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PubMed2002

Users' perspectives on implantable contraceptives for women.

Users of subdermal contraceptive implants report long duration of use, convenience, and high efficacy as liked features and bleeding irregularities, weight loss/gain, and headaches as disliked effects of these methods. Satisfied users tend to be women who do not experience side effects or women who value positive features and tolerate the side effects. Satisfaction of the users is also closely related to quality of services. Service delivery problems, such as lack of proper pre-insertion counseling, inadequacy in number and imbalance in the geographical distribution of providers who can insert and remove implants, and appropriately manage side effects have been observed in new programs. Insensitivity of some providers to side-effects, such as bleeding irregularities, and to requests for removal have caused user dissatisfaction and serious public concern. Care must be taken to provide implants in a context of high quality of care with adequate numbers and distribution of trained providers and a basic record-keeping and tracking system.

Contraceptive Agents, Female↗
PubMed2006

[How safe is magnetic resonance imaging in patients with contraceptive implants?].

When patients with an implanted contraceptive device undergo MRI, it must be ensured that the examination involves no risk to the patient (MR safety) and that the diagnosis is not affected by artifacts or the function of the device compromised (MR compatibility). Two basic types of intrauterine devices can be distinguished: the metal-containing/metal-free intrauterine device (IUD) and the hormone-containing implant, the fully metal-free intrauterine system (IUS), as well as the ESSURE insert made of stainless steel, which has been approved for use in Europe since February 2001. The metal-containing and metal-free IUDs and ESSURE are MRI compatible up to a magnetic field strength of 1.5 T. They do not interact in any relevant way with the external magnetic or high-frequency field and the temperature increase is within the physiologic range. The implants merely produce a local signal void with a shape that depends on their orientation relative to the magnetic field lines. At 3 T, only the metal-free IUD and the IUS are MRI safe in terms of the material used. In contrast, metal-containing IUDs and the ESSURE have not yet been fully evaluated in the 3 T field, which is why they represent a contraindication to MRI. No data are available on the MRI compatibility at 3 T for any of these devices.

Burns↗
PubMed1996

Contraceptive implants: long acting and provider dependent contraception raises concerns about freedom of choice.

David Bromham's editorial on contraceptive implants ignores the wider issues to voice concern that trial by media could limit contraceptive choice by jeopardising research into new methods. However, it is more beneficial to the public for points of conflict to be debated openly. Furthermore, the impetus for research into new contraceptive technology is driven by profit and political motives and is only marginally affected by the media. Implanted contraceptives may increase the choice of contraceptive methods, but they put control of fertility increasingly into the hands of the medical profession. Herein lies their greatest problem: their potential to increase providers' control over clients' choice. There is the danger that certain groups of women may be targeted for their use: in the United States the coercive use of Norplant for mothers receiving welfare benefit has been suggested. Long acting contraceptives are a contraceptive of choice only when they are available without pressure, as part of a wider menu; when instant removal on request is guaranteed; and when there is an open and free flow of information and opinions between users, health professionals, and special interest groups.

Biomedical Research↗
PubMed1998

Adverse effects associated with contraceptive implants: incidence, prevention and management.

Contraceptive implants are increasingly being used for fertility regulation all over the world. Reversible long-term use is their most appealing feature for many users. They have the practical advantage of overcoming the risks of user failure and low continuation rates associated with other methods that require continuous attention or motivation. Disruption of menstruation, complications of insertion and removal, and infection at implant site, constitute the majority of adverse effects associated with contraceptive implants. This article reviews these various common adverse effects associated with contraceptive implants and their possible management and prevention. In addition, we also discuss very rare events, like psychiatric disorders, pseudotumor cerebri, thrombotic, thrombocytopenic purpura and thrombocytopenia, that have been reported by some researchers. Further surveillance and research is necessary to determine if these rare adverse events are causally related to contraceptive implants. Until such a time, providers of contraceptive implants should be more selective in prescribing the contraceptive implants, especially in women with a history of and/or risk factors for stroke, cerebral and coronary heart disease, thrombocytopenia and pseudotumor cerebri.

Adolescent↗
PubMed1978

Clinical experience with implant contraception.

Subdermal implants of polysiloxane (Silastic) capsules containing a number of synthetic progestagens have been studied in clinical trials to determine their contraceptive effectiveness and acceptability. The steroids studied include norgestrienone (R2010), gestrigone (R2323), megestrol acetate, d-norgestrel, norethindrone, ST-1435, lynestrenol and R-1364. With some of these steroids, studies have been undertaken with a varying number of implanted capsules. The estimated duration of use varies from 6 months to 6 years depending on dose and release rate of the individual steroid. The results of these studies involving about 5000 women in 8 years, indicate in general a high rate of effectiveness, as well as acceptability. Continuation rates at one year were generally 80% or greater. Abnormal bleeding patterns are the major disadvantage. Studies with implatns containing a combination of estrogen and progestogen are being undertaken in an attempt to improve the bleeding pattern.

Contraceptive Agents, Female↗
PubMed2001

Endometrial effects of etonogestrel (Implanon) contraceptive implant.

The subdermal contraceptive implant etonogestrel (Implanon; NV Organon International, Oss, The Netherlands) exerts complex effects on the endometrium. These include direct effects on the endometrium through endometrial progestin target sites, and indirect effects through suppression of the hypothalamic-pituitary-ovarian axis. The resulting effects are categorized by alterations in endometrial histology, endometrial thickness, dysmenorrhoea and menstrual bleeding pattern. The exact mechanism of action of progestins on the endometrium has not been determined. The contraceptive effect in Implanon users is mainly due to inhibition of ovulation. Current research is concentrating on the potential of the progestin implant to modify endometrial vascular, angiogenic, steroid receptor and proto-oncogene function. These processes may be involved in the causation of progestin-induced breakthrough bleeding.

Contraceptive Agents, Female↗
PubMed1999

A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant.

To compare the contraceptive efficacy, tolerability, and bleeding patterns, 200 healthy female volunteers received, in an open, comparative, randomized, multicenter study in China, either a single-rod (Implanon) or a six-capsule (Norplant) contraceptive implant for 2 years with an optional extension of up to 4 years. Women were exposed to Implanon for 341.6 woman-years and Norplant for 329.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding/spotting days with Implanon decreased from 33.5 in the first period to 19.0-21.5 days in the last year. Similarly, with Norplant, the median number of bleeding/spotting days decreased from 34.5 to 18.0-23.0 days, respectively. The number of bleeding/spotting episodes during year 1 was 2.0 per 90-day reference period with Implanon and 3.0 per period with Norplant (p < 0.05 for periods 1-4). For the remaining 90-day periods, there was no statistical difference between the two groups. In general, there was less frequent bleeding with Implanon compared with Norplant, whereas the incidences of amenorrhea and infrequent bleeding were higher with Implanon than with Norplant. The mean overall incidence of prolonged bleeding fell markedly during the study, from 66.0% in reference period 1 to 27.3% in period 16 with Implanon and from 69.0% to 21.7% with Norplant, respectively. The most common adverse events were related to disturbed bleeding patterns, which were also the major reasons for discontinuation (Implanon n = 8; Norplant n = 14). Normal menses returned in almost all subjects within 3 months after removal of the implants. Implanon was inserted in a mean time of 0.61 min and Norplant in 3.90 min (p < 0.001). Similarly, the mean time required to remove the implant was significantly shorter for Implanon than for Norplant (2.18 min vs 11.25 min, p < 0.001). The maximum time required for removal of the implant was 10 min for the Implanon group and 60 min for the Norplant group. In both groups, blood pressure and hemoglobin were not affected, whereas body weight tended to increase. It can be concluded that both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated. Compared with Norplant, there was less frequent bleeding with Implanon, whereas the incidence of infrequent bleeding and amenorrhea was higher. Implanon was significantly quicker to insert and to remove than was the multiple capsule system.

Adult↗
PubMed1998

Levonorgestrel contraceptive implants in female patients 14 to 21 years old.

OBJECTIVE: To determine which factors are associated with duration of use of a levonorgestrel implant (Norplant) for contraception in adolescents and young adults. DESIGN: We retrospectively studied 144 young women (14 to 21 years of age) who chose a levonorgestrel contraceptive implant at Mayo Clinic Rochester between April 1990 and December 1993. MATERIAL AND METHODS: The following information was obtained at the time of insertion of the implant and from any follow-up visits: demographics, prior contraceptive experiences, frequency and management of complications, complications noted at removal of the implant, and subsequent contraceptive choice. The duration of use was examined. RESULTS: Of the 144 young women who underwent insertion of a Norplant system, 75 telephoned or made a medical appointment because of implant-related side effects. During the follow-up period, 64 patients had the Norplant system removed. The Kaplan-Meier estimate of the probability of the Norplant system remaining in place for at least 12 months was 83 % and for at least 24 months was 63 %. Duration of Norplant use was not found to differ with respect to age, prior contraceptive use, or timing of insertion, but it was significantly shorter among those with a prior pregnancy than in those who had never been pregnant. CONCLUSION: These findings suggest that a group of young women who are likely to continue use of a contraceptive implant (with or without treatment for side effects) are those who have never been pregnant.

Adolescent↗
PubMed1987

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗
PubMed1994

Hormonal implants: contraception for a new century.

Subdermal implants are contraceptive systems that release low, stable amounts of synthetic progestins from Silastic or other materials for periods of months to several years. Unlike other hormonal delivery systems, they do not cause unnecessary peaks in progestin levels and do not use estrogens, and thus their health risks are minimal. Norplant has been studied more extensively than any other subdermal contraceptive implant. More than 60,000 women have participated in clinical trials, which demonstrated that this approach is one of the most effective reversible contraceptive methods available (1% pregnancy rate in 5-year users). The implant also reduces the incidence of ectopic pregnancy to a level much below noncontraceptive users and about equivalent to TCu380A intrauterine device users. Exposure to the sustained, low dose of levonorgestrel delivered by Norplant has shown only minor metabolic changes. Side effects are minor but often bothersome, causing some discontinuation of the method. First-year continuation rates range from 76% to 90%. Fertility return after discontinuation is prompt. Difficulty in removal of the implant capsules by the less experienced practitioner has motivated researchers to develop systems that are easier to use, less obvious under the skin, and biodegradable. The Norplant 2 system is faster, easier, and less painful to insert and remove. Implants under investigation release desogestrel and other progestins; Capronor and subdermal norethindrone pellets are biodegradable systems.

Contraceptive Agents, Female↗
PubMed1996

The use of nomegestrol acetate subdermal contraceptive implant, uniplant, during lactation.

Uniplant is a single contraceptive implant intended for one year use. It contains the progestogen nomegestrol acetate. The clinical performance and the effect of its use during the first postpartum year on breastfeeding performance and growth and health of the infants were studied and compared to the findings in a parallel group who used an intrauterine contraceptive device (IUD) in a prospective, non-randomized study. This was carried out in Assiut, Egypt. Two-hundred-forty fully breastfeeding mothers asking for initiation of contraception early postpartum were assigned according to their choices into either nomegestrol subdermal contraceptive implant (Uniplant) (120 women) or intrauterine contraceptive device (CuT 380A) (120 women). The mother and infant pairs were followed up at monthly intervals during the first three months and at two-month intervals thereafter up until the first birthday of the baby. No pregnancy occurred in the two groups. Amenorrhea was significantly more prolonged in the Uniplant group than in the IUD group. There were no significant differences in net continuation rates between the two groups (88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the two groups in the number of breastfeeding episodes, time of weaning, and the cumulative rates of full and partial breastfeeding. There were no significant differences between the two groups in infant weight, weight gain per day, or in infant linear growth. There were no significant differences in the incidence of important health problems affecting the infants of the two groups. However, there were seven infant deaths, six of them were in the Uniplant group. Uniplant subdermal contraceptive implants can be offered as a new contraceptive option suitable for nursing mothers.

Adult↗
PubMedDate not supplied

Subdermal contraceptive implants in nurse-midwifery practice.

Subdermal contraceptive implants have only recently been approved for use in the United States. At present, only one subdermal contraceptive implant, Norplant, is approved in the United States. This article describes the development of Norplant, its efficacy and safety, a description of the system, education for clients, side effects, indications and contraindications, insertion and removal, incorporation into midwifery practice, and education for health professionals regarding its use.

Drug Implants↗
PubMedDate not supplied

Implantable contraceptives for women.

Progestogen-only implantable contraceptives are used by increasing numbers of women worldwide. This review outlines the evidence accumulated on these methods to date. Reviews of toxicological evaluations, clinical trials, endocrinological, epidemiological and social science studies, as well as operations research and economic evaluation were undertaken in preparation for an Expert Consultation convened by the World Health Organization in 2001. At the meeting, these reviews were further evaluated and the research results summarized in this consensus paper. A large body of evidence demonstrates the high contraceptive effectiveness and safety of the 5-year levonorgestrel-releasing implants Norplant and Jadelle. Information on the 3-year etonogestrel-releasing implant Implanon is more limited, but suggests that this implant has a high contraceptive effectiveness and a satisfactory safety profile. Information available on levonorgestrel-releasing implants manufactured and approved in China suggests that their clinical performance is satisfactory, but was insufficient to allow their full safety assessment. For all implants, there is insufficient information on their use by women with medical conditions. Provision of contraceptive implants requires good quality family planning services and specific provider training.

Contraceptive Agents, Female↗
PubMed1995

Physicians' experience with Norplant implantable contraceptives in Finland.

Norplant contraceptives are manufactured in Finland, but the majority of Norplant users live in the Third World. The objective of this study was to study Finnish family planning physicians experience with and attitudes towards Norplant contraceptives. Three data sources were used: (1) review of articles published in non-commercial Finnish medical journals between 1980 and 1990, (2) a sample of eleven physicians known to have experience with Norplant and chosen by a snow-ball method, and (3) a random sample of 22 physicians in charge of public family planning services stratified by municipality and degree of urbanization. The articles reflected a positive attitude towards Norplant, but the authors did not believe that Norplant should replace any previous method of contraception. In the random sample the amount of experience with Norplant was low. In both groups the general attitude towards Norplant was reserved. It was not used as a method of first choice, but was considered a good method for carefully selected women. Norplant was considered troublesome for the physician, requiring surgical procedures, producing side-effects and demanding time for counselling. Adequate use of Norplant calls for a good health care infrastructure, hygienic facilities and trained personnel. These are often lacking in Third World settings.

Attitude of Health Personnel↗