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Opinions in pediatric and adolescent gynecology
Adolesc Pediatr Gynecol (1995) 8:223-227
Adolescent and Pediatric Gynecology © 1995 Springer-Verlag New York Inc.
Opinions in Pediatric and Adolescent Gynecology Edited by Robert T . Brown, M.D. , Chief, Section of Adolescent Health, Professor of Clinical Pediatrics, Professor of Clinical Obstetrics & Gynecology, Ohio State University College of Medicine , Columbus, OH , and by Paula Hillard , M.D., Associate Professor, University of Cincinnati Medical Center, Department of Obstetrics & Gynecology , Department of Pediatrics , Cincinnati , OH Norplant for Adolescent Contraception: Yes or No Contraception for se xually active adolescents is problematic . The most popular method of contraception among adolescents is combination oral contraceptive s (OCs). With OCs, correct , consi stent. and ongoing use is problematic. The failure rate among typical adole scent users of OCs can be greater than 10% , du e primarily to missed pills and on-again/off-again use. The primary advantage of the progestin-only methods of contraception, Norplant and Depo-Provera (medroxyprogesterone), is ease of use. Compliance is much less likely to be a major problem . However, many clinicians hav e seen Norplant's popularit y initiall y wax, and later , wane . Drs . Barbara O'Connell and Paige Hertweck have writt en about the use of Norplant for adole scent contraception . Dr. O'Connell takes a positive po sition : that Norplant can be an ex cellent contraceptive choice for adol escents. Dr. Hertweck take s the negative position: that Norplant use by adole scents is ass ociated with a high risk of side effects which can lead to discontinuation . The middle position-which we believe both Drs. O'Connell and Hertweck would support- would say that appropriate counseling is necessary prior to the choice of an y method of contraception . Our patients must be aware of the potential side effects of Norplant as well as the potential risk s and side effects of other contraceptive methods (including the risk of pregnancy if the method chosen is not used consistently and correctly).
Norplant Use in the Adolescent Population: Pro Position In 1990 the Norplant (Wyeth-Ayerst Laboratories, Philadelphia) contraceptive system was approved for use in the United States by the Food and Drug Admini st ration. The Norplant device consists of six silastic rod s containing the progesterone , levonor-
gestrel. Norplant wa s felt to be an ideal contraceptive method for the adolescent population, secondar y to its long duration of action (5 years) and the fact that its effectiveness doe s not depend on patient compliance . Sinc e 1990, se ve ral studies have been publi shed evalu ating the use of Norplant in the adole scent population . Studies have revealed that proper patient sele ction and education are cruc ial for satisfactio n and continuation of the use of Norplant. Norplant is a valuable addition to the contraceptive methods available to the adolescent patient. A brief review of the literature on the use of Norplant in the adole scent population is presented. Berenson and Wiemann I were the first to report on side effects and satisfaction with Norplant in the adolescent age group . The y followed 21 adolescent s « 18 years old) and 30 adults ( > 19 years old ) over a 6-month period . The side effects reported by adole scents included abnormal men strual bleeding (71%), weight gain (38%) , emotional disturbances (33%) , and headaches (38%). Overall, 86% of adolescents were satisfied with Norplant and preferred it to their pre vious method , despite the side effects. Berenson and Wiemann have recentl y publi shed a case control study on the use of Norplant versu s oral contraceptives (OCPs) in adole scents. In this study 94 patients ~ 18 yea rs old who cho se Norplant were compared with the same number of agemat ched control s who selected OCPs , over a 6-month follow-up interval. The most frequently cited reasons for selecting Norplant were reliabilit y (40%), convenience (32%), and prior problems with OCP s (24%) . No patients had the Norplant removed during the 6-month follow-up compared to 43% OCP user s who discontinued the method. It is interesting to note that two of the adolescents who recei ved OCP s ne ver sta rted the medication , despite the fact that the y were given a supply prior to leaving the clinic. Six patients in the OCP group became pregnant , co mpared to none in the Norplant group. Satisfaction was reported by 93% of Norpl ant patients, despite the occurrence of side effects: menstrual irregularities (70%) , weight gain
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(52%), headaches (44%), and nervousness (15%). Patients who selected N orplant were more likely than those who chose OCP to have been pregnant or to have delivered a child. In other studies, Norplant has been chosen by patients who have experienced failures with other contraceptive methods. A prospective study conducted by Cromer et al. 3 compared patients choosing Norplant, Depo-Provera, or OCP. Adolescents who chose either Norplant (34%) or Depo-Provera (43%) were significantly more likely to have been pregnant previously than those choosing OCPs (12%). In addition, significantly more teens who chose Depo-Provera (30%) or Norplant (26%) reported problems with previous birth control methods compared with those choosing OCPs (8%). Adolescent mothers constitute a high-risk group for contraceptive failure, with 16-30% becoming pregnant within a year. 4.5 Adolescents who have one child may eventually attain levels of education and income similar to that achieved by their peers who delay childbearing, but adolescents who have more than one child within 5 years are more likely to be on welfare and discontinue their education.v" Polaneczky et al. 8 studied the use of Norplant for contraception in adolescent mothers. One hundred postpartum adolescents ('S 17 years old) who chose a contraceptive method were followed after delivery for an average of 15.5 months. The Norplant group was more likely to have conceived and given birth before the index pregnancy and to have used some type of birth control previously. At follow-up, 95% of those that chose Norplant were still using that method, compared with 33% of those who chose oral contraceptives. Interestingly, 24% of the OCP group never started their pills. Subjects in the Norplant group as compared with those in the OCP group were likely to be "very satisfied" with their choice of contraception. The risk of pregnancy within the first postpartum year was 2% in the Norplant group and 38% in the oral contraceptive group. In this group of high-risk adolescents, Norplant was a well accepted and reliable contraceptive method. Few studies have compared Norplant with DepoProvera in the adolescent population. Cromer et al' studied adolescents choosing Norplant, DepoProvera, or OCPs. Patients choosing Depo-Provera (73%) were more likely to have used another method of contraception than those choosing Norplant (30%) or OCP (26%). At 6-month follow-up, 60% of the Depo-Provera group were amenorrheic compared to 36% of the Norplant group. In regard to patient satisfaction, 25% of Norplant users were unhappy with their contraceptive choice, vs. 10% of Depo-Provera or OCP users, with the primary complaint being irregular bleeding.
Since Norplant is a progesterone-only contraceptive, it can be used by patients for whom estrogen use may be inadvisable. Medical conditions and situations in which the Norplant device may be advisable include systemic lupus erythematosus, hypertension, prior thromboembolism, mental disability, and drug addiction. Norplant can be considered for conditions in which pregnancy is associated with significant fetal and maternal morbidity, such as cardiovascular and pulmonary disease and teratogenic medication use." The issue of Norplant removal has received a great deal of attention in the lay press and has negatively affected the choice of Norplant as a contraceptive method among adolescent patients. Several class action suits have been filed in the United States against Wyeth-Ayerst by women who contend that they suffered injuries relating to removal of the implants. Unfortunately, the literature concerning Norplant removal is scant, and there are no specific studies aimed at adolescent patients. Dunson et al. 10 described the complications at removal of Norplant implants from 3416 users. Complications were reported in 4.5% of removals and were related most often to broken or deeply placed implants. The most important risk factors were complications at insertion and infection at the implant site. The conclusion of the article was that proper placement of the implants was the key to easy removal. In summary, Norplant is a reliable and safe contraceptive method for the adolescent population. It has been demonstrated in the studies reviewed that Norplant is chosen primarily by adolescent patients who have had difficulty with other contraceptive methods and have had previous pregnancies. For this group of patients, Norplant offers a convenient and effective alternative to other methods. Since side effects associated with the Norplant method, especially irregular bleeding, can reduce patient satisfaction, patient education and treatment are essential. References 1. BerensonAB, Wiemann CM: Patient satisfactionand
side effects with levonorgestrel implant (Norplant) use in adolescents 18 years of age or younger. Pediatrics 1993; 92:257 2. Berenson AB, Wiemann CM: Use of levonorgestrel implants versus oral contraceptives in adolescence: a case-control study. Am J Obstet Gynecol 1995; 172: 1128 3. Cromer BA, Smith RD, Blair JMc, et al: A prospective study of adolescents who choose among levonorgestrel implant (Norplant), medroxyprogesterone acetate (Depo-Provera), or the combined oral
Opinions in PAG
4. 5. 6. 7. 8. 9. 10.
contraceptive pill as contraception. Pediatrics 1994; 94:687 Zelnik M: Second pregnancies to premaritally pregnant teenagers, 1976 and 1971. Fam Plann Perspect 1980; 12:69 Ford K: Second pregnanciesamongteenage mothers. Fam Plann Perspect 1983; 15:268 Furstenberg FF Jr, Brooks-Gunn J, Morgan SP: Adolescent mothers and their children in later life. Fam Plann Perspect 1987; 19: 142 Mott FL: The pace of repeated childbearing among young American mothers. Fam Plann Perspect 1986; 18:5 Polaneczky M, Slap G, Forke C, et al: The use of levonorgestrel implants (Norplant) for contraception in adolescent mothers. N Engl J Med 1994; 331:1201 Darney PD: Hormonal implants: contraception for a new century. Am J Obstet Gynecol 1994; 170:1536 Dunson TR, Amatya RN, Krueger SL: Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995; 85:543 Barbara J. O'Connell, M.D.
Norplant: Reasons to Consider Not Using It in the Adolescent Patient N orplant (long-acting depo-Ievonorgestrel) has been well studied and found to be the most effective, reversible, long-term hormonal contraceptive method available in the adult population.l' Only recently has any data been presented regarding Norplant use in the adolescent patient. Norplant is especially suited for women who desire long-term, reversible contraception by means of a method that is independent of self or partner compliance or timing of coitus. These advantages would seem to indicate that Norplant might be the ideal contraceptive method for adolescents. However, the only prospective study to date of adolescents comparing those choosing Norplant, depomedroxyprogesterone acetate (Depo-Provera), or combined oral contraceptive pills (OCPs) provides some information to the contrary. In this study, Cromer and coworkers.' compared 78 OCP users with 66 DepoProvera users and 58 Norplant users. One-quarter of the Norplant users were unhappy with their choice of contraception vs. 10% of those on either Depo-Provera or OCPs, and significantly more patients receiving Norplant were unhappy with symptoms of vaginal bleeding, as compared with those in the other two treatment groups.
Menstrual Irregularity In the study of Cromer and co-workers, 40 adolescents evenly distributed across the three contracep-
225
tive groups (Norplant, Depo-Provera, and OCP) were interviewed at 6 months. One third of the adolescents, using Norplant, were amenorrheic at the first follow-up visit (3 months), and this percentage remained constant over the second 3-month interval. In contrast, the percentage of teens using Depo-Provera that was amenorrheic increased from 34% at the end of 3 months to 60% at the end of 6 months of treatment. The incidence of irregular bleeding in Norplant users occurred in about 30% of cases over the first 6 months vs. a decrease from 24 to 6% in Depo-Provera users at 3 and 6 months, respectively. This is in contrast to the fact that 90% of the adolescents using OCPs had regular cycles. In the case-control study of Berenson and Wiemann's," comparing adolescent Norplant users with adolescent combined OCP users over a 6-month period, menstrual irregularity was a side effect mentioned by 70% of Norplant users. Norplant users were five times more likely to report menstrual irregularity or spotting than OCP users. One quarter of Norplant users in the prospective evaluation of Cromer and co-workers were unhappy with their choice of contraception, as compared to 10% of those using Depo- Provera or OCP. Significantly more adolescents receiving Norplant were unhappy with vaginal bleeding (27%), as compared to the percentage of those in the other two treatment groups (DMPA, 8%; OCP, 12%).
Desire for Early Removal Fourteen percent (8 of 58) of adolescent patients in the study of Cromer and co-workers requested removal of their Norplant device with reasons stated that included uterine bleeding irregularity (n = 2), headache (n = 1), arm pain (n = 1), weight gain (n = 1), hair loss (n = 1), pregnancy (n = 1), and desire to have more children (n = 1). Four implants were removed in the study period. The average duration from insertion to removal was 11 months (range, 6-19 months).
Negative Influence on Compliance with Clinic Visits As stated by Cromer and co-workers," a potential concern with Norplant use is that because of its long-term effectiveness, patients may fail to return for routine care and, therefore, may miss early identification and management of problems such as sexually transmitted diseases and cervical dysplasia. The preliminary findings of Cromer and co-workers confirmed this concern in that only 40% of the Norplant patients returned at 6 months, which was
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about one half the percentage of those returning for Depo-Provera injections. They also found a low 6-month return for OCP users (46%). Appetite and Weight Increases Weight gain is another concern with adolescent patients using Norplant. Berenson and Weimann" noted that adolescent Norplant users reported an increase in appetite that was significantly greater than that of adolescent OCP users. Norplant users (n = 49) had an overall increase in weight of 6.4 ± 14.2 Ibs over 6 months vs. 1.3 ± 6.5 Ibs increase seen among OCP users (n = 37). Two Norplant patients had excessive weight gain of 36 and 82 Ibs. Even when these two patients were eliminated from the group and the data for the weight gain among the adolescent Norplant group was reevaluated, Norplant users gained significantly more weight than adolescent OCP users. These investigators found that when Norplant was placed within 6 weeks of pregnancy, Norplant users gained an average of 13.1 Ibs more than OCP patients.
Decreased Cost-Effectiveness A recent study" reported a cost comparison analysis of Norplant and Depo-Provera. Westfall and Main reported that over the course of 5 years the total cost of Norplant would be $533 while the cost of Depo-Provera would be $700, with the two respective annual costs being $107 and $140. Because of the initial cost of Norplant, if one were to project the cost of the implant and Depo-Provera by months of use, the implant would be less costly only when women used the implant for at least 48 months. When used for fewer than 48 months, Depo- Provera becomes less costly. Three international studies examining the length of implant use have found shorter average duration of use than 48 months (range, 27-37 monthsr.v" Using these discontinuation rates, Norplant could cost anywhere from $50 to $100 more per year than the injectable method of Depo-Provera. When the cost of the implant is evaluated on an annual per-woman cost of providing 5 years of contraceptive protection for 100 women, using the continuation rates of 85100%, it should be noted that when the continuation rate is maintained close to 100%, Norplant is more cost-effective than Depo-Provera. However, as the continuation rates drop lower than 95%, then DepoProvera becomes more cost effective. Annual continuation rates in the adult literature range from 92 to less than 90%. In an article by Cullins and co-
workers 12 on comparison of adolescent and adult experiences with Norplant, they report a continuation rate for adolescents and adults of 92 and 90% at 12 months and 89% for both groups at 18 months. If these continuation rates are accurate and are considered in the light of the previously quoted costanalysis study, then Norplant may not be the most cost-effective method of birth control in the adolescent patient. Similar findings were also the conclusion of a study concerning the cost-benefit analysis of DepoProvera in comparison with Norplant progesteroneonly oral contraceptive pills and combination oral contraceptive pills. 13 This study presented these data for a managed care setting." Possible Complications and Associated Risk with Removal A commonly accepted concept regarding the use of Norplant is that the removal procedure usually takes longer than insertion and is more likely to be complicated and difficult. The average time required to remove 6 capsules is 15-20 minutes.l" with some extreme cases requiring an hour or longer. 15 Complications occurring at Norplant removal are reported 4.5 to 6.2% of users. 16 Although there are no reports specifically addressing removal of Norplant in the adolescent patient, it is reasonable that a similar removal time and associated removal complications exist in the adolescent population. In cases where surgical removal is necessary or where local custom deems Norplant insertion/ removal a surgical procedure, the confidentiality of adolescent patients may be compromised. In summary, the need for reliable contraception in the adolescent patient has been well documented. Oral contraceptives with proven efficacy and ease of use are often the most frequently prescribed method for the adolescent patient. However, it has been documented that up to 50% of teenagers discontinue their use within 3 months of their initiation." While Norplant has many advantages, including 5 years of contraceptive efficacy and its being a method that does not rely on patient and partner compliance, there are considerable disadvantages in the adolescent. Altered menstrual patterns and the often resultant desire for early removal may decrease its cost effectiveness. Significant weight increases may be a result of treatment and may be worse for those postpartum teens who utilize Norplant in the immediate postpartum period. More long-term information regarding these findings is needed. When evaluating the available literature, one seems pointed toward the use of effective hor-
Opinions in PAG
monal methods that require less compliance, rather than toward that of oral contraceptives, the use of which is remote from coitus, such as in the method of Depo-Provera injections. This method may also be more cost effective and the associated menstrual irregularity more tolerable in the form of amenorrhea. Certainly, Norplant, with all of its advantages, is by no means a panacea. As health-care providers, we need to remember that Norplant is another contraceptive choice and should be offered to teenagers as one of many options available to them with appropriate education regarding possible complications and side effects. As always, with contraceptive devices the final choice must be the patient's.
References 1. Sivin I: International experience with Norplant and
Norplant-2 contraceptive. Stud Fam Plann 1988; 19: 81 2. Shoupe D, Mishell D: Norplant: Subdermal implant system for long term contraception. Am J Obstet Gynecol 1989; 160: 1286 3. Cromer BA, Smith RD, Blair JM, et al: A prospective study of adolescents who choose among levonorgestrel implant (Norplant), medroxyprogesterone acetate (Depo-Provera) or the combined oral contraceptive pill as contraception. Pediatrics 1994; 94:687 4. Berenson AB, Wiemann CM: Use of levonorgestrel implants versus oral contraceptives in adolescence: a case-control study. Am J Obstet Gynecol 1995; 172: 1128
5. Westfall JM, Main DS: The contraceptive implant and the injectable: a comparison of costs. Fam Plann Perspect 1995; 27:34. 6. Akhter H, Dunson TR, Amatya RN: A five-year clin-
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ical evaluation of Norplant contraceptive subdermal implants in Bangladesh acceptors. Contraception 1993; 47:569. 7. Sivin I, Stern J, Diaz S, et al: Rates and outcomes of planned pregnancy after use of Norplant capsules, Norplant II rods or levonorgestrel-releasing or copper TCU 880 ag intrauterine contraceptive devices. Am J Obstet Gynecol 1992; 166:1208 8. Konje JC, Odukoya OA, Otolorin EO, et al: Carbohydrate metabolism before and after Norplant removal. Contraception 1992; 46:61 9. Crosby UD, Schwarz BE, Gluck KL, et al: A preliminary report of Norplant insertions in a large urban family planning program. Contraception 1993; 48:359 10. Frank ML, Poindexter AN 3rd, Cornin LM, et al: One-year experience with subdermal contraceptive implants in the United States. Contraception 1993; 48:229 II. Kaeser L: Public funding and policies for provision of the contraceptive implant, fiscal year 1992. Fam Plann Perspect 1994; 26:11 12. Cullins VE, Remsburg RE, Blumenthal PD, et al: Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants. Obstet Gynecol 1994; 83:1026 13. Ortmeier BG, Sauer KA, Langley PC, et al: A cost benefit analysis offour hormonal contraceptive methods. Clin Ther 1994; 16:707. 14. Liskin L, Blackburn R, Ghagni R: Hormonal contraception: new long-acting methods. 1987. Population Reports; Series K, No.3. 15. Koetsawang A, Varakamin S, Satayapan S, Dutisin N: Norplant clinical study in Thailand. In: LongActing Contraceptive Delivery Systems. Edited by GI Satuchni, A Goldsmith, JD Shelton, JJ Sciarra. Philadelphia, PA, Harper & Row, 1984, pp 459-470. 16. Dunson TR, Anatya RN, Krueger SL: Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995; 85:543-548. S. Paige Hertweck, M.D.
Adolescent and Pediatric Gynecology © 1995 Springer-Verlag New York Inc.
Opinions in Pediatric and Adolescent Gynecology Edited by Robert T . Brown, M.D. , Chief, Section of Adolescent Health, Professor of Clinical Pediatrics, Professor of Clinical Obstetrics & Gynecology, Ohio State University College of Medicine , Columbus, OH , and by Paula Hillard , M.D., Associate Professor, University of Cincinnati Medical Center, Department of Obstetrics & Gynecology , Department of Pediatrics , Cincinnati , OH Norplant for Adolescent Contraception: Yes or No Contraception for se xually active adolescents is problematic . The most popular method of contraception among adolescents is combination oral contraceptive s (OCs). With OCs, correct , consi stent. and ongoing use is problematic. The failure rate among typical adole scent users of OCs can be greater than 10% , du e primarily to missed pills and on-again/off-again use. The primary advantage of the progestin-only methods of contraception, Norplant and Depo-Provera (medroxyprogesterone), is ease of use. Compliance is much less likely to be a major problem . However, many clinicians hav e seen Norplant's popularit y initiall y wax, and later , wane . Drs . Barbara O'Connell and Paige Hertweck have writt en about the use of Norplant for adole scent contraception . Dr. O'Connell takes a positive po sition : that Norplant can be an ex cellent contraceptive choice for adol escents. Dr. Hertweck take s the negative position: that Norplant use by adole scents is ass ociated with a high risk of side effects which can lead to discontinuation . The middle position-which we believe both Drs. O'Connell and Hertweck would support- would say that appropriate counseling is necessary prior to the choice of an y method of contraception . Our patients must be aware of the potential side effects of Norplant as well as the potential risk s and side effects of other contraceptive methods (including the risk of pregnancy if the method chosen is not used consistently and correctly).
Norplant Use in the Adolescent Population: Pro Position In 1990 the Norplant (Wyeth-Ayerst Laboratories, Philadelphia) contraceptive system was approved for use in the United States by the Food and Drug Admini st ration. The Norplant device consists of six silastic rod s containing the progesterone , levonor-
gestrel. Norplant wa s felt to be an ideal contraceptive method for the adolescent population, secondar y to its long duration of action (5 years) and the fact that its effectiveness doe s not depend on patient compliance . Sinc e 1990, se ve ral studies have been publi shed evalu ating the use of Norplant in the adole scent population . Studies have revealed that proper patient sele ction and education are cruc ial for satisfactio n and continuation of the use of Norplant. Norplant is a valuable addition to the contraceptive methods available to the adolescent patient. A brief review of the literature on the use of Norplant in the adole scent population is presented. Berenson and Wiemann I were the first to report on side effects and satisfaction with Norplant in the adolescent age group . The y followed 21 adolescent s « 18 years old) and 30 adults ( > 19 years old ) over a 6-month period . The side effects reported by adole scents included abnormal men strual bleeding (71%), weight gain (38%) , emotional disturbances (33%) , and headaches (38%). Overall, 86% of adolescents were satisfied with Norplant and preferred it to their pre vious method , despite the side effects. Berenson and Wiemann have recentl y publi shed a case control study on the use of Norplant versu s oral contraceptives (OCPs) in adole scents. In this study 94 patients ~ 18 yea rs old who cho se Norplant were compared with the same number of agemat ched control s who selected OCPs , over a 6-month follow-up interval. The most frequently cited reasons for selecting Norplant were reliabilit y (40%), convenience (32%), and prior problems with OCP s (24%) . No patients had the Norplant removed during the 6-month follow-up compared to 43% OCP user s who discontinued the method. It is interesting to note that two of the adolescents who recei ved OCP s ne ver sta rted the medication , despite the fact that the y were given a supply prior to leaving the clinic. Six patients in the OCP group became pregnant , co mpared to none in the Norplant group. Satisfaction was reported by 93% of Norpl ant patients, despite the occurrence of side effects: menstrual irregularities (70%) , weight gain
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(52%), headaches (44%), and nervousness (15%). Patients who selected N orplant were more likely than those who chose OCP to have been pregnant or to have delivered a child. In other studies, Norplant has been chosen by patients who have experienced failures with other contraceptive methods. A prospective study conducted by Cromer et al. 3 compared patients choosing Norplant, Depo-Provera, or OCP. Adolescents who chose either Norplant (34%) or Depo-Provera (43%) were significantly more likely to have been pregnant previously than those choosing OCPs (12%). In addition, significantly more teens who chose Depo-Provera (30%) or Norplant (26%) reported problems with previous birth control methods compared with those choosing OCPs (8%). Adolescent mothers constitute a high-risk group for contraceptive failure, with 16-30% becoming pregnant within a year. 4.5 Adolescents who have one child may eventually attain levels of education and income similar to that achieved by their peers who delay childbearing, but adolescents who have more than one child within 5 years are more likely to be on welfare and discontinue their education.v" Polaneczky et al. 8 studied the use of Norplant for contraception in adolescent mothers. One hundred postpartum adolescents ('S 17 years old) who chose a contraceptive method were followed after delivery for an average of 15.5 months. The Norplant group was more likely to have conceived and given birth before the index pregnancy and to have used some type of birth control previously. At follow-up, 95% of those that chose Norplant were still using that method, compared with 33% of those who chose oral contraceptives. Interestingly, 24% of the OCP group never started their pills. Subjects in the Norplant group as compared with those in the OCP group were likely to be "very satisfied" with their choice of contraception. The risk of pregnancy within the first postpartum year was 2% in the Norplant group and 38% in the oral contraceptive group. In this group of high-risk adolescents, Norplant was a well accepted and reliable contraceptive method. Few studies have compared Norplant with DepoProvera in the adolescent population. Cromer et al' studied adolescents choosing Norplant, DepoProvera, or OCPs. Patients choosing Depo-Provera (73%) were more likely to have used another method of contraception than those choosing Norplant (30%) or OCP (26%). At 6-month follow-up, 60% of the Depo-Provera group were amenorrheic compared to 36% of the Norplant group. In regard to patient satisfaction, 25% of Norplant users were unhappy with their contraceptive choice, vs. 10% of Depo-Provera or OCP users, with the primary complaint being irregular bleeding.
Since Norplant is a progesterone-only contraceptive, it can be used by patients for whom estrogen use may be inadvisable. Medical conditions and situations in which the Norplant device may be advisable include systemic lupus erythematosus, hypertension, prior thromboembolism, mental disability, and drug addiction. Norplant can be considered for conditions in which pregnancy is associated with significant fetal and maternal morbidity, such as cardiovascular and pulmonary disease and teratogenic medication use." The issue of Norplant removal has received a great deal of attention in the lay press and has negatively affected the choice of Norplant as a contraceptive method among adolescent patients. Several class action suits have been filed in the United States against Wyeth-Ayerst by women who contend that they suffered injuries relating to removal of the implants. Unfortunately, the literature concerning Norplant removal is scant, and there are no specific studies aimed at adolescent patients. Dunson et al. 10 described the complications at removal of Norplant implants from 3416 users. Complications were reported in 4.5% of removals and were related most often to broken or deeply placed implants. The most important risk factors were complications at insertion and infection at the implant site. The conclusion of the article was that proper placement of the implants was the key to easy removal. In summary, Norplant is a reliable and safe contraceptive method for the adolescent population. It has been demonstrated in the studies reviewed that Norplant is chosen primarily by adolescent patients who have had difficulty with other contraceptive methods and have had previous pregnancies. For this group of patients, Norplant offers a convenient and effective alternative to other methods. Since side effects associated with the Norplant method, especially irregular bleeding, can reduce patient satisfaction, patient education and treatment are essential. References 1. BerensonAB, Wiemann CM: Patient satisfactionand
side effects with levonorgestrel implant (Norplant) use in adolescents 18 years of age or younger. Pediatrics 1993; 92:257 2. Berenson AB, Wiemann CM: Use of levonorgestrel implants versus oral contraceptives in adolescence: a case-control study. Am J Obstet Gynecol 1995; 172: 1128 3. Cromer BA, Smith RD, Blair JMc, et al: A prospective study of adolescents who choose among levonorgestrel implant (Norplant), medroxyprogesterone acetate (Depo-Provera), or the combined oral
Opinions in PAG
4. 5. 6. 7. 8. 9. 10.
contraceptive pill as contraception. Pediatrics 1994; 94:687 Zelnik M: Second pregnancies to premaritally pregnant teenagers, 1976 and 1971. Fam Plann Perspect 1980; 12:69 Ford K: Second pregnanciesamongteenage mothers. Fam Plann Perspect 1983; 15:268 Furstenberg FF Jr, Brooks-Gunn J, Morgan SP: Adolescent mothers and their children in later life. Fam Plann Perspect 1987; 19: 142 Mott FL: The pace of repeated childbearing among young American mothers. Fam Plann Perspect 1986; 18:5 Polaneczky M, Slap G, Forke C, et al: The use of levonorgestrel implants (Norplant) for contraception in adolescent mothers. N Engl J Med 1994; 331:1201 Darney PD: Hormonal implants: contraception for a new century. Am J Obstet Gynecol 1994; 170:1536 Dunson TR, Amatya RN, Krueger SL: Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995; 85:543 Barbara J. O'Connell, M.D.
Norplant: Reasons to Consider Not Using It in the Adolescent Patient N orplant (long-acting depo-Ievonorgestrel) has been well studied and found to be the most effective, reversible, long-term hormonal contraceptive method available in the adult population.l' Only recently has any data been presented regarding Norplant use in the adolescent patient. Norplant is especially suited for women who desire long-term, reversible contraception by means of a method that is independent of self or partner compliance or timing of coitus. These advantages would seem to indicate that Norplant might be the ideal contraceptive method for adolescents. However, the only prospective study to date of adolescents comparing those choosing Norplant, depomedroxyprogesterone acetate (Depo-Provera), or combined oral contraceptive pills (OCPs) provides some information to the contrary. In this study, Cromer and coworkers.' compared 78 OCP users with 66 DepoProvera users and 58 Norplant users. One-quarter of the Norplant users were unhappy with their choice of contraception vs. 10% of those on either Depo-Provera or OCPs, and significantly more patients receiving Norplant were unhappy with symptoms of vaginal bleeding, as compared with those in the other two treatment groups.
Menstrual Irregularity In the study of Cromer and co-workers, 40 adolescents evenly distributed across the three contracep-
225
tive groups (Norplant, Depo-Provera, and OCP) were interviewed at 6 months. One third of the adolescents, using Norplant, were amenorrheic at the first follow-up visit (3 months), and this percentage remained constant over the second 3-month interval. In contrast, the percentage of teens using Depo-Provera that was amenorrheic increased from 34% at the end of 3 months to 60% at the end of 6 months of treatment. The incidence of irregular bleeding in Norplant users occurred in about 30% of cases over the first 6 months vs. a decrease from 24 to 6% in Depo-Provera users at 3 and 6 months, respectively. This is in contrast to the fact that 90% of the adolescents using OCPs had regular cycles. In the case-control study of Berenson and Wiemann's," comparing adolescent Norplant users with adolescent combined OCP users over a 6-month period, menstrual irregularity was a side effect mentioned by 70% of Norplant users. Norplant users were five times more likely to report menstrual irregularity or spotting than OCP users. One quarter of Norplant users in the prospective evaluation of Cromer and co-workers were unhappy with their choice of contraception, as compared to 10% of those using Depo- Provera or OCP. Significantly more adolescents receiving Norplant were unhappy with vaginal bleeding (27%), as compared to the percentage of those in the other two treatment groups (DMPA, 8%; OCP, 12%).
Desire for Early Removal Fourteen percent (8 of 58) of adolescent patients in the study of Cromer and co-workers requested removal of their Norplant device with reasons stated that included uterine bleeding irregularity (n = 2), headache (n = 1), arm pain (n = 1), weight gain (n = 1), hair loss (n = 1), pregnancy (n = 1), and desire to have more children (n = 1). Four implants were removed in the study period. The average duration from insertion to removal was 11 months (range, 6-19 months).
Negative Influence on Compliance with Clinic Visits As stated by Cromer and co-workers," a potential concern with Norplant use is that because of its long-term effectiveness, patients may fail to return for routine care and, therefore, may miss early identification and management of problems such as sexually transmitted diseases and cervical dysplasia. The preliminary findings of Cromer and co-workers confirmed this concern in that only 40% of the Norplant patients returned at 6 months, which was
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about one half the percentage of those returning for Depo-Provera injections. They also found a low 6-month return for OCP users (46%). Appetite and Weight Increases Weight gain is another concern with adolescent patients using Norplant. Berenson and Weimann" noted that adolescent Norplant users reported an increase in appetite that was significantly greater than that of adolescent OCP users. Norplant users (n = 49) had an overall increase in weight of 6.4 ± 14.2 Ibs over 6 months vs. 1.3 ± 6.5 Ibs increase seen among OCP users (n = 37). Two Norplant patients had excessive weight gain of 36 and 82 Ibs. Even when these two patients were eliminated from the group and the data for the weight gain among the adolescent Norplant group was reevaluated, Norplant users gained significantly more weight than adolescent OCP users. These investigators found that when Norplant was placed within 6 weeks of pregnancy, Norplant users gained an average of 13.1 Ibs more than OCP patients.
Decreased Cost-Effectiveness A recent study" reported a cost comparison analysis of Norplant and Depo-Provera. Westfall and Main reported that over the course of 5 years the total cost of Norplant would be $533 while the cost of Depo-Provera would be $700, with the two respective annual costs being $107 and $140. Because of the initial cost of Norplant, if one were to project the cost of the implant and Depo-Provera by months of use, the implant would be less costly only when women used the implant for at least 48 months. When used for fewer than 48 months, Depo- Provera becomes less costly. Three international studies examining the length of implant use have found shorter average duration of use than 48 months (range, 27-37 monthsr.v" Using these discontinuation rates, Norplant could cost anywhere from $50 to $100 more per year than the injectable method of Depo-Provera. When the cost of the implant is evaluated on an annual per-woman cost of providing 5 years of contraceptive protection for 100 women, using the continuation rates of 85100%, it should be noted that when the continuation rate is maintained close to 100%, Norplant is more cost-effective than Depo-Provera. However, as the continuation rates drop lower than 95%, then DepoProvera becomes more cost effective. Annual continuation rates in the adult literature range from 92 to less than 90%. In an article by Cullins and co-
workers 12 on comparison of adolescent and adult experiences with Norplant, they report a continuation rate for adolescents and adults of 92 and 90% at 12 months and 89% for both groups at 18 months. If these continuation rates are accurate and are considered in the light of the previously quoted costanalysis study, then Norplant may not be the most cost-effective method of birth control in the adolescent patient. Similar findings were also the conclusion of a study concerning the cost-benefit analysis of DepoProvera in comparison with Norplant progesteroneonly oral contraceptive pills and combination oral contraceptive pills. 13 This study presented these data for a managed care setting." Possible Complications and Associated Risk with Removal A commonly accepted concept regarding the use of Norplant is that the removal procedure usually takes longer than insertion and is more likely to be complicated and difficult. The average time required to remove 6 capsules is 15-20 minutes.l" with some extreme cases requiring an hour or longer. 15 Complications occurring at Norplant removal are reported 4.5 to 6.2% of users. 16 Although there are no reports specifically addressing removal of Norplant in the adolescent patient, it is reasonable that a similar removal time and associated removal complications exist in the adolescent population. In cases where surgical removal is necessary or where local custom deems Norplant insertion/ removal a surgical procedure, the confidentiality of adolescent patients may be compromised. In summary, the need for reliable contraception in the adolescent patient has been well documented. Oral contraceptives with proven efficacy and ease of use are often the most frequently prescribed method for the adolescent patient. However, it has been documented that up to 50% of teenagers discontinue their use within 3 months of their initiation." While Norplant has many advantages, including 5 years of contraceptive efficacy and its being a method that does not rely on patient and partner compliance, there are considerable disadvantages in the adolescent. Altered menstrual patterns and the often resultant desire for early removal may decrease its cost effectiveness. Significant weight increases may be a result of treatment and may be worse for those postpartum teens who utilize Norplant in the immediate postpartum period. More long-term information regarding these findings is needed. When evaluating the available literature, one seems pointed toward the use of effective hor-
Opinions in PAG
monal methods that require less compliance, rather than toward that of oral contraceptives, the use of which is remote from coitus, such as in the method of Depo-Provera injections. This method may also be more cost effective and the associated menstrual irregularity more tolerable in the form of amenorrhea. Certainly, Norplant, with all of its advantages, is by no means a panacea. As health-care providers, we need to remember that Norplant is another contraceptive choice and should be offered to teenagers as one of many options available to them with appropriate education regarding possible complications and side effects. As always, with contraceptive devices the final choice must be the patient's.
References 1. Sivin I: International experience with Norplant and
Norplant-2 contraceptive. Stud Fam Plann 1988; 19: 81 2. Shoupe D, Mishell D: Norplant: Subdermal implant system for long term contraception. Am J Obstet Gynecol 1989; 160: 1286 3. Cromer BA, Smith RD, Blair JM, et al: A prospective study of adolescents who choose among levonorgestrel implant (Norplant), medroxyprogesterone acetate (Depo-Provera) or the combined oral contraceptive pill as contraception. Pediatrics 1994; 94:687 4. Berenson AB, Wiemann CM: Use of levonorgestrel implants versus oral contraceptives in adolescence: a case-control study. Am J Obstet Gynecol 1995; 172: 1128
5. Westfall JM, Main DS: The contraceptive implant and the injectable: a comparison of costs. Fam Plann Perspect 1995; 27:34. 6. Akhter H, Dunson TR, Amatya RN: A five-year clin-
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ical evaluation of Norplant contraceptive subdermal implants in Bangladesh acceptors. Contraception 1993; 47:569. 7. Sivin I, Stern J, Diaz S, et al: Rates and outcomes of planned pregnancy after use of Norplant capsules, Norplant II rods or levonorgestrel-releasing or copper TCU 880 ag intrauterine contraceptive devices. Am J Obstet Gynecol 1992; 166:1208 8. Konje JC, Odukoya OA, Otolorin EO, et al: Carbohydrate metabolism before and after Norplant removal. Contraception 1992; 46:61 9. Crosby UD, Schwarz BE, Gluck KL, et al: A preliminary report of Norplant insertions in a large urban family planning program. Contraception 1993; 48:359 10. Frank ML, Poindexter AN 3rd, Cornin LM, et al: One-year experience with subdermal contraceptive implants in the United States. Contraception 1993; 48:229 II. Kaeser L: Public funding and policies for provision of the contraceptive implant, fiscal year 1992. Fam Plann Perspect 1994; 26:11 12. Cullins VE, Remsburg RE, Blumenthal PD, et al: Comparison of adolescent and adult experiences with Norplant levonorgestrel contraceptive implants. Obstet Gynecol 1994; 83:1026 13. Ortmeier BG, Sauer KA, Langley PC, et al: A cost benefit analysis offour hormonal contraceptive methods. Clin Ther 1994; 16:707. 14. Liskin L, Blackburn R, Ghagni R: Hormonal contraception: new long-acting methods. 1987. Population Reports; Series K, No.3. 15. Koetsawang A, Varakamin S, Satayapan S, Dutisin N: Norplant clinical study in Thailand. In: LongActing Contraceptive Delivery Systems. Edited by GI Satuchni, A Goldsmith, JD Shelton, JJ Sciarra. Philadelphia, PA, Harper & Row, 1984, pp 459-470. 16. Dunson TR, Anatya RN, Krueger SL: Complications and risk factors associated with the removal of Norplant implants. Obstet Gynecol 1995; 85:543-548. S. Paige Hertweck, M.D.