COIUlESPONDENCE
Progesterone-reieasing inirauterine contraceptive device
Tabie I. Number of events causing termination for each device
To the Editors: I read with great interest the report of Brenner and associates (AM. J. OBSTET. GYNECOL. 121: 704, 1975) on a progesterone-releasing intrauterine contraceptive device. We tested the same devices by inserting in a randomized fashion 99 T -devices releasing 65 f.Lg of progesterone daily and 99 "placebo" devices obtained under the auspices of the World Health Organization. Since both trials were conducted bv similar methods readers may be interested in our r~sults, >\'ith -diffe;~ ences in the population and in the habits and attitudes of the patients, which may affect the over-all acceptability pattern, kept in mind. Such local factors may account for the fact that our discontinuation rate was so much lower than that of Brenner and associates. We inserted devices from Tanuarv to Mav 1973 during menstruation in 198 w~men, 'an of wh~m had regular menses and normal pelvic findings. The patients were followed systematically, and the effectiveness of the devices was computed by the "life-table method" of Tietze. Our results are shown in Table I. After insertion, irregular bleeding occurred in 130 patients up to the seco~d follow-up ;isit (third month). At the one-month checkup, 102 women reported irregular bleeding, while a total of 63 women reported bleeding during the second and/or third month. With exclusion of patients requesting removal, bleeding stopped spontaneously or after treatment with uterotonic agents after one to three weeks. After the third month, only 13 instances of spotting and one instance of bleeding occurred. It should be mentioned that the devices were not immediately removed at the first report of bleeding, Removal was nerformed onlv in women who rontinnerl bleeding at l;ast three we:ks foli~~i-~g -~n~~~~~~;ful treatment with uterotonic agents. Removal had to be performed in only seven of 130 patients, six of whom had irregular bleeding during the first three months. With this management, there was a very marked reduction in removal for bleeding as compared with the results reported by Brenner and his co-workers. The one-year cumulative rate for wearing the
Device Event
No. of women No. of woman months
Medicated
Inert
99
99
1;324
1,270
0 4 4 2 3 0 13
9 2
16
0 I 1
2 0 2
Pertinent discontinuations
Accidental pregnancy Expulsion Bleeding Bleeding plus inflammation Inflammation Pain Total Other Planning pregnancy Other personal Total Total discontinuations Lost to foiiow-up
1 0 2 2
14
18
none
none
devices per 100 women was 83.84; for the progesterone type it was 85.86, and for the placebo device it was 81.82 (with 9 pregnancies). With exclusion of removal~ for nonmedical reasons, the cumulative wearing rates became: totai, 86.37; the progesterone device, 86.87; and the placebo device, 85.86. The incidence of removal of the device for bleeding may be minimized if the woman is informed that some bleeding is common in the first three months and that it occurs relatively infrequently after the fourth month. A patient, positive, communicative approach on the pari of the physician encourages the woman to ieave the device in place during the crucial first three months. It may be worth noting that, in the Brenner series and in our series, the incidence of removal for bleeding was greater in women with the progesterone device than in women with the placebo device, the totals being 24 and 12, respectively. Also, the progesterone devices in our series tended to be associated with alteration of the menstrual cycle. We are studying the clinical significance of these phenomena. Intensive evaluation of 10 of the patients with the progesterone device and 10 of the patients with the piacebo device faiied to reveai any difference in the serum progesterone levels or in pregnanediol and estriol excretion from the normal values, proving that the progesterone release acts only locally. Also the
This investigation received financial support from the World Health Organization.
214
Volume 124 Number 2
basal temperatures were biphasic. At endometrial biopsy, predecidual changes were found. To eliminate the relatively high occurrence of initial irregular bleeding which suggests removal, determining the optimal content and rate of progesterone release should provide a combination method having the advantage of both hormonal and local (mechanical and hormonal) acting methods of fertility control. Gergely Gyozo, M.D. Assistant Lecturer Department of Obstetrics arul Gynecology University Medical School Szeged, Hungary
Sterilization guidelines To the Editors: Recent urging of the need for sterilization guidelines, to determine whether requests will or will not be complied with, has been attacked as "male chauvinist control" over the life and reproduction of women and as an infringement of civil rights. Since it is clear that sterilization as a permanent irreversible removal of the childbearing option is to be viewed as a last resort, it should be equally clear that evaluation of motivations and alternatives is necessary and that no request for any elective operation can be mandatorily complied with regardless of data elicited or clinical judgement. A basic medical-surgical principle states that no elective irreversible extirpation of structure or function should ever be carried out unless all reversible alternatives have been genuinely exhausted. An equally solid medical-surgical principle states that the least chemical-physical ministration
Correspondence 215
which achieves a desired goal is preferred to any more extensive ministration. The burden of proof is on any practitioner who violates these principles. We know that an extremely important component of body image, self-image, or ego identity is intact anatomic structure and intact physiologic options. The permanent loss of any human functional option, of which potential generativity is a central example, cannot fail to reduce the human sense of self in the loser. In view of the above, in a person requesting sterilization of any age or parity, with or without past exposure to reversible contraceptive counseling and methods, regardless of the degree of self-hatred, self-contempt, rejection of gender, and self-mutilating motivation elicited on competent interview, and regardless of the degree of high acute stress which might be contaminating the decision (as in current unwanted pregnancy and abortion or imminent emergency cesarean section), to insist that regardless of all such clinical data the request must be complied with at that time, in defense of the civil libertarian, democratic freedom of the patient to be sterilized on request, indeed represents the height of professional abdication and irresponsibility and should be opposed by all conscientious clinicians. Raymond W. Rakow, M.D. Director Psychiatric Consultation and Liason Service Department of Psychiatry Metropolitan Hospital Center Room 9M29 1901 First Ave. New York, New York 10029
Progesterone-reieasing inirauterine contraceptive device
Tabie I. Number of events causing termination for each device
To the Editors: I read with great interest the report of Brenner and associates (AM. J. OBSTET. GYNECOL. 121: 704, 1975) on a progesterone-releasing intrauterine contraceptive device. We tested the same devices by inserting in a randomized fashion 99 T -devices releasing 65 f.Lg of progesterone daily and 99 "placebo" devices obtained under the auspices of the World Health Organization. Since both trials were conducted bv similar methods readers may be interested in our r~sults, >\'ith -diffe;~ ences in the population and in the habits and attitudes of the patients, which may affect the over-all acceptability pattern, kept in mind. Such local factors may account for the fact that our discontinuation rate was so much lower than that of Brenner and associates. We inserted devices from Tanuarv to Mav 1973 during menstruation in 198 w~men, 'an of wh~m had regular menses and normal pelvic findings. The patients were followed systematically, and the effectiveness of the devices was computed by the "life-table method" of Tietze. Our results are shown in Table I. After insertion, irregular bleeding occurred in 130 patients up to the seco~d follow-up ;isit (third month). At the one-month checkup, 102 women reported irregular bleeding, while a total of 63 women reported bleeding during the second and/or third month. With exclusion of patients requesting removal, bleeding stopped spontaneously or after treatment with uterotonic agents after one to three weeks. After the third month, only 13 instances of spotting and one instance of bleeding occurred. It should be mentioned that the devices were not immediately removed at the first report of bleeding, Removal was nerformed onlv in women who rontinnerl bleeding at l;ast three we:ks foli~~i-~g -~n~~~~~~;ful treatment with uterotonic agents. Removal had to be performed in only seven of 130 patients, six of whom had irregular bleeding during the first three months. With this management, there was a very marked reduction in removal for bleeding as compared with the results reported by Brenner and his co-workers. The one-year cumulative rate for wearing the
Device Event
No. of women No. of woman months
Medicated
Inert
99
99
1;324
1,270
0 4 4 2 3 0 13
9 2
16
0 I 1
2 0 2
Pertinent discontinuations
Accidental pregnancy Expulsion Bleeding Bleeding plus inflammation Inflammation Pain Total Other Planning pregnancy Other personal Total Total discontinuations Lost to foiiow-up
1 0 2 2
14
18
none
none
devices per 100 women was 83.84; for the progesterone type it was 85.86, and for the placebo device it was 81.82 (with 9 pregnancies). With exclusion of removal~ for nonmedical reasons, the cumulative wearing rates became: totai, 86.37; the progesterone device, 86.87; and the placebo device, 85.86. The incidence of removal of the device for bleeding may be minimized if the woman is informed that some bleeding is common in the first three months and that it occurs relatively infrequently after the fourth month. A patient, positive, communicative approach on the pari of the physician encourages the woman to ieave the device in place during the crucial first three months. It may be worth noting that, in the Brenner series and in our series, the incidence of removal for bleeding was greater in women with the progesterone device than in women with the placebo device, the totals being 24 and 12, respectively. Also, the progesterone devices in our series tended to be associated with alteration of the menstrual cycle. We are studying the clinical significance of these phenomena. Intensive evaluation of 10 of the patients with the progesterone device and 10 of the patients with the piacebo device faiied to reveai any difference in the serum progesterone levels or in pregnanediol and estriol excretion from the normal values, proving that the progesterone release acts only locally. Also the
This investigation received financial support from the World Health Organization.
214
Volume 124 Number 2
basal temperatures were biphasic. At endometrial biopsy, predecidual changes were found. To eliminate the relatively high occurrence of initial irregular bleeding which suggests removal, determining the optimal content and rate of progesterone release should provide a combination method having the advantage of both hormonal and local (mechanical and hormonal) acting methods of fertility control. Gergely Gyozo, M.D. Assistant Lecturer Department of Obstetrics arul Gynecology University Medical School Szeged, Hungary
Sterilization guidelines To the Editors: Recent urging of the need for sterilization guidelines, to determine whether requests will or will not be complied with, has been attacked as "male chauvinist control" over the life and reproduction of women and as an infringement of civil rights. Since it is clear that sterilization as a permanent irreversible removal of the childbearing option is to be viewed as a last resort, it should be equally clear that evaluation of motivations and alternatives is necessary and that no request for any elective operation can be mandatorily complied with regardless of data elicited or clinical judgement. A basic medical-surgical principle states that no elective irreversible extirpation of structure or function should ever be carried out unless all reversible alternatives have been genuinely exhausted. An equally solid medical-surgical principle states that the least chemical-physical ministration
Correspondence 215
which achieves a desired goal is preferred to any more extensive ministration. The burden of proof is on any practitioner who violates these principles. We know that an extremely important component of body image, self-image, or ego identity is intact anatomic structure and intact physiologic options. The permanent loss of any human functional option, of which potential generativity is a central example, cannot fail to reduce the human sense of self in the loser. In view of the above, in a person requesting sterilization of any age or parity, with or without past exposure to reversible contraceptive counseling and methods, regardless of the degree of self-hatred, self-contempt, rejection of gender, and self-mutilating motivation elicited on competent interview, and regardless of the degree of high acute stress which might be contaminating the decision (as in current unwanted pregnancy and abortion or imminent emergency cesarean section), to insist that regardless of all such clinical data the request must be complied with at that time, in defense of the civil libertarian, democratic freedom of the patient to be sterilized on request, indeed represents the height of professional abdication and irresponsibility and should be opposed by all conscientious clinicians. Raymond W. Rakow, M.D. Director Psychiatric Consultation and Liason Service Department of Psychiatry Metropolitan Hospital Center Room 9M29 1901 First Ave. New York, New York 10029
