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The results of the 1998 "Contraceptive Technology Update" Pill Survey indicate that Norplant implants continue to lag on providers list of family planning (FP) choices. 67% of US FP providers who responded to the survey reported no Norplant insertions in the year preceding the survey. For the 18.1% who inserted 1 to 5 implants, 11.7% removed the same number. The number of removals outranked insertions in the 3 subsequent insertion ranges. Headaches, irregular bleeding, and the end of the 5-year use period were among the major causes of method termination. Research on Norplant has indicated that method continuation is substantially enhanced when the acceptor is a mature woman with a long-term interest in contraception, has been counseled about potential side effects, and is able to accept these side effects. Partner attitudes toward Norplant are another important determinant of satisfaction.
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PMID:Norplant: overcoming barriers to method use. 1232 44

This article summarizes current knowledge on the mechanism of action, side effects, and effectiveness of Norplant contraceptive implants. The most common side effect of the implant method is its disruption of the menstrual cycle, especially in the 1st few months of use. Long intervals without frank bleeding may occur and be misinterpreted as pregnancy in women who have not been counseled about this possibility. The average annual continuation rate was 84/100 in a study of 324 women from several countries who were followed for 5 years after Norplant implantation. The net cumulative pregnancy rate for the 5-year study period was 0.6/100. Reasons for method termination included menstrual problems, other medical problems (headache, depression, fatique), planning pregnancy, and other personal reasons (change in marital status, change in residence). To provide training for doctors, nurses, and counselors, the Population Council has established a network of 5 training institutions. Within the next few years, drug regulatory agencies are expected to approve use of Norplant implants in many countries. Although at present the method is available only in Finland and Sweden, Thailand and Indonesia are considering the method and clinical trials are underway in India, China, Brazil, and the US. A consulting committee of the World Health Organization has concluded that Norplant implants are a suitable contraceptive method for use in family planning programs.
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PMID:Norplant contraceptive implants: a new contraceptive for women. 1234 Apr 73

"New Era for Injectables," a report published in the most recent issue of the Johns Hopkins University School of Hygiene and Public Health's Population Reports, notes that injectable contraceptives are among the most effective family planning methods. Most clinical trials report less than one pregnancy per 100 women during the first year of use, making injectables as effective as Norplant implants, the best copper IUDs, and voluntary sterilization. Injectables also protect women against ectopic pregnancy, help to prevent endometrial and possibly ovarian cancer, and may help women with anemia and sickle-cell disease. The major side effect of injectable use is changes in menstrual bleeding. Some women also experience weight gain, and a few report headaches, dizziness, abdominal discomfort, acne, and moodiness. The most widely-used injectable is the progestin-only DMPA (depot medroxyprogesterone acetate), known under the brand name Depo-Provera and manufactured by the Upjohn Company. Women receive an injection every 3 months. Another progestin-only injectable, NET EN (norethindrone enanthate), is taken every 2 months. Cyclofem and Mesigyna, two new monthly injectables which combine estrogen and progestin, are currently being introduced in a number of countries. Worldwide, 1.5% of all married women of reproductive age who use some form of family planning use injectables. The highest level of use among such women is in Indonesia and Thailand where 15% and 12%, respectively, use injectables. Donor agencies have been responding to increasing numbers of orders for injectables from family planning programs in developing countries, while the UN Population Fund, the largest supplier, shipped 12 million doses of injectables in 1992 and 20 million in 1994. The 1992 US Food and Drug Administration approval of DMPA has made it possible for the US Agency of International Development to respond to requests for it.
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PMID:Millions of couples to have choice of injectable contraceptive. 1234 10

Levonorgestrel-releasing implants are long acting contraceptives, approved for 5 years of continuous use. Two marketed systems, the six capsule Norplant use of tradenames is for product identification purposes only and does not imply endorsement. and the two rod Jadelle, have essentially equal rates of drug release, pregnancy and adverse events over 5 years of use. Randomised clinical trials and controlled cohort observations indicate that for the first 3 years, when pregnancy rates are at or almost zero, no other contraceptive system is more effective, although etonogestrel implants provide equal effectiveness. Annual pregnancy rates rise in the fifth year of continuous use but remain below 1 per 100 women. Annual pregnancy rates of Norplant users remain below 1 per 100 throughout 7 years of continuous use. Levonorgestrel implants provide low progestogen doses; 40-50 microg/day at 1 year of use, decreasing to 25-30 microg/day in the fifth year. Serum levels of levonorgestrel at 5 years are 60-65% of those levels measured at 1 month of use. Adverse effects with levonorgestrel implants are similar to those observed with progestogen only and combined oral contraceptives. Risks of ectopic pregnancy, other pregnancy complications and pelvic inflammatory disease are reduced in comparison with those of women using copper or non-medicated intrauterine devices. Risks of developing gallbladder disease and hypertension or borderline hypertension, although small, are about 1.5 and 1.8 times greater, respectively, in women using levonorgestrel implants than in women not using hormonal contraception. Other serious diseases have not been found to occur significantly more frequently in levonorgestrel implant users than in women not using hormonal contraception. The great majority of levonorgestrel implant users experience menstrual problems, but serious bleeding problems are not more frequent than in controls. Other health problems reported more frequently by levonogestrel implant users than by women not using hormonal contraception in a study of 16000 women included skin conditions, headache, upper limb neuropathies, dizziness, nervousness, malaise, minor visual disturbances, respiratory conditions, arthropathies, weight change, anxiety and non-clinical depression. Clinical depression is not more frequent in women using implants compared with those not using hormonal contraception (i.e. using intrauterine devices, sterilisation). Removal problems occur less frequently with Jadelle than with Norplant. The mean removal time for Jadelle is half that of Norplant. Levonorgestrel implants in nationally representative scientific samples, in randomised trials, and in controlled cohort studies have continuation rates as high as or higher than any other reversible contraceptive over a duration of 5 years. This would imply that the satisfaction women derive from the contraceptive effectiveness of levonorgestrel implants greatly outweighs the dissatisfaction that may accompany menstrual disturbances and other adverse effects associated with implants.
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PMID:Risks and benefits, advantages and disadvantages of levonorgestrel-releasing contraceptive implants. 1265 Jun 33

To improve counselling information to Nigerian family planning clients, we compared non-menstrual events reported by 248 Norplant users and 214 Uniplant users. Women using Norplant were significantly older and of higher parity and greater contraceptive experience than Uniplant users. Other admission characteristics of the two groups were similar. The total women-months of use of Norplant was 2,946 (mean 11.9 +/- 0.6 SE) months while that for Uniplant was 2,315 (mean 10.8 +/- 0.2 SE) months. About 36% of Norplant users and 15% of Uniplant users reported non-menstrual adverse events, the commonest ones being pain/itching at the insertion site, unexplained low abdominal pains and clinically diagnosed pelvic inflammatory disease (PID). The numbers of women reporting drug-related adverse events were 61 (24.6%) and 23 (10.8%), respectively, among Norplant and Uniplant users. Drug-related serious adverse events were reported by 3 (1.2%) Norplant users and 5 (2%) Uniplant users. The adverse events leading to Uniplant removal were severe urticaria, breast lumps, pruritus vulvae, headache with raised blood pressure, adnexal pains and ovarian cysts, and static weight while those leading to Norplant removal were breast lump and headache with raised blood pressure. Weight gain was reported by only 7 (3%) of Norplant users. Although of no serious clinical consequences, drug-related adverse events should be added to the counselling information to prospective users.
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PMID:Nonmenstrual adverse events associated with subdermal contraceptive implants containing normegestrel and levonorgestrel. 1503 62

A total of 55 non-breastfeeding informed volunteers were recruited into a prospective longitudinal study from a family planning clinic between September and December 2002. Blood samples were collected at pre-treatment and at 3, 6 and 12 months follow-up, for packed cell volume, platelet count, prothrombin and activated partial thromboplastin time. Statistical analysis was with paired t-tests. The level of significance was set at 5%. Each subject received a menstrual calendar to chart all bleeding and spotting events. The mean age and weight of acceptors were 32.5 +/- 6.1 years and 63.6 +/- 9.6 kg, respectively. Mean packed cell volume (PCV) was 35.2 +/- 2.9% at pre-insertion. This rose to significant mean +/- SD values of 36.5 +/- 3.1%; p<0.05, 38.5 +/- 2.8%; p<0.0001 and 38.4 +/- 3.6%; p<0.0001 at 3, 6 and 12 months, respectively when compared with the pre-insertion mean value. The mean values of the platelet count showed no significant change at 3 months (238,448 +/- 68,618 mm(3); p>0.9), compared with pre-treatment value (240,545 +/- 96,769 mm(3)). There was a significant reduction in mean concentration at 6 months (p<0.009; 191,364 +/- 55,531 mm(3)) and at 12 months (p<0.003; 202,773 +/- 81,544 mm(3)) follow-up. The prothrombin and the partial thromboplastin time did not show significant change over their pre-insertion mean values of 12.0 +/- 1.1 s and 36.9 +/- 2.9 s, respectively. At 12 months, 79.5% (35) of the users reported an abnormal menstrual pattern, which included 54.5% (24) reduced bleeding pattern, 20.5% (9) increased bleeding and 4.5% (2) of combination of patterns. Only 20.5% (9) had a normal menstrual pattern. The continuation rate was 98%, as one user discontinued because of headaches. Norplant (the registered trademark of the Population Council for levonorgestrel subdermal implants) had an effect on the bleeding pattern - mainly reduced bleeding. The increase packed cell volume is beneficial in preventing anaemia. There was no detrimental effect as a result of the reduced but normal platelet count and users were not predisposed to clotting abnormalities.
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PMID:Evaluation of haemostatic function in Nigerian Norplant acceptors after 12 months of use. 1609 25

In response to the need of some women for long-acting, effective and safe contraceptives, the scientific community developed non-biodegradable progestational subdermal implants that act by making the cervical mucus viscous, with ovulation inhibition and thinning of the endometrial lining. The contraceptive protection is within 24 hours and the cumulative failure rate is low. Contraceptive implants require little or no motivation following adequate counselling. In current use are multirod implants (Norplant I and Norplant II Jadelle) and single rod implant (Implanon and Uniplant). Although menstrual symptoms associated with progestational regimens are the major compliance and acceptability factors within the first year of use, menstrual disturbance generally improves. Continuation rates for implant use are high among those who have had adequate pre-insertion counselling because the perceived advantages greatly outweigh the nuisance effects. Other side effects of implants are similar to those observed with hormonal pills--headache, weight changes, mood swings and abdominal bloating. Training of physicians and nurses in the art of insertion and removal techniques is a pre-requisite for a successful implant programme. This should also be backed by integration of implants into the national commodity logistics systems to ensure adequate local budgetary provision for contraceptive implant procurement rather than reliance on donor supply.
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PMID:Contraceptive implants. 1610 51

The case notes of 377 clients who accepted Norplant out of 11961 acceptors of family planning methods in the Department of Obstetrics and Gynaecology University of Benin Teaching Hospital, between January 1985 and December 1996 were retrieved and analysed at the end of 2004, for socio-demographic characteristics of the clients, side effects and complications reported and reasons for discontinuation in relation to duration of use. The daily register of the acceptors were analysed for new acceptors of other methods during the same period and confirmed with their case notes. The acceptance incidence of Norplant was 3.2%. The mean age and parity of the acceptors were 32.2 +/- 4.5 years and 3.9 +/- 1.8 respectively. The duration of use ranged between 6 months and 13 years. 65% of the acceptors reported menstrual abnormalities. 48% of them reported reduced bleeding pattern, while 7.5% (25) discontinued method under 4 years of use because of increased bleeding episodes. Other side effects reported were headache 6%, weight gain 3%, mastalgia 1.8%, decreased libido 1.8%, abdominal pain 1.5% and hypertension 1.2%. 20.4% (68) discontinued the use under 4 years because of desire to have another baby. 38.6% (129) had implants removed at 5 years, while 20.1% (67) continued the use for 6-13 years before removal and replacement with another set. Husband's request for removal constituted 7.2% (24). The effectiveness was 100% as no pregnancy was reported during the study period. The continuation rate at 5 years was 58.7%. 43 clients were however lost to follow up. Norplant was found to be an effective and acceptable method of long-term reversible contraception with minimal side effects. The low incidence was attributed to the fact that the implants were donor driven and not included in the country contraceptive logistic system. Norplant acceptors who continued the use after 5 years did so, because they enjoyed it and did not want to part with them without replacement of new sets.
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PMID:Contraception with levonorgestrel subdermal implants (Norplant) in Benin-City, Nigeria: a 12-year review. 1798 51


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