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Continuation Rates of Long-Acting Methods of Contraception
ORIGINAL RESEARCH ARTICLE
Continuation Rates of Long-Acting Methods of Contraception A Comparative Study of Norplantt Implants and Intrauterine Devices Diana Fleming, J. Davie, and A. Glasier
Following adverse widespread publicity in the United Kingdom and the United States, it is commonly believed that discontinuation rates for the contraceptive implants Norplantt in the UK are high. We have compared discontinuation rates between new intrauterine device (IUD) users (253 women) and new Norplant implant users (502 women) over 33 months following the introduction of Norplant implants among a population of women attending the same clinic and counseled in the same manner by the same group of providers. Women choosing the IUD were slightly older and were more likely to be changing their contraceptive method because of dissatisfaction with their current method. Norplant implant users were more likely to have completed their families. Continuation rates for Norplant implants were significantly higher than for IUD at 12, 18, and 24 months after insertion. At 24 months, continuation rates for Norplant implants were 72% compared with rates of 55% for IUD users. Higher continuation rates may be related more to factors associated with the providers than with the users of these two long-acting methods. CONTRACEPTION 1998;57:19 –21 © 1998 Elsevier Science Inc. All rights reserved.
doctors were competent to insert and remove the rods. Adverse publicity in 19951–3 in both the UK and the United States resulted in a number of women requesting removal of implants, which, together with removals for side effects, led to the widespread impression that ‘‘everyone was having their implants removed.’’ We audited continuation rates among women who had had Norplant implants inserted in a large community family planning clinic in Edinburgh and demonstrated continuation rates of 84% at 1 year and 80% after 18 months of use.4 Despite these data and national figures5 showing similar continuation rates, anecdotally, many medical and nursing staff responsible for delivering contraceptive services in the UK had expressed the view that the Norplant implants launch had been a failure. We present a study comparing continuation rates among women choosing a copper intrauterine device (also requiring insertion and removal by a doctor), provided in the same clinic setting and during the same time span, with continuation rates among women choosing the Norplant implants.
KEY WORDS: Norplantt implants, intrauterine device, continuation rates
Materials and Methods
Introduction
N
orplantt implants became available in the United Kingdom in August 1993. Their introduction was accompanied by widespread publicity in the popular press. The pharmaceutical company who marketed Norplant implants had in place a national training program to ensure that a cohort of Edinburgh Healthcare National Health Service Trust, Family Planning and Well Woman Services, Edinburgh, Scotland Name and address for correspondence: Dr. J. Davie, 18 Dean Terrace, Edinburgh, EH4 1NL, United Kingdom Submitted for publication July 25, 1997 Revised November 17, 1997 Accepted for publication November 18, 1997
© 1998 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
A retrospective review of the case records was carried out of all women (n 5 370) who had had nonhormonal IUD inserted from August 1, 1993, to May 1, 1995, in a large Family Planning clinic in Edinburgh, Scotland. Only first time users of the method (253) were included in the study; all those who had used an IUD in the past were excluded, as the comparison was made with the new users of Norplant implants. There were no other exclusion criteria. If a patient had not attended the clinic for a follow-up within 1 year of the review, a standard letter of inquiry was sent out to the patient. If the patient failed to reply, a letter was sent to her general practitioner (family doctor) to ascertain whether an IUD was still being used as a method of contraception. If there was no reply following this the GP was conISSN 0010-7824/98/$19.00 PII S0010-7824(97)00202-3
20
Fleming et al.
tacted by telephone to establish whether he/she had further information as to the patient’s current contraceptive use. Those patients for whom no further information could be collected were recorded as lost to follow-up. Information collected from women who returned their questionnaires included age, parity, date of IUD insertion and removal (if applicable), prior method of contraception, reason for the IUD being requested as a method of contraception, and reasons why removal of the IUD was requested. The same data on new Norplant implants users were collected from the same family planning center, prospectively from August 1, 1993, to May 1, 1995.4 Both IUD and Norplant implants users had been counseled before the insertion of the device. Advantages, disadvantages, and suitability of the method were discussed at a general contraceptive clinic. The insertion of the device was undertaken at a second visit in a dedicated IUD or Norplant implants clinic, at which time the suitability for the method was confirmed and counseling reinforced. Results were analyzed using the x2 test for discreet variables. A p ,0.01 was considered to be significant.
Results From August 1, 1993, to April 30, 1995, 502 women had Norplant implants inserted and were followed-up until the removal of the implant or to April 30, 1996; 45 (9%) of these women were lost to follow-up. A total of 253 new users of nonhormonal IUD were identified, of which 42 (16%) were lost to follow-up. Characteristics of Users Women who chose an IUD tended to be slightly older than women choosing Norplant implants (mean age 30.7 vs 27.2 years, respectively). Fifty-four percent of IUD users (p ,0.001) were over 30 years of age at the time of insertion compared with 30% of Norplant users. There were no differences in parity or number of liveborn children between women choosing different contraceptive methods. Women who chose Norplant implants were more likely to have been using the combined oral contraceptive pill at the time of choosing their new method than were IUD choosers (p ,0.001) who were more likely to be using condoms (p ,0.01). The most common reason for choosing Norplant implants was as an alternative to sterilization whereas that for choosing the IUD was because of dissatisfaction with other contraceptive methods. Insertions and Removals Figure 1 shows the cumulative number of insertions and removals of the two methods over the 33-month
Contraception 1998;57:19 –21
Figure 1. Cumulative number of insertions and removals of Norplant implants and nonhormonal IUDs over the 33-month study period (August 1, 1993 to May 1, 1995) in a large family planning clinic in Edinburgh, Scotland.
study period. An average of 10.3 (SD 4.0) IUD were inserted each month compared with 24 (SD 13.8) insertions of Norplant implants. Although a higher percentage of IUD were removed during the study, they were removed steadily at an average of 3.2 (SD 1.8) per month. Removals of Norplant implants increased with time with a mean monthly removal rate of 1.4 (SD 2.2) in the first 18 months and a mean of 7.8 (SD 3.8) in the subsequent 15 months. Continuation Rates Continuation rates were higher at all time points among users of Norplant implants. At 12 months, continuation rates were 84% for Norplant users compared with 70% for the IUD users, and at 18 months, were 80% for Norplant and 63% for the IUD. By 2 years after insertion, 71.8% of women were continuing to use Norplant implants compared with only 54.6% for IUD users (p ,0.001). Reasons for Discontinuation More than one reason was often cited for discontinuation of a method. For both methods, the predominant reason for removal was bleeding problems (Table 1). Users of Norplant implants experienced menstrual irregularity, whereas for IUD users menorrhagia was common. In 10 of the 16 cases in which pain was cited as a reason for IUD removal, this was associated with menorrhagia. Other reasons for removal of Norplant implants included mood swings, weight gain, and headaches. Only one woman having the Norplant implants removed cited recent adverse publicity as a reason for removal.
Contraception 1998;57:19 –21
NorplantT Implants Versus IUD Continuation Rates
Table 1. Reasons for removal of norplant implants (n 5 142) and iud (n 5 104) Reason Removed Bleeding problems Pain Planning pregnancy Pregnant Expulsion Infection Preferred sterilization Postcoital insertion Mood swings Weight gain Headache Acne Hair problems Relationship ended Adverse Publicity
Norplant Removals
IUD Removals
64 6 9 1* 0 0 6 0 47 23 19 11 5 3 1
40 16 17 4 8 7 4 6† 0 0 0 0 0 2 0
*Pregnancy undiagnosed at time of insertion. †IUD inserted post coitally, initially planned to continue but changed mind.
Discussion Continuation rates among women using Norplant implants were much higher than those for IUD users, which is reassuring to both providers and users particularly as the IUD is regarded as a very useful (although not widely used) method of contraception in the UK. There were no differences in the manner in which the two groups of women were counseled about their choice of method and counseling was undertaken by the same staff in the same clinic. Women using Norplant implants tended to be a little younger than IUD users but, implicit in their choosing between sterilization and Norplant implants, they were perhaps more likely to have completed their families. This is reflected in the higher number of removals among IUD users who were planning another pregnancy. Although the cost of the chosen method, together with fees for removal or insertion, may play a part in continuation rates in other countries such as the US, this is not the case in the UK where contraception is free to the user. However, providers do pay for the cost of contraception in their clinic budgets and they have become much more cost conscious in recent
21
years. A ‘‘trial’’ of an IUD (at , $16.50 per device) may be regarded as acceptable, whereas a trial of Norplant implants (at $280) would be quite unacceptable. The threshold for insertion and removal of IUD may thus be lower. Access to removal may also have influenced continuation rates. Although no fees are charged for either insertion or removal of either method, whereas most doctors are capable of removing an IUD, only a small number have been trained to remove the Norplant implants. A woman wishing to have her IUD removed can be seen by her family doctor or by a doctor at a family planning clinic. For Norplant implants users, removal requires a visit to one particular clinic that may be much less geographically convenient, thus encouraging women to postpone removal for a little longer. However, easy access to the implant clinic by telephone, by self-referral, or at the request of her general practitioner was offered at the time of insertion. Assurance was given that removal could be undertaken, if necessary within 1 week. In conclusion, comparison of discontinuation rates between Norplant implants and the IUD demonstrate that, contrary to popular belief, women who have been well counseled will manifest high Norplant implants continuation rates.
Acknowledgment We would like to thank Wendy Smith for assistance with data collection.
References 1. Roberts J. Women in US sue makers of Norplantt. Br Med J 1995;309:145. 2. Kolata G. Will the lawyers kill off Norplantt? After breast implants, American Home Products’ birth-control method is this year’s target. New York Times, Sunday, May 28, 1995. 3. Dyer C. Action against contraceptive implant threatened. Br Med J 1995;311:470. 4. Davie J, Hiremath K, Glasier A. The introduction of a new contraceptive implant; two years’ experience with Norplantt. Health Bull 1996;54:314 –7. 5. Peers T, Stevens JE, Graham J, Davey A. Norplantt implants in the UK: first year continuation and removals. Contraception 1996;53:345–51.
Continuation Rates of Long-Acting Methods of Contraception A Comparative Study of Norplantt Implants and Intrauterine Devices Diana Fleming, J. Davie, and A. Glasier
Following adverse widespread publicity in the United Kingdom and the United States, it is commonly believed that discontinuation rates for the contraceptive implants Norplantt in the UK are high. We have compared discontinuation rates between new intrauterine device (IUD) users (253 women) and new Norplant implant users (502 women) over 33 months following the introduction of Norplant implants among a population of women attending the same clinic and counseled in the same manner by the same group of providers. Women choosing the IUD were slightly older and were more likely to be changing their contraceptive method because of dissatisfaction with their current method. Norplant implant users were more likely to have completed their families. Continuation rates for Norplant implants were significantly higher than for IUD at 12, 18, and 24 months after insertion. At 24 months, continuation rates for Norplant implants were 72% compared with rates of 55% for IUD users. Higher continuation rates may be related more to factors associated with the providers than with the users of these two long-acting methods. CONTRACEPTION 1998;57:19 –21 © 1998 Elsevier Science Inc. All rights reserved.
doctors were competent to insert and remove the rods. Adverse publicity in 19951–3 in both the UK and the United States resulted in a number of women requesting removal of implants, which, together with removals for side effects, led to the widespread impression that ‘‘everyone was having their implants removed.’’ We audited continuation rates among women who had had Norplant implants inserted in a large community family planning clinic in Edinburgh and demonstrated continuation rates of 84% at 1 year and 80% after 18 months of use.4 Despite these data and national figures5 showing similar continuation rates, anecdotally, many medical and nursing staff responsible for delivering contraceptive services in the UK had expressed the view that the Norplant implants launch had been a failure. We present a study comparing continuation rates among women choosing a copper intrauterine device (also requiring insertion and removal by a doctor), provided in the same clinic setting and during the same time span, with continuation rates among women choosing the Norplant implants.
KEY WORDS: Norplantt implants, intrauterine device, continuation rates
Materials and Methods
Introduction
N
orplantt implants became available in the United Kingdom in August 1993. Their introduction was accompanied by widespread publicity in the popular press. The pharmaceutical company who marketed Norplant implants had in place a national training program to ensure that a cohort of Edinburgh Healthcare National Health Service Trust, Family Planning and Well Woman Services, Edinburgh, Scotland Name and address for correspondence: Dr. J. Davie, 18 Dean Terrace, Edinburgh, EH4 1NL, United Kingdom Submitted for publication July 25, 1997 Revised November 17, 1997 Accepted for publication November 18, 1997
© 1998 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
A retrospective review of the case records was carried out of all women (n 5 370) who had had nonhormonal IUD inserted from August 1, 1993, to May 1, 1995, in a large Family Planning clinic in Edinburgh, Scotland. Only first time users of the method (253) were included in the study; all those who had used an IUD in the past were excluded, as the comparison was made with the new users of Norplant implants. There were no other exclusion criteria. If a patient had not attended the clinic for a follow-up within 1 year of the review, a standard letter of inquiry was sent out to the patient. If the patient failed to reply, a letter was sent to her general practitioner (family doctor) to ascertain whether an IUD was still being used as a method of contraception. If there was no reply following this the GP was conISSN 0010-7824/98/$19.00 PII S0010-7824(97)00202-3
20
Fleming et al.
tacted by telephone to establish whether he/she had further information as to the patient’s current contraceptive use. Those patients for whom no further information could be collected were recorded as lost to follow-up. Information collected from women who returned their questionnaires included age, parity, date of IUD insertion and removal (if applicable), prior method of contraception, reason for the IUD being requested as a method of contraception, and reasons why removal of the IUD was requested. The same data on new Norplant implants users were collected from the same family planning center, prospectively from August 1, 1993, to May 1, 1995.4 Both IUD and Norplant implants users had been counseled before the insertion of the device. Advantages, disadvantages, and suitability of the method were discussed at a general contraceptive clinic. The insertion of the device was undertaken at a second visit in a dedicated IUD or Norplant implants clinic, at which time the suitability for the method was confirmed and counseling reinforced. Results were analyzed using the x2 test for discreet variables. A p ,0.01 was considered to be significant.
Results From August 1, 1993, to April 30, 1995, 502 women had Norplant implants inserted and were followed-up until the removal of the implant or to April 30, 1996; 45 (9%) of these women were lost to follow-up. A total of 253 new users of nonhormonal IUD were identified, of which 42 (16%) were lost to follow-up. Characteristics of Users Women who chose an IUD tended to be slightly older than women choosing Norplant implants (mean age 30.7 vs 27.2 years, respectively). Fifty-four percent of IUD users (p ,0.001) were over 30 years of age at the time of insertion compared with 30% of Norplant users. There were no differences in parity or number of liveborn children between women choosing different contraceptive methods. Women who chose Norplant implants were more likely to have been using the combined oral contraceptive pill at the time of choosing their new method than were IUD choosers (p ,0.001) who were more likely to be using condoms (p ,0.01). The most common reason for choosing Norplant implants was as an alternative to sterilization whereas that for choosing the IUD was because of dissatisfaction with other contraceptive methods. Insertions and Removals Figure 1 shows the cumulative number of insertions and removals of the two methods over the 33-month
Contraception 1998;57:19 –21
Figure 1. Cumulative number of insertions and removals of Norplant implants and nonhormonal IUDs over the 33-month study period (August 1, 1993 to May 1, 1995) in a large family planning clinic in Edinburgh, Scotland.
study period. An average of 10.3 (SD 4.0) IUD were inserted each month compared with 24 (SD 13.8) insertions of Norplant implants. Although a higher percentage of IUD were removed during the study, they were removed steadily at an average of 3.2 (SD 1.8) per month. Removals of Norplant implants increased with time with a mean monthly removal rate of 1.4 (SD 2.2) in the first 18 months and a mean of 7.8 (SD 3.8) in the subsequent 15 months. Continuation Rates Continuation rates were higher at all time points among users of Norplant implants. At 12 months, continuation rates were 84% for Norplant users compared with 70% for the IUD users, and at 18 months, were 80% for Norplant and 63% for the IUD. By 2 years after insertion, 71.8% of women were continuing to use Norplant implants compared with only 54.6% for IUD users (p ,0.001). Reasons for Discontinuation More than one reason was often cited for discontinuation of a method. For both methods, the predominant reason for removal was bleeding problems (Table 1). Users of Norplant implants experienced menstrual irregularity, whereas for IUD users menorrhagia was common. In 10 of the 16 cases in which pain was cited as a reason for IUD removal, this was associated with menorrhagia. Other reasons for removal of Norplant implants included mood swings, weight gain, and headaches. Only one woman having the Norplant implants removed cited recent adverse publicity as a reason for removal.
Contraception 1998;57:19 –21
NorplantT Implants Versus IUD Continuation Rates
Table 1. Reasons for removal of norplant implants (n 5 142) and iud (n 5 104) Reason Removed Bleeding problems Pain Planning pregnancy Pregnant Expulsion Infection Preferred sterilization Postcoital insertion Mood swings Weight gain Headache Acne Hair problems Relationship ended Adverse Publicity
Norplant Removals
IUD Removals
64 6 9 1* 0 0 6 0 47 23 19 11 5 3 1
40 16 17 4 8 7 4 6† 0 0 0 0 0 2 0
*Pregnancy undiagnosed at time of insertion. †IUD inserted post coitally, initially planned to continue but changed mind.
Discussion Continuation rates among women using Norplant implants were much higher than those for IUD users, which is reassuring to both providers and users particularly as the IUD is regarded as a very useful (although not widely used) method of contraception in the UK. There were no differences in the manner in which the two groups of women were counseled about their choice of method and counseling was undertaken by the same staff in the same clinic. Women using Norplant implants tended to be a little younger than IUD users but, implicit in their choosing between sterilization and Norplant implants, they were perhaps more likely to have completed their families. This is reflected in the higher number of removals among IUD users who were planning another pregnancy. Although the cost of the chosen method, together with fees for removal or insertion, may play a part in continuation rates in other countries such as the US, this is not the case in the UK where contraception is free to the user. However, providers do pay for the cost of contraception in their clinic budgets and they have become much more cost conscious in recent
21
years. A ‘‘trial’’ of an IUD (at , $16.50 per device) may be regarded as acceptable, whereas a trial of Norplant implants (at $280) would be quite unacceptable. The threshold for insertion and removal of IUD may thus be lower. Access to removal may also have influenced continuation rates. Although no fees are charged for either insertion or removal of either method, whereas most doctors are capable of removing an IUD, only a small number have been trained to remove the Norplant implants. A woman wishing to have her IUD removed can be seen by her family doctor or by a doctor at a family planning clinic. For Norplant implants users, removal requires a visit to one particular clinic that may be much less geographically convenient, thus encouraging women to postpone removal for a little longer. However, easy access to the implant clinic by telephone, by self-referral, or at the request of her general practitioner was offered at the time of insertion. Assurance was given that removal could be undertaken, if necessary within 1 week. In conclusion, comparison of discontinuation rates between Norplant implants and the IUD demonstrate that, contrary to popular belief, women who have been well counseled will manifest high Norplant implants continuation rates.
Acknowledgment We would like to thank Wendy Smith for assistance with data collection.
References 1. Roberts J. Women in US sue makers of Norplantt. Br Med J 1995;309:145. 2. Kolata G. Will the lawyers kill off Norplantt? After breast implants, American Home Products’ birth-control method is this year’s target. New York Times, Sunday, May 28, 1995. 3. Dyer C. Action against contraceptive implant threatened. Br Med J 1995;311:470. 4. Davie J, Hiremath K, Glasier A. The introduction of a new contraceptive implant; two years’ experience with Norplantt. Health Bull 1996;54:314 –7. 5. Peers T, Stevens JE, Graham J, Davey A. Norplantt implants in the UK: first year continuation and removals. Contraception 1996;53:345–51.