This article reviews the advantages and disadvantages of progestogen-only contraceptive implants in light of the development of Implanon, a new, single-rod, etonogestrel-releasing system. Implants rapidly produce serum progestogen levels sufficient to ensure contraception for 1-5 years. The steady release ofprogestogen avoids the peaks and troughs associated with oral contraceptives, the profound ovarian suppression observed with depot injections and the need for user compliance. Implants have few serious complications. Ectopic pregnancy rates are low, and follicular hypertrophy is generally self-limiting. The principal acceptability limitation to both users and providers of Norplant is insertion and removal. Implanon is easy to insert and remove with minimal complications and pain. The main adverse event causing discontinuation of implants is a change in bleeding pattern. However, with good counselling, this is well tolerated by most women. Implants thus provide an effective, safe, economical and convenient alternative to oral, injectable or intrauterine contraceptives. Implanon is an extremely effective single-rod implant with a Pearl index of 0. It employs a new polymer and a less androgenic progestogen. These features provide easier insertion and removal for both users and clinicians, a more stable release rate and potentially fewer adverse androgenic effects compared with existing formulations.

OBJECTIVE

To determine the learning curves and rapidity with which clinicians become competent in implant removal using two Norplant removal techniques.

METHODS

Twenty-four physicians, none of whom were experienced in the use of Norplant implants, were randomly assigned to learn either the "U" removal technique or the standard technique. The physicians in the two groups received identical training in all other respects. Each physician then performed ten supervised removals. Removal times, procedure problem rates, and the number of procedures performed by the clinicians before they were judged "competent" were assessed for both groups.

RESULTS

Data from 240 removals were analyzed. Mean removal times were 38% faster in the "U" group than in the standard group. None of the "U" group procedures took longer than 20 minutes, compared with 11% of removals in the standard group (P < .001). The mean number of cases required before the provider consistently performed all steps adequately was significantly (P < .02) higher in the standard group (5.8 cases) than in the "U" group (3.9 cases).

CONCLUSIONS

Using competency-based training methods, the "U" removal technique was learned easily by inexperienced clinicians. It appears to offer significant improvements in speed and achievement of proficiency over the standard technique recommended by the manufacturer. Large-scale programs should consider using competency-based training and the "U" technique as the removal method of choice when providing training in implant removal.

OBJECTIVE

Men's attitudes toward contraceptives are an understudied area, even though many men participate in contraceptive decision making. The purpose of this study was to examine attitudes and perceptions regarding a selection of contraceptive methods among a national sample of African Americans, with a particular focus on gender differences.

METHODS

Data come from a telephone survey of African Americans (aged 15-44 years) living in the contiguous United States. For the present analyses, the sample was restricted to 152 men and 281 women who reported having had a sexual partner of the opposite gender at some point in their lives. Bivariate analyses compared men and women's ratings of birth control pills, male condoms, female condoms, Norplant, Depo Provera, female sterilization, and male sterilization along several dimensions: bad/good, harmful/beneficial, difficult/easy, dangerous/safe, immoral/moral, and effectiveness. Multiple logistic regressions were performed to determine the association between gender and contraceptive attitudes, adjusting for sociodemographic variables.

RESULTS

Male condoms were given the most favorable ratings along most dimensions by both African-American men and women. In general, ratings of male condoms, female condoms, and Norplant did not significantly differ by gender. African-American men did, however, give female and male sterilization, birth control pills, and Depo Provera significantly poorer ratings than did African-American women.

CONCLUSIONS

African-American men had less favorable evaluations of some contraceptive methods than did African-American women. Further research is needed to examine how such gender differences may play a role in contraceptive decisions.

The aim of this study was to develop a profile of urban American women who chose Norplant(R), determine factors associated with retention and early termination of implants, and to determine reasons for early removal. A total of 197 adult black and Hispanic women who had Norplant inserted were followed prospectively for up to 5 years. Interval and cumulative termination rates were calculated. Data were stratified by race and analyzed to include lost-to-follow-up (LTFU) subjects. Multivariate survival analysis was used to determine variables independently associated with termination. Cumulative continuation rates were 68% after year 1 and 13% after year 4. Significant predictors of retention included black race and lower parity. Probability of early termination increased with higher parity and Hispanic race. For black subjects, recent use of hormonal contraception was a predictor of retention. Menstrual changes and weight concerns were common reasons for removal. The Norplant 1-year continuation rate is lower than previously reported, but is higher than reported for oral contraceptives and Depo-Provera(R). Future studies should stratify by age, race, and parity, and use standardized terminology to report intervals of use.

Despite international efforts to plan for Norplant introduction, the method has drawn the attention of critics of family planning programmes, and has raised several issues for debate since it was introduced into family planning programmes. The experiences of three countries with the introduction of Norplant highlight some of the unique features of the method that have affected its introduction. Indonesia, Bangladesh and the United States represent diverse cultural settings and systems of family planning provision. Experience in each country has highlighted the need to focus on quality of care for clients, most notably the need for good counselling and attention to removal as well as insertion. The cost of Norplant also has influenced its introduction in each country. Another issue includes the need to work with women's health advocacy groups, which is illustrated particularly in Bangladesh. Finally, the role of litigation in the United States, and its potential role in influencing Norplant introduction in other countries, is discussed. These three countries' experience illustrate the importance of understanding the programmatic context of contraceptive introduction.

OBJECTIVE

To evaluate the "U" technique versus the manufacturer-recommended technique for Norplant removal.

METHODS

We conducted a randomized comparison of the manufacturer-recommended method of removal and the "U" technique. The latter involves an incision between and parallel to the third and fourth implants and uses a modified vasectomy clamp to remove the implants by pulling perpendicular to the implant's axis.

RESULTS

Twenty-one physicians (three experienced, 18 inexperienced) performed 200 Norplant removals. Inexperienced physicians took significantly less time for removal using the "U" technique than the standard technique (7.9 versus 10.5 minutes), even after controlling for other factors. Experienced physicians also required less time for removal using the "U" technique (3.1 versus 3.7 minutes), but the difference was not statistically significant after controlling for other factors. Both experienced and inexperienced physicians broke implants more frequently using the standard technique, although the difference was significant only for experienced physicians (relative risk 3.6, 95% confidence interval 1.2, 10.8). No differences were noted between the techniques with respect to tissue damage or patient reports of pain during or after removal.

CONCLUSIONS

These results suggest that the "U" technique is an improvement over the standard technique, particularly for personnel who are not highly experienced in Norplant removal.

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.

BACKGROUND

The purpose of this study was to examine specific factors that motivated the request for early removal of Norplant among a group of young, low-income women who were dissatisfied with this contraceptive method.

METHODS

Focus groups were conducted to obtain qualitative in-depth attitude and opinion data about Norplant from women who had used this method of contraception for a period ranging from 2 months to 25 months and had requested its removal because of side effects.

RESULTS

Patient motivation for requesting Norplant removal was based on side effects. No other reason for early removal requests emerged from the focus group discussions. However, the comments of many participants raised questions about the psychosocial context in which patients obtain information about Norplant and request early removal. Many participants mentioned having felt pressured to accept Norplant and not being fully informed about possible side effects. All but two said they were encouraged to "wait out" side effects and that physicians were reluctant to remove the Norplant capsules. Many participants recalled that they had to request removal several times before their physicians complied with their wishes.

CONCLUSIONS

The results of this study suggest that there is a need to review the process of educating patients about Norplant, the situational context of Norplant counseling, and physician practices related to patients' requests for early removal.

Within the limitations of the available data, it has been reported that oral contraceptive use versus other contraceptive methods is associated with a greater or similar frequency of candidiasis, increased numbers of anaerobic microorganisms, an increased or similar frequency of chlamydia trachomatis, and a reduced frequency of bacterial vaginosis and trichomoniasis. The impact of contraceptive steroids on cellular and humoral immunologic factors may explain these observations. Intrauterine contraceptive device use is reported to be associated with an increased rate of bacterial vaginosis and anaerobic organism recovery from the vagina regardless of symptoms. Patients having a contraceptive vaginal ring were found to have the same number and types of vaginal organisms as oral contraceptive users. Levonorgestrel-releasing subdermal implant (Norplant, Wyeth-Ayerst, Philadelphia, Pa.) users have been reported to have approximately half the rate of vaginitis and vaginosis compared with that of Copper T-200 intrauterine device users.

A longitudinal study on one-hundred Singaporean women using Norplant-2 rod implant for contraception and their effects on the haemostatic function was carried out. There was a decrease in vitamin K-dependent Factors II, VII and a tendency towards lowered fibrinolytic activity after prolong use of Norplant-2 rods. The results indicate that the Norplant-2 rod implant system does not contribute towards hypercoagulable state but increased platelets and accelerated platelet aggregation observed will require further study to ascertain whether there is a concomitant increase in platelet activation.

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Dhaka, Bangladesh. The study was designed to evaluate the contraceptive efficacy, safety and overall acceptability of Norplant implants. Six hundred women were enrolled in the clinical trial, which began in 1985 at three study sites. Follow-up visits were scheduled at 1, 3, and 6 months after Norplant implant insertion, and every six months thereafter until removal or at the end of five years. There were no post-insertion pregnancies during Norplant implant use in this study. After five years of Norplant implant use, there was no clinically significant change in body weight, systolic or diastolic blood pressure. Less than 3% of the women ever reported having any significant medical problems such as migraine, respiratory or cardiac problems during the study. The gross cumulative continuation rate was 41.2 per 100 women at the end of five years. The two most frequently reported reasons for discontinuation during the study were menstrual problems and desired pregnancy. Of the women who completed the five-year user satisfaction questionnaire, the majority of the women (86.3%) planned to continue using contraception after study completion. Of these women, approximately one-third said they planned to use another Norplant set. The findings presented suggest that the Norplant system is a highly effective, safe and acceptable method among Bangladeshi women.

Progestogen-only contraception is almost invariably associated with changes in menstrual bleeding patterns. Changes in the endometrial vasculature, and in particular an increase in vascular fragility, may contribute to this bleeding. In this study, endometrial vascular density and endothelial cell basement membrane components were examined using immunohistochemistry before and after insertion of Norplant. Endometrial vascular density was increased from a mean (+/- SEM) of 189.6 +/- 7.0 vessels/mm2 during the control cycle to 253.9 +/- 80.7 vessels/mm2 at 2-13 weeks of Norplant exposure, and to 212.7 +/- 12.9 vessels/mm2 at 14-42 weeks. During the control cycle, a mean of 161.4 +/- 4.5 vessels/mm2 stained for collagen IV (85% of all vessels), while at 2-13 weeks, 144.5 +/- 13.0 vessels/mm2 stained for collagen IV (57% of all vessels) (t ratio = 2.08, P = 0.0057). By 14-42 weeks, 71% of vessels (151.0 +/- 9.8) vessels/mm2 were surrounded by collagen IV. This was not significantly different from control values (t ratio = 2.03). Endometrial vascular laminin was also reduced following Norplant insertion, from a mean of 176.0 +/- 4.2 vessels/mm2 in the control cycle (93% of vessels), to 156.3 +/- 6.7 vessels/mm2 at 2-13 weeks of exposure (57% of vessels) (t ratio = 2.08, P = 0.01). By 14-42 weeks of exposure to Norplant, 162.5 +/- 9 vessels/mm2 (76%) stained for laminin. This was not significantly different from control values (t ratio = 2.04). Endometrial vascular heparan sulphate proteoglycan (HSPG) was reduced from 58.6 +/- 3.0 vessels/mm2 during the control cycle (31% of vessels) to 43.6 +/- 5.6 vessels/mm2 (only 17% of vessels) at 2-13 weeks (t ratio = 2.08, P = 0.025). At 14-42 weeks, only 19% of vessels stained for HSPG (41.3 +/- 5.8 vessels/mm2; t ratio = 2.04, P = 0.009).

Contraceptive implant technology has been used by millions of women throughout the world. The three marketed implant systems today are levonorgestrel-releasing implants: Norplant and Jadelle, and a single etonogestrel-releasing implant, Implanon. The main benefits common to these delivery systems are their safety, high effectiveness, ease of use, long duration of action (3 - 5 years) and reversibility. Bleeding disturbances are the main adverse events associated with implantable contraceptives. Other minor risks relate to the insertion and removal procedures, which require adequately trained providers as well as aseptic techniques. Furthermore, since initiation and discontinuation of use is provider-dependent and not controlled by the user, there may be a risk of coercion of use on the one hand or, on the other hand, difficulty in access to initiating use, if trained providers are not readily available. Although no single contraceptive method is perfect or appealing to all, contraceptive implants are safe and fulfil a very important need among fertility regulation methods.

This integrated analysis evaluates nonmenstrual adverse events, blood pressure, and body weight changes during the use of the single-rod etonogestrel-containing contraceptive implant, Implanon; these aspects are compared for Implanon and Norplant, the six-capsule implant containing levonorgestrel. Overall, 47% of Implanon users had drug-related adverse events, whereas in the comparative studies the figure for those using Implanon (61%) was slightly lower than that for Norplant users (69%). In all Implanon studies, 12 of 1716 women (0.7%) were affected by serious adverse events that were considered drug related. In comparative studies three of the 689 Implanon users (0.4%) and one of 689 Norplant users (0.1%) had such experiences. The most frequently reported drug-related adverse events were acne, breast pain, headache and weight gain. The adverse events that most often caused discontinuation of Implanon were weight gain and acne. The development or aggravation of acne was a frequent adverse event (in 18.5% of Implanon and 22.3% of Norplant users in the comparative studies) but individual studies indicated that there were also many subjects whose acne improved during implant use. There were gradual increases in body weight over time but these may be only partly attributable to implant use and partly attributable to normal increases over time.

Background. Women's preferences for various contraceptive methods attribute vary according to the type of relations and other aspects of their life. The discrepancy between fertility preferences and contraceptive practice is regarded as an indicator of unmet demand for family planning. Objective. To assess modern contraceptive methods preference and its determinant factors among women of reproductive age group in Shire Indaselassie town, Tigray Region, Northern Ethiopia. Method. A community based cross-sectional study design was employed on 367 sampled women. Stratified sampling technique was used to select the study subjects. Then, data was collected using structured questionnaire. Result. In this study, the most commonly preferred modern contraceptive method was injectable contraceptive 202 (55%), the second 61 (16.6%) was oral contraceptives, and the third 47 (12.8%) was Norplant. Condom 31 (8.4%), IUD 14 (3.8%), female sterilization 7 (1.9%), and others were less commonly preferred methods. Some of the reasons for preference were effectiveness of the method, reversibility, fewer side effects, convenience, long duration of use, and no need to remember daily. Conclusion. This study clearly described that women preferences of modern contraceptive methods increased after they had higher number of children and less desire to limit family size.

This article describes the first use of ultrasound in locating in vivo NORPLANT subdermal contraceptive implants. Providing low dose, continuous contraception for women. the NORPLANT system utilizes Silastic tubing filled with levonorgestrel. The progestin-filled tubing is not radiopaque. Anticipating the large scale use of NORPLANT subdermal implants, the potential, but rare problem of difficult localization of an implant is recognized. The feasibility of using ultrasound for the painless and safe localization of NORPLANT rods and capsules is demonstrated.

Norplant implants can be removed easily, if inserted properly. When they are inserted deeply and can not be palpated, or if they are located close to the neurovascular structures of the upper arm, radiological guidance may be needed to locate and remove the implants without causing injury to the surrounding vital structures. Digital subtraction fluoroscopic guidance is helpful in removing deeply located contraceptive implants and those that are close to the neurovascular structures, where blind removal may result in injury to those structures. We describe a case in which an implant that was located close to a major nerve near the axilla was removed under digital subtraction fluoroscopic guidance.

OBJECTIVE

The purpose of this study was to understand the transition process from providing Norplant, the six-capsule first contraceptive implant system, to providing Jadelle, the two-rod second-generation system, in a clinical setting with extensive experience providing Norplant implants.

METHODS

Two hundred forty-nine women requesting contraceptive implants from the PROFAMILIA clinic (Santo Domingo, Dominican Republic) were provided with information regarding the differences and similarities between the two implant systems being studied, including the easier insertion and removal procedures and the possible shorter use life associated with Jadelle. A questionnaire evaluating their preference and the reason why they chose either system was provided. The health care providers' opinions about the two systems were also studied.

RESULTS

Fifty-three percent of the women preferred Jadelle over Norplant. The main reason behind their preference for Jadelle was its reduced number of implants with easier insertion and removal and less visibility in the arm, whereas that for Norplant was greater familiarity. Providers overwhelmingly preferred Jadelle. A 1-h presentation was sufficient training for providers experienced with Norplant. None had any problem with the management of Jadelle.

CONCLUSIONS

The inclusion of Jadelle in a clinic with extensive experience with Norplant was easy and uneventful, but both methods should be available during a transition period of several months while confidence in the new method is being acquired by the community.

Women using the progestin-only contraceptive Norplant often suffer from unpredictable bouts of breakthrough bleeding, which usually occurs from a thin atrophic endometrium. The role of cellular apoptosis in the endometrial response to Norplant has not been investigated. The aim of the present study was to use immunohistochemistry to produce semi-quantitative scores for expression of the apoptosis-related proteins Bcl-2, Fas and caspase 3 in endometrium from 16 controls and 42 women using Norplant with minimal or major breakthrough bleeding problems. The results showed no difference in endometrial immunostaining for any of the three proteins between Norplant users with and without breakthrough bleeding. There was also no evidence of endometrial endothelial cell immunostaining for any of the proteins. Bcl-2 was the only protein to show a cyclical pattern, with higher expression in the proliferative compared to secretory glands. All three proteins showed different expression levels in control functionalis versus basalis, with the survival protein Bcl-2 being higher in basalis, and the death receptor Fas and the proteolytic enzyme caspase 3 being higher in the functionalis. Overall, the results suggest that apoptosis is regulated differently in functionalis compared to basalis, and that atrophic Norplant-exposed endometrium appears more like functionalis than basalis with respect to expression of Fas and caspase 3. There was no evidence for a role for apoptosis in the mechanisms that underlie progestin-induced endometrial breakthrough bleeding.

Background. Data on the incidence of Trichomonas vaginalis and use of hormonal contraception (HC) are limited. Methods. 2,374 sexually active women aged 15-49 years from cohort surveys in Rakai, Uganda, were included. Incidence of T. vaginalis was estimated per 100 person years (py) and association between HC (DMPA, Norplant, and oral contraceptives) and T. vaginalis infection was assessed by incidence rate ratios (IRR), using Poisson regression models. Results. At baseline, 34.9% had used HC in the last 12 months, 12.8% HIV+, 39.7% with high BV-scores (7-10), and 3.1% syphilis positive. The 12-month incidence of T. vaginalis was 2.4/100 py; CI (1.90, 3.25). When stratified by type of HC used, compared to women who did not use HC or condoms, incidence of T. vaginalis was significantly higher among users of Norplant (adj.IRR = 3.01, CI: 1.07-8.49) and significantly lower among DMPA users (adj.IRR = 0.55, CI: 0.30, 0.98) and women who discontinued HC use at follow-up (adj.IRR = 0.30, CI: 0.09, 0.99). HIV infection was associated with an increase in incidence of T. vaginalis (adj.IRR = 2.34, CI: 1.44, 3.78). Conclusions. Use of Norplant and being HIV+ significantly increased the risk of T. vaginalis, while use of DMPA and discontinuation of overall HC use were associated with a decreased incidence of T. vaginalis.