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Characteristics and attitudes of early contraceptive implant acceptors in Texas.

In 1991, shortly after Norplant became available in the United States, 678 women who had received the implant from 17 providers in Texas were surveyed. Forty-five percent of these women were under 21 years old. The majority (56%) had tried the implant because they were dissatisfied with their previous contraceptive method. Forty-four percent of the sample indicated that the implant was one of the first contraceptive methods they had used and that they had only recently decided to prevent unplanned pregnancy. The average number of children per woman was 1.2, and one-third of the sample had had at least one abortion. While 37% of the women said they wanted no more children, 63% said they were using the implant as a spacing method. The reasons for choosing the implant and concerns about it varied according to the user's age, educational level and race or ethnic group.

Adolescent↗

Health services at the clinic level and implantable contraceptives for women.

The quality of implant service provision, particularly counseling, has been associated with successful use and with fewer discontinuations for side-effects. Requirements necessary for quality service provision include cadres of health care workers who can provide implants, training curriculum, duration of training, and training techniques; knowledge of the facilities, surgical equipment, and other supplies necessary; infection prevention steps to safely provide implants; techniques for managing side-effects; methods for managing difficult implant removals, the importance of maintaining close relationships with implant clients, and establishing communication and notification systems for removal (and sometimes replacement) when the effective life-span of the implants has been reached. In this article we review the components and training necessary for the establishment and maintenance of quality implant service delivery systems, discuss the implications of providing more than one type of implant, and describe trends in use.

Contraceptive Agents, Female↗

Ovulation detection following removal of levonorgestrel subdermal contraceptive implants.

The time to resumption of ovulation following the discontinuation of levonorgestrel subdermal implants (Norplant) was assessed in 10 women. A blood sample (2 ml) was taken at the time of Norplant removal and then twice weekly until the first evidence of ovulation (serum progesterone concentration greater than or equal to 5 ng/ml) was documented. Ovulation was resumed in 80% of the cases by 3 weeks and in all the cases by 7 weeks. Prompt return of ovulation following Norplant removal is an additional advantage of this mode of long-acting contraception.

Adult↗

Norplant--a contraceptive implant.

Norplant, a progestagen implant designed to provide contraception for five years, was launched in the UK in October 1993. Almost 3 million women world wide are using it. The manufacturer claims that Norplant is "one of the most effective and practical forms of contraception for any woman who wants long-term reliability, convenience and the opportunity to change her mind". In this article we assess its use.

Adult↗

Continuation rates with a levonorgestrel-releasing contraceptive implant (Norplant). A prospective study in Belgium.

Contraceptive protection offered by a method depends on its duration of use, which reflects costs, side effects, and relatives' opinions. This study investigated in Norplant implants users the continuation rates, some of their determinants, and the motives for removals. Since 1988, 612 Norplant implants sets, designed to protect for 5 years, have been inserted. Observing 13,907 months of use, we determined over time the continuation rates and how age, parity, circumstances at insertion (postpartum, postabortum, others), and patronymic origins (surrogate for sociocultural factors) influenced them. Statistics included Kaplan-Meier's method and log rank tests, and uni- and multivariate Cox models. Continuation increased with age and depended on sociocultural factors. Parity exerted influence only in younger women. Median duration of use was 3 years 11 months. Removals before 5 years related almost equally to irregular bleeding, other side effects, and pregnancy wish. The cumulative 5-year failure rate was 1.5%. Unsatisfied users returned earlier, distorting the first results. A literature search showed that implants yield, in the mean, slightly better continuation figures than do intrauterine devices, and clearly higher than those obtained with pills and injectables. To optimize costs and counseling, warnings about the risk of short duration of use in young nullipara, especially if negative sociocultural influences prevail, are recommended. In no category are the implants absolutely to be avoided. Individual and programmatic contraceptive choice should take into account the expected continuation of use.

Adolescent↗

A study on the effects of Norplant implantable contraceptive on lipid, lipoprotein, and apolipoprotein metabolism in Singaporean women.

The Norplant subdermal implants system is rapidly becoming acceptable as a contraceptive system all over the world. Earlier studies in Singapore indicated that the implants do not appear directly contributory to cardiovascular risk. However, extraneous environmental effects could have contributed to the observed changes. In this study, when nonsteroid copper intrauterine device (IUD) users were used as control, we have shown that the findings are in concordance with the results of the earlier studies. There was a decrease in serum triglycerides, total cholesterol, and HDL and LDL cholesterol over the period of study. However, despite these changes the HDL cholesterol/total cholesterol ratio remained stable and was above 0.200. As regards apolipoprotein, there was generally a significant full in apolipoprotein AI, AII, and B. As a result, the apolipoprotein AI/AII ratio showed a significant decrease in the first 3 months before increasing close to its preinsertion value at 2 years. Similarly, the apolipoprotein AI/B ratio also stabilized at the end of 2 years. This study thus confirms our earlier findings that Norplant implants do not appear directly contributory to cardiovascular risk.

Adult↗

Clinical profile of Implanon: a single-rod etonogestrel contraceptive implant.

This 3-year study investigating the contraceptive efficacy and tolerability of Implanon in 635 volunteers demonstrates that it was well tolerated and had excellent, reversible, contraceptive efficacy. No pregnancies (Pearl index, 0; 95% CI 0.0-0.2) occurred during 1,200 woman-years of exposure. Irregular bleeding, mainly frequent and prolonged, was the primary reason for discontinuation (19.0%). Infrequent bleeding (29-51%) was the most common bleeding disturbance. Adverse events, other than bleeding irregularities, were generally mild to moderate in intensity and resulted in 9.3% of discontinuations. Over 85% of women with dysmenorrhea at baseline noted an improvement at the end of treatment, while 4% reported new or worsened symptoms. The most commonly reported non-bleeding adverse events were breast pain (16%), acne (12.6%), vaginitis (12%) and pharyngitis (10.5%). However, acne present at enrolment improved or disappeared during treatment in 59% of women. Less than 5% of women experienced implant site symptoms after insertion or removal, mainly mild pain of short duration. Average insertion and removal times were 2.2 and 5.4 min, respectively. In most women, menses returned to normal within 3 months of implant removal. Of those using no contraceptive method, 13.8% became pregnant within 90 days. Implanon represents a highly effective contraceptive option for women.

Adolescent↗

Levonorgestrel subdermal implants. Contraception on trial.

When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world. Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention. Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.

Administration, Cutaneous↗

The contraceptive implant and the injectable: a comparison of costs.

A comparison of the relative costs of the injectable contraceptive (depot medroxyprogesterone acetate) and the hormonal implant (Norplant) indicates that the implant is a less costly contraceptive option when it is used for its full five-year lifespan. Over a five-year period, the implant costs $107 annually, compared with $140 per year for the injectable. However, if a woman discontinues the implant before she has used it for at least four years, the injectable becomes the less costly option. Relatively high continuation rates--around 95% annually--are necessary to make the implant the more cost-effective contraceptive method.

Cost-Benefit Analysis↗

Pregnancy after removal of Norplant implants contraceptive.

Many concerns have been expressed regarding the introduction of a new contraceptive method into family planning programmes. One of the concerns is the return of fertility after discontinuing the method. To evaluate the subsequent fertility status of the Indonesian women after removal of Norplant, a prospective longitudinal study was undertaken in Klinik Radeb Saleh, Jakarta. Fifty-one women whose Norplant were removed because of their wish to become pregnant were followed-up for a period of two years or until pregnancy occurred, whichever was earlier. Two groups of women who had Lippes C IUD removed or discontinued the use of DMPA for planning pregnancy served as control and were followed-up for equal length of time. The cumulative conception rate for ex-Norplant users, ex-IUD users and ex-DMPA users at one year was 76.5, 74.7 and 70.2 per 100 women, respectively. There was no significant difference between the groups (p greater than 0.05). The present study, along with other studies, indicate that the prolonged use of Norplant do not impair the return of fertility.

Adult↗

[Norplant contraceptive implant].

OBJECTIVE: Norplant is a long lasting contraceptive method which protect again pregnancy for five years. We studied the side effects and the variations related to weight and blood pressure. MATERIAL AND METHODS: The study was carried out in three family planning clinics in Dakar with 450 women who have had their implants for at least six months. Data collection was based on patient interviews and review of medical files. RESULTS: The side effects reported were mainly menstrual problems with 54.7% of the women reporting menstrual spotting. The other non-menstruel side effects were headaches (64.2%) and dizziness (59.1%). The side effects at the insertion site were pruritus (16%) and pain (3.1%). Regarding weight and blood pressure, an increase in weight was observed up to three years of Norplant use and a decrease to the initial weight was seen during the fifth year of use. No variation was noted regarding blood pressure. CONCLUSION: Norplant is a contraceptive method widely used in Senegal. Most of the side effects involve menstrual problems. A slight increase of weight was observed in general with no variation in blood pressure.

Adult↗

The interaction between sex hormone binding globulin and levonorgestrel released from Norplant, an implantable contraceptive.

Two-hundred-and-eighty Indonesian women were provided with Norplant, a levonorgestrel-releasing implant. At various time intervals, up to 5 years after Norplant insertion, levonorgestrel and sex hormone binding globulin (SHBG) were assayed in blood plasma. After an initial burst of approximately 7 nmol/l, the levels of levonorgestrel rapidly decreased during the first month. The decrease continued to a nadir (1.1 nmol/l) which was reached 10 months later. The decrease was followed by an increase to a broad peak of 1.5 nmol/l which was reached 2 years after insertion. Thereafter, a slow-decrease at a rate of approximately 18 pmol/month was seen. SHBG levels decreased significantly already 1 week after insertion. A nadir of levels (25 nmol/l) was reached 3 months later. The levels increased slowly again and remained constant (32 nmol/l) from about 15 months to 5 years. During the entire period of study highly significant correlations of levonorgestrel with SHBG were seen. In another group of 25 women the levels of levonorgestrel and SHBG were studied before and one week after insertion of Norplant. A significant correlation (r = 0.77) was found between the preinsertion levels of SHBG and postinsertion levels of levonorgestrel.

Adult↗

A detailed analysis of menstrual blood loss in women using Norplant and Nestorone progestogen-only contraceptive implants or vaginal rings.

Changes to the pattern of menstrual bleeding are almost universal in women using progestogen-only methods of contraception, and are an important cause of discontinuation of these methods. The present study was designed to explore the changes in menstrual bleeding patterns and objectively measure menstrual blood loss (MBL) in 110 women before and during one year of use of 4 different progestogen-only contraceptives: Norplant subdermal levonorgestrel implants; Nestorone progestogen 4-cm or 6-cm implants nominally delivering 100 microg or 150 microg daily; or a vaginal ring (CVR) delivering 100 microg of Nestorone (NES) daily (CVR users were limited to only 6 months of use). Groups could not be directly compared because of the differences in numbers of subjects and durations of treatment. The total MBL during each of the three 8-week collection periods during treatment decreased significantly in each group compared to the total blood loss in the two control cycles (greater than 50% decrease in all groups during the first 6 months), although the differences between individual women at the extremes remained considerable. The highest blood loss measured on any single day during the treatment collection periods was significantly reduced (p <0.001) in users of all four devices in all three collection periods compared to the control period (CVR users did not have a 3rd collection period). The Nestorone-releasing CVR was associated with an 88% reduction in mean MBL and a high incidence of amenorrhea at 6 months. There was considerable variation in percentage reduction in total blood loss at 6 and 12 months between individual women ranging from 100% (women with amenorrhea) to a small minority experiencing an increase compared with control cycles. The increases in measured blood loss during treatment were almost entirely in women with light bleeding in the control period and were related to prolonged episodes of light bleeding rather than heavy bleeding. Women contemplating use of a progestogen-only contraceptive method need to be counseled about alterations to the menstrual cycle but can be reassured that total blood loss will usually be much less than with normal cycles.

Administration, Intravaginal↗

Restoration of reproductive potential following expiration or removal of melengestrol acetate contraceptive implants in golden lion tamarins (Leontopithecus rosalia).

Although reversible contraception is important to successful management of small populations, there are concerns about the reversibility of melengestrol acetate (MGA), the most commonly used implant in captive animals. Female golden lion tamarins (Leontopithecus rosalia) placed in potential breeding situations after surgical MGA implant removal showed a 75% return to reproduction within 2 yr, unlike golden-headed tamarins (Leontopithecus chrysomelas), which have had a 29% return to reproduction following implant removal. This rate was indistinguishable from the breeding probability for newly formed pairs involving nonimplanted females. Litter size, stillbirth rate, and infant survival rate were not significantly different between nonimplanted and implant-removed female golden lion tamarins. However, females with implants left in (and assumed to have expired) showed higher stillbirth and infant mortality rates than did females with implants removed. For seven female golden lion tamarins for which reproductive histories before and after MGA implantation were available, litter size was unaffected by MGA implantation and subsequent removal. Infant survival rate for these females appeared to be lower after removal but was indistinguishable from rates in the nonimplanted females. Prior reproductive experience, length of time with an implant, and age of the females did not affect the probability of breeding for females after removal of the implants. Overall, breeding probability of nonimplanted females declined with age. Although the results of this study confirm the reversibility of MGA implants in golden lion tamarins, there appear to be some effects on viability of offspring, particularly offspring born to females with implants left in and presumed expired.

Age Factors↗

Ovarian endocrine function through five years of continuous treatment with NORPLANT subdermal contraceptive implants.

Ovarian endocrine function was assessed in 88 women using NORPLANT subdermal implants during different periods of use and in a control group of 15 women using non-hormonal contraception. Blood samples for estradiol (E2) and progesterone (P) assays were obtained twice a week for five consecutive weeks. Three distinct E2 patterns were observed: one was characterized by fluctuating levels within a normal range (20 to 400 pg/ml), a second pattern corresponded to continuous low E2 levels (below 75 pg/ml in the 10 samples) and the third was characterized by high broad estradiol peaks reaching over 400 pg/ml. The proportion of sampling runs characterized by normal fluctuating levels increased from 38% in the first two years of use to 80% during the fifth year of use. Low E2 profile was only observed during the first two years of use (27%) and in only 1 case at the beginning of the third year of use (5%). The percentage of cycles with high broad estradiol peaks remained between 20-40% without a clear tendency to change in either direction with duration of use. Thirty-three percent of the observed sampling runs had luteal activity (P above 3 ng/ml). The proportion of runs with luteal activity increased from 14% during the first two years of use to 40% during the third and fourth, and 60% during the fifth year of use. All control subjects had luteal activity. The mean highest progesterone level was lower in the NORPLANT runs (8.7 +/- 3.9 ng/ml) as compared to the controls (11.3 +/- 3.8 ng/ml). NORPLANT sampling runs with luteal activity had normal fluctuating E2 levels with only one exception. However, not all cycles with normal E2 levels showed luteal activity. On the other hand, all runs with low E2 levels or high broad E2 peaks were without luteal activity. In summary, women using continuous low-dose levonorgestrel contraception through NORPLANT subdermal implants, have a variable degree of ovarian activity as compared with the more complete depression of ovarian function observed among pill or injectables' users. Ovarian activity becomes closer to normal during the third through fifth year of use.

Contraceptive Agents, Female↗