Use of the levonorgestrel-releasing intrauterine system and breast cancer.

OBJECTIVE: The effect of exogenous hormones on the incidence of breast cancer has been extensively studied. Most studies regarding hormonal contraception have focused on combined oral contraceptives, and there is paucity of literature regarding nonoral and progestin-only contraceptives. The present study analyzed the relationship between breast cancer and use of the levonorgestrel-releasing intrauterine system. METHODS: This study was based on data gathered from a large postmarketing study on levonorgestrel-releasing intrauterine system users (n = 17,360) carried out in Finland. The results present an incidence comparison between levonorgestrel system user data and the data on average Finnish female population (derived from the Finnish Cancer Registry), between 30 and 54 years of age. RESULTS: Based on the 95% confidence intervals for the incidences of breast cancer, and the Fisher exact test, there is no indication of a difference between the levonorgestrel system users and average Finnish female population in any of the 5-year age groups. The incidence rate per 100,000 woman-years was for the age groups 30-34 years 27.2 and 25.5, for 35-39 years 74.0 and 49.2, for 40-44 years 120.3 and 122.4, for 45-49 years 203.6 and 232.5, and for 50-54 years 258.5 and 272.6, in the levonorgestrel system group and in Finnish female population, respectively. CONCLUSION: The results suggest that the use of the levonorgestrel-releasing intrauterine system is not associated with an increased risk of breast cancer.

Benefit-risk assessment of the levonorgestrel intrauterine system in contraception.

The levonorgestrel-releasing intrauterine system (IUS) is a long-acting, fully reversible method of contraception. It is one of the most effective forms of contraception available, and combines the advantages of both hormonal and intrauterine contraception. The levonorgestrel-releasing IUS also gives the users many non-contraceptive benefits: the amount of menstrual bleeding and the number of days of menstrual bleeding are reduced, which makes it suitable for the treatment of menorrhagia (heavy menstrual blood loss). Dysmenorrhoea (painful menstruation) and premenstrual symptoms are also relieved. In addition, the levonorgestrel-releasing IUS provides protection for the endometrium during hormone replacement therapy. The local release of levonorgestrel into the uterine cavity results in a strong uniform suppression of the endometrial epithelium as the epithelium becomes insensitive to estradiol released from the ovaries. This accounts for the reduction in menstrual blood loss. All possible patterns of bleeding are seen among users of the levonorgestrel-releasing IUS; however, most of the women who experience total amenorrhoea continue to ovulate. The first months of use are often characterised by irregular, scanty bleeding, which in most cases resolves spontaneously. The menstrual pattern and fertility return to normal soon after the levonorgestrel-releasing IUS is removed. The contraceptive efficacy is high with 5-year failure rates of 0.5-1.1 per 100 users. The absolute number of ectopic pregnancies is low, as is the rate per 1000 users. The levonorgestrel-releasing IUS is equally effective in all age groups and the bodyweight of the user is not associated with failure of the method. In Western cultures continuance rates among users of the levonorgestrel-releasing IUS are comparable with those of other long-term methods of contraception. Premature removal of the device is most often associated with heavy menstrual bleeding and pain, as with other long-term methods of contraception, and is most common in the youngest age group. When adequately counselled about the benign nature of oligo- or amenorrhoea, most women are very willing to accept life without menstruation. The risk of premature removal can be markedly diminished with good pre-insertion counselling, which also markedly increases user satisfaction. User satisfaction is strongly associated with the information given at the time of the levonorgestrel-releasing IUS insertion. Thus, the benefits of the levonorgestrel-releasing IUS make it a very suitable method of contraception for most women.

Concomitant vaginal surgery did not affect outcome of the tension-free vaginal tape operation during a prospective 3-year followup study.

PURPOSE: We compare outcomes when vaginal surgery and a tension-free vaginal tape (TVT) operation were done concomitantly and when only a TVT operation was done in patients with stress or mixed urinary incontinence. MATERIALS AND METHODS: Outcomes in 75 consecutive patients who underwent a TVT operation concomitantly with vaginal surgery (group 1) were compared with outcomes in 75 who underwent only a TVT operation (group 2) between August 1998 and June 2000. Group 2 patients were matched for age and incontinence type with group 1 patients. All study subjects had a followup visit to the study hospital 2 months after the operation. Questionnaire based assessments were done 2 and 3 years after the operation. RESULTS: Ten group 1 (13%) and 6 group 2 (8%) patients had a lower urinary tract infection. Other infections occurred after operation in 10 group 1 (13%) and 1 group 2 (1.3%) patients. Four cases (5.3%) of intraoperative bladder perforation occurred in group 1. A total of 15 group 1 (20%) and 7 group 2 (9.3%) patients were treated for transient urinary retention. Two months after the operation 93% of group 1 and 97% of group 2 were free of stress urinary incontinence. The corresponding percents 2 years after operation were 88% and 93%, and at 3 years they were 87% and 92%, respectively. CONCLUSIONS: Complications and transient urinary retention occurred more often after TVT operations and concomitant vaginal surgery than after the TVT operation alone. There were no statistically significant differences in regard to the cure of stress urinary incontinence and incidence of urge symptoms during the 3-year followup.

Pregnancy during the use of levonorgestrel intrauterine system.

OBJECTIVES: This study was undertaken to evaluate the pregnancy rate with the levonorgestrel intrauterine system (LNG IUS) and to analyze the outcome of pregnancies with the LNG IUS in situ in regular use. STUDY DESIGN: Questionnaires from 17,360 users of the LNG IUS were analyzed. With the consent of women reporting pregnancy during the use of the LNG IUS, related hospital records were reviewed concerning the pregnancies. RESULTS: Originally 132 pregnancies were reported. Medical records were reviewed from 108 of these women. In 64 pregnancies, conception occurred with the LNG IUS in situ. Thirty-three pregnancies were ectopic. The 5-year cumulative pregnancy rate per 100 users was 0.5 and the 5-year Pearl rate was 0.11. CONCLUSION: Pregnancy with the LNG IUS in situ is rare. Ectopic pregnancies constitute 53% of all pregnancies. Typical pregnancy symptoms occur during pregnancies with the LNG IUS. The importance to counsel about the risk of pregnancy before insertion is emphasized.

Advance information improves user satisfaction with the levonorgestrel intrauterine system.

OBJECTIVE: To evaluate parameters associated with and the impact of advance information given in a regular outpatient setting on user satisfaction with the levonorgestrel-releasing intrauterine system. METHODS: A questionnaire was sent to 23,885 women in Finland who had had a levonorgestrel intrauterine system inserted between 1990 and 1993. The number of returned questionnaires was 17,914 (response rate 75%). Cumulative logistic regression analysis was based on the five-grade scale of satisfaction as a dependent variable. RESULTS: Most users of the levonorgestrel-releasing intrauterine system (74%) were very or fairly satisfied with it, although over 70% of them had chosen it because of dissatisfaction with their previous method of contraception. User satisfaction increased with age and was associated with the amount of information about different symptoms (menstrual, greasiness of hair/skin, pregnancy, pelvic inflammatory disease, and missed periods) regardless of whether the symptom in question was actually experienced. The women who received information about the possibility of absence of menstruation were more satisfied than the less informed women (odds ratio 5.0, 95% confidence interval 4.1, 5.9). CONCLUSION: Information received at the insertion visit is strongly associated with increased user satisfaction among the users of the levonorgestrel intrauterine system. The association between high user satisfaction and advance information was strongest regarding the possibility of missing periods.