Effectiveness of the Majzlin spring intrauterine contraceptive device

Effectiveness of the Majzlin spring intrauterine contraceptive device

Effectiveness of the Majzlin spring intrauterine GEORGE I. contraceptive SOLISH, SCHUYLER G. GREGORY MAJZLIN, Brooklyn, New M.D., KOHL, M...

1MB Sizes 0 Downloads 29 Views

Effectiveness of the Majzlin spring intrauterine GEORGE

I.

contraceptive

SOLISH,

SCHUYLER

G.

GREGORY

MAJZLIN,

Brooklyn,

New

M.D.,

KOHL,

M.D.,

device

PH.D.,

F.A.C.O.G.

F.A.C.O.G.

M.D.?

York

Since March 1967, 3,687 first insertions of the Majzlin spring were performed at the State University of Mew York Downstate Medical Center Family Planning Clinic. Seven different forms of this device, with different degrees of jlexibility, made of wire gauges varying from 0.010 to 0.020 inches in diameter, were used, The 14T device made of a metal core measuring 0.014 inches in diameter with a tail string tied to one limb of the spring was found to be the most sficient. The accidental pregnancy rate was 2.0; spontaneous expulsion rate, 3.8; and the need for medical removal, 7.5 per 100 woman-months of use. At the end of the study period, nearly 86 per cent of the women were still active users. The nurse-midwife training Program of the Family Planning Clinic at the Downstate Medical Center has had an important positive effect on the success of the Majzlin spring program as well as other aspects of family planning at this medical center.

THE

INTRAUTERINE contraceptive device (IUD) as a means for fertility control stands in great danger of again falling into “medical disrepute” as it did in the 1920’s after a brief period of prominence. If this should happen, it may well again be due to “poor design and careless insertions,” reasons suggested by Sobrerol as causes for earlier failures of the IUD. Indeed, it would be an unfortunate loss of an already established contraceptive method proved to be

effective, safe, and practical with special advantages over other methods.2 At the Downstate Medical Center Family Planning Clinic, two approaches have been adopted to improve the effectiveness and acceptability of the Majzlin spring IUD. The first is directed toward modifying the design of the metal spring currently in use, and the second approach involves the training of nurse-midwives in family planincluding the proper ning techniques, method of insertion, removal, and followup treatment of IUD users.

From the Department of Obstetrics and Gynecology, State University of New York, Downstate Medical Center. Supperted in part Grant M70.0129C.

by Population

y;;;ived

for gublication

August

f;;;pted

for publication

February

Modifications of the Majzlin spring design The Majzlin spring has been used successfully and continuously at the Family Planning Clinic of the Downstate Medical Center since March, 1967.2-4 However, the need for modification of its original design to eliminate some of the undesired effects, such as pain and bleeding, was recognized early, and attempts were made to eliminate these medical indications for removal. However,

Council 1 I, 19,

Reprint requests: Dr. George I. Solish, Dept. of Ob./Gyn., State University of Mew York, Downstate Medical Center, ;zo$larkson Ave., Brooklyn, New York TDeceased

September

10, 1971.

106

Volume Number

114 1

Majzlin

Table I. Effects of changing event

and closure

the gauge rates per 100 women

of the Majzlin spring IUD: to the end of the first year Spring

20 Events Accidental pregnancies First expulsions Later expulsions Removal for medical Removal for planned Removal for personal

(

18

gauge 1

16

14

IUD

107

net cumulative

(thousandths 1

spring

of an

1

14T

inch) 1

12

)

10

reasons pregnancy reasons

0.0 5.26 0.0 26.32 0.0 10.53

1.48 2.15 0.09 12.22 0.96 2.83

0.89 2.66 0.0 la.93 0.44 1.52

3.35 9.09 0.46 a.81 1.37 1.71

2.00 7.69 0.65 7.45 0.0 1.03

0.0 15.38 0.0 38.68 0.0 0.0

17.57 26.54 0.0 9.85 0.0 0.0

Closures Accidental pregnancies First expulsions Later expulsions Removal for medical reasons pregnancy Removal for planned Removal for personal reasons

0.0 5.26 0.0 26.32 0.0 10.53

1.48 1.26 0.09 11.93 0.96 2.74

0.89 1.78 0.0 la.93 0.44 1.52

3.35 7.96 0.46 8.81 1.37 1.71

2.00 3.82 0.40 7.45 0.0 0.79

0.0 15.38 0.0 38.68 0.0 0.0

17.57 26.54 0.0 7.89 0.0 0.0

Active users No. of women Woman-months

57.89 19 301

al.54 2,273 37,828

76.45 232 2,133

76.33 450 3,431

85.54 783 2,645

45.93 13 96

48.00 52 371

of use

modification in design is difficult without sacrificing the special advantages of this device over other IUD’s, i.e., low expulsion rate, low pregnancy rate, and ease and safety of insertion. Furthermore, difficulty in removal of the Majzlin spring, not a problem in this clinic but frequently reported by others,5, 6 influenced adversely, more than any other factor, its acceptability by other clinics. The tension of the spring action, obviously important in decreasing the spontaneous expulsion rate, was thought to be the basis for the bleeding and pain, requiring removal in 10 to 15 per cent of patients. Difficult removal was also attributed to spring tension. To overcome these difficulties, the spring tension was reduced by decreasing the diameter of the metal. Results Table I shows the effects of varying the diameter of the metal core of the Majzlin spring IUD. The data show that as the wire gauge was decreased and spring tension diminished the pregnancy rates and expulsion rates increased but removal for medical indications decreased. Decreasing spring gauge beyond 0.014 inches seemed to pro-

duce no further improvement. However, the number of insertions and the woman-months of use of the 12 and 10 gauge springs were insufficient to make statistical comparisons. The length of time each device was used in this study is recorded in Table II. Changing the method of attaching the tail strings to the spring also had an effect on pregnancy, expulsion, and medical removal rates. The model currently in use at the Downstate Medical Center, designated as the “14T,” has its tail strings tied to one member of the spring as shown in Fig. 1. This eliminates the question of the Majzlin spring as an open or closed device. This tie attachment (Fig. 1) makes the Majzlin spring an open device. The over-all shape and dimensions of all 7 forms of the spring, listed in Table I, are approximately the same in the unloaded position. However, the number of coils varies inversely with the thickness of the metal, in order to conform to a predetermined size. The predetermined size is based on reported measurements by Davis and Israel.? With the two smaller gauge devices, 10 and 12, the decreased spring tension predisposed to overlapping and snagging of the spring members so that some of these de-

108

Soiish,

Kohl,

and

September J. Obstet.

Majzlin Am.

Table II. Months Medical Spring

of use of the different

types of Majzlin

springs

1, I972 Gynecol.

at the Downstate

Center gauge

(thousandths of an inch) 20 18 16 14 14T 12

10

Period

of use

(month/year) 3/67-lo/70 4/67-12/70

Months studied

l/70-12/70 6/70-12/70 l/70-12/70

44 45 26 12 7 12

10/69-12/70

15

11/68-12/70

TotaI

vices did not open fully after insertion into the uterus. This tended to increase the expulsion rate and may have accounted for some of the other side effects. Ease of removal increased as spontaneous expulsion rate increased and spring tension decreased. The criterion for determining difficulty of removal was the need for using a “retriever” special instrument.4 Usually, grasping the tail strings with a surgical needle holder is all that is needed to draw the spring members together as the device is removed. In the more difficult cases, a sterile retriever is gently inserted through the cervix, grasping one of the coils of the spring, and, with simultaneous traction on both the needle holder and the retriever, the device is readily removed (Fig. 2 ) . Most effective of the 7 devices tested is the 14T. This model has an accidental pregnancy rate of 2.0 per 100 woman-months of use, a slightly increased expulsion rate of 3.8, but the lowest rate of removal for medical reasons, 7.5. In addition, the removal of the 14T is as easy, if not easier, than any other IUD used in this clinic. Nurse-midwife training program in family planning It is becoming increasingly apparent that design alone is not the sole determining factor in the success or failure of an IUD. Physician attitude, experience, and technical ability, as well as proper preparation and instruction of the patient, may be as important as the type of device used. The

No. of first insertions

19 2,178 229 444 753 13 51 3,687

Woman-months Reinsertions

0 95 3 6 30

0 1

135

of

use

301 37,828 2,133 3,431 2,645

96 371 46,805

effect of the nurse-midwife training program in Family Planning at the Downstate Medical Center illustrates this point. The inception of the Majzlin spring program in the Family Planning Clinic of the Kings County-Downstate Medical Center coincided approximately with the beginning of a training program for nurse-midwives in family planning at this institution. As a consequence, nurse-midwives have been trained in all family planning techniques including the insertion and removal of IUD’s. Since 1966, a training program in family planning for foreign nurse-midwives, sponsored successively by the Population Council, the Rockefeller Foundation, the Ford Foundation, and United States State Department Agency for International Development, has had a profound effect on the delivery of family planning services at this Medical Center. During this period, a total of 139 nursemidwife trainees from 29 different countries have returned to their native lands after a 12 week training program in family planning techniques at the Downstate Medical Center. These women and their nurse-midwife instructors were responsible for the insertion of almost 90 per cent of the 3,687 Majzlin springs inserted as well as the majority of approximately one thousand removals between 1967 and 1970. At the end of the training period, each nurse-midwife had inserted an average of 25 IUD’s of different types and learned how to remove them, in addition to prescribing other methods of

Volume Number

Majzlin

114 1

Fig. 1. The Majzlin birth control. Although other IUD’s are available in this clinic, the Majzlin spring is preferred by the nurse-midwives, because of the ease and safety of insertion and the relative paucity of side effects. It is a tribute to these women and to their training that not a single perforation has occurred with any of the devices inserted during this period. Fig. 2 shows a nurse-midwife trainee removing a Majzlin spring. The nurse-midwife trainee program in family planning at the Downstate Medical Center is described elsewhere.8 The relationship that has developed between patient and nurse-midwife has helped immeasurably in the success of the IUD program. Patients feel free to discuss all aspects of their sexual problems and are counseled by a staff of experienced and sympathetic people. If problems arise in connection with the IUD, patients may telephone at any time or may come to the clinic and be seen and examined without appointment. Some of the effects of the midwife-patient relationship are reflected in the decrease in the number of IUD removals for “personal reasons,” such as fear of cancer, hus-

spring

IUD

109

spring.

band’s objections, hearsay adverse comments from friends, fear of the consequences of the presence of a foreign body in the uterus, and religious reasons. The nurse-midwife program has played no small part in the successful management of the 11,600 new patients seen from 1966 through 1970. TabIe III shows that approximately half of the new patients choose the IUD for their method of contraception. In most instances, the IUD used is the Majzlin spring. Comment The Majzlin spring has been shown to be an effective and safe method of contraception. However, its ease of insertion, decreased spontaneous expuIsion rate, and low accidental pregnancy rate were overshadowed by the difficulties some physicians encountered in its removal. The metal construction retained its shape and integrity, resisting tissue reactions after long periods of use, but the thought of a metallic foreign body inserted into the female genital area was repugnant to some physicians and to some patients. The present study confirms the importance of the spring action of the Maj-

110

Solish,

Kohl,

and Majzlin

Fig. 2. Nurse-midwife

Table III.

Downstate

removing

Medical

September 1, 1972 Am. J. Obstet. Gynecol.

a MajzIin

Center

spring.

Family

Note

method

Planning

Clinic

of holding

retriever

(arrow)

visits, 1966 through

1970

Year I966 1967 1968 1969 1970 Total

New

patients 3,629 2,788 1,416 1,619 2,148 17,000

New patients choosing IUD’s (No.) 1,510 1,287 645 749 1,073 5,264

zlin spring on its effectiveness as well as its implication in the causation of pain and bleeding. More effective designs may have to await further elucidation of the precise mechanism of action. Perhaps only when the essential characteristics necessary for contraception are known can the undesirable features responsible for side effects be eliminated. At this point, it is known that, to be effective, the IUD must remain in the uterine fundus and have a three-dimensional form which permits contact with the maximum endometrial surface. The device must collapse to a size small enough to be inserted without

New patients choosing IUD’s (96) 41.6 46.2 45.6 46.3 50.0

Revisits

Total

&its

8,486 10,769 8,971 9,309 10,056

12,115 13,599 10,387 10,928 12,204

47,591

59,193

dilatation of the cervix, be flexible enough to be removed easily when desired, and be firm enough to be retained against the normal expulsion forces of the uterus. Recent modifications in the design of IUD’s, designated by Tietze as “the second generation of IUD’s,” seem to have contributed less to use-effectiveness of the IUD than the increase in experience, improved techniques of insertion, and proper training of inserters. The success of the IUD program at Downstate Medical Center makes it apparent that factors other than the desi
Volume Number

114 1

clinics are further evidence for this. At the Downstate Medical Center Family Planning Clinic, the nurse-midwife program has had a profound beneficial effect on the useeffectiveness of the Majzlin spring, as well as other methods of contraception. For the future, efforts are in the direction

Majzlin

spring

of investigating the effects of terials used in construction Copper, iron, and other heavy been suggested.gp lo These have to be spermicidal and may also dal. Their toxicity, however, known.

IUD

111

various maof IUD’s. metals have been found be bactericiis still un-

REFERENCES

Sobrero, A. J.: FamiIy Planning Perspect. 3: 16, 1971. Solish, G. I., and Majzlin, G.: Obstet. Gynecol. 32: 116, 1968. Sol&h, G. I., and Majzlin, G.: In Sobrero, A. J., and Lewit, S., editors: Advances in Planned Parenthood, New York, 1969, vol. 4, Excerpta Medica Foundation, International Congress Series No. 177, p. 73. Solish, G. I., and Majzlin, G.: In Sobrero, A. J., and Lewit, S., editors: Advances in Planned Parenthood, New York, 1970, vol. 5, Excerpta Medica Foundation, International Congress Series No. 207, p. 117.

5. 6. 7.

8.

9. 10.

Tietze, C.: Contraception 1: 73, 1970. Sobrero, A. J., and Pierotti, D.: Obstet. Gynecol. 36: 911, 1970. Davis, H. J., and Israel, R.: Intrauterine Contraception, Amsterdam, 1964, Excerpta Medica Foundation, International Congress Series No. 86. Majzlin, G., and Kohl, S. G.: Advances in Planned Parenthood, New York, 1972, vol. 7, Excerpta Medica Foundation International Congress Series No. 246, p, 62. Loewit, K.: Contraception 3: 219, 1971. Chang, C. C., and Tatum, H. J.: Contraception 1: 265, 1970.