 0
0 0 1
12
5
Loop I
1 5 0 0 0
5
0 1
1 3
4 0 0 0 0 0 0 0 0
49 32 10 3 3
1 0 1
3 1 0 1 0 0 1 0
23
75
17
4
136
I Loop 21
Bow 3
Bow 5
26
9 0 1 1 3
3 0 0 1 0
39
0 6 3 28
1
4 5 1
0 0 1
2
0 0 0 0
13 8 2
n
v
n
v
£\
n
23
75
17
3
18 5 3 2
23
11
34 2 1
2
Table XI. Fate of IUCD in pregnancy
? Still in utero Expelled before conception Expelled during or before pregnancy Expelled during pregnancy Expelled or removed at termination of pregnancy Removed during pregnancy Removed after pregnancy In utero after pregnancy Ex utero after pregnancy Unknown Total
0 2 0 2 1
0 0 0
0
2
1
9 4
4 2 0 0
1 0 0 0
4
12
5
1
4
0 0
Steel
2
v
ring
v
4
Total
2
11
18 37
4
".
136
72
Hall
Am .
i~ l" 0
2
I
4
6
.J.
.J;uniJ.I\'
L lYht,
Ob:-:t. &
Gyo ~c .
i!iiii!i!jjjjjji!\ 8 10 12 14 16 18 20 22 24
20 10
20 10
:~L 20
10
0
0
2
4
6
8
~~~~~~~
10 12 14 16 18 20 22 24
Number of Months
Fig. 4. Cumulative incidences of pregnancies following first insertions.
6, the incidence of relevant removals and expulsions after reinsertions is considerably higher than after first insertions. The cumulative 12 month relevant removal rate increased from 26.8 per cent to 35.1 per cent for coil 5, from B.7 per cent to 10.0 per cent for loop 2, and from 8.0 per cent to 17.7 per cent for bow 3; after 9 months the increase was from 4.4 per cent to 10.1 per cent for bow 5. The 12 month expulsion rate increased from 21.4 per cent to 35.2 per cent for coil 5, from 9.1 per cent to 11.2 per cent for loop 2, and from 4.0 per cent to 9.6 per cent for bow 3; after 9 months, from 1.5 per cent to zero for bow 5. Changes in the pregnancy rates after reinsertion were less consistent. Twelve months after insertion and reinsertion, respectively, the pregnancy rates were 3.4 per cent and 6.3 per cent with coil 5, 3.2 per cent and 0. 7 per cent with loop 2, and 12.4 per cent and 11.9 per cent with bow 3; after 9 months with bow 5 they were 4.5 per cent and 2.5 per cent. The total cumulative rates for relevant removals, expulsions, and pregnancies after
reinsertions were: coil 5, 76.6 per cent at 12 months, 98.2 per cent at 24 months; loop 2, 21.9 per cent at 12 months, 30.8 per cent at 20 months; bow 3, 39.2 per cent at 12 months, 39.2 per cent at 18 months; and bow 5, 12.6 per cent at 9 months.
Technical facility Although impossible to measure quantitatively, the technical facility involved in inserting and removing the IUCD's is almost as important as their effectiveness. The variability encountered in this regard is presented in Table XIII. The difficulty in inserting bmv 5 and the steel ring is due to their greater diameter ; dilatation of the cervix is almost invariably required in the insertion of these two devices even when the insertion is done 6 weeks post partum. Insertion of the other IUCD's is easier and less painful, rarely requiring cervical dilatation. Removal of the tailed devices is extremely simple, rapid, and pain-free; removal of the bows and the steel ring is sometimes extremely difficult and traumatic.
Evaluation of intrauterine contraceptive devices 73
Volume 94
Number 1
0
Removots
Rtlti/Onl
0- E•puls•ons
• - Prttqnanc•t\,
'I,
I
I I I
I
18 20 22 24
& ~0
<
:o j 20
~-
~
o -1hA
0 2 Po•,ents ?J1
a
6
:: ""'
l
r---------~
o:.,~
8
10 12 14 16
I
I
i j
8 20 22 24
20 0
Pott#nls 560 60
50 40
30 20 I0
~if!ijiiiii-~~'7"""':::;::-=-:;:: 0
z
4
6
8
10 12 14 16 18 20 22 24
Poll•nls J25
Fig. 5. Cumulative incidences of relevant removals, expulsions, and pregnancies following first insertions.
Table XII. Reinsertions First reinsertions Expulsion of first IUCD followed by reinsertion Expulsion of first IUCD followed by no reinsertion Nonelective removal of first IUCD followed by reinsertion Nonelective removal of first IUCD followed by no reinsertion Elective removal of first IUCD followed by reinsertion Elective removal of first IUCD followed by no reinsertion Pregnancy with first IUCD followed by reinsertion Subsequent reinsertions 45 Patients with 2 reinsertions 10 Patients with 3 reinsertions 1 Patient with 4 reinsertions Total reinsertions
56 233 4
143 (73%)
72 (23%) 285 8 45
20
3
576
J, l~HJf) & Gynec.
.faJJllary
74 Hall
Am.
0-Relevonl Removals
0- Expuls1ons
J.
Ob~t.
• - PreQnonctes
"1. 100
90
eo 70 60 50 40
30
~r·-----
~~~ I I o
2
li
4
6
e
10 12
Pal!ents /6
50~
40
:: "·x·=~HN#;j~ 0
o
• 2
4
6
e
10 12 14
I • 16 1e 20 22 24
Pottents 172 50 40
30 20 / 10 0
Palilnfs 74
~:~ o
2
4
6
e
10 12 14 16 1e 20 22 24
Poli#nls 83 Number of Months
Fig. 6. Cumulative incidences of relevant removals, expulsions, and pregnancies following reinsertions.
Serious complications The serious complications encountered in this series are listed in Table XIV. The above-mentioned difficulties in insertion and removal v;ere due to or responsible for 19 of these 24 complications ( 17 with the bows, 2 with the steel rings). In 4 instances, the terminal bead of a coil became imbedded beneath the cervical or vaginal mucosa (Fig. 7), necessitating local excision. Fragmentation of a bow during attempt at removal occurred 4 times (Fig. 8) ; the remaining fragment was left in situ on 2 occasions and removed at dilatation and curettage on 2 occasions. In addition to 7 bows which became im-
Table XIII. Technical facility Coil 5 Loop 1 Loop 2 Bow 3 Bow 5 Steel rtng Nylon ring
Insertion
Removal
Easy Easy Easy Easy Difficult Difficult Easy
Easy Easy Easy Difficult Difficult Difficult Easy
bedded in the myometrium, 5 bows and one loop were found free in the peritoneal cavity (Fig. 9). The incidence of known perforations in this series is 0 among 363 coil insertions, 1 among 969 loops, and 5 among 1,041 (or 1 per 208) bows. It is
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
75
Fig. 7. At yearly checkup, the coil's terminal bead was found to be imbedded beneath the vaginal mucosa. Attempt at removal resulted in avulsion of the terminal bead, which v;as subsequently excised.
Table XIV. Serious complications Coil Terminal bead imbedded in cervix or vagina IUCD imbedded in uterus IUCD ex utero IUCD fragmented during attempt at removal Uterus perforated during attempt at removal Hemorrhage from cervix after insertion Total
sl Loop 21
Bow 3
Bow
s
I
Steel rinf{
Total 4
24
0
0
0 0 0 0
0 0 1 0 0 0
2
3 1 0
3
0 0
0 0 0 0 1 1
4
1
11
6
2
4 0
believed that all of t..~ese perforations occurred at the time of insertion and that the preponderance of bow perforations is due to the greater rigidity of its inserter. Comment
The IUCD is a relatively new and controversial means of birth control. Only in the past few years has it become commercially available. Many physicians and laymen remain skeptical about it. Its mechanism of action remains unestablished.
5
2 1
7
6
4 2 1
It is incumbent upon those v1ho are interested in promoting the IUCD to abandon the inferior devices and to seek further improvements in the use and design of the superior devices. To do otherwise will surely jeopardize the entire IUCD progrd.J.-n. Evidence from this series, as well as from the Cooperative Statistical Program for the evaluation of IUCD's 2 (Table XV), thus far suggests that the loop is clearly superior to the coil, the bow, and the stainless steel ring. Although effective as a contraceptive,
76
.Ja '" '~'Y
Holl
:\rn.
I. 196h
J. Oh>t . & Gynec.
Fig. 8. Fragmentation of this bow 3 occurred during an attempt at removal. The removal was later completed without anesthesia.
Fig. 9. Conception occurred immediately after insertion of this bow 3. This hysterogram, taken ~j months after delivery, shows why.
Table XV. Cooperative statistical program 2
technical difficulties have already been encountered and both the pregnancy and expulsion rates reported from the Cooperative Statistical Program are rather high. Studies of other IUCD's, such as the nylon ring of Jaime Zipper and the plastic ring of The Johns Hopkins Hospital are in progress. The rates of side effects, expulsions, pregnancies, and technical difficulties with the loop all are within acceptable limits. It is to be hoped, however, that the 25 per cent loss through removal, expulsion, and pregnancy during the first 12 months after first insertions (even though roughly comparable to the first-year abandonment of oral contraceptives) can be further lessened through improvements in the loop itself or improvements in the design of still other devices.
( 11,222 first insertions) Cumulative incidences at 12 months Steel
Coil5 Total removals Expulsions Pregnancies
25.7% 21.8 1.8
ILoop 2 IBow 5* I rinR 15.6% 9.3 2.4
11.1% 1.1
5. 7
10.2% 15.8 7.5
*Rates calculated by extrapolation from 6 month data.
the coil is associated with an unacceptably high rate of side effects and expulsions. Although rarely expelled and seldom responsible for side effects, the bows are associated with an unacceptably high pregnancy rate as well as technical difficulties in insertion and removal. Although data on the stainless steel ring are as yet inconclusive from this series,
Volume 94 Number 1
Summary
1. Two years' experience with 2,906 insertions of seven different types of IUCD are reported from the Sloane Hospital for 'llon1en. 2. The incidence of side effects and expulsions was found to be unacceptably high with coil 5.
Evaluation of intrauterine contraceptive devices
77
3. The incidence of pregnancies and technical difficulties was found to be unacceptably high with bow 3 and bow 5. 4. Evidence thus far available suggests that loop 2 is superior to the other IUCD's tested.
REFERENCES
1. Hall, R. E.: Bull. Sloane Hosp. Women 10: 65, 1964. 2. Tietze, C.: Cooperative Statistical Program for the Evaluation of Intrauterine Contraceptive Devices, Fifth Progress Report. Na-
tiona! Committee on Maternal Health, New York, February, 1965.
622 West !68th Street New York, New York 10032
New York, New York
T H E P u R P o s E of this study is to compare the advantages and disadvantages of the various intrauterine contraceptive devices most widely used in the United States.
Of the 2,375 requests for initial insertion, 71 were refused for the reasons shown in Table II. Insertions were subsequently performed in 26 of these 71 cases. The social composition of the case material is outlined in Table III. Because of the greater incidence of pain and expulsion experienced by nulliparas, insertions are no longer done on these women. The vast majority of initial insertions were
Material
The number of IUCD insertions performed during the past 2 years at the Sloane Hospital for Women is shown in Table I. The coil 5,* loop l,t and loop 2t have been used for 2 years; the bovv 3~ for 19 months; the bow St for 9 months; the steel ring§ for 6 months; and the nylon ring for 2 months. The presentation of data will therefore be largely restricted to those pertaining to coil 5, loop 2, and bows 3 and 5. The type of IUCD reinserted after removal or expulsion was randomly determined.
performed 6 \veeks post partum.
Through the first 23 months of this study, there was a total of 20,444 woman-months of IUCD use. Method The technique of IUCD insertion has been described previously .1 Each patient is given a written list of
Tabie I. IUCD insertions (April i, i963, to March 31, 1965)
From the Department of Obstetrics and Gynecology, Columbia University, College of Physicians and Surgeons. Supported by Grant No. M-6455 from the Population Council. *Gynecoil, Ortho Pharmaceutical
Total insertions Coil 5 Loop 1 Loop 2 Bow 3 Bow 5 Steel ring Nylon ring
Corporation, Raritan:> J.AJew jersey.
tHohabe, Inc., P.O. Box 36, Buffalo, New York. Loops I and 2 are now designa-ted loops A and D J respectively. :j:Marco and Son, 4 Kenneth Avenue, Old Bridge, New Jersey. §Goshen Instrument Corporation, P.O.
Total
Box 102, Goshen, New York.
65
347 51 737 560 325 277 33
16 9 172 74 82 206 17
634 407 483 50
2,330
576
2,906
363 60
909
66 Hall
Am.
Table II. Initial IUCD insertion not performed
Reason
No.
Subsequent insertion
Recent or current pelvic infection Suspected pregnancy Cervical stenosis Fibromyomas of uterus Abnormal uterine bleeding Perforation of uterus on attempt at insertion Hysteria Double uterus Vulvar furunculosis Retained secundines Adenomatous hyperplasia Severe vaginitis and vulvar edema Influenza Condylomata acurninata Appendicitis Ah~ormal cervical cytology Hematoma of episiotomy Incomplete abortion Ovarian cyst Colitis Subinvolution of uterus
18
7
Total
71
7
14 8 7
0 0 5
5 3
2
0 0 1 0
2 I 1
0 1 1
0 1 1 0 0 0 0 0
26
Table III. Case material 2,330
Total patients Private Ward
183 2,147
Nulliparas Gravidas
6 2,324
Catholic Noncatholic
1,026 (44%) 1,304
Unmarried Married
324 2,006
Negro White Puerto Rican Oriental
1,018 (44%) 771 536 5
/1 &.Oi. \
\ .1.& /U
I
instructions. She is requested to return ( 1 ) for evaluation of adverse side effects, ( 2) for annual examination, and ( 3) for removal if she intends to move away. The number and character of patient visits necessitated by this regime are shown in Table IV. Patients more than 3 months overdue for their
J.
Jauuary 1. 19titi Oh:"t. & Gym·c.
annual checkup are regarded as lost to follow-up; 51 have been thus categorized. The monthly rates of complications were computed by dividing the number of individual complications occurring during a given month by the number of patients still at risk during that month-the number of patients at risk having been determined by monthly elimination of patients who became lost to follow-up 15 months later and patients who had experienced removal, expulsion, or pregnancy during the previous month. The cumulative rates of complications were computed by multiplying the difference between a given month's rate and 100 per cent by the difference between the folJowing month's rate and 100 per cent and subtracting the product from 100 per cent.
Side effects 1 he cumulative incidence of initial complaints registered during the first year following initial insertion of the various devices is shown in Table V, together with the nature of these complaints. Note that the incidence of every side effect except the serious complications was highest among coil-\vearers and that t\vo of the complaints ("excess number of beads" and "felt by husband") are peculiar to the coil. During the first year after initial insertions, 90 per cent of the patients with coil 5 returned with some complaint, as opposed to 39 per cent of patients with loop 2 and 40 per cent of patients with bow 3. Fig. 1 illustrates the higher incidence of severe bleeding and pain encountered with the coii, together with the tendency for these difficulties to subside with the passage of time. Table VI shows the number and nature of pelvic infections occurring in IUCDwearers. Although symptoms, physical findings, body temperature, erythrocyte sedimentation rate, and vvhite blood count \vere taken into consideration whenever possible in differentiating between the degrees of severity of the infection, these classifications are admittedly arbitrary. In some
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
67
Table IV. IUCD patient visits Totals
No insertion First insertions Removals after first insertions Expulsions after first insertions Pregnancies after first insertions Minor complaints after first insertions Annual checkups after first insertions Removals after reinsertions Expulsions after reinsertions Pregnancies after reinsertions Minor after reinsertions Annual after reinsertions Totals
10 1
51 25 14 5 15 6 2 6 0 1 0
737 76 60 23 175 150 9 12 3 20 7
560 347 21 67 96 15 35 6 8 16 9
325 25 5 14 54 0 11 0 3 10 0
277 7 27 3 16 1 12 13 4 16 0
33 1 5 0 1 0 1 0 0 0 0
71 2,330 594 199 124 573 322 73 43 19 73 1
926
125
1,272
1,180
447
376
41
4,438
347 113 67 12 216 150 3 6
1
Table V. Cumulative incidences of first complaints following first insertions Nine months Coil 5 !Loop
Severe bleeding Mild bleeding Severe pain Mild pain Excess number of beads Inability to feel tail Felt by husband Miscellaneous Infection Serious complications
38.7% 17.4 14.0 11.2 14.5 4.8 6.5 8.0 5.4 0
21 Bow 31 Bow
8.8% 7.0 5.4 3.8 0 3.5 0 5.5 0.8 1.7
7.8% 3.6 3.2 1.3 0 0 0 9.8 1.6 0.6
Twenty-four months
Twelve months 5
6.7% 3.2 1.0 3.5 0 0 0 5.0 1.0 1.0
Coil 5 43.1% 20.2 15.7 12.9 16.2 4.8 6.5 12.4 6.5 1.1
I Loop 2 I Bow 10.1% 8.3 5.7 5.4 0 3.8 0 5.8 1.4 1.7
3
8.8% 5.6 3.7 2.7 0 0 0 5.3 2.4 1.4
Coil 5 45.4% 28.4 17.1 16.6 17.7 6.3 8.7 24.9 10.9 2.6
I Loop
2
12.0% 13.2 6.7 10.3 0 3.8 0 7.7 1.4 1.7
Table VI. Pelvic infections Total Infections No. of infections Patient hospitalized Antibiotic therapy IUCD removed Previous pelvic infection Severity Questionable Mild Moderate Severe
19 3 13 10 4
3 1 3 1 1
11 2 9 2 0
16 3 10 6 0
5 3 3 1 2
6 1 5 2
6 6 4 3
0 2 1 0
1 5 5 0
1 8 6 1
1 2 1 1
0 5
cases, particularly during the early phase of the study, hospitalization of the patient, administration of antibiotics, and/or removal of the IUCD was done unnecessarily. It is noteworthy that only 5 severe pelvic
1
1
0
1 0 1 0 0
61 13 44 22 8
0 0 1 0
28
9 19 5
infections were seen among 2,330 predominantly ward patients and that 4 of these 5 occurred more than 7 months after insertion of the IUCD. As seen from Table V, pelvic infections
68
.JanuaJy lj 1966 Am. j. Obst. & Gynec.
Hall
'·
BLEEDING
50
£ ,------"
40
/" 30
20
-Cot! 5 2
/'
:
-
~1
~::: 3
Bow5
...
,:r~ ~u ~
%
50
6
12
18
.•
24
PAIN
40
30
20 -
months, 10.2 per cent at 18 months; and bow .5, 4.4 per cent at 9 months. In addition, removals for nonrelevant reasons after first insertions were performed at the following rates: coil 5, 7.8 per cent at 12 months, 12.2 per cent at 24 months; loop 2, 4.2 per cent at 12 months, 6.2 per cent at 24 months; bow 3, 6.2 per cent at 12 months, 11.4 per cent at 18 months; and bow 5, 4.9 per cent at 9 months. Hence, the total removal rates after first insertions were: coil 5, 34.6 per cent at 12 months, 45.5 per cent at 24 months; loop 2, 12.9 per cent at 12 months, 17.2 per cent at 24 months; bow 3, 14.2 per cent at 12 months, 21.6 per cent at 18 months; and bow 5, 9.3 per cent at 9 months. As can be seen from Fig. 2, as is the case with all other IUCD problems, the removal rate decreases with time. Elective removals of loop 1 and bow 3 have been performed routinely since the discovery that they are too small to provide adequate contraception. Expulsions
2
4
6
8
10
12 14 16 18 20 22 24 TIME in MONTHS
Fig. 1. Cumulative incidences of severe bleeding and pain following insertions.
were more common with the coil than with the other devices. Removals
The reasons for IUCD removal following first insertions are cited in Table VII. Bleeding and/or pain accounted for the rP'YY'II"''..,r<:tT'-' ,...._. ......... '-'Y~.L~
{,..,"' .LV.L
-rol.c.,,"::...,.+ .....a..,...,_...,.., ,....f OA _ _ ,.._ ...,...,._,"-
.L1...-.L'-'Va.J.J.L
J.\...Q.iJVJ.liJ
VJ.
U"'T p.:::;1
\..C11l.
The cumulative rates of complete and partial expulsions following first insertions (Fig. 3) were: coil 5, 21.4 per cent at 12 months, 23.0 per cent at 24 months; loop 2, 9.1 per cent at 12 months, 10.7 per cent at 24 months; bow 3, 4.0 per cent at 12 months, 6.4 per cent at 18 months; and bow 5, 1.5 per cent at 9 months. As can be seen from Table VIII, most of the IUCD expulsions \Vere noticed by the patient. Of the 238 expulsions for which this fact was recorded, 86 per cent were observed by the patient. Two pregnancies followed the 34 unnoticed expulsions.
of the coil 5, 94 per cent of the loop 2, 92 per cent of the bow 3, and 100 per cent of the bow 5 devices. The cumulative incidences of removals
Sixty-one per cent of the expulsions occurred during menstruation.
for relevant reasons after first insertions
.1 ne cum mauve inc10ences of pregnancy with the various devices is depicted by Fig. 4. Numerically, these rates were as follows: coil 5, 3.4 per cent at 12 months, 4.5 per cent at 24 months; loop 2, 3.2 per cent at
(Fig. 2) were: coil 5, 26.8 per cent at 12 months, 33.3 per cent at 24 months; loop 2, 8. 7 per cent at 12 months, 11.0 per cent at 24 months; bow 3, 8.0 per cent at 12
Pregnancies
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
69
.,.
:~~ 0
2
4
8
6
10 12 14
16
18 20 22 24
~~L~~~ 0
2
4
B 10. 12 14
6
16
16 20 22 .24
~:~:::J ..... 0
2
4
8
6
10 12 14
~
18 20 22 24
i~l . . =··············· 0
2
4
8
6
10 12 14 16 18 20 22 24
Number of Months
Fig. 2. Cumulative incidences of relevant removals following first insertions.
Table VII. Reasons for removals following first insertions Coil 5
Relevant Bleeding Bleeding and pain Pain Infection IUCD in utero Accidental Terminal bead buried Subtotal N onrelevant Religion Psychological Moving away Desire to conceive Husband's insistence Lack of confidence Separated from husband ll-1 ••
:~
.1..'-'.Lv.u....
48 21
5
8 0
4 2 88 1 6 4 5
5 2 0
. , ___ , "'""5\....J.}'
Suspected pregnancy Subtotal Elective Grand total
1
--25
0
113
Loop I
1 1
I Loop 2 I Bow 3 19 19
15 9
12 1
3
Bow 5
Steel ring
Nylon ring
6 3
4 1
0 0 0 0 0 0 0
1 0
0 0 0
3 0 0 0 0
3
53
39
12
0 0 0
5
1
0 0 0
1
1 1 2 2
2
5 6 3 13 1
0
1
0 3 0
5 0
0
4 0
0 1 0 0 0
1
3
1
1
4 5
---
---
17 25
76
5
23
0
12
6
--36
--13
272 347
25
0
1 0 0 0 0
--6
---
0 0 0 0 0 0
0 0 0 0 1 0 0
0 0
0 0
0
0
1
--1
7
0
1
70
,l a uud • y 1, J~ H.it t
Hall
Am .
J. OOsl.
& G yrH~ C .
.,.
~: ,.:;,,c;~ :;"~ 0
2
6
4
I
I
I
I
I
8
10 12 14 16 18 20 22 24
''''"''';
.. ~ .....
2
4
6
201 10
0
I
. . . :: .........
~:k 0
I
10 '2 14 16 18 20 22 24
8
2
4
6
8
10 12 14 16 18 20 22 24
il . . . . . "''"""""' 0
2
4
6
8
10 12 14 16 18 20 22 24
Number of Months
Fig. 3. Cumulative incidences of expulsions following first insertions.
Table VIII. Number of expulsions noticed by patients Total Expulsion noticed by patient Tail's absence noticed by patient Unnoticed by patient Unknown whether noticed by patient Total
12 months, 3.2 per cent at 24 months; bow 3, 12.4 per cent at 12 months, 14.5 per cent at 18 months; and bow 5, 4.5 per cent at 9 months. The location of the IUCD at the time of conception is shown in Table IX. Although no attention was paid to the time of the menstrual cycle at the time of insertion, only 5 patients were pregnant at this time (including one "pregnancy with I UCD ex utero") . Five other patients were pregnant at the time of elective removal of one device and reinsertion of another. In addition to these 136 proved pregnancies, there were 51 suspected pregnancies which were disproved by pregnancy
Complete
IncomPlete
No.
%
185
14
82 2
4 13 3
1
199 5
21 1
34 4
14 2
205
3i
242
100
tests and 7 suspected early abortions which could be neither proved nor disproved. The outcome of the pregnancies is shown in Table X. Of the 2 premature births with neonatal deaths, one occurred in a patient who conceived after unnoticed expulsion of the device and the other in a patient who had had 3 previous premature deliveries. The maternal death was due to rupture of a congenital cerebral arteriovenous malformation. The fate of the IUCD in these pregnancies is shown in Table XI. There are too few cases to warrant correlation between the fate of the pregnancy and the fate of the device.
Volume 94 Number 1
71
Evaluation of intrauterine contraceptive devices
24.9 per cent at 24 months; bow 3, 24.4 per cent at 12 months, 31.1 per cent at 18 months; and bow 5, 10.4 per cent at 9 months. If the removals for nonrelevant reasons are included, these rates increase to: coil 5, 59.4 per cent at 12 months, 73.0 per cent at 24 months; loop 2, 25.2 per cent at 12 months, 31.1 per cent at 24 months; bow 3, 30.6 per cent at 12 months, 42.5 per cent at 18 months; and bow 5, 15.3 per cent at 9 months.
Removals, expulsions, and pregnancies
Fig. 5 is a composite of Figs. 2, 3, and 4, showing the cumulative rates of relevant removals, expulsions, and pregnancies after first insertions. The totals of these events for the various devices were: coil 5, 51.6 per cent at 12 months, 60.8 per cent at 24 months; loop 2, 21.0 per cent at 12 months,
Table IX. Pregnancies: location of IUCD at time of conception Pregnancies before insertion of IUCD Pregnancies after unnoticed expulsion of IUCD Pregnancies with expulsion of IUCD before or after conception Pregnancies with location of IUCD unknown Pregnancies with IUCD in utero Pregnancies with IUCD ex utero
4 2
Reinsertions
The number of IUCD reinsertions following removals, expulsions, and pregnancies are shown in Table XII. Note that reinsertion was performed following 73 per cent of initial expulsions and following only 23 per cent of initial removals. As can be seen by comparing Figs. 5 and
11 39 76 4 136
Total
Table X. Pregnancy outcome Loop I Still pregnant Spontaneous abortion Induced abortion Therapeutic abortion Ectopic pregnancy Term birth, living child Premature birth, neonatal death Died during pregnancy No follow-up Total
I LooP 2
Total
22
0 0
11 5 3 0 0
1 0 0
0 0 0
0 0 1
12
5
Loop I
1 5 0 0 0
5
0 1
1 3
4 0 0 0 0 0 0 0 0
49 32 10 3 3
1 0 1
3 1 0 1 0 0 1 0
23
75
17
4
136
I Loop 21
Bow 3
Bow 5
26
9 0 1 1 3
3 0 0 1 0
39
0 6 3 28
1
4 5 1
0 0 1
2
0 0 0 0
13 8 2
n
v
n
v
£\
n
23
75
17
3
18 5 3 2
23
11
34 2 1
2
Table XI. Fate of IUCD in pregnancy
? Still in utero Expelled before conception Expelled during or before pregnancy Expelled during pregnancy Expelled or removed at termination of pregnancy Removed during pregnancy Removed after pregnancy In utero after pregnancy Ex utero after pregnancy Unknown Total
0 2 0 2 1
0 0 0
0
2
1
9 4
4 2 0 0
1 0 0 0
4
12
5
1
4
0 0
Steel
2
v
ring
v
4
Total
2
11
18 37
4
".
136
72
Hall
Am .
i~ l" 0
2
I
4
6
.J.
.J;uniJ.I\'
L lYht,
Ob:-:t. &
Gyo ~c .
i!iiii!i!jjjjjji!\ 8 10 12 14 16 18 20 22 24
20 10
20 10
:~L 20
10
0
0
2
4
6
8
~~~~~~~
10 12 14 16 18 20 22 24
Number of Months
Fig. 4. Cumulative incidences of pregnancies following first insertions.
6, the incidence of relevant removals and expulsions after reinsertions is considerably higher than after first insertions. The cumulative 12 month relevant removal rate increased from 26.8 per cent to 35.1 per cent for coil 5, from B.7 per cent to 10.0 per cent for loop 2, and from 8.0 per cent to 17.7 per cent for bow 3; after 9 months the increase was from 4.4 per cent to 10.1 per cent for bow 5. The 12 month expulsion rate increased from 21.4 per cent to 35.2 per cent for coil 5, from 9.1 per cent to 11.2 per cent for loop 2, and from 4.0 per cent to 9.6 per cent for bow 3; after 9 months, from 1.5 per cent to zero for bow 5. Changes in the pregnancy rates after reinsertion were less consistent. Twelve months after insertion and reinsertion, respectively, the pregnancy rates were 3.4 per cent and 6.3 per cent with coil 5, 3.2 per cent and 0. 7 per cent with loop 2, and 12.4 per cent and 11.9 per cent with bow 3; after 9 months with bow 5 they were 4.5 per cent and 2.5 per cent. The total cumulative rates for relevant removals, expulsions, and pregnancies after
reinsertions were: coil 5, 76.6 per cent at 12 months, 98.2 per cent at 24 months; loop 2, 21.9 per cent at 12 months, 30.8 per cent at 20 months; bow 3, 39.2 per cent at 12 months, 39.2 per cent at 18 months; and bow 5, 12.6 per cent at 9 months.
Technical facility Although impossible to measure quantitatively, the technical facility involved in inserting and removing the IUCD's is almost as important as their effectiveness. The variability encountered in this regard is presented in Table XIII. The difficulty in inserting bmv 5 and the steel ring is due to their greater diameter ; dilatation of the cervix is almost invariably required in the insertion of these two devices even when the insertion is done 6 weeks post partum. Insertion of the other IUCD's is easier and less painful, rarely requiring cervical dilatation. Removal of the tailed devices is extremely simple, rapid, and pain-free; removal of the bows and the steel ring is sometimes extremely difficult and traumatic.
Evaluation of intrauterine contraceptive devices 73
Volume 94
Number 1
0
Removots
Rtlti/Onl
0- E•puls•ons
• - Prttqnanc•t\,
'I,
I
I I I
I
18 20 22 24
& ~0
<
:o j 20
~-
~
o -1hA
0 2 Po•,ents ?J1
a
6
:: ""'
l
r---------~
o:.,~
8
10 12 14 16
I
I
i j
8 20 22 24
20 0
Pott#nls 560 60
50 40
30 20 I0
~if!ijiiiii-~~'7"""':::;::-=-:;:: 0
z
4
6
8
10 12 14 16 18 20 22 24
Poll•nls J25
Fig. 5. Cumulative incidences of relevant removals, expulsions, and pregnancies following first insertions.
Table XII. Reinsertions First reinsertions Expulsion of first IUCD followed by reinsertion Expulsion of first IUCD followed by no reinsertion Nonelective removal of first IUCD followed by reinsertion Nonelective removal of first IUCD followed by no reinsertion Elective removal of first IUCD followed by reinsertion Elective removal of first IUCD followed by no reinsertion Pregnancy with first IUCD followed by reinsertion Subsequent reinsertions 45 Patients with 2 reinsertions 10 Patients with 3 reinsertions 1 Patient with 4 reinsertions Total reinsertions
56 233 4
143 (73%)
72 (23%) 285 8 45
20
3
576
J, l~HJf) & Gynec.
.faJJllary
74 Hall
Am.
0-Relevonl Removals
0- Expuls1ons
J.
Ob~t.
• - PreQnonctes
"1. 100
90
eo 70 60 50 40
30
~r·-----
~~~ I I o
2
li
4
6
e
10 12
Pal!ents /6
50~
40
:: "·x·=~HN#;j~ 0
o
• 2
4
6
e
10 12 14
I • 16 1e 20 22 24
Pottents 172 50 40
30 20 / 10 0
Palilnfs 74
~:~ o
2
4
6
e
10 12 14 16 1e 20 22 24
Poli#nls 83 Number of Months
Fig. 6. Cumulative incidences of relevant removals, expulsions, and pregnancies following reinsertions.
Serious complications The serious complications encountered in this series are listed in Table XIV. The above-mentioned difficulties in insertion and removal v;ere due to or responsible for 19 of these 24 complications ( 17 with the bows, 2 with the steel rings). In 4 instances, the terminal bead of a coil became imbedded beneath the cervical or vaginal mucosa (Fig. 7), necessitating local excision. Fragmentation of a bow during attempt at removal occurred 4 times (Fig. 8) ; the remaining fragment was left in situ on 2 occasions and removed at dilatation and curettage on 2 occasions. In addition to 7 bows which became im-
Table XIII. Technical facility Coil 5 Loop 1 Loop 2 Bow 3 Bow 5 Steel rtng Nylon ring
Insertion
Removal
Easy Easy Easy Easy Difficult Difficult Easy
Easy Easy Easy Difficult Difficult Difficult Easy
bedded in the myometrium, 5 bows and one loop were found free in the peritoneal cavity (Fig. 9). The incidence of known perforations in this series is 0 among 363 coil insertions, 1 among 969 loops, and 5 among 1,041 (or 1 per 208) bows. It is
Volume 94 Number 1
Evaluation of intrauterine contraceptive devices
75
Fig. 7. At yearly checkup, the coil's terminal bead was found to be imbedded beneath the vaginal mucosa. Attempt at removal resulted in avulsion of the terminal bead, which v;as subsequently excised.
Table XIV. Serious complications Coil Terminal bead imbedded in cervix or vagina IUCD imbedded in uterus IUCD ex utero IUCD fragmented during attempt at removal Uterus perforated during attempt at removal Hemorrhage from cervix after insertion Total
sl Loop 21
Bow 3
Bow
s
I
Steel rinf{
Total 4
24
0
0
0 0 0 0
0 0 1 0 0 0
2
3 1 0
3
0 0
0 0 0 0 1 1
4
1
11
6
2
4 0
believed that all of t..~ese perforations occurred at the time of insertion and that the preponderance of bow perforations is due to the greater rigidity of its inserter. Comment
The IUCD is a relatively new and controversial means of birth control. Only in the past few years has it become commercially available. Many physicians and laymen remain skeptical about it. Its mechanism of action remains unestablished.
5
2 1
7
6
4 2 1
It is incumbent upon those v1ho are interested in promoting the IUCD to abandon the inferior devices and to seek further improvements in the use and design of the superior devices. To do otherwise will surely jeopardize the entire IUCD progrd.J.-n. Evidence from this series, as well as from the Cooperative Statistical Program for the evaluation of IUCD's 2 (Table XV), thus far suggests that the loop is clearly superior to the coil, the bow, and the stainless steel ring. Although effective as a contraceptive,
76
.Ja '" '~'Y
Holl
:\rn.
I. 196h
J. Oh>t . & Gynec.
Fig. 8. Fragmentation of this bow 3 occurred during an attempt at removal. The removal was later completed without anesthesia.
Fig. 9. Conception occurred immediately after insertion of this bow 3. This hysterogram, taken ~j months after delivery, shows why.
Table XV. Cooperative statistical program 2
technical difficulties have already been encountered and both the pregnancy and expulsion rates reported from the Cooperative Statistical Program are rather high. Studies of other IUCD's, such as the nylon ring of Jaime Zipper and the plastic ring of The Johns Hopkins Hospital are in progress. The rates of side effects, expulsions, pregnancies, and technical difficulties with the loop all are within acceptable limits. It is to be hoped, however, that the 25 per cent loss through removal, expulsion, and pregnancy during the first 12 months after first insertions (even though roughly comparable to the first-year abandonment of oral contraceptives) can be further lessened through improvements in the loop itself or improvements in the design of still other devices.
( 11,222 first insertions) Cumulative incidences at 12 months Steel
Coil5 Total removals Expulsions Pregnancies
25.7% 21.8 1.8
ILoop 2 IBow 5* I rinR 15.6% 9.3 2.4
11.1% 1.1
5. 7
10.2% 15.8 7.5
*Rates calculated by extrapolation from 6 month data.
the coil is associated with an unacceptably high rate of side effects and expulsions. Although rarely expelled and seldom responsible for side effects, the bows are associated with an unacceptably high pregnancy rate as well as technical difficulties in insertion and removal. Although data on the stainless steel ring are as yet inconclusive from this series,
Volume 94 Number 1
Summary
1. Two years' experience with 2,906 insertions of seven different types of IUCD are reported from the Sloane Hospital for 'llon1en. 2. The incidence of side effects and expulsions was found to be unacceptably high with coil 5.
Evaluation of intrauterine contraceptive devices
77
3. The incidence of pregnancies and technical difficulties was found to be unacceptably high with bow 3 and bow 5. 4. Evidence thus far available suggests that loop 2 is superior to the other IUCD's tested.
REFERENCES
1. Hall, R. E.: Bull. Sloane Hosp. Women 10: 65, 1964. 2. Tietze, C.: Cooperative Statistical Program for the Evaluation of Intrauterine Contraceptive Devices, Fifth Progress Report. Na-
tiona! Committee on Maternal Health, New York, February, 1965.
622 West !68th Street New York, New York 10032