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PubMed1999

RETRACTED: The effects of Implanon on lipid metabolism in comparison with Norplant.

This open, randomized study was intended to assess the effects of the new single-rod contraceptive implant (Implanon) containing etonogestrel on lipid metabolism in Indonesian women, in comparison with the six-rod implant Norplant, containing levonorgestrel. The effects of both products were compared with a control group using an intrauterine device (IUD) over a 3-year period. A total of 135 healthy volunteers of childbearing potential, aged 22 to 41 years, were enrolled in Jakarta, Indonesia. Ninety volunteers were randomized to use Implanon (n = 45) or Norplant (n = 45), and a nonrandomized group of 45 Multiload Cu 250 IUD users served as a control. Serum concentrations of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein AI, apolipoprotein AII, and apolipoprotein B were measured. The ratios of HDL cholesterol to total cholesterol, of HDL to LDL cholesterol, and of apolipoprotein AI to apolipoprotein B were determined. Lipid and lipoprotein determinations were done at screening and after 3, 6, 12, 18, 24 and 36 months. Contraceptive efficacy and insertion and removal times were also recorded. Mean changes from baseline in the lipid and apolipoprotein parameters, although occasionally statistically significant, were small in all groups (less than 1 standard deviation of the mean concentration at baseline) and clinically not significant. Statistically significant differences between the Implanon and Norplant groups were only occasionally observed. In both implant groups, total mean cholesterol, LDL cholesterol, and apolipoprotein AI concentrations tended to decrease during the study, but statistically significant changes from baseline were only occasionally observed, suggesting that drug-related factors are not involved. The mean ratios of HDL/total cholesterol and the HDL/LDL cholesterol showed very little change over time in both implant groups; slight and statistically nonsignificant increases were noted at most time points. Similar changes were seen in the group of IUD users. It can be concluded that changes from baseline in the lipid and apolipoprotein parameters tested were generally small and did not differ between Implanon and Norplant.

Adolescent↗
PubMed1992

Interactions between intrauterine contraceptive device use and breast-feeding status at time of intrauterine contraceptive device insertion: analysis of TCu-380A acceptors in developing countries.

OBJECTIVE: This paper is a reassessment of earlier findings from a preliminary analysis of data from a multicenter international trial regimen on breast-feeding and non-breast-feeding women in which events related to insertion, expulsion, and removal of the TCu-380A intrauterine contraceptive device (ParaGard 380) were investigated. STUDY DESIGN: Performance of the TCu-380A through 12 months after insertion was compared with life-table rate analysis, chi 2, Fisher exact test, or Student's t test. Variables were events reported during intrauterine contraceptive device insertion and events throughout the 12 months of study participation by breast-feeding status. RESULTS: Breast-feeding among intrauterine contraceptive device users was associated with fewer insertion-related complaints and lower removal rates for bleeding and pain. No uterine perforations were reported throughout the study. CONCLUSION: Differences in the performance of the TCu-380A intrauterine contraceptive device suggest physiologic effects associated with lactational amenorrhea. The TCu-380A intrauterine contraceptive device is a viable option for women breast-feeding at the time of intrauterine contraceptive device insertion.

Adult↗
PubMed2004

Complications of the intrauterine device in nulliparous and parous women.

OBJECTIVES: The intrauterine device (IUD) is still related to pelvic inflammatory disease (PID), pregnancy, expulsion, perforation and menstrual problems, particularly in nulliparous women. We aimed to study the complications and symptoms of the intrauterine device in general practice, particularly in nulliparous women. METHODS: We used a retrospective cohort study in four general practices participating in the Nijmegen Continuous Morbidity Registration. Selected women had one or more IUDs inserted between 1981 and 2000. Data on complications, symptoms and removal of the IUD were obtained from the medical records. RESULTS: 461 women were included, 129 nulliparous and 332 parous women. Users of copper IUDs had a rate of PID of 3.5 per 1000 women-years, rates of (ectopic) pregnancy of 0.6 to 1.1% per year and rates of expulsion of 0 to 1.2% per year. Rates of expulsion for the levonorgestrel-releasing IUDs were 0 to 0.2% per year. Nulliparous women did not show more complications than parous women. Menstrual problems were frequent among users of copper and levonorgestrel-releasing IUDs. One third of the IUDs were removed within the first year after insertion. There was no significant excess of IUD removal among nulliparous women compared with parous women. Main reasons for removal were 'menstrual problems' and 'contraception no longer necessary'. CONCLUSION: Both copper and levonorgestrel-releasing IUDs are safe and highly effective contraceptives, which can adequately be inserted and monitored by general practitioners in nulliparous and parous women.

Adolescent↗
PubMedDate not supplied

Unusual late complications after two previous cesarean deliveries: a case report.

BACKGROUND: Women with multiple previous cesarean deliveries (CDs) risk the development of uterine synechiae and ventral fixation of the uterus to the abdominal wall. CASE: A para 2, gravida 2 women who had two prior CDs experienced prolonged menstrual bleeding with persistent cramps, both of which became more severe after insertion of an intrauterine contraceptive device that was subsequently removed. Pelvic ultrasound revealed an enlarged uterus with fibroids. After a failed attempt to perform a dilation and curettage because of uterine synechiae, the patient underwent a total abdominal hysterectomy. During surgery, the gynecologist observed a total dehiscence of the previous uterine incision, with ventral fixation of the uterus to the lower anterior abdominal wall and marked elongation of the portio cervix. CONCLUSION: Dysmenorrhea in a patient with multiple previous CDs, mainly of the classical type, should be carefully evaluated and, in addition, when such patient requires a dilation and curettage, the possibility of cervical stenosis and uterine synechiae should be kept in mind. Having had a number of previous CDs may have an adverse impact on the uterine complication rate.

Adult↗
PubMed2005

Symptomatic cecal perforation by an intrauterine device with appendectomy removal.

BACKGROUND: The intrauterine device is the most used contraceptive in the world, but it is not without risk of perforation of intra-abdominal organs. We report a perforation of the cecum and removal via appendectomy. CASE: A 23-year-old woman developed chronic abdominal pain after insertion of an intrauterine device 8 weeks postpartum. At laparoscopy, the device was found in the cecum and removed via appendectomy. CONCLUSION: Perforation is more common in the immediate postpartum state. An alternate method of removal via appendectomy proved useful.

Abdominal Pain↗
PubMed1999

Norplant utilization in a Latina inner-city population.

This study was a consecutive-case series of 138 Latinas (age 16 to 36) who received levonorgestrel implants (Norplant) in a community health center between September 1, 1992, and December 31, 1994, and were observed through September 30, 1997. Continuation rate at one year was 70 percent, and 43, 28, and 22 percent at two, three, and four years, respectively. Average observation time was 32 months. Most frequent reasons for removal were excessive bleeding (34 percent), weight gain (26 percent), hair loss (16 percent), amenorrhea (13 percent), desire for pregnancy (11 percent), and headaches (9 percent). Five women discontinued due to fear of ill effects, four to undergo sterilization. No pregnancies occurred while using the method. Norplant is an effective contraceptive for inner-city Latinas; removal rate was higher than in previous reports. Side effects or fear of side effects led to removal in more than half the patients by two years' use.

Caribbean Region↗
PubMed2003

Risks and benefits, advantages and disadvantages of levonorgestrel-releasing contraceptive implants.

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.

Contraceptive Agents, Female↗
PubMed2002

An assessment of the use of Implanon in three community services.

AIMS: The aims of the study were three-fold, namely to assess continuation rates with Implanon fitted in clients from three contraception and sexual health services; to identify factors associated with early removal of Implanon; and to assess clinician compliance with recommended practice in counselling and insertion. METHODS: Retrospective review of client records, and comparison with audit criteria. Postal survey. MAIN FINDINGS: One hundred and ninety women had Implanon inserted in the study period. Continuation rates were between 84% and 88% at 6 months and 67% and 78% at 12 months. There were no pregnancies or procedure complications. The main reasons for removal were identified as intolerance of recognised side effects or a change of mind about wanting contraception. Younger women were more likely to have the device removed early. There was evidence of excellent or good recording of many criteria for best practice in counselling and insertion. The assessment highlighted certain issues around counselling and insertion that services needed to consider further. CONCLUSIONS: The three services have been reassured that they are providing a good standard of care to clients requesting Implanon and that their 'real life' 6- and 12-month continuation rates are reasonable.

Adolescent↗
PubMed2005

Nongenital malformations following exposure to progestational drugs: the last chapter of an erroneous allegation.

In the late 1960s and 1970s, a number of epidemiological studies were published indicating that pregnant women who were exposed to an array of sex steroids delivered infants with an increased incidence of nongenital congenital malformations. Because of these publications, the Food and Drug Administration (FDA), in conjunction with various pharmaceutical companies, labeled the therapeutic exposure of progestational drugs and contraceptives in pregnant women as a risk factor for limb-reduction defects (LRDs) and congenital heart defects (CHDs). Subsequently there was a rapid decrease in the exposure of pregnant women to these drugs and the initiation of numerous lawsuits alleging that a particular progestational drug was responsible for a child's nongenital congenital malformation. Wilson and Brent (1981) published an article indicating that epidemiological and animal studies of these drugs, and basic science did not support the package insert's warnings. Many new and previous animal and epidemiological studies did not support the FDA box warning. In 1987 the FDA held a hearing in which the FDA, the Teratology Society, the Centers for Disease Control and Prevention, the American College of Obstetrics and Gynecology, and other organizations supported the position that progestational agents did not result in nongenital malformations. An editorial appeared in Teratology congratulating the FDA for removing the warning label on oral contraceptives regarding nongenital malformations. In 1999 the FDA published new wording for package inserts that removed warnings for nongenital malformations for all progestational agents. In spite of the recent changes in the package inserts, lawsuits have alleged that progestational drugs cause nongenital malformations. It took 22 years from the time a box warning was required by the FDA until the warnings were removed in 1999. The 1999 FDA publication, which is a scholarly and objective document, should put an end to 2 decades of concern and anxiety for pregnant women or women of reproductive age. Could scientists, the pharmaceutical companies, or the FDA have prevented the mislabeling of progestational drugs with regard to their teratogenic risks? Was the epidemiological or teratology community at fault because they did not critique and respond to the early publications? Did the FDA act too slowly? The epidemiologic analyses, animal studies, and basic science principles have been reviewed, and it is obvious that clinically utilized progestational drugs do not cause nongenital malformations (i.e., LRDs and CHDs).

Abnormalities, Drug-Induced↗
PubMed2006

Access to modern contraception.

Access to modern contraception has become a recognized human right, improving the health and well-being of women, families and societies worldwide. However, contraceptive access remains uneven. Irregular contraceptive supply, limited numbers of service delivery points and specific geographic, economic, informational, psychosocial and administrative barriers (including medical barriers) undermine access in many settings. Widening the range of providers enabled to offer contraception can improve contraceptive access, particularly where resources are most scarce. International efforts to remove medical barriers include the World Health Organization's Medical Eligibility Criteria. Based on the best available evidence, these criteria provide guidance for weighing the risks and benefits of contraceptive choice among women with specific clinical conditions. Clinical job aids can also improve access. More research is needed to further elucidate the pathways for expanding contraceptive access. Further progress in removing medical barriers will depend on systems for improving provider education and promoting evidence-based contraceptive service delivery.

Contraception↗
PubMed1984

Immediate postabortal contraception with Norplant: levonorgestrel, gonadotropin, estradiol, and progesterone levels over two postabortal months and return of fertility after removal of Norplant capsules.

Six Silastic levonorgestrel-releasing capsules, Norplant, were introduced subcutaneously into the ventral aspect of the left forearm or upper arm of thirteen patients immediately after first trimester pregnancy termination. Blood samples were taken twice a week over two months after abortion and from one subject over one month after removal of Norplant capsules. Plasma concentrations of levonorgestrel were measured by radioimmunoassay and the effects of treatment on pituitary and ovarian function were determined by assaying plasma concentrations of LH, FSH, estradiol and progesterone. If removal of Norplant capsules took place because of planning pregnancy, the subjects were asked to inform us if they had become pregnant. During the first month after abortion the mean levonorgestrel concentration (489 pg/ml) was statistically significantly higher than during the second month (237 pg/ml). The mean estradiol values fell to prefollicular levels within four days, remaining a little suppressed. The mean progesterone concentrations were below 2 ng/ml three days after abortion. Three subjects had a transient increase in plasma progesterone concentrations nine days after abortion. Thereafter no ovulatory progesterone concentrations were seen. The LH concentrations ranged within normal values of the follicular phase and FSH values were just beneath the lower limit of follicular phase FSH values, apart from a few peaks, indicating mild suppression. After removal of Norplant capsules, progesterone concentrations increased to ovulatory levels fifteen days after removal. The Norplant capsules were removed from two subjects because of planning pregnancy and they delivered healthy babies 9.5 and 12.5 months after removal.

Abortion, Induced↗
PubMed1985

Return to fertility after IUD removal for planned pregnancy.

The ability to conceive after discontinuing contraceptive practice is an important concern for women who have not completed their families. This paper focuses on 576 women who had their IUDs removed for planned pregnancy. The data from this study add further evidence that fertility subsequent to IUD removal is not impaired. Among these women followed-up, 94.3% conceived. The majority of these conceptions (55.9%) occurred during the first three months after IUD removal. In addition to analyzing conception rates, there were four factors that were considered in relationship to return to fertility. These were age at removal, duration of use, type of IUD (medicated vs non-medicated) and timing of insertion (interval vs postabortion). Age at removal was the only variable which seemed to influence conception rates.

Abortion, Spontaneous↗
PubMed2001

Is the intrauterine device appropriate contraception for HIV-1-infected women?

OBJECTIVE: To assess whether the risk of complications is higher in HIV-1-infected women compared with non-infected women in the two years following insertion of the intrauterine contraceptive device. DESIGN: Prospective cohort study. POPULATION: Six hundred and forty-nine women (156 HIV-1-infected, 493 non-infected) in Nairobi, Kenya who requested an intrauterine contraceptive device and met local eligibility criteria. METHODS: We gathered information on complications related to the use of the intrauterine contraceptive device, including pelvic inflammatory disease, removals due to infection, pain or bleeding, expulsions, and pregnancies at one, four, and 24 months after insertion by study physicians masked to participants' HIV-1 status. Cox regression was used to estimate hazard ratios. RESULTS: Complications were identified in 94 of 636 women returning for follow up (14.7% of HIV-1-infected, 14.8% of non-infected). The incidence of pelvic inflammatory disease was rare in both infected (2.0%) and non-infected (0.4%) groups. Multivariate analyses suggested no association between HIV-1 infection and increased risk of overall complications (hazard ratio = 1.0; 95% CI 0.6-1.6). Infection-related complications (e.g. any pelvic tenderness, removal for infection or pain) were also similar between groups (10.7% of HIV-1-infected, 8.8% of non-infected; P = 0.50), although there was a non-significant increase in infection-related complications among HIV-1-infected women with use of the intrauterine contraceptive device longer than five months (hazard ratio = 1.8; 95% CI 0.8-4.4). Neither overall nor infection-related complications differed by CD4 (immune) status. CONCLUSIONS: HIV-1-infected women often have a critical need for safe and effective contraception. The intrauterine contraceptive device may be an appropriate contraceptive method for HIV-1-infected women with ongoing access to medical services.

Adult↗
PubMed2006

Oral contraceptives for functional ovarian cysts.

BACKGROUND: Functional ovarian cysts are a common gynecological problem among women of reproductive age worldwide. When large, persistent, or painful, these cysts may require operations, sometimes resulting in removal of the ovary. Since early oral contraceptives were associated with a reduced incidence of functional ovarian cysts, many clinicians inferred that birth control pills could be used to treat cysts as well. This became a common clinical practice in the early 1970s. OBJECTIVES: This review examined all randomized controlled trials that studied oral contraceptives as therapy for functional ovarian cysts. SEARCH STRATEGY: We searched the computer databases of CENTRAL, PubMed, POPLINE, and EMBASE for randomized controlled trials. We also examined the reference lists of articles and wrote to authors of all studies identified to seek articles we had missed. SELECTION CRITERIA: We included randomized controlled trials in any language that included oral contraceptives used for treatment and not prevention of functional ovarian cysts. Criteria for diagnosis of cysts were those used by authors of studies. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from the articles and entered them into RevMan 4.2. We used Peto odds ratios with 95% confidence intervals for dichotomous outcomes. MAIN RESULTS: We identified four randomized controlled trials from three countries; the studies included a total of 227 women. Treatment with combined oral contraceptives did not hasten resolution of functional ovarian cysts in any trial. This held true for cysts that occurred spontaneously as well as those that developed after ovulation induction. Most cysts resolved without treatment within a few cycles; persistent cysts tended to be pathological (e.g., endometrioma or para-ovarian cyst) and not physiological. AUTHORS' CONCLUSIONS: Although widely used for treating functional ovarian cysts, combined oral contraceptives appear to be of no benefit. Watchful waiting over several cycles is appropriate. Should cysts persist, surgical management is often indicated.

Contraceptives, Oral, Combined↗
PubMed1995

Contraception update: implantable and injectable methods.

There are currently more options available to pediatricians caring for sexually active adolescents who wish to prevent pregnancy. The two progestin-only methods, levonorgestrel subdermal implants and DMPA injections, minimize or entirely remove the obstacle of patient compliance from contraceptive efficacy. Adolescents considering a progestin-only method of contraception should be counseled explicitly about the likelihood of menstrual irregularity with use. Perhaps more importantly, adolescents should be reminded that hormonal methods of contraception do not provide protection from sexually transmitted disease. Thus, male condom use should not only be recommended, but also concrete discussion and instruction on appropriate use should be given.

Adolescent↗
PubMed1996

New hormonal methods of contraception.

Three types of new contraceptive delivery system have been discussed in this chapter. Each have novel methods of delivery and may be acceptable to certain groups of women. It is clear that subdermal contraceptive implants are extremely useful as a long-term method of contraception, and provided insertion occurs correctly, removal will then be easy. The second-generation implants using a single rod, compared with the first-generation ones using six capsules, would appear to offer advantages both to the patient and in relation to the training of medical and paramedical personnel who have to fit the subdermal implant. The main disadvantage is the incidence of irregular bleeding, which, by and large, can be overcome by pre-insertion counselling and by time. The second method of delivery, vaginal rings, offers high patient acceptability, but a usable ring for contraception has as yet to be developed. Two approaches appear to be the use of a continuous progestogen-only ring, or a combined ring releasing oestrogen and progestogen with a 21-day-in, 7-day-out cycle of use. Ongoing studies will indicate whether vaginal lesions are significant or related to the flexibility of the ring. If these studies prove satisfactory, further development of the vaginal rings, both as an alternative method for interval use or as a specific postpartum form of contraception using progesterone-releasing rings, will be developed. Significant developments in the use of a combined monthly injectable have led to the release of two preparations, Cyclofem and Mesigyna, which are now available in many countries. This combined approach offers a significant reduction in amenorrhoea rates and unacceptable bleeding, the majority of women having acceptable menstrual patterns even during the first 3 months of use. All three methods have low and acceptable rates of pregnancy, the lowest being seen with the subdermal implants and with combined monthly injectables. Due to the length of action of subdermal implants, these may find a niche for women wishing to use a long-acting method and not wishing to be sterilized. They also provide a useful method where medical intervention is not available on a regular basis. Monthly injectable preparations can be given by paramedical personnel, and introductory studies have indicated that in developing and developed countries, they are highly acceptable. All three methods offer an increased choice for women and safe and effective methods of contraception.

Administration, Intravaginal↗
PubMed1985

Long-term experience with Norplant contraceptive implants in Finland.

Silastic implants containing the progestin, levonorgestrel, were tested as a long-term contraceptive system in 124 women. During five years of use no accidental pregnancy occurred. The first year continuation rate was 90% and the five-year continuation rate was 54%, including terminations for wish to become pregnant. The medically relevant continuation rate was 68% after five years. Menstrual irregularities were the most frequent reason for termination, but only in the first two years. 70% of the terminations for that reason occurred during the first two years. Terminations for other steroid-related reasons were infrequent. The follow-up will continue up to the end of the seventh year. Seven of seventeen women who requested removal of the implants because they wanted to become pregnant conceived during the first two cycles and only three were not pregnant one year after removal.

Adult↗