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The efficacy and side effects of Norplant contraceptive implants (6 capsules) versus silastic rods were compared in 250 women for 4464 months of use. Both systems were found to be highly effective and well tolerated. There was only 1 pregnancy, and this occurred during the 27th month of use in a woman who had received the Norplant implants. 34 patients (14%) discontinued the study during the 3-year study period because of side effects. Irregular uterine bleeding (either prolonged or too frequent) accounted for 50% of these removals in both groups. Other reasons for removal included mood swings, excessive weight gain, headaches, and ovarian cyst. The total drop-out rate for all reasons was only 20%, indicating that the Norplant method is highly acceptable to US women. Many subjects indicated they were willing to tolerate the bleeding problems associated with Norplant in order to have a convenient longterm method of contraception. 4 of the 8 women who had the implants removed to become pregnancy had achieved this goal by 4 months after removal, indicating that restoration of fertility is not a problem. In general, the 2-rod system has the advantages of easier insertion technique and shorter insertion time, as well as ease of removal, compared to the 6-capsule system.
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PMID:Norplant contraceptive implants: rods versus capsules. 311 87

In the US, the 90% of women, at risk of pregnancy, who use contraceptives account for 47% of all unplanned pregnancies. Thus, if women using no contraceptives or using user-dependent methods were to switch to long-acting hormonal contraceptives like Norplant or injectables, unplanned pregnancy rates would drop. Norplant was approved for use in the US in 1992. The device consists of six rods that release levonorgestrel over a period of five years to suppress the luteinizing hormone surge responsible for ovulation and thicken cervical mucus to prevent sperm penetration. Norplant is highly effective, results in few metabolic changes in users, and can be used by lactating mothers. Side effects (most prevalent in the first six months) include abnormal bleeding, weight gain, depression, and headaches. Adolescents studied reported overall satisfaction with the method. Difficulties with removal can be minimized if the implants are inserted properly. The injectable use of depot medroxyprogesterone acetate (DMPA) was approved in the US in 1992. Contraceptive plasma levels are reached within 24 hours of the injection and are maintained for 14 weeks. DMPA inhibits ovulation and is highly effective when administered once every three months. DMPA is associated with a longer delay in return to fertility than other methods. The side effects of DMPA are similar to those seen in Norplant users. Concern about changes in bone density are currently being investigated. DMPA users have increased low-density lipoprotein cholesterol levels and decreased high-density lipoprotein cholesterol levels as compared to IUD users. DMPA (unlike Norplant) can be used effectively in women using anticonvulsant medications or antibiotics. It is also safe during lactation. Research into hormonal methods is being concentrated on the development of a two-rod and one-rod Norplant delivery system, on biodegradable delivery systems, and on various injectable formulations, including once-a-month estrogen/progesterone combination methods.
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PMID:New contraceptives in the 1990s. 758 38

Questionnaires completed by 107 adolescents (average age, 16.5 years) recruited from Florida clinics indicated substantial interest in Norplant contraceptive implants, especially among those with a previous pregnancy. Included in the sample were 28 adolescents 13-20 years of age who were caring for one or more children. 40 (55%) of the adolescents with a history of sexual activity acknowledged having intercourse in the past year without use of contraception. Overall, 56% had heard of Norplant prior to the survey; the mass media was the primary knowledge source. 70% of those without children and 79% of adolescent mothers stated that they were interested in the method; moreover, 73% of nulliparous women and 89% of mothers thought Norplant would be superior to oral contraceptive use. Convenience and effectiveness were the most frequently cited positive aspects of Norplant. On the other hand, significant percentages of adolescents expressed concern about Norplant-related side effects: acne (87%), headache (83%), weight change (71%), and menstrual irregularities (71%). The main predictor of interest in Norplant was number of pregnancies; the 12 adolescents who had two or more previous pregnancies expressed the highest degree of interest. Early age at menarche (12.5 years and under) and a high number of sexual partners (4.5 and above) were also positively associated with interest in Norplant. Thus, adolescents who are most at risk of an unintended pregnancy are also the subgroup most receptive to Norplant use.
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PMID:Adolescent girls' attitudes toward contraceptive subdermal implants. 766 85

This prospective study of 122 Black and Hispanic inner-city adolescent Norplant users recruited from a teen clinic in Rochester, New York, was the first to include a two-year follow-up period. The study period extended from June 1, 1991, to June 30, 1993. The mean age of Norplant acceptors was 17.4 years; 76% had a parity of at least one. Recorded was a one-year retention rate of 71% and a two-year rate of 62%. The greatest number of removals occurred in the first three months after insertion. There was no association between Norplant retention and age, weight, race, parity, or school status. The only significant predictor of Norplant continuation was a history of at least one induced abortion. The reasons most frequently cited by the 30 adolescents who discontinued Norplant were headache, fatigue, hair loss, nausea, weight changes, breast symptoms, and appetite changes. Menstruation irregularities were reported only by terminators in the 3-6 month use interval. Considering the high continuation rates recorded in this survey and the method's proven effectiveness, Norplant has the potential to widen substantially the birth interval between adolescent pregnancies.
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PMID:Contraceptive implant use among inner city teens. 766 90

Focus group discussions were utilized to increase understanding of the factors associated with Norplant discontinuation among young, low-income women and identify counseling needs. The 15 participants--all of whom had requested Norplant removal after at least two months of use--were drawn from health clinics in three South Carolina cities. Group participants were 18-26 years old; the mean duration of Norplant use was 13.8 months. Norplant's convenience, effectiveness, long-term duration, and low cost were cited as the major advantages of the method, while prolonged bleeding, headaches, weight gain, hair loss, and mood swings were identified as the worst side effects. These side effects were the reason for requesting early Norplant removal. Although participants had been exposed to a combination of educational methods before Norplant insertion, they noted that the possibility of adverse side effects was minimized. Others felt they had been pressured to agree to Norplant insertion while still in the hospital following a delivery. The majority reported that medical staff responded negatively to their request for removal and were unsympathetic about Norplant-related side effects. As a result, these women developed a mistrust of the medical system. Since young, low-income women comprise a major target population for Norplant use, it is important to develop a counseling protocol that prepares them for side effects and suggests various coping strategies.
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PMID:A qualitative study of the perceptions of dissatisfied Norplant users. 773 Jul 70

During the period of March-October 1993 Norplant was implanted in 58 women who appeared at first, third, and sixth monthly control examinations at the OB/GYN Service, US Army Hospital, Berlin, Germany. The six rods were inserted under local anesthesia within 4-5 minutes. The average age was 24.6 years, and they were counseled individually after watching a video film about the procedure. One month after the implantation the skin appeared normal without hematoma or infection. Only 2 women had a regular menstrual cycle in the course of six months, but no pregnancy occurred. 27 women (46.5%) reported at least one side effect. Most frequent was weight gain (21 cases, or 36.2%); other side effects were headache (8 cases, or 13.2%), loss of hair (5 cases, or 8.6%), mood changes (5 cases, or 8.6%), fatigue (2 cases, or 3.4%), decreased libido (1 case, or 1.7%), and nausea (1 case, or 1.7%). In women aged 20 years or younger fewer problems occurred than in older women (p 0.025). 54 women had also used oral contraceptives. 25 of these (46.3%) had side effects, i.e., headache, migraine, or nausea. There was an association between the side effects of Norplant and those of oral contraceptives (p 0.025). At the end of the study 86.2% of women (50) reported to be satisfied with Norplant, 10.3% of women (6) said they were not satisfied, and 3.4% of women (2) were undecided. Norplant was removed in 6 cases because of side effects. Among these were 3 women with heavy hair loss, 2 with mood changes, and 1 with increasing headaches. Almost 90% of the women accepted Norplant. It is very important to instruct women in detail about the action of Norplant and counsel them in order to reduce the rate of removals.
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PMID:[Norplant and its side effects]. 779 68

During June 1992-February 1993, physicians in Charlotte, North Carolina, randomly assigned 250 women who had delivered vaginally at the Carolinas Medical Center to receive the contraceptive implant Norplant either before being discharged from the hospital on postpartum day 1, 2, or 3 or 4-6 weeks later at the scheduled postpartum follow-up visit. They wanted to ascertain whether insertion of Norplant in the immediate postpartum period was safe and well-tolerated. 26 women were lost to follow-up. 11 of these women were in the delayed insertion group, so they did not receive Norplant or an alternative contraceptive method, placing them at risk of pregnancy. Another 34 women in the same group returned for their follow-up visit but did not receive Norplant. The mean interval from delivery to insertion stood at 1.7 days for the immediate insertion group and 34.3 days for the delayed insertion group. No one in either group experienced acute postpartum hemorrhage. The immediate insertion group had much more bleeding and spotting than did the delayed insertion group (17 vs. 13.6 days, p 0.01, and 11.1 vs. 8.8 days, p = 0.03, respectively; 28.2 vs. 22.4 days for both spotting and bleeding, p 0.01). Since hemoglobin values of the two groups did not differ (12.9 vs. 12.7), the increased bleeding was not clinically significant. Women in the immediate insertion group were more likely than those in the delayed insertion group to have headaches on at least seven days between insertion and study follow-up (15.1% vs. 2.8%; p 0.01). They also were more likely to have acne during at least three days (18.9% vs. 6.4%; p 0.01). They were just as likely as the delayed insertion group to report nausea, hair loss, and hirsutism. 40% of the women in both groups had sexual intercourse before their 4-6 week follow-up visit. These findings show that Norplant can be safe and well-tolerated if inserted in the immediate postpartum period.
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PMID:Use of Norplant contraceptive implants in the immediate postpartum period: safety and tolerance. 784 30

Australian women face compliance, availability, and cost problems with contraceptives. In reality, oral contraceptives (OCs) have a high failure rate. An abortion survey in New South Wales in 1992 found that 14.4% of women were using OCs at the time of conception. Complete compliance with OCs is uncommon (28-40%). Abrupt cessation of OC use and forgetting to use pills at either end of the pill cycle are major reasons for noncompliance. Leading reasons for abrupt cessation of OCs are concerns about OCs, poor cycle control, weight gain, and headaches. Some ways to improve OC compliance are improved packaging, uniform missed pill instructions, clearer and more readable package inserts, improved verbal and written counseling, and detailed instructions on how to take the pills and what to do when one misses a pill. The abortion survey found that 22% of women seeking an abortion were using condoms at the time of conception. Many report a broken or slipped condom, both of which are generally caused by incorrect usage. Women who use the diaphragm only when they have intercourse have a higher failure rate than those who keep it in place for 24 hours, even though the latter do not use spermicides. Women are less likely to use their contraceptive method if the instructions are difficult and complicated. The vaginal ring has potential because it does not require action every day and can be left in place. The mass media and attitudes of providers influence women's choice of contraceptives. In New South Wales, only 50% of general practitioners discuss IUDs when they talk to women about contraception. 11% of women in the abortion survey could not obtain postcoital contraception from their physicians. A postcoital contraceptive and low dose OCs should be readily available in Australia. Contraceptives are expensive in Australia. Some contraceptives which are unavailable in Australia are OCs with gestodene, postcoital contraceptives, the levonorgestrel-releasing IUD, Norplant, the vaginal sponge, the female condom, and RU-486.
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PMID:Practical problems which women encounter with available contraception in Australia. 784 7

This study attempted to quantify an achievable removal rate of subdermal levonorgestrel implants (SLIs) in an unselected population and develop strategies for increasing continuation. Over 16 months, 1,076 SLIs were inserted in eligible patients from a lower socioeconomic group at high risk for unintended pregnancy. Extensive preinsertion and postinsertion counseling and follow-up care were given. Patients developing problems were counseled and managed conservatively. If a patient requested removal of the Norplant after this process, removal was done. Twenty-two removals occurred due to SLI-related problems, for a rate of 2.04%; no trends based on age or parity were found. The most common reasons for removal were bleeding/irregular menses (31.8%), headaches (18.1%) and hair loss (13.6%). An episode of thrombophlebitis, not thought to be caused by the SLI, led to one removal. Seventy-seven percent of removals occurred in the first six months, with peak rates in the fourth and fifth. Five patients became pregnant inadvertently within six months of removal. An extremely low removal rate and high continuation rate are possible in an inner city clinic population at risk for unintended pregnancy. Acceptance will increase if the SLI can be maintained at least past six months. Extensive counseling, patient support and conservative medical management constitute a successful approach.
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PMID:Removal rates of subdermal levonorgestrel implants. 785 77

An analysis is provided of 208 women who accepted Norplant between March 1991 and July 1992 at Columbia Presbyterian Medical Center in New York City. About 9600 patients attended the family planning clinics during the study period. The findings indicated that 45% of Norplant users were insured by Medicaid, 52% were not charged, and 3% paid in full or partially. The waiting list for Norplant was 400 persons long due to budget constraints and limited product availability. There were 353 visits among 170 Norplant users by October 20, 1993, of which 25% took place within the first month following insertion. The mean follow-up time after insertion was 10.8 months for 208 patients and 11.9 months for those with any follow-up visit. Follow-ups visits were similar for teenagers and adults. 64 women returned for removal by October 20, 1993. The mean duration of use before removal was 12.1 months. The reasons for removal were given as irregular bleeding, weight gain, and headache. The mean age of those with implants removed was 26.1 years. 19.0% of Norplant acceptors were teenagers, of whom 64.0% were discontinuers. One ectopic pregnancy occurred at 24 months, and one intrauterine pregnancy occurred at 14 months. The ectopic pregnancy did not require surgery. 163 users had a contraceptive history. 93% had used oral contraceptives, and 56% had discontinued use due to side effects. The mean duration of implant use was 19.9 months distributed as follows: 45 women for 16 months, 89 women for 16-23 months, 35 women at 23-28 months, and 39 women after 28 months. The removal rate was 19/100 woman years. Teenage removal rate was 2.7/100 woman years. The first 12 months removal rate among 179 women was 15/100 woman years. The two-year removal rate was 32/100 woman years. The return visit rate was considered low, and acceptance was considered high among a Hispanic population; continuation was high among teenagers.
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PMID:Use of Norplant implants in a New York City clinic population. 807 Feb 60


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