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Report on the use of the Dalkon Shield intrauterine device
REPORT ON THE USE OF THE DALKON SHIELD INTRAUTERINE DEVICE
E. Sadovsky, M.D. S. Yarkoni, M.D. S.O. Anteby, M.D.
Department of Obstetrics and Gynecology, Hadassah University Hospital, Jerusalem, Israel
ABSTRACT
The Dalkon Shield intrauterine device was inserted in 274 women comprising 3738 months of use. Thirteen pregnancies and four expulsions occurred, In 44 instances, the Shield was removed for medical reasons (side effects). The net cumulative termination rates for 12 months after insertion (life table method) are: for pregnancies and expulsions 4.5% and 1.5%, respectively; medical removal rate, 13.9%. No perforations and no tubal pregnancies occurred.
Accepted for publicationSeptember 26, 1974
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
INTRODUCTION The intrauterine devices presently available are far from ideal because of significant pregnancy, expulsion and removal rates. Constant improvements have been noted leading to the development of modern intrauterine devices of superior performance, the purpose of which is to lower the rate of pregnancy, expulsion and removal. In a previous clinical report of our experience with the Lippes Loop intrauterine device (l), it was found that the pregnancy rate was 8.9% and the continuation rate was only 58.3%. Recent experience with the Dalkon Shield (2,3), which covers a greater surface area of endometrium, appears to approach the ideal of combining a very low pregnancy rate, l.l/hwy (2) and 1.06% (3), with minimal side effects. The contour of the Shield conforms to mid-range of the uterine cavity, with small lateral fins promoting retention, and therefore the expulsion rate is expected to be low. The above results and characteristics justified the trial of this IUD in our out-patient clinic. The aim of this study is to report our experience with the Dalkon Shield IUD.
MATERIAL AND METHODS The Dalkon Shield IUD was inserted in 325,women in the outpatient clinic of Hadassah University Hospital, Jerusalem, from April 1971 until July 1973 (27 months). The study group comprises 274 women, 3738 women months of use. Fifty-one women were lost to follow-up. The duration of use varied from 1 to 27 months. The IUD was inserted by the Senior and Junior staff of the clinic. After insertion of the IUD, the women were examined in a month, 6, 12 and 24 months.
age.
476
Table I shows the distribution of the study group according to Most of the women were between 26-30 years old.
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
Table I.
Distribution of study group according to age.
Age in years
No. of women
Percent
1
< 20
0.4
21
-
25
43
15.7
26
-
30
113
41.2
31
-
35
57
20.8
36
-
40
42
15.3
>
41
18
6.6
274
100%
Total
The majority of the women had 1 - 4 deliveries. 13 nulliparous women (Table II). Table II.
There were only
Distribution of study group according to parity before the insertion No. of women
Parity
Percent
0
13
4.7
1
54
19.7
2
95
34.7
3
51
18.6
4
28
10.2
5 or more
33
12.1
274
100%
Total
The indications for treating the majority of patients were socioeconomic conditions (91.6%) although a few had medical diseases. Before the insertion of the IUD, a medical history was taken and gynecological examination performed. The majority of women had normal pelvic examination (82.9%) although a few had an enlarged uterus, lacerated cervix and cervical erosion. Cases suffering from menometrorrhagia, salpingitis, or vaginal discharge were excluded from the study or deferred until after cure. Two-hundred-sixty-two women were fitted with the standard Dalkon Shield and 12 with the small one.
NOVEMBER
1974
VOL. 10 NO. 5
477
CONTRACEPTION
The majority of the women were fitted with the IUD immediately after the first, second or third menstruation following delivery or abortion. Only five cases were fitted with the IUD during the first month after delivery or abortion. Seventy-five women were fitted with the IUD more than six months after delivery or abortion. The insertion was performed on the last day of the menstruation or a few days afterward. In Table III the distribution of duration of use in months is shown. Altogether there were 3738 women months of use. Table III.Distribution of duration of use. Months of use
No. of women
Percent
Women-months of use
1 -3
13
4.7
23
4-6
24
8.8
126
7-9
18
6.6
146
10 -12
84
30.7
932
13 -15
47
17.2
652
16 -18
7
2.5
120
19 -21
55
20.1
1082
22 -24
7
2.5
165
25 -27
19
6.9
492
Total
274
100%
3738
Forty-eight women of the group had used another IUD in the past. The net cumulative rates, life table method (4), were calculated for 21 months. RESULTS The study demonstrates that 197 women continued over the whole period. For the computation of termination and continuation rates, only a period of 12 months was taken into account. Table IV shows the net cumulative rates, for 12 months, computed from the life table. The continuation rate was 77.1% and the discontinuation rate 22.9%. Pregnancies; Thirteen pregnancies occurred with the device in situ. The net cumu atlve rate for 12 months was 4.5%. Of these 13 womz,five aborted spontaneously during 2-4 months of pregnancy. No pregnancy occurred following unnoticed expulsion. The pregnancies occurred 1-12 months after the insertion. No infection was noted in pregnancy associated with the ShieldIUD. Expulsions: Expulsion occurred in four patients. The net cumulative rate for 12 months was 1.5%. 478
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
Table IV. Net cumulative termination rates and continuation rate with their 95% confidence limits (12 months).
Number
Percent
95% Confidence limits
Continuation
148
77.1
72.0 - 82.2
Total Discontinuation
61
22.9
17.8 - 28.0
Pregnancy
12
4.5
Medical removal
37
13.9
Expulsion
4
1.5
0.4 -
3.9
Planned pregnancy
8
2.9
1.3 -
5.8
2.0 -
7.1
9.6 - 18.1
Removals: During a period of 27 months, the Shield IUD was removed from 60 women (Table V); 44 for medical reasons: 33.3% because of bleeding, 11.7% because of pains, 25% because of bleeding and pains and 3.3% because of infection. In a few cases there was some difficulty with the removal of the device, but only in one case was the hook used.
Table V.
Causes for removal of the IUD No. of women
Causes
Percent
20
33.3
7
11.7
15
25.0
2
3.3
Desire pregnancy
16
26.7
Total
60
Bleeding Pains Bleeding + pains Infection
There were no perforations or tubal pregnancies. fainted due to vaso-vagal reflex during IUD insertion.
NOVEMBER
1974
VOL.
10 NO. 5
100% Only one woman
479
CONTRACEPTION
DISCUSSION Our results with the Dalkon Shield IUD show a higher rate of pregnancy and removal than had been shown by others (2,3). The expulsion rate was found to be very low in our series as had been expected by virtue of the shape of the Shield with the lateral fins. The claim that surface area of endometrium in contact with this device results in very low pregnancy rate was not proven by our series. In our opinion, the most important factor in minimizing the removal rate due to side effects of the IUD is the proper selection of the cases not only by the history and bimanual examination but also according to the personality of the women. ACKNOWLEDGMENT We wish to express our gratitude to the nurses of the Gynecological Clinic who aided in this project.
REFERENCES 1.
Schenker, J.G., Sadovsky, E. and Adoni, A. Factors affecting failure of intra-uterine devices. Harefuah 75:409-412 (1968).
2.
Davis, H.J. The Shield intra-uterine device. Gynec. 106: 455-456 (1970).
3.
Ostergard, D.R. and Broen, E.M. The Dalkon Shield: Evaluation. Contraception 4:313-317 (1971).
4.
Tietze C. and Lewit S. Recommended procedures for the statistical evaluation of intra-uterine contraception. Studies in family planning. The Population Council 4:35 (1973).
480
NOVEMBER
Am. J. Obstet.
1974
A Clinical
VOL. 10 NO. 5
E. Sadovsky, M.D. S. Yarkoni, M.D. S.O. Anteby, M.D.
Department of Obstetrics and Gynecology, Hadassah University Hospital, Jerusalem, Israel
ABSTRACT
The Dalkon Shield intrauterine device was inserted in 274 women comprising 3738 months of use. Thirteen pregnancies and four expulsions occurred, In 44 instances, the Shield was removed for medical reasons (side effects). The net cumulative termination rates for 12 months after insertion (life table method) are: for pregnancies and expulsions 4.5% and 1.5%, respectively; medical removal rate, 13.9%. No perforations and no tubal pregnancies occurred.
Accepted for publicationSeptember 26, 1974
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
INTRODUCTION The intrauterine devices presently available are far from ideal because of significant pregnancy, expulsion and removal rates. Constant improvements have been noted leading to the development of modern intrauterine devices of superior performance, the purpose of which is to lower the rate of pregnancy, expulsion and removal. In a previous clinical report of our experience with the Lippes Loop intrauterine device (l), it was found that the pregnancy rate was 8.9% and the continuation rate was only 58.3%. Recent experience with the Dalkon Shield (2,3), which covers a greater surface area of endometrium, appears to approach the ideal of combining a very low pregnancy rate, l.l/hwy (2) and 1.06% (3), with minimal side effects. The contour of the Shield conforms to mid-range of the uterine cavity, with small lateral fins promoting retention, and therefore the expulsion rate is expected to be low. The above results and characteristics justified the trial of this IUD in our out-patient clinic. The aim of this study is to report our experience with the Dalkon Shield IUD.
MATERIAL AND METHODS The Dalkon Shield IUD was inserted in 325,women in the outpatient clinic of Hadassah University Hospital, Jerusalem, from April 1971 until July 1973 (27 months). The study group comprises 274 women, 3738 women months of use. Fifty-one women were lost to follow-up. The duration of use varied from 1 to 27 months. The IUD was inserted by the Senior and Junior staff of the clinic. After insertion of the IUD, the women were examined in a month, 6, 12 and 24 months.
age.
476
Table I shows the distribution of the study group according to Most of the women were between 26-30 years old.
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
Table I.
Distribution of study group according to age.
Age in years
No. of women
Percent
1
< 20
0.4
21
-
25
43
15.7
26
-
30
113
41.2
31
-
35
57
20.8
36
-
40
42
15.3
>
41
18
6.6
274
100%
Total
The majority of the women had 1 - 4 deliveries. 13 nulliparous women (Table II). Table II.
There were only
Distribution of study group according to parity before the insertion No. of women
Parity
Percent
0
13
4.7
1
54
19.7
2
95
34.7
3
51
18.6
4
28
10.2
5 or more
33
12.1
274
100%
Total
The indications for treating the majority of patients were socioeconomic conditions (91.6%) although a few had medical diseases. Before the insertion of the IUD, a medical history was taken and gynecological examination performed. The majority of women had normal pelvic examination (82.9%) although a few had an enlarged uterus, lacerated cervix and cervical erosion. Cases suffering from menometrorrhagia, salpingitis, or vaginal discharge were excluded from the study or deferred until after cure. Two-hundred-sixty-two women were fitted with the standard Dalkon Shield and 12 with the small one.
NOVEMBER
1974
VOL. 10 NO. 5
477
CONTRACEPTION
The majority of the women were fitted with the IUD immediately after the first, second or third menstruation following delivery or abortion. Only five cases were fitted with the IUD during the first month after delivery or abortion. Seventy-five women were fitted with the IUD more than six months after delivery or abortion. The insertion was performed on the last day of the menstruation or a few days afterward. In Table III the distribution of duration of use in months is shown. Altogether there were 3738 women months of use. Table III.Distribution of duration of use. Months of use
No. of women
Percent
Women-months of use
1 -3
13
4.7
23
4-6
24
8.8
126
7-9
18
6.6
146
10 -12
84
30.7
932
13 -15
47
17.2
652
16 -18
7
2.5
120
19 -21
55
20.1
1082
22 -24
7
2.5
165
25 -27
19
6.9
492
Total
274
100%
3738
Forty-eight women of the group had used another IUD in the past. The net cumulative rates, life table method (4), were calculated for 21 months. RESULTS The study demonstrates that 197 women continued over the whole period. For the computation of termination and continuation rates, only a period of 12 months was taken into account. Table IV shows the net cumulative rates, for 12 months, computed from the life table. The continuation rate was 77.1% and the discontinuation rate 22.9%. Pregnancies; Thirteen pregnancies occurred with the device in situ. The net cumu atlve rate for 12 months was 4.5%. Of these 13 womz,five aborted spontaneously during 2-4 months of pregnancy. No pregnancy occurred following unnoticed expulsion. The pregnancies occurred 1-12 months after the insertion. No infection was noted in pregnancy associated with the ShieldIUD. Expulsions: Expulsion occurred in four patients. The net cumulative rate for 12 months was 1.5%. 478
NOVEMBER
1974
VOL. 10 NO. 5
CONTRACEPTION
Table IV. Net cumulative termination rates and continuation rate with their 95% confidence limits (12 months).
Number
Percent
95% Confidence limits
Continuation
148
77.1
72.0 - 82.2
Total Discontinuation
61
22.9
17.8 - 28.0
Pregnancy
12
4.5
Medical removal
37
13.9
Expulsion
4
1.5
0.4 -
3.9
Planned pregnancy
8
2.9
1.3 -
5.8
2.0 -
7.1
9.6 - 18.1
Removals: During a period of 27 months, the Shield IUD was removed from 60 women (Table V); 44 for medical reasons: 33.3% because of bleeding, 11.7% because of pains, 25% because of bleeding and pains and 3.3% because of infection. In a few cases there was some difficulty with the removal of the device, but only in one case was the hook used.
Table V.
Causes for removal of the IUD No. of women
Causes
Percent
20
33.3
7
11.7
15
25.0
2
3.3
Desire pregnancy
16
26.7
Total
60
Bleeding Pains Bleeding + pains Infection
There were no perforations or tubal pregnancies. fainted due to vaso-vagal reflex during IUD insertion.
NOVEMBER
1974
VOL.
10 NO. 5
100% Only one woman
479
CONTRACEPTION
DISCUSSION Our results with the Dalkon Shield IUD show a higher rate of pregnancy and removal than had been shown by others (2,3). The expulsion rate was found to be very low in our series as had been expected by virtue of the shape of the Shield with the lateral fins. The claim that surface area of endometrium in contact with this device results in very low pregnancy rate was not proven by our series. In our opinion, the most important factor in minimizing the removal rate due to side effects of the IUD is the proper selection of the cases not only by the history and bimanual examination but also according to the personality of the women. ACKNOWLEDGMENT We wish to express our gratitude to the nurses of the Gynecological Clinic who aided in this project.
REFERENCES 1.
Schenker, J.G., Sadovsky, E. and Adoni, A. Factors affecting failure of intra-uterine devices. Harefuah 75:409-412 (1968).
2.
Davis, H.J. The Shield intra-uterine device. Gynec. 106: 455-456 (1970).
3.
Ostergard, D.R. and Broen, E.M. The Dalkon Shield: Evaluation. Contraception 4:313-317 (1971).
4.
Tietze C. and Lewit S. Recommended procedures for the statistical evaluation of intra-uterine contraception. Studies in family planning. The Population Council 4:35 (1973).
480
NOVEMBER
Am. J. Obstet.
1974
A Clinical
VOL. 10 NO. 5