Norplant Use Research Articles

Levonorgestrel Contraceptive Implants in Female Patients 14 to 21 Years Old

To determine which factors are associated with duration of use of a levonorgestrel implant (Norplant) for contraception in adolescents and young adults. We retrospectively studied 144 young women (14 to 21 years of age) who chose a levonorgestrel contraceptive implant at Mayo Clinic Rochester between April 1990 and December 1993. The following information was obtained at the time of insertion of the implant and from any follow-up visits: demographics, prior contraceptive experiences, frequency and management of complications, complications noted at removal of the implant, and subsequent contraceptive choice. The duration of use was examined. Of the 144 young women who underwent insertion of a Norplant system, 75 telephoned or made a medical appointment because of implant-related side effects. During the follow-up period, 64 patients had the Norplant system removed. The Kaplan-Meier estimate of the probability of the Norplant system remaining in place for at least 12 months was 83 % and for at least 24 months was 63 %. Duration of Norplant use was not found to differ with respect to age, prior contraceptive use, or timing of insertion, but it was significantly shorter among those with a prior pregnancy than in those who had never been pregnant. These findings suggest that a group of young women who are likely to continue use of a contraceptive implant (with or without treatment for side effects) are those who have never been pregnant.

Social factors predicting postpartum choice of norplant among African-American and non-hispanic white adolescents

This study was designed to determine the factors associated with Norplant choice for postpartum teens. A total of 151 teenagers, ages 12-20 years, who delivered at the Medical Center of Delaware from July to December 1992, were offered insertion of Norplant within 48 h postpartum. A structured interview was conducted in the postpartum period after nondirective counseling sessions including a physical demonstration using anatomical models of various contraceptive methods. Student's t-tests, chi-square, and multivariate analyses were used. Eighty-six teenagers were African-American (mean age = 17.3 +/- 1.9 years) and 65 non-Hispanic white (NHW) (mean age = 18.3 +/- 1.5 years). The NHW teenagers were older (p < 0.001); the African-American teenagers were more likely to have Medicaid (49% vs. 14%; p < 0.001) and to have one or more friends who use Norplant (62% vs. 34%; p < 0.001). In multivariate analyses, NHW teenagers were more likely to choose Norplant if they had discussed their choice with a parent or guardian [adjusted odds ratio (AOR) = 14.6, 95% confidence interval (CI), 2.12-100.57]; had Medicaid funding (AOR = 12.1; 95% (CI), 10.6-91.34); and had any friends who used Norplant (AOR = 6.3; 95% (CI), 1.38-28.40). However, for African-American teenagers, the strongest predictor for choice of Norplant was number of prior children delivered. After two deliveries, there was a better than four-fold likelihood (AOR = 4.8; 95% (CI), 1.47-15.94) that African-American teenagers would choose Norplant. For the African-American teenagers, parental discussion, Medicaid status, and friends' use of Norplant were not as important as family size, but far greater percentages of the African-American teenagers had access to Medicaid funding and peers who used Norplant. NHW and African-American teenagers choose Norplant for different reasons. Lack of funding may have been a barrier to choosing Norplant. Discussions with parents and friends have a positive influence on choosing Norplant for NHW teenagers. African-American teenagers were more likely than NHW to have Medicaid coverage, and more frequently choose Norplant if the current birth was their third child.

Unplanned Pregnancy Following Norplant Removal in Adolescents and Adults

Background Norplant is a user-independent subdennal contraceptive composed of six silastic, levonorgestrel containing capsules. Previously reported data demonstrated that the majority of women in our population chose Norplant within one year of a pregnancy (89% of adolescents and 69% of adults); 65% of these women initially became pregnant while using oral contraceptives. The purpose of this study is to prospectively compare the length of time between Norplant removal and unplanned pregnancy in adolescent ( Methods Women using Norplant are prospectively followed from device insertion through removal and subsequent annual examinations as part of an ongoing study. Patient data is collected by personal interview and chart review and entered into a computer database. Data is evaluated for significance by chi-square analysis where p Results Post-removal follow-up data for between 11 and 62 months is currently available for 367 Norplant removals (125 adolescents, 212 adults, and 30 individuals with incomplete data). The average length of follow-up is 24.8 months with a standard deviation of 9.9 months. There have been 41 pregnaneies to date following Norplant removal (18 adolescents and 23 adults). Thirty six (88%) of these pregnancies were unplanned (15 adolescents and 21 adults). The average length of time from device removal to unplanned pregnancy was 4.7 months in adolescents and 5.3 months in adults. Eighty seven percent of adolescent and 57% of adult unplanned pregnancies occurred following device removal despite placement on oral contraceptives. Conclusions Adolescent women discontinuing Norplant use are no more likely to experience unplanned pregnancy than adults. Women experiencing oral contraceptive failure are likely to experience repeat oral contraceptive failure. In this population, user dependent contraceptive methods are less reliable than user independent contraceptive methods.

Does Licensing of Drugs in Industrialized Countries Guarantee Drug Quality and Safety for Third World Countries? The Case of Norplant Licensing in Finland

Norplant implantable contraceptives were developed mainly for use in Third World countries, but first were approved for marketing in Finland in 1983 and in Sweden in 1985. Since then Norplant has been approved in more than 40 countries, most of them in the Third World. The authors analyzed the clinical documentation submitted to the Finnish and Swedish drug control authorities, and the assessments made of the data. The Finnish review process lasted for three years, and the number of data increased substantially during that time. The authors have not been allowed to publish the clinical data submitted in Finland, but a reconstruction from the Swedish data showed that the clinical data were of poor quality and were mainly focused on assessing efficacy. Side effects, acceptability, and requirements of the health care system for proper use of Norplant were poorly studied. This example of Norplant licensing in Finland shows that licensing of drugs in industrialized countries is insufficient for guaranteeing their safety in Third World countries.

Topics for our times: Norplant coercion--an overstated threat.

The identification of the contraceptive implant Norplant as an agent of coercion has been unfortunate. While legislators in 13 states have proposed bills which would require Norplant acceptance as a condition of receiving welfare payments or would provide financial incentives to women on welfare for accepting the contraceptive none has been enacted into law. In addition early attempts by the judicial system to force use of Norplant (for example as a condition of probation) have abated and have been met with disapprobation. The public efforts to use Norplant in a coercive fashion caused concern about whether health care providers were exerting pressure upon women to accept the method. A study involving a sample of over 2000 low-income women in three large urban areas of the US who were choosing a contraceptive method (with an oversampling of those who choose Norplant) revealed that health care providers are not pressuring women to accept the method. Only three of the 45% who accepted Norplant felt any pressure. One choose sterilization and the other two reported that they had to return to the clinic a number of times before insertion. Women indicated that they choose Norplant because of convenience effectiveness and duration. Norplant acceptors had to make more clinic visits than oral contraceptive (OC) acceptors and received an average of 22 minutes more counseling than OC acceptors. Fears about coercion haunt all long-acting methods and have overshadowed the desires of many women who welcome such methods. A balance must be struck between prevention of coercion and guarantee of access.

Contraceptive implants: long acting and provider dependent contraception raises concerns about freedom of choice.

David Bromham's editorial on contraceptive implants ignores the wider issues to voice concern that trial by media could limit contraceptive choice by jeopardising research into new methods. However, it is more beneficial to the public for points of conflict to be debated openly. Furthermore, the impetus for research into new contraceptive technology is driven by profit and political motives and is only marginally affected by the media. Implanted contraceptives may increase the choice of contraceptive methods, but they put control of fertility increasingly into the hands of the medical profession. Herein lies their greatest problem: their potential to increase providers' control over clients' choice. There is the danger that certain groups of women may be targeted for their use: in the United States the coercive use of Norplant for mothers receiving welfare benefit has been suggested. Long acting contraceptives are a contraceptive of choice only when they are available without pressure, as part of a wider menu; when instant removal on request is guaranteed; and when there is an open and free flow of information and opinions between users, health professionals, and special interest groups.

Endometrial angiogenic response in Norplant users.

The levonorgestrel-releasing subdermal contraceptive implant Norplant is well accepted among Indonesian users, despite the problems with irregular and prolonged menstrual bleeding. Bleeding can be the major reason for women discontinuing their use of Norplant. The causes of endometrial bleeding may include disturbances in endometrial regeneration and angiogenesis. The aim of this study was to investigate endometrial angiogenic activity in Norplant users and to compare it to that in the normal menstrual cycle. The study also aimed to determine the correlation between endometrial angiogenic activity and plasma concentrations of oestradiol, progesterone, sex hormone binding globulin and levonorgestrel, as well as the free levonorgestrel index. The subjects for this study were selected from Norplant users with an exposure of between 3 and 12 months. Endometrial angiogenic response was assayed using an endothelial cell migration assay. Six blood samples to monitor oestradiol and progesterone concentrations were taken during the 2 weeks prior to endometrial biopsy. Samples for the analysis of sex hormone binding globulin and levonorgestrel were taken on the day of biopsy. The results showed that the median score of endometrial angiogenic activity in the 30 women used as controls were significantly higher than the 40 Norplant acceptors (z = -3.80, one tail, P < 0.001). There was no significant correlation between the endothelial migration score and peripheral hormonal concentrations or the free levonorgestrel index in Norplant users. There was no difference in the endometrial angiogenic activity in endometrium with and without bleeding problems. However, it is interesting to note that four Norplant acceptors who had an endothelial cell migration score > or = 1.0 had the lowest free levonorgestrel index.

Use of norplant in women with or at-risk for noninsulin-dependent diabetes

This review addresses the use of Norplant in women with or at-risk for noninsulin-dependent diabetes mellitus (NIDDM). Background information on NIDDM is given, including pathogenesis, effect on glucose and lipid metabolism, and management. The effect of exogenous estrogen and progestogens on glucose tolerance is briefly discussed. In reviewing the effects of Norplant on glucose metabolism, studies on women with normal glucose tolerance were reviewed, along with the one study of Norplant use in women with a past history of gestational diabetes. Norplant does have a minor effect on glucose metabolism. Studies are contradictory regarding lipid metabolism but most suggest that Norplant does not have a negative effect on the high density lipoprotein/total cholesterol ratio. Factors influencing contraceptive choice are reviewed. Protocols for management of Norplant in women with or at-risk for NIDDM are then presented, followed by a case study and a brief discussion. OCP use by women with specific conditions in estimating the potential effects of Norplant use on these conditions. One of these difficult areas is the use of Norplant in women with noninsulin-dependent diabetes mellitus (NIDDM) or in women who are at-risk for NIDDM, ie, those with impaired glucose tolerance (IGT), those with a history of gestational diabetes mellitus (GDM), and those at-risk due to other factors. This article will address the research done with Norplant so as to come to some conclusions regarding the safety of Norplant use in these groups of women.

Adolescents' reasons for and experience after discontinuation of the long-acting contraceptives depo-provera and norplant

The objectives of this study were to examine the reasons for discontinuation of the long-acting contraceptives Depo-Provera and Norplant in adolescents, and to assess the adolescents' experience after discontinuation of the methods. A total of 35 adolescents [gynecologic age 4.7 +/- 0.3 years, and body mass index (BMI) 24.2 +/- 0.6] who discontinued Depo-Provera, and 31 adolescents (gynecologic age 3.4 +/- 0.3 years, BMI 24.1 +/- 0.9) who discontinued Norplant were periodically assessed during use of the methods and up to 12 months after discontinuation. The most common reasons for discontinuation of both Norplant (after 21.8 +/- 1.6 months of use) and Depo-Provera (9.2 + 0.9 months of use) were irregular menstrual bleeding (64%), weight gain (41%), and increased headaches (30%). Resumption of menstrual regularity and dysmenorrhea was noted sooner after discontinuation of Norplant, compared with Depo-Provera. The increase in BMI noted at discontinuation of Depo-Provera (1.1, P = .0005) and Norplant (1.3, P = .03) persisted up to 6 months after discontinuation of either method (0.6, P = .01 post-Depo-Provera discontinuation; and 0.9, P = 0.02 post-Norplant discontinuation). Only 62% of the adolescents reported no break in contraceptive practice. The condom was the most popular method (37%) after discontinuation of Depo-Provera, and oral contraceptive (39%) after discontinuation of Norplant. The cumulative conception proportion reached 0.93 at 12 months after discontinuation of Norplant, and was significantly higher (P = .01) compared with the cumulative proportion of conception after discontinuation of Depo-Provera (P = .50). Health care providers should aggressively manage physical problems associated with Depo-Provera and Norplant use, and expedite the transition to a new contraceptive method to minimize the high pregnancy rate observed after discontinuation of these methods in adolescents.

Norplant vs. oral contraceptive use by adolescent mothers: Long term outcome

Norplant vs. oral contraceptive use by adolescent mothers: Long term outcome

Materials, methods and results of the Norplant training program.

Norplant subdermal implants for contraception were introduced into UK clinical practice in October 1993. Use of Norplant requires providers to learn additional skills. A training program designed to give providers to opportunity to obtain these skills was designed and implemented through the co-operation of Hoechst Roussel, JHPIEGO and members of the UK medical profession. Uptake of training for Norplant provision has been widespread and Norplant has been established as a realistic contraceptive choice for women in the UK. Introduction of Norplant in the UK has raised many issues that go beyond clinical considerations.

Social and health policy concerns raised by the introduction of the contraceptive Norplant.

Norplant has been hailed as a vast improvement over other contraceptive devices since its approval by the U.S. Food and Drug Administration in 1990. Studies of Norplant's performance and acceptability demonstrate that it is very effective in preventing pregnancy, that its effects are rapidly reversible, and that women are willing to tolerate its common side effects to receive the benefits of the device. Despite its many positive features, a number of social and health policy concerns about Norplant's use must be addressed. This article focuses on three of those concerns: accessibility, potential for coercive use, and use of Norplant as a social remedy.

Norplant use by adolscents: Viewpoints of three stakeholder groups

In the months following FDA approval of Norplant, discussions of the controversies surrounding its introduction took place largely in newspaper and magazine articles detailing interviews with legal and health professionals and scientists who developed the device. This qualitative study brings the viewpoints of selected groups of consumers, reproductive health care workers, and local policy makers to the public discussions of Norplant. This article explores one of several themes raised by study participants--Norplant use by adolescents. Eighteen different focused group interviews were conducted in California between November 1991 and November 1992. A total of 146 individuals attended--63 consumers, 44 health care providers, and 39 policy makers. Participants included consumers identified as so-called "targets" of Norplant use, individuals providing reproductive health services, and individuals in policy and decision-making roles. Participants in all the focus groups agreed that Norplant should not be used to accomplish social goals or viewed as the answer to society's pressing social and economic problems. There was no agreement, however, on the issue of Norplant use by adolescents. Study participants argued persuasively on both sides of the question, expressing ambivalence concerning the incidence of teenage pregnancies, the longterm health effects of Norplant use on adolescents, and the threat of increased risk of STDs and HIV/AIDS among adolescents using Norplant. Study findings highlight a critical need for ongoing dialogue among key stakeholder groups to develop an understanding of the diverse values informing the debate. Participants' responses reinforced that decision-making in public health need not only be the jurisdiction of policy makers, elected officials, and others. Ordinary citizens can be part of the task as well by offering insights for practical and ethical solutions to some of our most pressing social issues.

The use of norplant and depo provera in adolescents

Although oral contraception is the fertility control method most frequently selected by US adolescents, factors such as inconsistent usage, payment inability, and cognitive-emotional immaturity lead half of these young women to discontinue pill use in the first year. Norplant and Depo-Provera--long-acting hormonal methods that do not require daily compliance--offer the potential to reduce the number of unintended pregnancies among adolescents; however, no data exist on the use of either method in this population. Before Norplant and Depo-Provera can be unconditionally recommended for use by adolescents, numerous research questions must be addressed. For example, it must be determined whether the pregnancy rates and side effects (especially on bone deposition) are the same in adolescents as in adult women. The possibility that adolescents who use long-acting contraception will abandon condom use due to the low risk of pregnancy--and thus place themselves at increased risk of sexually transmitted diseases--must be assessed. For Norplant, the medical-legal issues and responsibilities regarding insertion and removal must be clarified. More research is needed on the impact of partner perceptions on method continuation. It must be determined whether the role of health care providers in ongoing reproductive health promotion will be diminished by the need for fewer clinic visits. Also in need of attention are the demographic factors associated with use of these methods and the impact of their initial high expense on accessibility. If the continuation rates among adolescents of Norplant and Depo-Provera do not exceed that for the pill, the invasiveness and high cost of these methods may outweigh their benefits.

Contraceptive implant use among inner city teens

This study develops a clinical profile of urban teens who selected Norplant for contraception; determines which variables identify the subjects most likely to be compliant with the method; and determines the most common reasons for early termination of use. Demographic and health history data and reasons for termination of use were collected prospectively for 122 inner city teens who received Norplant. Life table analysis and the Mantel-Haenszel procedure were used to investigate differences between Norplant retainers and terminators. The sample consisted of black and Hispanic teens between the ages of 13-19 years, the majority of whom had one or more children and were in school. One and two year retention rates were 71% and 62%. The highest removal rates occurred during the 3-6 month interval after insertion. A significant finding was that teens who have experienced induced abortion were more likely to retain Norplant. Common reasons for termination of use included general and social concerns, including pregnancy desire. Norplant retention rates for this teen sample were greater than the compliance rates reported for other conventional methods. Similar to noncompliance with oral contraceptives, discontinuance of the method was most likely to occur in the first 6 months of use. A history of induced abortion identifies those teens most likely to retain Norplant, suggesting that these teens might evaluate contraceptive risks and benefits differently than those with no abortion history. Pregnancy desire was a common reason for terminating Norplant use.

The use of Levonorgestrel Implants (Norplant) for Contraception in Adolescent Mothers

Polaneczky, Margaret; Slap, Gail; Forke, Christine; Rappaport, Aviva; Sondheimer, Steven Author Information

Serious adverse events in norplant users reported to the food and drug administration's medwatch spontaneous reporting system

To describe serious adverse events in Norplant users from reports submitted to the Food and Drug Administration's (FDA) MedWatch Spontaneous Reporting System. Reports of certain serious adverse events in Norplant users in the United States from February 1991 to December 1993 were reviewed and analyzed. From the introduction of Norplant in the United States in February 1991 to December 1993, the FDA received reports of 24 women hospitalized for infections at the insertion site, 14 hospitalized or disabled because of difficulties removing the capsules, 14 hospitalized for stroke, three for thrombotic thrombocytopenia purpura, six for thrombocytopenia, and 39 for pseudotumor cerebri. The comparison of reported rates with expected rates and the relationship of some of these disorders with oral contraceptives raises the suspicion of a causal association with Norplant. The FDA has received reports of hospitalization or disability for infections, capsule removal difficulties, stroke, thrombotic thrombocytopenia purpura, thrombocytopenia, and pseudotumor cerebri in Norplant users. Health care professionals need to be trained in Norplant insertion and removal to ensure the proper technique. Studies are needed to determine if stroke, thrombocytopenia, and pseudotumor cerebri are causally related to Norplant use.

Feminism, Social Policy, and Long-Acting Contraception

The authors apply a feminist approach to two social debates over the use of Norplant. A woman convicted of child abuse was offered the use of Norplant as a condition of parole. She would have had to remain in jail had she opted to not accept the method. While such an offer may be justified the authors find it to be harmful and disrespectful to women. In order to justify offering long-term contraception as a condition of probation it would have to be clear that the future benefits were quite significant and unlikely to be obtained through other less harmful or disrespectful methods. The second debate involves CURE a clergy group in East Baltimore which has raised concerns about the use of Norplant among teenagers. The group argues that Black society sees the birth of a baby as a joyous occasion and that the majority White culture in the US may not understand Black culture. As such the majority culture should stay out of the procreational decision making and activities of the minority community. The feminist view of the authors however is that although many Black girls choose to have babies their mothers and grandmothers are saddled with much of the burden of rearing them. This male clergy which has spoken for the African American community actually may not understand what women want. Although the clergy which comprises CURE may be interpreting many of the communitys values correctly Black women may have other interests which are being poorly served by their interpretation.

Norplant and Irresponsible Reproduction

Norplant has been controversial because of attempts by judges and legislators to encourage or require that certain women use it to avoid reproduction which is considered socially irresponsible or harmful to children and society. There has been a wide range of response to proposals to control population growth among population subgroups considered to be socially unacceptable. While some would trust and support the state to take action to discourage or end irresponsible reproduction others argue that proposals to offer entice or compel women to use Norplant violate basic human rights and are a racist or elitist response to problems which should be resolved by other means. The author notes however that regardless of ones personal views about proposals regarding the application of Norplant one must acknowledge that this particular method of contraception has fomented considerable public debate over reproductive responsibility and the states role in regulating such responsibility. The author discusses reproductive responsibility the limits of social policy compulsory contraception to prevent congenital disease compulsory contraception for the retarded and encouraging procreative responsibility. He concludes that unless voluntarily chosen the use of Norplant can rarely be justified as a solution to problems of what some consider to be irresponsible reproduction. Neither the protection of future offspring nor the conservation of public funds is a good enough reason to justify abusing individuals right to procreate. A danger of discrimination or antipathy toward targeted groups also exists. That concluded the state should not be prevented from informing women about the availability of Norplant subsidizing its provision or offering incentives for its use.

Dethroning Choice: Analogy, Personhood, and the New Reproductive Technologies

There is something about the debate over reproductive technologies of all kinds—from coerced use of Norplant to trait-selection technologies, to issues surrounding in vitro fertilization (IVF), to fetal tissue transplantation—that seems to invite dubious analogies. A Tennessee trial court termed Mary Sue and Junior Davis's frozen embryos “in vitro children” and applied a best-interests standard in awarding “custody” to Mary Sue Davis; the Warnock Committee drew an implicit analogy between human gametes and transplantable organs in its recommendation of a voluntary, nonprofit system for collecting and distributing gametes in the United Kingdom; Owen Jones compares the right to trait-selection to the right to abortion; Robert Veatch once claimed that if a woman had signed an organ donation card and then died while pregnant, she had in effect given consent to the attempt to sustain the pregnancy after her death; John Robertson has argued that contract pregnancy poses no problems we have not already encountered with adoption; and Andrea Bonnicksen has compared the wonders of preembryonic genetic screening to the riches housed in the gold museum in Bogota, Colombia.