Using currently available equipment for panoramic hysteroscopy, the size of images viewed cannot be accurately judged because of the magnifying and distorting effects of the objective lens. This study has demonstrated that magnification by the hysteroscope lens can alter the apparent size of images by up to 27%. An additional effect of lens distortion can alter the apparent size of images viewed by up to 28%, depending on the position of the image in the field of view. These effects are independent and may be additive. Thus, the apparent size of intrauterine structures at hysteroscopy may bear little resemblance to their actual size. Image-correction methods are described which reduce the effects of image magnification on the apparent size of an object viewed through the hysteroscope to 7%, and the effect of distortion to 3 %. This technique can greatly improve the accuracy of measurement at hysteroscopy, and has been utilized in this study for the precise measurement of superficial endometrial vascular diameter (mean+/-SEM) in 34 Norplant users (120+/-11.6 microm) and 20 women with spontaneous menorrhagia (74+/-7.2 microm). It has also confirmed the presence of scattered dilated vessels (up to 777 microm in diameter) on the endometrial surface in some Norplant users.

This study used electrocardiography to determine any inherent cardiovascular dangers with the use of Norplant, an implant contraceptive among Nigerian females using the device. As part of a major study of metabolic, physical and cardiovascular changes consequent upon the use of Norplant implant contraceptive, all subjects underwent serial electrocardiograms at pre-insertion, 3, 6, and 12 months of use. Given the observed prolongation ofelectrocardiographic intervals, the ECG of all the study subjects were secondarily analysed for QT and corrected QT (QTc) dispersions. QT intervals was measured from the ECG of each of the 21 subjects who were available at pre-insertion and 12 months post-insertion; from the onset of QRS to the end of T wave or nadir of the curve between T and U waves as the case may be. Corrected QT intervals was calculated by determining the RR interval and using the Bazett's formula. The difference of the lowest and highest QT intervals and QTc intervals over the 12 leads determined their respective dispersions. These were then analysed. The subjects whose ages ranged from 25-45 years weighed between 43 and 87.2 kg. The mean QT dispersion increased with time but did not reach statistical significance by the twelve month visit (ANOVA - QT dispersion 0 month vs 12 months: F=0.98, p=0.48). However the mean QTc dispersion increased and reached statistical significance by 12 months (0 month vs 12 months: F=5.49, p=0.006). QT and QTc dispersion increases are known to predict cardiovascular death in health and disease. With the use of this device, these indices rose gradually with time reaching statistical significance by 12 months only with the QTc dispersion. The use of this device may increase the tendency to cardiovascular morbidity and mortality. Whether this translates into real risk will require a long-term study to determine. For now, application of the device on patients with cardiovascular disease or tendency thereof should still attract caution.

This research examines the use of condoms to protect from disease women who selected hormonal implants for contraception. After receiving contraceptive implants, subjects were surveyed regarding their past use of condoms and their plans for using them to inhibit the transmission of HIV and other sexually transmitted diseases in the future. Twenty-one percent of women in the sample had used condoms in the past, but did not plan to use them once they have the implants. While decreasing their risk for unplanned pregnancy, they and/or their partners can be expected to experience an increased risk of exposure to sexually transmitted disease. Contraceptive providers must emphasize to their patients the need for protection from disease, in addition to pregnancy, when prescribing contraceptive methods.

The prevalence of local signs and symptoms related to the site of insertion of implants, and the association of these signs and symptoms with time of use, skin color and body mass index (BMI) was evaluated among users of the Norplant implant system. Three hundred and three Norplant users attending at the reproductive health clinic of PROFAMILIA in Santo Domingo, Dominican Republic, were asked if they had ever had any discomfort at the site/arm of implant insertion and the implant insertion area was examined and hyperpigmentation and hollowing of the surface was recorded. Half of the subjects reported either pain or paresthesia or both, in almost equal numbers, some time since insertion. Hyperpigmentation was observed in 35.6% and hollowing in 22.4% of the subjects. Report of pain and paresthesia was inversely associated to time of use and to BMI. Hyperpigmentation was directly associated to time of use and darker skin, and hollowing of the arm surface in the implants area with time of use and BMI. Local signs and symptoms were more frequent than previously reported, although they were of mild nature and appeared not to worry most of the users.

This study evaluates a unique and completely different approach from the original removal technique. The main objective of this technique is to facilitate removal of widely-spaced, deeply-positioned, and misplaced Norplant capsules. A local anesthetic is injected deep and perpendicular to the long axis of the Norplant rods. The hypodermic needle is left in place underneath the six silicone rods for the entire removal procedure. One or two 3-4mm vertical incisions were made between the capsules over the needle. The Norplant rods were dissected free from the fibrous tissue and the skin with a #11 blade. A curved mosquito forceps was inserted between the skin and the Norplant rod, to hook and deliver the capsule through the incision, from where it can be easily removed. This method resulted in far less time, effort, and skill from the health care provider, no damage to the capsules, and much less trauma to the clients.

OBJECTIVE

(1) Assessment of longest effective contraceptive duration of Norplant (containing levonorgestrel, LNG) by serum levonorgestrel levels. (2) To observe the possible relationships between the serum LNG levels of long-term use (5 years) and body weight.

METHODS

To determine serum LNG levels in 230 women among 1,356 cases at various intervals between 1 and 11 years after implantation using RIA kits provided by WHO.

RESULTS

The average serum levels of LNG in users of Norplant at the 1st, 3rd, 5th years were 1,273.5, 924.0 and 739.6 pmol/L respectively. From the 5th to 7th years average serum LNG levels showed almost a linear decline, and from the 7th through 10th year it did not show much changes. The average serum LNG level was (511.1 +/- 209) pmol/L. A significant negative correlation was found between serum LNG levels and body weight at the 5th years.

CONCLUSIONS

One set of Norplant implants may provide effective contraception for 8-10 years in women with body weights less than 60 kg.

BACKGROUND

This study tested the hypothesis that teenagers who have Norplant inserted during the puerperium report more depressive symptoms during the first postpartum year than their peers who do not receive Norplant.

METHODS

We studied the prevalence of depressive symptoms in a group of 212 mothers aged 19 years less, in relation to the timing of Norplant insertion. The participants were divided into 3 groups: 100 (47%) had Norplant inserted during the puerperium (early Norplant users); 72 (34%) had Norplant inserted during the next 10 months (late Norplant users); and 40 (19%) used other contraceptives (40% oral contraceptives; 17% condoms; 43% nothing). Depressive symptoms were measured with the Center for Epidemiologic Studies - Depression Scale. Postpartum depression was defined as a scale score>>/=16, 6-12 months after Norplant insertion or delivery. Variables examined as potential confounders were identified a priori from a review of the literature and controlled for in analysis of variance.

RESULTS

At delivery, members of the 3 contraceptive groups did not differ significantly with regard to age, race, parity, educational, marital, or socioeconomic status. Late Norplant users were, however, more apt to have new boyfriends (p =. 03), to rate the support they received from the baby's father as poor (p =.004), and experience depression prior to Norplant insertion (p =.02). Contrary to the study hypothesis, late rather than early Norplant insertion was associated with postpartum depression. Multivariate analyses identified 3 independent predictors of the severity of depressive symptoms at follow-up (depression prior to Norplant insertion, a new boyfriend at delivery, and late Norplant insertion); R(2) = 41.3%.

CONCLUSIONS

Contrary to the study hypothesis, puerperal Norplant insertion did not exacerbate postpartum depression. Delaying Norplant insertion may increase the risk of depression during the first postpartum year, particularly in teenagers with other psychosocial risk factors.

Perinatal transmission and reproductive decisions of HIV-infected women can be categorized in statistical and epidemiological terms. These reports and figures, however, do little to fully explain the complexities of human relationships, life experiences, personal and cultural influences, and situational and environmental variables that impact on the HIV-infected woman regarding reproductive decision-making. It is only with genuine attempts to understand the woman's perspective and the dynamic and unique variables that influence reproductive decision-making, as well as maintaining a non-judgmental and culturally sensitive perspective, can we hope to assist women, and society as a whole, in coming to terms with the complexities of HIV and reproductive decision-making. Further study is needed to identify factors that influence reproductive decision-making in HIV-infected women. The determinants of contraceptive use regarding demographic factors, barriers to contraceptive use, and factors that contribute to successful contraceptive use in this population must be understood if efforts to reduce the number of unplanned pregnancies are to be successful. More conclusive data are needed on the safety and efficacy of oral contraceptives in HIV-infected women as well as data that describe the effects of longer acting hormonal contraceptives such as levonorgestrel implants (Norplant; Wyeth-Ayerst, Philadelphia, PA) and injectable medroxyprogesterone acetate (Depo Provera; Upjohn Company, Kalamazoo, MI). More research is needed to determine the effects of patient education and counseling and closer follow-up on effective long-term contraception in HIV-infected women.

OBJECTIVE

Norplant and Norplant-2 have been available for use by Finnish women since 1984 and 1986, respectively. The objective of this study was to explore Norplant users' experiences of insertions, removals and medical treatments.

METHODS

A questionnaire was sent to women who had received Norplant or Norplant-2 implants one to two years earlier (n = 262) in normal clinical settings; the response rate was 79%.

RESULTS

At insertion, problems were experienced by 9% and at least some pain by 23% of women. During the first year 20% of all users (14% of Norplant and 33% of Norplant-2 users) had their implants removed. Problems were experienced at removal by 33% of women and pain was experienced by 40%; nevertheless most users were satisfied with the device. Findings were similar for the two types of Norplant. Forty-two percent of the women had received minipills containing levonorgestrel before Norplant insertions in an attempt to assess Norplant's suitability, and 8% had received drugs for adverse effects caused by Norplant.

CONCLUSIONS

Studies including perspectives of Norplant users and the whole lifespan of Norplant (including removal) should be conducted in all clinical settings where Norplant is provided.

NORPLANT is the newest contraceptive system to be introduced world-wide, with nearly a million current users. It consists of six Silastic capsules containing levonorgestrel (LNg), which are inserted under the skin in the arm. Release of the steroid commences immediately so that, after several weeks, circulating levels of LNg stabilize between 0.3 and 0.4 ng/ml of plasma, and they persist elevated with a minor decline for over 5 years. The gross cumulative pregnancy rate at 5 years is 2.6 per 100 woman-years. In the majority of women it produces no abnormalities in a variety of clinical chemistry, metabolic, haematological and coagulation parameters. The most common side-effect is disruption of the menstrual bleeding pattern; this is reported by two-thirds of the users in the first months and by one-third by the fifth year. Because it is the most disturbing side-effect for many users, counselling prior to insertion is of paramount importance. NORPLANT exerts varying degrees of gonadotrophin and ovarian inhibition, including anovulation and luteal insufficiency. Endometrial development is irregular and, irrespective of oestrogen levels, cervical mucus is thick and scanty at all times due to the strong antioestrogenic effect of LNg. Inhibition of sperm penetration fully accounts for the antifertility effect of NORPLANT in ovulatory cycles. The high contraceptive efficacy, lack of serious side-effects, reversibility and the convenience of long-term unattended use explain the high acceptability of NORPLANT.

We describe a simple technique to facilitate the removal of difficult-to-remove Norplant implants. Through a standard skin incision for Norplant removal, the fibrous capsule surrounding the implant is secured using either a dermatologic skin hook or a 25-gauge hypodermic needle fashioned into a hook with a hemostat. Traction is applied to bring the fibrous sheath into the incision site, where the implant tip is dissected free using a scalpel. The precisely localized countertraction afforded by this technique provides increased accuracy and speed for the removal of difficult-to-extract implants. Tissue trauma is minimized and the need to extend the skin incision is reduced.

OBJECTIVE

The purpose of this study is to evaluate the effects of tranexamic acid and placebo on controlling irregular uterine bleeding secondary to Norplant use.

METHODS

A prospective randomized, double-blind, placebo-controlled trial was conducted. Sixty-eight Norplant users who had irregular bleeding were randomly allocated into two groups. A total of 34 users received tranexamic acid 500 mg twice a day for 5 days; the placebo was given to the other 34 users in the same manner. The total number of days of bleeding and spotting and the percentage of women whose irregular uterine bleeding was stopped was analyzed at the end of weeks 1 and 4.

RESULTS

In the follow-up period (4 weeks after the initial treatment), a bleeding-free interval of>> 20 days was found in 58.8% of the subjects treated with tranexamic acid and in 76.5% treated with placebo (p = .12). The percentage of subjects whose irregular uterine bleeding stopped during week 1 after the initial treatment was significantly higher in the tranexamic acid group than those in the placebo group (64.7% vs. 35.3%, p = .015). The mean number of bleeding/spotting days was not significantly different between the groups (15.4 vs. 12.7 days, p = .182).

CONCLUSIONS

Tranexamic acid for 5 days appears to be an effective treatment for irregular uterine bleeding associated with Norplant use only while it is being used. However, treatment for 5 days does not seem to provide long-term benefit.

Norplant, a sc contraceptive device, releases levonorgestrel in a sustained fashion. Its effectiveness is offset by irregular bleeding patterns. Because vascular endothelial growth factor (VEGF) is stimulated by synthetic progestogens in vitro and in vivo, we postulated that correlations between this angiogenic factor and uterine bleeding patterns might exist. Twenty-eight women who were exposed to Norplant and 13 control women were prospectively followed for 6-8 months. Bleeding diaries were collected, hysteroscopies were performed, endometrial biopsies were obtained for standardized histological evaluation, and VEGF histochemical immunostaining (H)-scores were assigned. Cluster determination-34 (CD34) staining was also performed to quantify the number of endometrial blood vessels per high-power field. Irregular uterine bleeding was common among women using Norplant devices. Endometrial VEGF H-scores were greater in women using Norplant than in control women. New findings of this study show that vessel density did not correlate with epithelial VEGF H-scores but was highly associated with the intensity of stromal and perivascular VEGF. VEGF expression in the latter regions correlated significantly with hysteroscopic abnormalities and irregular bleeding. The expression of this angiogenic protein, particularly in the stromal and perivascular compartments, correlated with microvascular density, hysteroscopically documented hypervascularity, and uterine bleeding profiles. Irregular bleeding with Norplant use appears to reflect paracrine-mediated effects on vascular function by angiogenic factors, such as VEGF.

A double-blind, placebo-controlled, randomized trial, was carried out in 120 Norplant users to evaluate the effect of mifepristone, 100 mg/day administered for 2 consecutive days every 30 days, on the vaginal bleeding pattern. Treatment was given from months 2-7 of implant use. Volunteers recorded bleeding and spotting days, during treatment and for the ensuing 6-month period. During treatment, women on mifepristone recorded the same frequency of bleeding/spotting episodes but significantly less prolonged bleeding episodes than placebo controls (mean +/- SD: 11 +/- 3 vs. 22 +/- 23 days) and their total number of bleeding days was 35% lower than in the placebo group. After the end of mifepristone use, bleeding patterns were similar in both groups. One pregnancy occurred in the mifepristone-treated group, in month 6 of treatment, the outcome was a healthy male baby. We conclude that intermittent administration of mifepristone can offer a clinically significant improvement of the vaginal bleeding pattern in Norplant users.

Unpredictable endometrial bleeding is the major side-effect of levonorgestrel-releasing s.c. implants (Norplant), otherwise a method of choice for long-term contraception. The mechanisms responsible for bleeding are still unknown and no reliable treatment is available. Several matrix metalloproteinases (MMP) are expressed and activated in human endometrium only at menstruation and specific synthetic inhibitors of MMP fully prevent the tissue breakdown that occurs in menstrual-like endometrial explants. To investigate whether MMP are inappropriately expressed and activated in Norplant-treated endometria during bleeding episodes, volunteers were recruited to provide blood and endometrial biopsies at the start of bleeding episodes and during non-bleeding intervals. Whereas serum concentrations of levonorgestrel and sex hormones showed no change at bleeding, except for a slight decrease of oestradiol concentration, the expression and activation of stromelysin-1 released by explants cultured for 1 day were consistently increased at the start of bleeding episodes. Furthermore, stromelysin-1 was immunolocalized in stromal cells within breakdown areas of several bleeding endometria, but not in non-bleeding endometria. These observations suggest that the expression and activation of stromelysin-1 participate in the initiation of bleeding episodes upon Norplant contraception. New strategies in the prevention and treatment of abnormal bleeding based on MMP control should be envisaged.

OBJECTIVE

To investigate the experience of the users of a levonorgestrel-releasing contraceptive implant (Nor-plant) and reasons for early removal.

METHODS

Two hundred fifty-one women who had Norplant placed through the Ohio State University Department of Obstetrics and Gynecology were sent a questionnaire that included general demographic questions and questions regarding preplacement education; reasons for choosing Norplant; problems experienced due to Norplant; reasons for removal, if applicable; and overall satisfaction.

RESULTS

One hundred eleven questionnaires (44%) were completed and analyzed. Twenty-four (21.6%) of patients had Norplant removed, 32 (28.8%) planned on early removal, and 55 (49.5%) desired continued use. Ninety-eight percent of women who planned continued use of Norplant had received reading material as part of their preplacement counseling and 95% felt adequately counseled. This is significantly higher than women who had Norplant removed or planned on early removal. Convenience, problems with other contraceptive methods and effectiveness were the most important reasons why patients chose Norplant. Menstrual changes were the most common side effect, experienced by 80% of all women in the study. Weight gain, headache, mood changes, mastalgia and acne were also frequently reported. Women who had Norplant removed were significantly more likely to have experienced dizziness when compared to women desiring continued use. Women planning early removal were also more likely to have experienced dizziness in addition to acne, headache, hair loss and other side effects. Menstrual irregularities, followed by mood changes and headaches, were the most important side effects associated with early Norplant removal. Overall, 68% of users were at least somewhat satisfied with Norplant.

CONCLUSIONS

Norplant contraception was a satisfactory form of birth control for the majority of patients in the study despite the frequent occurrence of side effects. Reading material regarding benefits and side effects of Norplant is an important aspect of patient counseling and may improve long-term use of Norplant.

A study (ISRCTN 77665712) was undertaken to test the effectiveness and the acceptability of vitamin E and low-dose aspirin, alone or in combination, as treatment for prolonged vaginal bleeding induced by Norplant. A total of 486 Norplant users who were requesting treatment for bleeding lasting longer than 7 days were enrolled in five centers: Beijing, China; Jakarta, Indonesia; Santiago, Chile; Santo Domingo, Dominican Republic; and Tunis, Tunisia. They were randomized to one of four different 10-day oral treatments: 200 mg vitamin E daily, 80 mg aspirin daily, both or a placebo. Treatment packs were designed to ensure blinding of both the subjects and the clinical staff. Neither vitamin E nor low-dose aspirin nor their combination was found to have any effect on reducing the length of the bleeding episode for which treatment was taken or on the vaginal bleeding patterns these women experienced during the year of follow-up.

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.

Implantable contraception represents a safe, reversible form of long-term family planning with distinct advantages. It does not contain estrogen, thus avoiding many of it contraindications. Importantly, it is extremely effective, has high continuation rates, and is well tolerated. The main side effects of Norplant are irregular menstrual bleeding and the occasional difficult removal. Although recent high-profile litigation has severely diminished enthusiasm for Norplant, the FDA has reaffirmed its safety and efficacy. Norplant remains a viable family planning option for carefully selected women. New contraceptive implants may soon be available accentuating the advantages of Norplant while minimizing the disadvantages.

The subdermal implant NORPLANT II contraceptive was studied for its safety, efficacy and acceptability over a period of 5 years of use in a phase III multicentre clinical trial. A total of 1,466 women were observed for 52,849 women-months of use. Only four pregnancies were reported during the study period, giving a method failure rate of 0.8 per 100 users at 5 years of use. The continuation rates were 61.4, 49.0 and 42.1 per 100 users at 3, 4 and 5 years of use, respectively. The majority of the discontinuations were due to bleeding irregularities which accounted for 22.2, 26.3 and 28.5 per 100 users at 3, 4 and 5 years of use, respectively. The next common reason was planning pregnancy which was observed mainly in women having one child. The discontinuations due to infection, expulsion or displacement of device were very low (0.2-0.3 per 100 users). Due to vigorous efforts made by the centers to follow the subjects, the lost-to-follow-up rate was very low (1.6% at 5 yr).

In order to assess efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II in Mexican women, a comparative phase III clinical trial was undertaken in eight clinics across the country. The study involved 1052 women who were followed-up trimonthly for three years. Cumulative pregnancy rates were 0.29% and 0.34% for Norplant and Norplant-II implants, respectively. Similar overall cumulative discontinuation rates were observed at three years: 50.38% for Norplant capsules, and 50.44% for Norplant-II rods. The main method-related reason for termination was endometrial bleeding irregularity which led to discontinuation rates of 11.94% and 11.62% for Norplant and Norplant-II contraceptive systems, respectively. In 15,279 woman-months of experience accumulated with Norplant implants and 14,092 with Norplant-II implants, there were few adverse events reported. No difference was found between the two groups in either difficulty for implants placement and removal or women's discomfort, even though the time required for insertion and removal of Norplant capsules was longer than for Norplant-II rods. It is concluded that during the first three years of use, both implants systems are equally effective, safe, and acceptable.

A series of 191 endometrial biopsy procedures were performed on Indonesian women who had received between 3 and 12 months exposure to Norplant. In all, 87 biopsy procedures were attempted with a microhysteroscope using biopsy forceps, and 104 procedures were attempted with either Pipelle or Karman suction curettes. Regardless of the biopsy method, diagnosable endometrium was obtained in only approximately 50% of procedures. Myometrium was often found in microhysteroscope but not in suction biopsies. An analysis of a number of clinical characteristics showed that women from whom diagnosable endometrial tissue was obtained had higher mean peripheral oestrogen concentrations in the 2 weeks prior to biopsy (439 +/- 35 versus 289 +/- 33 pmol/l; P = 0.0018) and significantly more days when endometrial bleeding occurred in the 90 days prior to biopsy (26.5 +/- 2.1 versus 16.2 +/- 1.8; P = 0.0003). These results suggest that after 3-12 months exposure to Norplant approximately 50% of women have an endometrium too thin to sample, and that this group is characterized by lower peripheral oestrogen concentrations and reduced menstrual bleeding.

OBJECTIVE

To assess the relative contraceptive effectiveness, tolerability and acceptability of the levonorgestrel-releasing (20 microg per day) intrauterine system (LNG-20) compared with reversible contraceptive methods in women of reproductive age.

METHODS

A systematic review and meta-analysis of randomised controlled trials.

METHODS

Studies were identified through seven databases, and by contacting investigators and organisations working in the contraceptive field.

METHODS

Unplanned pregnancy and continuation of contraceptive method.

RESULTS

Five of the seven randomised controlled trials which met the inclusion criteria were included in the meta-analyses; four were comparisons of the LNG-20 intrauterine system with nonhormonal intrauterine devices. LNG-20 intrauterine systems were compared with intrauterine devices divided into two categories, those>> 250 mm3 (Copper T 380 Ag and Copper T 380A intrauterine devices) and those < or = 250 mm3 (Nova-T, Copper T 220C and Copper 200 intrauterine devices). Pregnancy rates for the LNG-20 intrauterine system users were significantly less likely to become pregnant compared with users of intrauterine devices < or = 250 mm3, and significantly less likely to have an ectopic pregnancy. LNG-20 intrauterine system users were more likely to experience amenorrhoea and device expulsion than women using intrauterine devices>> 250 mm3. LNG-20 intrauterine system users were significantly more likely than all the intrauterine device users to discontinue because of hormonal side effects and amenorrhoea. When the LNG-20 intrauterine system was compared with Norplant-2, the LNG-20 users were significantly more likely to experience oligo-amenorrhoea, but significantly less likely to experience prolonged bleeding and spotting.

CONCLUSIONS

The effectiveness of the LNG-20 intrauterine system was similar to or better than other contraceptive methods with which it was compared. Amenorrhoea was the main reason for the discontinuation of the LNG-20 intrauterine system, usually unnecessarily, since this end-organ suppression of bleeding is benign, associated with normal oestrogen levels. Women choosing this method should be informed of potential amenorrhoea when having pre-contraceptive counselling and that absent bleeding may be viewed as a positive outcome.

The study describes the experiences of 430 women who had Norplant(R) contraceptive implants removed prior to the five years of method effectiveness. Each subject was surveyed when the implants were inserted and again at the time of removal. Descriptive data are presented concerning perceptions of the method before insertion and after removal, reactions to the contraceptive and experiences associated with the removal procedure. Subjects' use of Norplant implants ranged from 14 days to 40 months, with a mean of 13.3 and median of 13 months. Over 95% reported changes in menstrual bleeding patterns and 95% experienced other non-bleeding related side effects. Non-bleeding side effects were the most frequently indicated reasons for removal, followed by bleeding changes. The mean removal time was 34 minutes with a median of 25 minutes. Over 48% reported experiencing significant pain during the removal procedure, and 27% stated that the pain was greater than expected. Despite electing for early removal of implants,the majority of women surveyed indicated satisfaction with all aspects of the method save its effect on their overall health. Although method-related side effects were intolerable for most subjects, their overall perception of the method was generally satisfactory.