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This paper describes the first two years of Norplant use among 1560 acceptors in two rural counties of Hebei province and two rural counties of Shandong province, China. No pregnancies were reported during Norplant use, with an overall continuation rate of 88.4% after two years. Many women did, however, report side effects, including menstrual problems, headache, dizziness, and nausea among 46.7%, 6.7%, 6.3%, and 3.3% of women, respectively. Menstrual cycle disruption accounted for 77% of all Norplant removals. The majority of removals due to menstrual problems occurred in the second year of use, while most of the removals due to other causes occurred during the first year of use. Clinical performance among the four counties was diverse, with two-year continuation rates of 73.9-95.3%. Factors which may contribute to the diversity among study sites and the overall high continuation rate are discussed in the context of Chinese family planning.
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PMID:Introduction of Norplant implants in four counties of rural China: a two-year evaluation. 874 98

Although Thailand's National Family Planning Program introduced Norplant contraceptive implants in 1986, few women infected with human immunodeficiency virus (HIV) select this method, and its efficacy, clinical effects, and side effects in this population have not been investigated. To address these issues, a prospective cohort study was conducted during 1993-96 of 41 asymptomatic HIV-infected women who presented to the Family Planning Clinic at Ramathibodi Hospital in Bangkok, Thailand, and voluntarily accepted Norplant implants. All implants were inserted within 4 weeks after delivery or abortion. 63.4% of acceptors had not used any contraceptive method prior to pregnancy. At 6 and 12 months after insertion, 26% and 23%, respectively, reported irregular menstrual periods and 24.4% and 36.6%, respectively, reported amenorrhea. Side effects, reported by 3-10% of women, included headache, acne/chloasma, anorexia, and nausea. There were no significant changes in body weight, blood pressure, and hemoglobin between insertion and the 12-month follow-up. No pregnancies occurred during the study period. These findings suggest that Norplant implants are an effective, appropriate contraceptive method for HIV-infected women who want to avoid pregnancy but are not interested in sterilization.
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PMID:Use of Norplant implants in asymptomatic HIV-1 infected women. 917 51

Field research conducted in 24 rural townships in four counties (Zunhua and Leting in Hebei Province and Boshan and Yiyuan in Shandong Province) in China identified potential local-level obstacles to widespread use of Norplant contraceptive implants. A total of 1556 women received the implants between June 1992 and June 1993. In 1992, Norplant represented 20% of total contraceptive use in the study area; however, in 1993, this statistic dropped to 10% in 3 of the 4 counties. About 49% of Norplant acceptors experienced at least 1 side effect in the first 6 months, primarily menstrual disorders, headache, vertigo, and nausea. The gross discontinuation rate due to menstrual disorder was 1% at 6 months, 3% at 12 months, and 8% at 24 months; the overall discontinuation rates were 2%, 4%, and 10%, respectively. There were only 3 pregnancies due to method failure in the 24-month study period. Despite the high acceptability and effectiveness of this method, family planning workers complained that the required acceptor screening, insertion, follow-up visits, counseling, and treatment of side effects associated with Norplant increased their work loads. The decline in the method's popularity from 1992 to 1993 is presumed due to local program-related factors such as decreased implementation of an informed choice policy, unavailability of daily Norplant insertion services, the slow response of family planning workers to requests for treatment of side effects or capsule removal, and the improved availability of alternative contraceptive choices. However, demand for Norplant remained stable in Yiyuan County, where there was widespread resistance to sterilization and a willingness on the part of family planning workers to accept the increased work load associated with this method.
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PMID:Acceptance, efficacy, and side effects of Norplant implants in four counties in north China. 921 32

The Norplant system is a long-acting hormonal contraceptive method for women which offers high efficacy. The active principal is levonorgestrel, a progestin widely used in oral contraceptives. The Norplant system is in use in various countries including the US, the Dominican Republic, Colombia, Brazil, Chile, Sweden, and Denmark. Norplant consists of silastic capsules containing levonorgestrel which are inserted subdermally in the arm. The progestin is released in constant form from the moment of implantation. 50 mcg are released daily during the first year and approximately 30 mcg are released in subsequent years. Norplant is effective for at least 5 years if a set of 6 capsules is used. Norplant II, consisting of 2 capsules used for 3 years, has come into use more recently. The cumulative pregnancy rate after 5 years of use by 992 women was 2.7/100 continuous users. The annual pregnancy rate was generally less than .5%. No other reversible method has demonstrated the same level of effectiveness during such prolonged periods of use. The mechanism of action is based on inhibition of ovulation in about 50% of cycles, thickening of cervical mucus, and endometrial suppression. Norplant users may present some adverse effects such as menstrual irregularities, amenorrhea, nausea, dizziness, or headaches, but these symptoms are less frequent than with other hormonal methods. Menstrual irregularity is the most frequent secondary effect and the principal cause of termination of use. The secondary effects are generally acceptable. Follow-up during the period of effectiveness of the implants is simple and infrequent. Norplant is an excellent contraceptive choice for women who do not desire pregnancy but do not wish to use a definitive contraceptive method. Once the implant is removed, fertility rapidly is restored.
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PMID:[Norplant: a new alternative in family planning]. 1217 15

71 Egyptian women using Norplant contraceptive implants for 1 year were followed with laboratory testing of carbohydrate, lipid and protein metabolism, liver and kidney function tests, serum iron and iron binding capacity and pituitary response to GnRH. The subjects were normal, healthy fertile, non-pregnant, non-lactating women who had not used hormone for 6 months. There were no pregnancies. Most women complained of altered menstrual patterns. Some reported headache, dizziness, increased vaginal discharge, nausea, and pain at the insertion site. There was no significant change in fasting or post-prandial glucose, or kidney function. Cholesterol decreased significantly at 3 months, triglycerides fell at 3 and 12 months, and HDL rose significantly at 3 and 12 months. SGPT fell significantly at 3 and 12 months. Total protein and albumin was significantly lower at 12 months. Serum iron and total iron binding capacity were significantly elevated at 3 and 12 months. Secretion of LH and FSH fluctuated around normal limits. The lipoprotein findings are discrepant from those reported from other developing countries in Norplant trials.
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PMID:Clinical chemistry and pituitary response changes in Egyptian acceptors of L. Norgestrel six rods implants during the first year of use. 1228 53

This article is about the decision made by Wyeth-Ayerst to settle lawsuit claims filed by more than 36,000 American women concerning the use of the Norplant contraceptive implant system. The settlement, estimated at $50 million, would end 5 years of litigation involving Norplant. The plaintiff's lawyers claimed that the company downplayed such side effects as irregular menstrual bleeding, nausea, headaches, and depression. Wyeth-Ayerst Laboratories and parent company American Home Products Corp. have denied any wrongdoing and claimed that the side effects were described in the product label. The agreement to settle the Norplant claims were described as purely a business decision by Wyeth-Ayerst North America president Joseph Mahady.
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PMID:Manufacturer moves to settle Norplant claims. 1229 28

Results are presented of a clinical study of Norplant subdermal implants in Colombian adolescents. Implants have been used by 365 adolescents, of whom 174 have completed 2 years of follow-up. Study participants were monitored at months 1, 3, 6, 12, 18, and 24 postinsertion. Among the 174 women, 14% were 14-17 years old and 87% were 17-19. 21% were single, 30% married, and 49% in consensual unions. 38.5% were nulliparous, 56% had 1 child, and 5.7% had 2. 14.3% had a history of abortion. There were no pregnancies in the 2 years. 47.9% of users experienced menstrual irregularities at least once during the 2 years, with 9.3% reporting spotting or staining, 21.2% bleeding, and 19.3% amenorrhea. 6.4% reported nausea, 4.3% headache, 4.3% weight alterations, 2% acne, and 1.4% hair loss. There were 12 removals in the 2 years, 3 each because of menstrual and weight alterations, 2 for headaches, and 4 because of desire for pregnancy. 91.4% declared themselves satisfied with the method. The continuation rate was 93.2% at 2 years. The results suggest that Norplant is a good contraceptive choice for adolescents, but a prolonged study over 5 years is needed to confirm the findings.
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PMID:[Norplant: an effective option for adolescent women. Subdermal implant contraception in adolescent women. Preliminary findings in 174 cases]. 1231 5

Bangladesh has achieved a considerable decline in fertility level in the past four decades through a strong family planning programme in spite of its poor social and economic growth. However, discontinuation of contraceptive methods and decline in the use of long-acting and permanent methods (LAPMs) are still the major concerns of the family planning programmes. This paper describes various factors that lead to the acceptance of the long-term method--Norplant and those that lead to early discontinuation. This descriptive, cross-sectional study was conducted in the Family Planning Association of Bangladesh (FPAB), Dinajpur, during March-June 2005 among 73 women who visited the clinic to remove their Norplant before its usual duration (5 years). The women were in the 25-31 years age-group--around two-thirds of them (57.5%) without formal education, and three-fourths of them (75.3%) were housewives. Most of them had been married for nine years, on average, and had two and/or more children. Sixty-seven percent of the women experienced regular menstruation, and 95% had used other contraceptive methods prior to using Norplant. Past users of Norplant were the single-most important source of information for about three-fourths of the women (74%); half of the women (51%) had discussed the method with their husbands, and majority (96%) of the husbands were informed about the women's decision on accepting the method before its implantation. All women were aware about the usual length of the effectiveness of Norplant. The most common reason for early removal of Norplant was menstrual disorder (59%), followed by desire for children (16%), husband's death, for abandonment or residing abroad (8%), anorexia, nausea, vomiting (7%), weight gain (4%), husband's objection (3%), and religious beliefs (3%). Service providers should properly counsel the couple before providing any contraceptive method, informing them about method-related side-effects and clearing any religious misconceptions. They should also explore the perception of women as well as their partners' desire for children; couples who would like to have a baby within a year or two can be encouraged to use a short-term method that can be more easily discontinued.
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PMID:Importance of appropriate counselling in reducing early discontinuation of Norplant in a northern district of Bangladesh. 2484 3


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