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1
GYNECOLOGY
A reappra isal of intrauterine
contraceptive
devices Prompted
by the
ROBERT Nm
York,
delayed
E. HALL. Nerv
discovery
of uterine
perforations
M.D.
York
Nineteen IUD
perforations are reported from the Sloane Hospital for Women, The perforation rate for first insertions of the Birnberg bow varied with the skill of the individual physician from I:13 to 1:?38. The perforation rate for first insertion< by two experienced physicians varied from I :I11 for the boul to I:738 for the other IUD’s. Of the 100 IUD perforations reported thus far in the English literature. only 13 have been attributed to the Lippes loop. Of the 7 cases of intestinal damage associated with II/D perforations, none her bpen cauted by n loop.
T H E evaluation of medical discoveries, from ether to Enovid, has generally progressed through a recognizable series of stages. At first there is boundless enthusiasm, based upon the discovery’s ability to do something good ; then proportionate horror, based upon its simultaneous tendency to do something evil ; and, eventually, acceptance or rejection based upon the preponderance of good or evil. The IUD has reached Stage 2. Adequate data have been amassed to show that the IUD does good. Evidence is now accumulating to show that the IUD may perforate thr uterine wall, and this is evil. The literature is replete with articles extolling the virtues From the Department Gynecology, Columbia College of Physicians Supported Population Nm York.
of 0bhtetric.r
of these devices, of which several have emanated from the Sloane Hospital for Women.‘-’ Now come the articles proclaiming the perils of perforation, of which this is one. History Esposito!’ reviewed the literature on IUD perforations through July, 1966. Includina case of his own, 62 such mishaps were allegedly reported. Thirty-three of these wcrr culled from Tietze’s Sixth Progress Report of the Cooperative Statistical Program to? tllr Eaaluation of Intrauterine Contraceptirw Ihicr.r”’ and, inadvertently, 18 of these 33 were also attributed by Esposito to theil original sources.‘ls I’, I” III addition to his own casr, then, Esposito found 43, not 61, in the literature. This discrepancy is of little importance, however, for he made no attempt to calculate the incidence of perforation from these figures and. of course. many per-
and
University, and Surgeons.
by a grant from The Council. New York.
808
Volmle Number
YY fi
forations have not been reported at all. At least 17 additional perforations have been reported since Esposito’s review.13-l” Esposito made the following incontrovertible points: (1) that uterine perforation occurs most frequently with the Birnberg bow, (2) t;hat partial perforations are more dangerous than complete perforations since the former present a fixed foreign object with which the bowel may become involved, (3) that bowel obstruction is most apt to occur with closed devices such as the bow, (4) that laparotomy should certainly be carried out when bow perforations are discovered and proba’bly when other IUD perforations are found. Rather than concluding that the entire problem of IUD perforations would be negligible if the Birnberg bow were abandoned, Esposito” recommended that “hysterogram be performed routinely after all insertions.” Tietze’” reported 43 perforations by 33 investigators who performed 27,507 total insertions in 22,403 women over a span of 2vZ years. For the Birnberg bow the perforation rate was one per 150 total insertions; for all other devices, one per 2,489. The perforation rate also varied significantly with the time of insertion: the sooner postpartum the insertion was performed, the higher the rate of perforation (ranging from 3.4 per cent at 5 weeks post partum to 0.2 per cent at 3 months). Ledger and Willson1-1 reported 5 loop perforations, or one per 400 insertions. Incicdence Between April 1, 1963, and Feb. 15, 1966, at Sloane Hospital, 3,988 IUD insertions were performed on 3,116 women in a separate clinic set up for this purpose (Table I) . Since Feb. 15, 1966, these original patients have been followed in this separate clinic but new IUD applicants have been referred to the regular postpartum clinic. Nineteen uterine perforations have been discovered in the original series. It is probable, for the following reasons that all or nearly all of the perforations in this series have already been detected:
Intrauterine
contraceptive
devices
Table I. First
809
insertions and reinsertions IUD’s at Sloane Hospital between April 1963, and Feb. 15, 1966
Coil 5 Loop 1 (A) Loop 2 (D) Loop 3 (C) Bow 3 Bow 5 Stainless steel ring Nylon ring Total
of 1,
34.7 51 873 517 563 324 277
16 9 264 157 76 82 207
363 60 1,137 674 639 406 484
164 3,116
61 872
225 3,988
1. Perforation is usually followed by pregnancy and the perforation discovered at the time of delivery or abortion. No new insertions having been performed during the past 18 months, most of these pregnancies, deliveries, abortions, and discoveries have already occurred. 2. The bow is recognized as the IUD most often associated with perforation. Seven hundred and sixty-six of the 1,045 bows inserted in this series have already been removed or expelled. 3. Although it would be virtually impossible to detect perforations caused by the radiolucent nylon rings, 189 or 84 per cent of the 225 nylon rings inserted in this series have already been removed o’r expelled. 4. X-rays have been taken in all cases when the terminal threads of a loop or the beads of a spiral have not been observed. 5. Only 11.3 per cent of the patients in this study have been lost to follow-up. Perforation vis-his type of IUD. Of the 19 IUD perforations found in this series, 16 were caused by bows, 2 by loops, and one by a stainless steel ring. This gives an uncorrected (v.i.) perforation rate of 16: 1,045 or 1:65 total bow insertions and 3: 2,943 or 1:981 total insertions of other types of IUD’s. Although the individual perforation rates in this series were 0: 363 for the coil, 2 : 1,871 or 1: 936 for the loop, and 1:484 for the steel ring, Tietze’s larger series sug-
810
November Am. J. Obst.
Hall
gests that these differences are statistically insignificant.l” Perforation vis-&is individual physician. As seen in Table II, most of the IUD insertions in this series were performed by the same two attending physicians, Drs. X and Y. During a one-month vacation by Dr. Y, however, his share of the insertions was handled by a third-year resident, Dr. Z., and occasional insertions by visiting physicians were performed under the supervision of Drs. X and Y. The data in Table II dramatically demonstrate the difference in perforation rates among these individual physicians. Excluding the perforations which followed insertions by resident Dr. Z, the “corrected” perforation rate for total insertions in this series would be 7: 932 or 1: 133 for the bow, which is similar to the 1: 150 reported by Tietze. The corrected rate for the other IUDs would be 3:2,928 or 1:976, compared to 9:22,397 or 1:2,489 reported by Tietze; but this can hardly represent a significant difference since the original numerators are so small. It is possible, of course, that the perforation rate at Sloane Hospital is higher because of (a) inferior technique, superior follow-up, or (c) both a (b) and b. Perforation vis&vis time of insertion. Almost all of the IUD insertions in this series were performed at the time of the patient’s postpartum checkup. Hence it is not surprising that all of the IUD perforations fol-
Table
II. First
insertion
perforation
A.rations perfo-BirF;;;;: Attending Attending Resident Others
X Y Z
Total Total excluding resident
Z’s
lowed insertions performed 5 to 7 weeks post partum. As can be seen from Table I, however, there were 872 reinsertions of IUD’s at a date more remote from pregnancy. It is noteworthy that no perforations occurred among these 872 reinsertions, even though 158 of them were bows. Since perforations occur almost exclusively with first insertions and since first insertions (rather than total insertions) accurately represent the number of patients involved, it would seem more meaningful to express IUD perforation rates in terms of first insertions. Thus calculated for this series, with the excusable omission of resident Dr. Z’s contribution to it, the perforation rate for the bow would be 7: 774 or 1: 111 first insertions or patients and for the other devices 3:2,214 or 1:738. There is, incidentally, no reason to suppose that these perforations occur at any time other than the moment of insertion or, in the case of tailless devices, during attempts at removal. Supportive evidence that they do usually occur at insertion includes the following: (a) Perforation occurs more frequently if the insertion is done by physicians inexperienced in IUD technique. (b) Perforation occurs more frequently in the soft, recently pregnant uterus. (c) Perforation occurs more frequently with a springed, inflexible inserter. (d) Perforation is sometimes discovered soon after insertion and, if not. pregnancy usually ensues promptly.
rates for individual
1 A,B
physicians
) A;i;;;t;;;;:
/ A,B
1 A,B
1 A;z;;!;i?;;:
1 6 9 0
338 415 113 21
1:338 1:69 1:13 0:21
1 2 0 0
875 1.268 15 71
1:875 1:635 0:15 0:71
2 8 9 0
16
887
1:55
3
2.229
1:743
774
1:lll
3
2,214
1:738
7
15, 1967 8i Gynec.
1;213 1,683 128 92
1:607 1:210 1:14 0:92
19
3,116
1: 164
10
2,988
1:299
Volume 99 Nwnbr,~ 6
Diagnosis
Signs and symptoms. None
of the 19 women with uterine perforation experienced any symptoms which could be directly attributed to the perforation. In 3 cases the IUD could be palpated in the cul-de-sac on rectovaginal examination. Pregnancies. Sixteen of the 19 women became pregnant, 7 within 3 months, 5 of them twice. Two of the perforations in the 3 women who did not conceive were discovered within a month after insertion of the device. The remaining perforation was discovered 11 months after insertion and soon after a traumatic attempt to remove the device elsewhere. This high rate of pregnancy is in part due to the fact that the first follow-up visit for patients in this series was scheduled for one year after insertion. X-rays. Anterior-posterior and/or lateral plane films of the pelvis were taken in 17 cases and indicative of perforation in only 4. More often than not these x-rays fostered a false sense of complacency by showing the IUD to be “in the vicinity of the uterus.” Hysterography. Hysterography in 8 cases consistently revealed the true state of affairs. In another case, the truth was learned through taking x-rays with a metallic probe in the uterine cavity, Uterine exploration. Fruitless probing of the uterus suggested ectopic IUD’s in 5 cases, one during curettage for an abortion. Although probing the uterus and not finding an ITJD cannot be regarded as conclusive evidence that the device is extrauterine, it does suggest that further investigation should be undertaken. The beolocator, designed to detect the presence of foreign bodies in the uteru:,, was not used in this series. If reliable, it would have obviated the need for x-rays in many cases. Manual exploration of the uterus immediately following vaginal delivery revealed the absence of the device in 8 cases. The opportunity for such exploration was missed in 3 cases early in the study, due to the house staff’s insufficient appreciation of the importance of this maneuver. And cesarean
Intrauterine
contraceptive
devices
811
sections were performed for obstetric reasons in 2 cases with recovery of the errant IUD in neither; in one, the resident surgeon forgot to look for the device and in the other a search was made but it was unsuccessful! The discovery of one intraperitoneal device was made at the autopsy of a 5-month pregnant woman who died of a ruptured cerebral arteriovenous malformation. Serendipity. Following vaginal delivery in one case in which postpartum uterine exploration had been omitted and pelvic x-ray was reported as showing “a stainless steel ring in the uterus,” bilateral tubal ligation was performed 24 hours later and the ring was unexpectedly found to be lodged between the uterus and the bladder. Management When the first perforations were noticed in this series the policy governing their management was laissez faire. It was felt that a free-floating bit of polyethylene was not apt to cause trouble. Several factors soon led to a reversal of this policy: (1) Some patients cannot psychologically cope with a freefloating bit of polyethylene. (2) Case reports eventually demonstrated that anchored,
Table III. extrauterine Laparotomy Laparotomy Colpotomy Laparotomy Laparotomy Laparotomy Autopsy
Operative IUD’s with alone alone with with with
bilateral
procedures
tubal
to remove
ligation
cholecystectomy resection of endometriomas resection of small bowel
Total
14
Table IV. Site of extrauterine Lying free in Embedded in Embedded in Lying between Embedded in Penetrated by Total
4 4 2 1 1 1 1
abdomen or pelvis omentum uterus bladder and cervix broad ligament small bowel
IUD’s 7 2 2 1 1 1 14
812
Nuvernbrr .Arn. J. Obrt.
Hall
partially extrauterine IUD’s can wreak intestinal havoc, Although individualization in the management of some of these cases continues a determined effort has been to prevail, made to remove extrauterine devices whenever possible, most especially those partly embedded in the uterine wall. In order to minimize patient apprehension over the perforation itself, these procedures have been carried out, whenever possible (a) via colpotomy, (b) at cesarean section, (c) with bilateral tubal ligation, or (d) in conjunction with other indicated surgery. To date, 14 of the 19 errant IUD’s have been extricated. The coincidental reasons for surgery are shown in Table III and the ultimate locations of the devices are listed in Table IV. The IUD is to be removed at the time of repeat cesarean section in 2 cases. One patient has refused surgery and 2 others have as yet failed to return to the clinic. Complications
Two incidents were encountered
of small bowel in this series:
pathology
Case No. 1627. July 30, 1964, a Bow 5 was inserted in a 31-year-old gravida vii, para vi patient, with no previous pertinent history. Sept. 27, 1966, there was premature birth of a living 2,310 gram infant delivered one month prematurely. No attempt was made to locate the IUD. On Dec. 8, 1966, a futile attempt was made to remove the bow from the uterine cavity. On Dec. 15, a hysterogram revealed the bow to be ex utero. The patient agreed to undergo tubal ligation and removal of the IUD in January, but she failed to return to the hospital. On April 18, 1967, the patient reported to the clinic with the signs and symptoms of intestinal obstruction. She was admitted to the hospital for hydration and decompression of the bowel with a Miller-Abbott tube. April 20, 1967, at laparotomy a knuckle of terminal ileum was found to be herniated through one of the triangles of the bow (see Fig. 1). The bowel was partially obstructed but viable. The bow was removed without bowel surgery and
Fig. 1. The knuckle of bowel held gloved hand has herniated through triangles of the bow.
the patient’s quested the
recovery insertion
in
was uneventful. of another IUD.
Case No. 712. Dec. 5, 1963:
15, 1967 & Gymr.
the lightone of the
She
re-
a Bow 3 was
inserted in a 25-year-old gravida ii, para i patient with no previous pertinent history. On May 2 1, 1964, the patient was thought to be clinically pregnant. Her last menstrual period was March 29, 1964, and her AZ test was positive. On June 3, 1964, spontaneous abortion was c?‘>.gnosed in the outpatient department.
On March telephone the family
reported
b)
that the bow had been removed doctor because she preferred to
12, 1965, the patient
bl use
a diaphragm. Dec. 18, 1965, she gave birth to a term living infant after an uneventful pregnancy. On Jan. 4, 1967, half of the terminal ileum was resected for volvulus. The bow. protruding into the peritoneal cavity from its bed in the uterine wall, was removed. No direct connection between the bow and the bowel could be demonstrated. The patient recovered from the operation without further complications. Comment
Intrauterine contraceptives have been used extensively in the past 5 years. Comparison of their relative merits has shown the Lippes loop to be superior to its steel and plastic counterparts.6g ” Recent reports of IUD perforations require that all of the IUD’s be reappraised.
Volume Number
99 6
Intrauterine
Table V. IUD medical
perforations
reported
in the
literature Total perforations
Espor;itoa* Tietzers+ Hall Ledger and DeHaanis Beaslevi”
Loop perforations
44 30 19 5 1 1
Willson’
Total
1 5 2 5 0 0
100
*Excluding Tietze.‘”
5 loop
tExc:luding herein.
1 loop
and
18 total
13
perforations
reported
by
contraceptive
devices
813
moval, and expulsion rates would indicate that the loop is the superior IUD.‘* I5 Despite the fact that the loop has been used more widely than the other IUD’sseveral hundred thousand loops having been inserted the world over-only 13 of the 100 IUD perforations thus far reported in the English literature (see Table V) have been attributed to loops. And of the 7 cases of intestinal damage associated with IUD perforations,“-‘” none has been caused by a loop.
and
13
total
perforations
reported
From the data now available it would appear that the bow should be abandoned both for its high rate of pregnancy and its high rate of perforation. Although the perforation rates may be similar for the loop, the coil, the steel ring, and the nylon ring, lower pregnancy, re-
The precise incidence of loop perforations is not yet known. Probably it varies with the time of insertion and the skill of the operator. It is of crucial importance to determine whether this rate is 1: 2,392 as reported by Tietze, 1:936 as reported here, or 1:400 as reported by Ledger and Willson. Ultimate judgment of the over-all value of intrauterine contraception must await the acquisition of this knowledge.
REFERENCES
1. Hall, R. E.: Bull. Sloane Hosp. 10: 65, 1964. 2. Hall, R. E.: In Sobrero, Aquiles J., and Lewit, Sarah, editors: Advances in Planned Parenthood, Cambridge, Massachusetts, 1965, Schenkman Publishing Co. 3. Hall, R. E.: Ob/Gyn Dig. 7: 76, 1965. 4. Hall, R. E.: Excerpta med. Internat. Congr. Ser. 86: 66, 1965. 5. Hall, R. E.: Bull. Sloane Hosp. 11: 107, 1965. 6. Hall, R. E.: AM. J. OBST. & GYNEC. 94: 65, 1966. 7. Tietze, C., and Hall, R. E.: In Calderone, Mary S., editor: Manual of Contraceptive Practice, Baltimore, The Williams & Wilkins Company. In Press. 8. Hall, R. E.: Bull. Sloane Hosp. 13: 1, 1967. 9. E,sposito, J. M.: Obst. & Gynec. 28: 799, 1966. 10. Tietze, C.: Cooperative Statistical Program for the Evaluation of Intrauterine Devices, Sixth Progress Report, New York, Dec. 3 1, 1965, National Committee on Maternal Health.
11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
Nakamoto, M., and Buchman, M. I.: AM. J. OBST. & GYNEC. 94: 1073, 1966. Willson, J. R.: Personal communication. DeHaan, Q. C.: AM. J. OBST. & GYNEC. 96: 294, 1966. Ledger, W. J., and Willson, J. R.: Obst. & Gynec. 28: 806, 1966. Tietze, C.: AM. J. OBST. & GYNEC. 96: 1043, 1966. Beasley, W. B.: AM. J. OBST. & GYNEC. 98: 201, 1967. Price, C. W. R.: M. J. Australia 1: 106, 1955. Seward, P. J., Burns, G. T., and Quattlebaum, E. G.: J. A. M. A. 194: 1385, 1965. Thambu, J.: Brit. M. J. 2: 407, 1965. Rutherford, A. M.: New Zealand M. J. 60: 413, 1961. 180 Fort Washington New York, New York
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