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A two-year experience with Norplant implants in Assiut, Egypt.

This report describes the two-year experience of 250 acceptors of NORPLANT implants and 100 TCu-380-Ag IUD acceptors in Assiut, Egypt. The two-year net continuation rate was 67.9 per 100 for implant users and 52.3 per 100 for IUD users. The most important cause for NORPLANT removal was the disruption of menstrual rhythm. However, by the end of the second year, three-quarters of NORPLANT users had monthly menstrual periods and about 60 percent described the amount of blood loss as average, 15 percent as decreased, 15 percent as increased and 10 percent as variable. About 88 percent of the NORPLANT acceptors rated their experience with the contraceptive as good or excellent.

Adult↗

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗

The effects of Norplant-2 rods on clinical chemistry in Singaporean acceptors after 1 year of use: metabolic changes.

In this longitudinal study involving 100 Singaporean acceptors, the effects of Norplant-2 rods on metabolic function was evaluated. With respect to liver function, the results indicate possible hepatocellular dysfunction. There was a significant rise in mean serum bilirubin from 0.54 mg/dl to 0.85 mg/dl after 12 months of use (p less than 0.001). Furthermore, there was also a significant fall in total proteins from 7.37 gm/dl to 7.12 gm/dl (p less than 0.001) and serum globulin from 3.18 gm/dl to 2.84 gm/dl (p less than 0.001). As regards lipid metabolism, we have demonstrated significant decreases in mean serum triglycerides (1.04 mmol/l to 0.83 mmol/l), p less than 0.001; total cholesterol (5.04 mmol/l to 4.64 mmol/l), p less than 0.001; and LDL-cholesterol (3.36 mmol/l to 3.10 mmol/l), p less than 0.001 after one year of use. There was a small fall in the HDL-cholesterol (1.21 mmol/l to 1.16 mmol/l) after 12 months of use; this fall was not significant. Despite this, there was a rise in the HDL-cholesterol/Total cholesterol - HDL-cholesterol ratio (0.258 cf 0.244; p less than 0.05) after 1 year of use. As we have not incorporated a simultaneous non-pill treated control group, the observed changes in lipoprotein lipids could be attributed to extraneous factors such as diet, exercise or other environmental changes. Nevertheless, the findings, though speculative, indicate Norplant-2 use to be non-contributory to cardiovascular risk and indeed it may be a protective factor against such risks in this population. The use of Norplant-2 rods was not associated with any significant effect on glucose tolerance after 12 months of use.

Adult↗

Bleeding patterns and acceptability among Norplant users in two Asian countries.

Changes in menstrual bleeding patterns are the most frequent reason for discontinuing NORPLANT during the first year of use. Although NORPLANT is used by more women in Asia than in any other region, the changes that occur among these women are not well documented. In pre-introductory clinical trials of NORPLANT in the Philippines and Sri Lanka, 175 women were enrolled with greater than 95% continuing the method after one year. Daily menstrual bleeding calendars were kept by 94% of subjects for nine months and by 66% for one year. In contrast to findings in previous studies which showed that approximately 60% of NORPLANT users had bleeding disruptions in the first year of use, almost all of these women experienced bleeding disruptions. In a one-year study of menstrual pattern changes, increased bleeding was found to occur with the same frequency as reduced bleeding. However, the changes experienced by the Asian women tended to be decreases, rather than increases, in menstrual bleeding.

Adult↗

A preliminary report of Norplant implant insertions in a large urban family planning program.

During the 21-month period between August 1, 1991, and April 30, 1993, 2,358 women received Norplant system insertions in either Parkland Memorial Hospital or the Dallas Maternal Health and Family Planning clinics. Forty-three percent of these women were teenagers with 14% 16 years of age or less. Overall, 431 patients received Norplant implants insertions postpartum prior to discharge from the hospital. To date, 138 Norplant systems have been removed, with the proportion of contraceptive implant removals among teenagers being essentially the same as that in more mature women. Of the reasons given by women discontinuing the Norplant system, an unanticipated high incidence of pain in the arm containing the implants, hair loss, and mood changes were noted. We have found the Norplant system to be a highly effective and highly acceptable contraceptive method for a large number of indigent women.

Adolescent↗

One-year experience with subdermal contraceptive implants in the United States.

Women who received Norplant contraceptive implants from any of fifteen clinical settings in southeast Texas, U.S.A., were followed for one year to determine their reactions to the method. Of 1,385 who enrolled to receive Norplant implants, 1,253 had implants inserted. Side effects were reported by 78% of those receiving implants and 70% described changes in bleeding patterns. Spotting or irregular bleeding, weight gain and headaches were the conditions reported most frequently. Nine pregnancies were reported during the study period. Six of these, however, existed before the implants were inserted. At the one year anniversary, 143 of women receiving implants had had them removed. Those who discontinued method use were less satisfied, reported more side effects and were more likely to have planned to have another child, thus using the method for spacing, or to have had a change in their marital status while they were using the contraceptive. Providers should counsel patients to focus attention on plans for the future in selecting their contraceptive method. In addition, we recommend, as does the product's distributor, that providers confirm that patients are not pregnant prior to inserting implants.

Adolescent↗

Menstrual blood loss with contraceptive subdermal levonorgestrel implants.

Six Silastic capsules each containing 30 mg of levonorgestrel were inserted subcutaneously in the left forearms of 13 volunteer women for contraceptive purposes. Quantitative determinations of menstrual blood loss were performed during a control cycle and during a 1-month period at the 1st, 6th, and 12th months of treatment. Days on which bleeding and spotting occurred were recorded and hemoglobin concentrations were determined. No changes were found in the amount of menstrual blood loss between the control cycles and the treatment cycles. The mean number of bleeding days during each of the three recorded treatment periods was significantly greater than that in the control cycles. No changes in hemoglobin concentration were found. None of the patients became pregnant during the study.

Adult↗

Endometrial endothelial cell proliferation in long-term users of subdermal levonorgestrel.

The aim of the present study was to quantify endothelial cell proliferation (a component of angiogenesis) using immunohistochemistry, in the endometrium of users of subdermal levonorgestrel (Norplant). It was postulated that the increased endometrial microvascular density seen in Norplant users, compared to normally cycling women, was associated with an increased rate of endothelial cell proliferation. The results, however, showed that the endometrial endothelial cell proliferative index of Norplant users (0.39 +/- 0.16%; mean +/- SEM) was significantly reduced compared to that seen in normally cycling women (8.99 +/- 1.64). At the same time, total numbers of endometrial endothelial cells per mm2 in Norplant users (317.40 +/- 13.88) were significantly higher than in normally cycling women (223.35 +/- 10.31). It is possible that in the endometrium with levonorgestrel use, there is either a reduced rate of regression of the blood vessels relative to the rest of the tissue, or there is a reduced rate of endothelial cell death or turnover. Peripheral oestrogen and progesterone concentrations, bleeding pattern over the previous 90 days, and the histological appearance of the endometrium did not appear to be associated with the endothelial cell proliferative index. The results suggest that subdermal levonorgestrel use affects the mechanisms that dictate the normal relationship between endometrial blood vessel growth and regression, and the surrounding non-vascular tissue.

Cell Count↗

Norplant.

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Drug Implants↗

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↗

[Norplant].

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Adult↗

Acceptance and perceptions of NORPLANT among users in San Francisco, USA.

Two hundred and five women participating in a five-year clinical trial of NORPLANT and NORPLANT-2 were interviewed about their contraceptive and reproductive history, sources of information and knowledge of NORPLANT, experiences using the method, and the impressions of friends and family about the method. The most common reasons for trying the implants were dissatisfaction with other methods and perceptions about NORPLANT's ease of use. Forty-one percent of acceptors had anxiety prior to insertion; 49 percent of these feared pain, but only 5 percent said that they actually experienced significant pain. Women also feared implant removal, but their fear did not influence their decision to continue or discontinue use, and 74 percent reported little or no pain at removal. Most of the women were pleased with NORPLANT, although 95 percent reported side effects, with 82 percent reporting changes in menstruation. More than one-half of those women who discontinued reported that they would use the implants again. Seventy-four percent of the current users interviewed said they would like to use the implants in the future. For the women enrolled in the clinical trial, NORPLANT appeared to be a highly acceptable method of contraception, despite the frequent occurrence of bothersome side effects.

Adult↗

International experience with NORPLANT and NORPLANT-2 contraceptives.

Experience encompassing more than 20,000 woman-years of use of NORPLANT capsules and 6,000 woman-years of trials of NORPLANT-2 rods is reviewed. Implant contraception repeatedly has been associated with low pregnancy rates and high continuation rates through five full years of use. Weight has proved to be a factor related to effectiveness. Women weighing less than 50 kg experienced cumulative five-year pregnancy rates well below 1 per 100, whereas the overall cumulative rate has been 3.5 per 100. Medical events reported during use that have led to discontinuation are analyzed from four large data sets.

Body Weight↗

Norplant neuropathy: peripheral neurologic symptoms associated with subdermal contraceptive implants.

Seventy to 80% of women using subdermal contraceptive implants (Norplant) have reported side effects, such as uterine bleeding, headache, mastalgia, and local pain at the site of insertion. This is a report of two patients who presented with peripheral neuropathy associated with the implants. One patient responded to removal of the device. The second patient, whose symptoms were thought to be related to trauma, was successfully treated with nonsteroidal anti-inflammatory agents.

Adult↗