- Email: [email protected]
Long-term use of copper intrauterine devices
1322
unnecessary electron microscopy of tissues containing no polytef. However, there is no evidence to suggest that the
microspheres migrate in the same manner as the polytef particles. The gross variation in polytef particle size suggests that these particles would behave differently from homogeneous radiolabelled microspheres. Fluorine is notoriously difficult to analyse by microanalysis since the X-ray emission from fluorine is very weak. Only large concentrations of particles would be likely to be detected by labelled
this method. After injection of polytef paste a granulomatous reaction occurs and the fibrous capsule that later forms around the polytef particles holds them in place. Kaplan16 carefully followed up 10 patients treated with subureteric teflon injections for up to 3 years with computed tomography and ultrasound scans and found no instance of an enlarging injection granuloma. Similarly Mann et al6 did not find any change in the size of the teflon granuloma on sonography in their patients in a 1-year follow-up study. Polytef paste has been injected for vocal cord surgery for over 25 years and for stress incontinence for 20 years.10-ls No untoward effects have been reported.
REFERENCES 1.
Report of the International Reflux Committee. Medical versus surgical treatment of primary vesicoureteral reflux. Pediatrics 1981; 67:
392-400. 2. Puri . O’Donnell B.
Correction
of experimentally
Long-term
use
produced
vesicoureteric reflux in the piglet by intravesical injection of Teflon. Br Med J 1984; 289: 5-7. 3. O’Donnell B, Puri P. Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7-9. 4. Puri P, O’Donnell B. Endoscopic correction of grades IV and V primary vesicoureteric reflux. J Pediatr Surg 1986; 22: 1087-91. 5. Kaplan WE, Dalton DP, Firlit CF. The endoscopic correction of reflux by polytetrafluoroethylene injection. J Urol 1987; 138: 953-55. 6. Mann CI, Jequier S, Patriquin H, LaBerge I, Homsy YL. Intramural Teflon injection of the ureter for the treatment of vesicoureteric reflux: sonographic appearance. AJR 1988; 151: 543-45. 7. Puri P, Guiney EJ, Endoscopic correction of vesicoureteric reflux secondary to neuropathic bladder. Br J Urol 1986; 58: 504-06. 8. Purl P, O’Donnell B. Endoscopic correction of vesicoureteric reflux using subureteric Teflon injection. In: Spitz L, Nixon HH, eds. Operative paediatric surgery. Sevenoaks: Butterworths, 1988: 522-27. 9. Malizia A, Reiman H, Myers R, et al. Migration and granulomatous reaction after periurethral injection of Polytef paste. JAMA 1984; 251: 3277-81. 10. Arnold GE. Alleviation of aphonia or dysphonia through intrachordial injection of teflon paste. Ann Otol Rhinol Laryngol 1963; 72: 384-95. 11. Dedo HH, Urria RD, Lawson L. Intrachordial injection of teflon in the treatment of 135 patients with dysphonia. Ann Otol Rhinol Laryngol 1973; 82: 661-67. 12. Lewy RB. Experience with vocal cord injection. Ann Otol Rhinol Laryngol 1976; 85: 440-50. 13. Politano VA. Periurethral polytetrafluoroethylene injection for urinary incontinence. J Urol 1974; 111: 180-83. 14. Schulman CC, Simon J, Wespes E, et al. Endoscopic injection of Teflon to treat urinary incontinence in women. Br Med J 1984; 288: 192. 15. Vorstman B, Lockhart J, Kaufman M, et al. Polytetrafluoroethylene injection for urinary incontinence in children. J Urol 1985; 133: 248-50. 16. Spencer J, Donaldson J, Zaontz M, Kaplan W. The sting: postoperative evaluation for granuloma development in the paediatric patient. Presented at the 83rd Annual Meeting of the American Urological Association, Boston, Massachusetts, 1988 (abstr 93).
of copper intrauterine devices
A statement from the Medical Advisory Committee of the Family Planning Association and the National Association of Family Planning Doctors
The intrauterine device (IUD) is now probably the second most commonly used reversible method of birth control, with more than 60 million users worldwide. The original devices, such as the Lippes loop, were made of inert plastic. Copper-bearing IUDs became available in the 1970s and the first two models, the copper 7 and the copper Twere soon in widespread use. In the first, second, and subsequent years after insertion they gave lower pregnancy rates than inert IUDs.4,s IUDs are thought to exert their contraceptive effect by interfering with the reproductive process before the ovum reaches the intrauterine cavity, and the presence of the copper probably potentiates this effect.6 The two early copper IUDs (copper 7 and copper T) have 200 mmz surface area of copper in the form of a thin wire wound round the stem of the device. In early models the wire was only 0-2 mm thick and after long-term use sometimes fragmented or disappeared completely. Copperbearing IUDs act by releasing copper at a mean rate of 38 ng per day. Like all devices placed in the uterus they are subject to deposition of cellular debris and of calcium and
magnesium salts but copper ions are still able to diffuse. At one time the salts were thought to reduce the effectiveness of IUDs7 but this is
not
so.8
Subsequent development of the
copper IUD has led to effective and have a longer active life devices that with a lower rate of wire fragmentation. This has been achieved firstly by increasing the wire thickness to 03 or 0-4 mm (eg, ’Multiload’), secondly by the preparation of a silver-core copper wire (eg, ’Nova-T’), and thirdly by the use of solid copper collars or sleeves, either alone as on the copper T 220C or in conjunction with copper wire as on the copper T 380 slimline. The copper T 380 slimline, with copper placed near the fundus of the uterus and in the form of sleeves, has a theoretical lifespan of up to ten years.6 Some of the copper-bearing IUDs used in the UK-the are more
ADDRESSES Family Planning Association, 27-35 Mortimer St, London W1N 7RJ, UK (Prof J. Newton, FRCOG); National Association of Family Planning Doctors, 27 Sussex Place, London NW1 4RG (Dr D. Tacchi). Correspondence to either.
1323
TABLE II-LICENSED USE AND LONG-TERM CLINICAL EFFECTIVENESS
TABLE I-ANNUAL PREGNANCY RATES WITH LONG-TERM USE
Because different definitions were used, rates are given as annual ’earlmdex rates, gross pregnancy rates, from a range of studies Source, refs 5 a d 6.
or
NA= not available.
multiload, the nova-T, and the copper T 380 S (slimline)— known to have an effective lifespan in excess of the manufacturers’ recommendations .5,6 (The copper 7, which has not been used by choice for some time, and the ’Minigravigard’, which is very useful for nulliparous women and for post-coital contraception, are no longer available.) In British law, a doctor is at liberty to use a drug or device in ways other than those specified in the product licence. Advice and treatment should be determined by the best interests and safety of the client, as judged from the opinions of acknowledged experts and from study of the published work. are
Evidence
on
long-term
use
Modem copper IUDs are clinically effective and safe for least five years. S,6 Comparative data on pregnancy rates during the fourth and subsequent years show that there is no significant increase in cumulative pregnancy rates or in medical discontinuation rates with the passage of time. Table I, summarising results from multinational randomised studies and from non-randomised multicentre studies, illustrates the poorer results with first-generation copper-bearing devices than with the newer devices. Clinical efficacy data, both published and theoretical, support the use of copper IUDs for at least five years.4,9 The second-generation copper IUDs have low cumulative pregnancy rates after six years of use. This means that with modem copper IUDs (eg, nova-T and multiload Cu 250) the pregnancy rates will range from 1 to 3 per 100 women per year. The newer third-generation devices (multiload Cu 375 and copper T 380S and 380A) are even more effective, with rates about 1 per 100 women per year or less (table I).
leaving it in (it is wise to record this discussion in the notes). Factors to take into account are the natural decline in fertility with age, the degree of technical difficulty expected in removal and reinsertion, and the willingness of the woman to accept a possible small loss of contraceptive efficacy, as yet undocumented, for the advantages of leaving well alone. IUD use can be continued up to the menopause if necessary. The device should be extracted at that time since difficulties with removal have been reported after the menopause, especially with the larger inert silastic devices. We recognise that this policy may mean that there will be even fewer opportunities to gain experience of IUD insertion. On the other hand, it may result in a greater acceptability of IUDs-particularly in older women whose families are complete and who want a method that will take them up to the menopause.
at
When should copper IUDs be Less
REFERENCES 1.
Zipper J, Tatum HJ, Pastene L, Medel M, Rivea M. Metallic copper as an intra-uterine adjunct to the "T" device. Am J Obstet Gynecol 1969;
105: 1274-78. 2. Newton J, Elias J, McEwan J. Intrauterine contraception using the copper 7 device. Lancet 1972; ii: 951-54. 3. Tatum HJ. Comparative experience with newer models of the copper T in the USA. In: Hefnawi F, Segal S, eds. Analysis of intrauterine contraception. Amsterdam: Elsevier, 1974. 4. Snowden R. Copper IUCDs and the pregnancy rate. Br J Fam Planning
1981; 6 (4): 104-08. 5. Intrauterine devices. Population reports series B, no 5. Baltimore: Population Information Program, Johns Hopkins University, 1988. 6. WHO. Mechanism of action, safety and efficacy of intrauterine devices. WHO Tech Rep Ser no 753, 1987. 7. Gosden C, Ross A, Loudon NB. Intrauterine deposition of calcium on copper bearing intrauterine contraceptive devices. Br Med J 1977; i: 202-06. 8. Van Eyck J, Lagasse A, Thiery M. Scanning electron microscopy of inert and copper bearing IUCDs. Contraception 1976; 13: 65-77. 9. Batar I. Clinical experience with the Ml Cu IUD (eight year results). Adv Contraception 1985; 1 (4): 329-35.
changed?
frequent replacement would
reduce the risks of
pelvic inflammatory disease, uterine perforation, expulsion, and other
complications
that
mainly
occur
soon
after
insertion. Also, less frequent insertion would reduce cost,
inconvenience, pain, and upset (some women are fearful at the thought of changing their IUD). Routine changing after less than five years seems a pointless exercise. Table 11 shows the clinical lifespan and current licensed use of IUDs. We recommend that for routine management the modem copper-bearing IUDs mentioned in this article should be assumed to have an active lifespan of five years or more. Beyond that interval, an experienced doctor or nurse should discuss with the client the option of changing the IUD or
From The Lancet Why should not ladies take to pharmacy? A daily journal has recently pointed out that pharmacy is now quite open to persons of the female sex, and suggests, what is certainly true, that it is a calling for which their neat touch and delicacy would seem peculiarly to suit them. For a long time there were difficulties in the way, but these have now been overcome, and there is no reason why lady chemists should not commence business, under the patronage-if they can secure it-of the lady doctors.
(17 May 1890)
unnecessary electron microscopy of tissues containing no polytef. However, there is no evidence to suggest that the
microspheres migrate in the same manner as the polytef particles. The gross variation in polytef particle size suggests that these particles would behave differently from homogeneous radiolabelled microspheres. Fluorine is notoriously difficult to analyse by microanalysis since the X-ray emission from fluorine is very weak. Only large concentrations of particles would be likely to be detected by labelled
this method. After injection of polytef paste a granulomatous reaction occurs and the fibrous capsule that later forms around the polytef particles holds them in place. Kaplan16 carefully followed up 10 patients treated with subureteric teflon injections for up to 3 years with computed tomography and ultrasound scans and found no instance of an enlarging injection granuloma. Similarly Mann et al6 did not find any change in the size of the teflon granuloma on sonography in their patients in a 1-year follow-up study. Polytef paste has been injected for vocal cord surgery for over 25 years and for stress incontinence for 20 years.10-ls No untoward effects have been reported.
REFERENCES 1.
Report of the International Reflux Committee. Medical versus surgical treatment of primary vesicoureteral reflux. Pediatrics 1981; 67:
392-400. 2. Puri . O’Donnell B.
Correction
of experimentally
Long-term
use
produced
vesicoureteric reflux in the piglet by intravesical injection of Teflon. Br Med J 1984; 289: 5-7. 3. O’Donnell B, Puri P. Treatment of vesicoureteric reflux by endoscopic injection of Teflon. Br Med J 1984; 289: 7-9. 4. Puri P, O’Donnell B. Endoscopic correction of grades IV and V primary vesicoureteric reflux. J Pediatr Surg 1986; 22: 1087-91. 5. Kaplan WE, Dalton DP, Firlit CF. The endoscopic correction of reflux by polytetrafluoroethylene injection. J Urol 1987; 138: 953-55. 6. Mann CI, Jequier S, Patriquin H, LaBerge I, Homsy YL. Intramural Teflon injection of the ureter for the treatment of vesicoureteric reflux: sonographic appearance. AJR 1988; 151: 543-45. 7. Puri P, Guiney EJ, Endoscopic correction of vesicoureteric reflux secondary to neuropathic bladder. Br J Urol 1986; 58: 504-06. 8. Purl P, O’Donnell B. Endoscopic correction of vesicoureteric reflux using subureteric Teflon injection. In: Spitz L, Nixon HH, eds. Operative paediatric surgery. Sevenoaks: Butterworths, 1988: 522-27. 9. Malizia A, Reiman H, Myers R, et al. Migration and granulomatous reaction after periurethral injection of Polytef paste. JAMA 1984; 251: 3277-81. 10. Arnold GE. Alleviation of aphonia or dysphonia through intrachordial injection of teflon paste. Ann Otol Rhinol Laryngol 1963; 72: 384-95. 11. Dedo HH, Urria RD, Lawson L. Intrachordial injection of teflon in the treatment of 135 patients with dysphonia. Ann Otol Rhinol Laryngol 1973; 82: 661-67. 12. Lewy RB. Experience with vocal cord injection. Ann Otol Rhinol Laryngol 1976; 85: 440-50. 13. Politano VA. Periurethral polytetrafluoroethylene injection for urinary incontinence. J Urol 1974; 111: 180-83. 14. Schulman CC, Simon J, Wespes E, et al. Endoscopic injection of Teflon to treat urinary incontinence in women. Br Med J 1984; 288: 192. 15. Vorstman B, Lockhart J, Kaufman M, et al. Polytetrafluoroethylene injection for urinary incontinence in children. J Urol 1985; 133: 248-50. 16. Spencer J, Donaldson J, Zaontz M, Kaplan W. The sting: postoperative evaluation for granuloma development in the paediatric patient. Presented at the 83rd Annual Meeting of the American Urological Association, Boston, Massachusetts, 1988 (abstr 93).
of copper intrauterine devices
A statement from the Medical Advisory Committee of the Family Planning Association and the National Association of Family Planning Doctors
The intrauterine device (IUD) is now probably the second most commonly used reversible method of birth control, with more than 60 million users worldwide. The original devices, such as the Lippes loop, were made of inert plastic. Copper-bearing IUDs became available in the 1970s and the first two models, the copper 7 and the copper Twere soon in widespread use. In the first, second, and subsequent years after insertion they gave lower pregnancy rates than inert IUDs.4,s IUDs are thought to exert their contraceptive effect by interfering with the reproductive process before the ovum reaches the intrauterine cavity, and the presence of the copper probably potentiates this effect.6 The two early copper IUDs (copper 7 and copper T) have 200 mmz surface area of copper in the form of a thin wire wound round the stem of the device. In early models the wire was only 0-2 mm thick and after long-term use sometimes fragmented or disappeared completely. Copperbearing IUDs act by releasing copper at a mean rate of 38 ng per day. Like all devices placed in the uterus they are subject to deposition of cellular debris and of calcium and
magnesium salts but copper ions are still able to diffuse. At one time the salts were thought to reduce the effectiveness of IUDs7 but this is
not
so.8
Subsequent development of the
copper IUD has led to effective and have a longer active life devices that with a lower rate of wire fragmentation. This has been achieved firstly by increasing the wire thickness to 03 or 0-4 mm (eg, ’Multiload’), secondly by the preparation of a silver-core copper wire (eg, ’Nova-T’), and thirdly by the use of solid copper collars or sleeves, either alone as on the copper T 220C or in conjunction with copper wire as on the copper T 380 slimline. The copper T 380 slimline, with copper placed near the fundus of the uterus and in the form of sleeves, has a theoretical lifespan of up to ten years.6 Some of the copper-bearing IUDs used in the UK-the are more
ADDRESSES Family Planning Association, 27-35 Mortimer St, London W1N 7RJ, UK (Prof J. Newton, FRCOG); National Association of Family Planning Doctors, 27 Sussex Place, London NW1 4RG (Dr D. Tacchi). Correspondence to either.
1323
TABLE II-LICENSED USE AND LONG-TERM CLINICAL EFFECTIVENESS
TABLE I-ANNUAL PREGNANCY RATES WITH LONG-TERM USE
Because different definitions were used, rates are given as annual ’earlmdex rates, gross pregnancy rates, from a range of studies Source, refs 5 a d 6.
or
NA= not available.
multiload, the nova-T, and the copper T 380 S (slimline)— known to have an effective lifespan in excess of the manufacturers’ recommendations .5,6 (The copper 7, which has not been used by choice for some time, and the ’Minigravigard’, which is very useful for nulliparous women and for post-coital contraception, are no longer available.) In British law, a doctor is at liberty to use a drug or device in ways other than those specified in the product licence. Advice and treatment should be determined by the best interests and safety of the client, as judged from the opinions of acknowledged experts and from study of the published work. are
Evidence
on
long-term
use
Modem copper IUDs are clinically effective and safe for least five years. S,6 Comparative data on pregnancy rates during the fourth and subsequent years show that there is no significant increase in cumulative pregnancy rates or in medical discontinuation rates with the passage of time. Table I, summarising results from multinational randomised studies and from non-randomised multicentre studies, illustrates the poorer results with first-generation copper-bearing devices than with the newer devices. Clinical efficacy data, both published and theoretical, support the use of copper IUDs for at least five years.4,9 The second-generation copper IUDs have low cumulative pregnancy rates after six years of use. This means that with modem copper IUDs (eg, nova-T and multiload Cu 250) the pregnancy rates will range from 1 to 3 per 100 women per year. The newer third-generation devices (multiload Cu 375 and copper T 380S and 380A) are even more effective, with rates about 1 per 100 women per year or less (table I).
leaving it in (it is wise to record this discussion in the notes). Factors to take into account are the natural decline in fertility with age, the degree of technical difficulty expected in removal and reinsertion, and the willingness of the woman to accept a possible small loss of contraceptive efficacy, as yet undocumented, for the advantages of leaving well alone. IUD use can be continued up to the menopause if necessary. The device should be extracted at that time since difficulties with removal have been reported after the menopause, especially with the larger inert silastic devices. We recognise that this policy may mean that there will be even fewer opportunities to gain experience of IUD insertion. On the other hand, it may result in a greater acceptability of IUDs-particularly in older women whose families are complete and who want a method that will take them up to the menopause.
at
When should copper IUDs be Less
REFERENCES 1.
Zipper J, Tatum HJ, Pastene L, Medel M, Rivea M. Metallic copper as an intra-uterine adjunct to the "T" device. Am J Obstet Gynecol 1969;
105: 1274-78. 2. Newton J, Elias J, McEwan J. Intrauterine contraception using the copper 7 device. Lancet 1972; ii: 951-54. 3. Tatum HJ. Comparative experience with newer models of the copper T in the USA. In: Hefnawi F, Segal S, eds. Analysis of intrauterine contraception. Amsterdam: Elsevier, 1974. 4. Snowden R. Copper IUCDs and the pregnancy rate. Br J Fam Planning
1981; 6 (4): 104-08. 5. Intrauterine devices. Population reports series B, no 5. Baltimore: Population Information Program, Johns Hopkins University, 1988. 6. WHO. Mechanism of action, safety and efficacy of intrauterine devices. WHO Tech Rep Ser no 753, 1987. 7. Gosden C, Ross A, Loudon NB. Intrauterine deposition of calcium on copper bearing intrauterine contraceptive devices. Br Med J 1977; i: 202-06. 8. Van Eyck J, Lagasse A, Thiery M. Scanning electron microscopy of inert and copper bearing IUCDs. Contraception 1976; 13: 65-77. 9. Batar I. Clinical experience with the Ml Cu IUD (eight year results). Adv Contraception 1985; 1 (4): 329-35.
changed?
frequent replacement would
reduce the risks of
pelvic inflammatory disease, uterine perforation, expulsion, and other
complications
that
mainly
occur
soon
after
insertion. Also, less frequent insertion would reduce cost,
inconvenience, pain, and upset (some women are fearful at the thought of changing their IUD). Routine changing after less than five years seems a pointless exercise. Table 11 shows the clinical lifespan and current licensed use of IUDs. We recommend that for routine management the modem copper-bearing IUDs mentioned in this article should be assumed to have an active lifespan of five years or more. Beyond that interval, an experienced doctor or nurse should discuss with the client the option of changing the IUD or
From The Lancet Why should not ladies take to pharmacy? A daily journal has recently pointed out that pharmacy is now quite open to persons of the female sex, and suggests, what is certainly true, that it is a calling for which their neat touch and delicacy would seem peculiarly to suit them. For a long time there were difficulties in the way, but these have now been overcome, and there is no reason why lady chemists should not commence business, under the patronage-if they can secure it-of the lady doctors.
(17 May 1890)