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At least 19 recordsLinked to original sources
PubMed2001

Norplant and other implantable contraceptives.

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.

Biodegradation, Environmental↗
PubMed1999

Condom practices of urban teens using Norplant contraceptive implants, oral contraceptives, and condoms for contraception.

OBJECTIVES: The availability of long-acting hormonal birth control methods has created new contraceptive options for adolescents. The purpose of this study was to determine whether teens initiating these methods use condoms less frequently than teens using oral contraceptive pills or condoms alone and may therefore be at an increased risk of acquiring sexually transmitted infections. STUDY DESIGN: To investigate ongoing condom behavior in teens using levonorgestrel (Norplant) contraceptive implants, oral contraceptives, and condoms alone, we examined data from a 2-year prospective cohort study of 399 urban teens. The study consisted of 3 clinic-based cohorts of adolescent female contraceptive users: Norplant contraceptive implants (n = 200), oral contraceptives (n = 100), and condoms alone (n = 99). Data were collected at an admission interview and at 1- and 2-year follow-up from method continuers. RESULTS: Norplant contraceptive implant users were less likely than oral contraceptive or condom users to report condom use at last sex or consistent condom use at 1- and 2-year follow-up. The implant group showed a significant decrease in condom use from admission to 2 years after method initiation. The proportion of implant users self-reporting new sexually transmitted infections at 2-year follow-up, however, was not significantly greater than that of oral contraceptive or condom users. CONCLUSIONS: Our findings indicate that teen users of Norplant contraceptive implants are less likely to use condoms than teens who choose oral contraceptives but, probably because of differences in sexual behavior, are no more likely to self-report sexually transmitted infections. Our findings also indicate that teens who choose oral contraceptives and condoms do not use them consistently enough to avoid pregnancies or sexually transmitted infections.

Adolescent↗
PubMed2002

Vaginal bleeding disturbances and implantable contraceptives.

Implantable contraceptives allow safe and effective fertility regulation for up to 5 years. Currently available devices release low doses of progestogens. Disruption of vaginal bleeding patterns is almost inevitable, particularly during the initial months of use. Irregular and prolonged bleeding as well as amenorrhea are common. Irregular bleeding is unpopular with most women and unacceptable to some. This review describes the vaginal bleeding disturbances induced by modern implantable contraceptives and discusses the implications of these in terms of method use and discontinuations. The cause of the irregular bleeding is not fully understood, but recent evidence suggests that an increase in endometrial vascular fragility might precipitate vessel breakdown and, hence, breakthrough bleeding. This review discusses this evidence and outline the possible mechanisms underlying breakthrough bleeding associated with implantable contraceptives. In addition, therapies for bleeding disturbances are described and their efficacy reviewed.

Contraceptive Agents, Female↗
PubMed2003

Risk-benefit effects of implantable contraceptives in women.

Contraceptive implant technology has been used by millions of women throughout the world. The three marketed implant systems today are levonorgestrel-releasing implants: Norplant and Jadelle, and a single etonogestrel-releasing implant, Implanon. The main benefits common to these delivery systems are their safety, high effectiveness, ease of use, long duration of action (3 - 5 years) and reversibility. Bleeding disturbances are the main adverse events associated with implantable contraceptives. Other minor risks relate to the insertion and removal procedures, which require adequately trained providers as well as aseptic techniques. Furthermore, since initiation and discontinuation of use is provider-dependent and not controlled by the user, there may be a risk of coercion of use on the one hand or, on the other hand, difficulty in access to initiating use, if trained providers are not readily available. Although no single contraceptive method is perfect or appealing to all, contraceptive implants are safe and fulfil a very important need among fertility regulation methods.

Clinical Trials as Topic↗
PubMed2005

Effective use of hormonal contraceptives: Part II: Combined hormonal injectables, progestogen-only injectables and contraceptive implants.

Our objective in this systematic review was to evaluate evidence regarding controversial issues in the clinical management of women using injectable and implantable contraceptives. We searched MEDLINE and EMBASE for reports of primary research, published from 1966 through April 2005 in peer-reviewed journals, related to the initiation of combined or progestogen-only injectables and contraceptive implants, the effects of late contraceptive injections or the duration of levonorgestrel implant effectiveness. Results of the studies we reviewed showed that initiating injectable and implantable contraceptives through day 7 of the menstrual cycle suppresses follicular activity. Time to ovulation after study participants discontinued using injectables varied widely: from 4 to 8 weeks after the last administration of combined injectables, from 15 to 49 weeks after the last injection of depot medroxyprogesterone acetate and from 5 to 19 weeks after the last injection of norethisterone enanthate. Norplant implants left in place for up to seven completed years remained effective among women who weighed <70 kg at the time of implant insertion, but their effectiveness decreased among women weighing >or=70 kg.

Contraception↗
PubMed2002

Safety of implantable contraceptives for women: data from observational studies.

Contraceptive implants are registered in over 60 countries and have been used by millions of women for three decades. This article reviews findings from observational studies on the safety of contraceptive implants and examines the risk of specific health outcomes. Fifty-five articles were reviewed, and the body of evidence for each health outcome was summarized. Available evidence suggests that contraceptive implants are safe and, overall, implant users do not experience adverse events at rates higher than women not using implants. With respect to specific outcomes, the evidence suggests no increased risks of pelvic inflammatory disease, decreased bone mineral density, anemia, thrombocytopenia, or death with implant use. The evidence was too limited to draw meaningful conclusions for neoplastic disease, cardiovascular events, and HIV/AIDS. Nonsignificantly elevated associations were reported for diabetes, serious mental disorders, and rheumatoid arthritis. Conditions for which risks were marginally, yet significantly, elevated were hypertension and gall bladder disease.

Bone Density↗
PubMed1993

Recent experience with and future directions of contraceptive implants and injectable contraceptives.

Subdermal implantable contraception has been the most important addition to contraceptive technology in the past 2 decades. The Norplant system is only the first of a new family of long acting methods of high effectiveness, high acceptability, and prompt reversibility. The main advantage of the second generation implant systems, to be available soon, is the reduction in the number of implants, which greatly facilitates insertion and removal. However, great improvement in bleeding control is not to be expected. Large and carefully designed epidemiological studies have contributed to clear the main objections to the US Food and Drug Administration (FDA) approval of depot medroxyprogesterone acetate (DMPA) as an injectable contraceptive. New progestin-only, long acting injectables are being tested, but significant improvements over existing methods are difficult to foresee, although every alternative is welcome. Monthly combined injectables have been in great demand, at least in China and Latin America, because of better bleeding control. Improved combined monthly injectables, less estrogenic and more progestin dominated, have been developed and are being introduced in several countries and should soon replace the old monthly injectables. Contraceptive implants and injectables have shown to be an important addition to the contraceptive options available to women throughout both the developing and developed world.

Clinical Trials as Topic↗
PubMed2001

Post-marketing surveillance of Norplant contraceptive implants: I. Contraceptive efficacy and reproductive health.

The subject of this study to examine the safety and contraceptive efficacy of Norplant, we undertook a 5-year study of follow-up of women initiating use of Norplant, intrauterine device (IUD) or sterilization in eight developing countries. Women attending family clinics were enrolled if they consented and were medically eligible to use Norplant, IUD, or female sterilization. Women who chose to initiate use of IUDs or surgical sterilization served as controls and were frequency matched in 5-year age-bands with women who chose to use Norplant. At admission women had a physical examination, and their medical histories, demographic, and socio-economic characteristics were recorded. Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually thereafter for 5 years irrespective of change of contraceptive method. Incidence rate ratios of health events were estimated for initial and current contraceptive method use. This paper reports reproductive health events and contraceptive efficacy. Altogether, 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of surgical sterilization were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively. More than 99% were married or cohabiting, and parous. Five-year follow-up was completed by 94.6% of the women. By the end of 5 years, the mean duration of first segment use per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and 7,071 for sterilization. The study accumulated 78,323 woman-years of observation. Pearl pregnancy rates for Norplant, copper IUDs and female sterilization were 0.27, 0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs, and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1,000 woman-years, respectively. Major health events related to the reproductive system were rare. Rates of acute PID were significantly lower among Norplant users than IUD users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant users than controls (p <0.001), but not rates of hospitalization for this condition. Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent in Norplant users than in the other groups. Bleeding disturbances were more frequent among Norplant users than controls but not anemia. The study confirms the high contraceptive efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of major reproductive health problems were low. There was no significant excess of serious reproductive morbidity among users of Norplant compared to users of IUDs and sterilization.

Abdominal Pain↗
PubMed1994

Localization of contraceptive implant capsules for removal.

Implanted contraceptive capsules occasionally cannot be removed by means of palpation with local dissection, and imaging guidance is necessary. The authors report obtaining a single antero-posterior radiograph of the upper arm followed by sonography to localize the capsule and to allow precise marking of the skin over the capsules. The method can be performed quickly and is inexpensive and effective, allowing the localization and removal procedures to be scheduled independently.

Adult↗
PubMed2000

Implantable contraception.

Although levonorgestrel contraceptive implants have been available for over 15 years, innovations have only recently led to a wider choice. These new implants offer easier insertion and removal and other advantages depending on the type of progestin. Implants prevent pregnancy by several mechanisms, including inhibition of ovulation and luteal function and alteration of cervical mucus and the endometrium. The high efficacy and ease of maintenance make implants an ideal contraceptive for many women, including adolescents, a population that uses implants infrequently but reports high satisfaction. Implants are appropriate for women who are breastfeeding, who have contraindications to estrogen, or who have diseases such as diabetes, hypertension, sickle cell anemia, or an HIV infection because implants have few metabolic or hematologic effects. Long-term use has not been associated with a decrease in BMD and generally leads to increased blood levels and iron stores. Women who wish to space their pregnancies appreciate the nearly immediate onset of action with insertion and the rapid termination of all effects with removal. All types of implants lead to menstrual changes and other side effects in some women. Adverse effects that occur in implant users more than the general population include headaches and acne. Women must be thoroughly counseled regarding the potential for menstrual alteration, side effects, and sexually transmitted infections if they do not use condoms. Despite their initial high cost, implants are a cost-effective method over several years, even when discontinued before the life of the implant.

Adolescent↗
PubMed1994

Contraceptive implants.

Available contraceptive implants appeal to women of diverse cultural and socioeconomic background because they offer long-term contraception, safety, effectiveness, reversibility and lack of estrogenic side-effects. Experience with Norplant I indicates that despite some side-effects the continuation rate is the highest for any reversible method of contraception. Disruption of the menstrual cycle is the main reason for discontinuation, hence research effort needs to focus on the mechanism of progestogen-induced endometrial bleeding and appropriate therapy. Implant service programs should have trained and skilled personnel who can provide adequate counseling that complements any public education effort and also provides effective services. Because contraceptive implants offer no protection against sexually transmitted infections, those who engage in high-risk sexual behavior should be encouraged to use condoms as well.

Adolescent↗
PubMedDate not supplied

Impact of patient counseling on acceptance of the levonorgestrel implant contraceptive in the United Kingdom.

Patient counseling is an important aspect of family planning. Patient choice, compliance, and satisfaction with a contraceptive method depend heavily on the counseling experience. This is especially true in the United Kingdom where contraceptives are provided to patients at no direct cost to them. Women are therefore more likely to choose a contraceptive option based on perceived desirability as opposed to cost. We surveyed physicians from six family planning centers in the United Kingdom who have extensive experience with levonorgestrel contraceptive implants with respect to counseling issues and patient acceptability of levonorgestrel implants. The physicians reported on their experience with 521 women. They acknowledged the need for and importance of counseling, and these centers provided preinsertion counseling 100% of the time. Primary responsibility for counseling was handled by the physician who spent, on average, 19 minutes per patient discussing the advantages and risks of levonorgestrel implants. Physicians felt that the majority of women (82%) accepting levonorgestrel implants had a positive experience. The incidence of bleeding irregularities was consistent with that reported in clinical trials, and this did not substantially affect the postinsertion acceptability of the product. Effective counseling is no doubt responsible for the high level of patient acceptance of these side effects. In a review of the literature, we found counseling to be a significant factor in a woman's tolerance of contraceptive-induced bleeding irregularities, which are frequently experienced with levonorgestrel implants. The results of our survey support the literature findings.

Adolescent↗
PubMed2000

Implantable contraception.

This article reviews the advantages and disadvantages of progestogen-only contraceptive implants in light of the development of Implanon, a new, single-rod, etonogestrel-releasing system. Implants rapidly produce serum progestogen levels sufficient to ensure contraception for 1-5 years. The steady release ofprogestogen avoids the peaks and troughs associated with oral contraceptives, the profound ovarian suppression observed with depot injections and the need for user compliance. Implants have few serious complications. Ectopic pregnancy rates are low, and follicular hypertrophy is generally self-limiting. The principal acceptability limitation to both users and providers of Norplant is insertion and removal. Implanon is easy to insert and remove with minimal complications and pain. The main adverse event causing discontinuation of implants is a change in bleeding pattern. However, with good counselling, this is well tolerated by most women. Implants thus provide an effective, safe, economical and convenient alternative to oral, injectable or intrauterine contraceptives. Implanon is an extremely effective single-rod implant with a Pearl index of 0. It employs a new polymer and a less androgenic progestogen. These features provide easier insertion and removal for both users and clinicians, a more stable release rate and potentially fewer adverse androgenic effects compared with existing formulations.

Contraceptive Agents, Female↗
PubMed2002

Toxicology of polymers for implant contraceptives for women.

This article reviews the toxicology of polymers that are used in contraceptive implants. The two main classes of synthetic, nondegradable polymers used in the delivery of female contraceptives are silicone elastomers (e.g., Silastic) and ethylene co-vinyl acetate (EVA; ELVAX). The controversies surrounding the silicone breast implants have prompted several studies to evaluate the toxicity of silicones. The epidemiologic data obtained thus far have overwhelmingly concluded that no correlation exists between certain chronic symptoms, such as arthritis, in patients and silicone prosthesis. This conclusion has been echoed by the expert panel report by the Institutes of Medicine. Although the IOM report focused on the safety of silicone breast prosthesis, data emerging from the joint reconstruction area also suggests that Silastic is safe for in vivo use. The toxicological studies on EVA are few, and the conclusion thus far is that they elicit no adverse local or systemic response over extended periods in vivo. In conclusion, the prognosis for Silastic and ELVAX as of now is excellent. However, any future implant development using these polymers should place an emphasis on processing parameters to minimize potential small molecule leachants and establish safety as a function of both site and duration of implantation.

Animals↗
PubMed1995

Subdermal contraceptive implants.

Subdermal contraceptive implants involve the delivery of a steroid progestin from polymer capsules or rods placed under the skin. The hormone diffuses out slowly at a stable rate, providing contraceptive effectiveness for 1-5 years. The period of protection depends upon the specific progestin and the type of polymer. Advantages of progestin implants include long term contraceptive action without requiring the user's or provider's attention, low dose of highly effective contraception without the use of estrogen, and fertility is readily reversible after the removal of implants. The levonorgestrel implant Norplant R system is the only one that has been approved for distribution. The contraceptive efficacy of Norplant is the highest observed amongst the most effective methods with an annual pregnancy rate of 0.2 during the first and second year and 1.1 on the fifth year. Menstrual problems are the main reason for the discontinuation of Norplant and 9% of women stopped using it during the first year of treatment. Other implants are still under development trying to simplify the method by reducing the number of units and to introduce other progestins that may minimize side effects. Norplant-2 was designed to release the same dose of progestin from only two covered rods. Evaluation of 1400 women enrolled, indicates that over 2 years the cumulative pregnancy rate is below 0.5 per 100 women. There are three single implants under development: Nestorone, 3-Keto-desogestrel and Uniplant that are expected to be effective for 1-2 years. Phase II clinical trials with Nestorone have been completed and no pregnancies have been observed in 1570 woman-months of use. Bleeding irregularities occurred in 20-30% of the women but there were only four terminations because of bleeding problems. A multricentric study is ongoing with a newly designed 3-keto-desogestrel implant named Implanon, which releases approx. 60 micrograms/day of the hormone. The objectives of this study are to assess contraceptive efficacy, safety and acceptability of Implanon. Another multricentric study is ongoing with Uniplant, which releases nomegestrol acetate with a duration of action for only 1 year. The objectives of the trial are to study the endocrine profile of Uniplant users and to evaluate the efficacy and acceptability of the method.

Contraceptive Agents, Female↗
PubMed2002

Implantable contraceptives for women: effectiveness, discontinuation rates, return of fertility, and outcome of pregnancies.

Progestogen-only contraceptive implants are highly effective. In most studies, 5-year cumulative pregnancy rates are less than 1.5/100 women for Norplant and Norplant II. No study has yet reported any failures with Implanon. Weight over 70 kg and age at insertion under 25 years both increase the failure rate of Norplant and Norplant II; however, data are as yet lacking for Implanon. The effectiveness of other progestogen-only implants for which there are as yet few data are unlikely to be any different. Continuation rates are high compared with other hormonal methods and with the intrauterine device. In most cohorts at least 35% of women, and often many more, are still using Norplant by the end of 5 years. Rates vary according to a number of factors, including population studied, age, and parity. Menstrual disturbance is by far the most common reason for discontinuation, with headache, acne, weight gain, and desire for pregnancy accounting for other common reasons for implant removal. Fertility returns rapidly following implant removal, and pregnancy rates (76-100% 1 year after removal) are usually no different from those following discontinuation of any other contraceptive method. There is no increase in the risk of ectopic pregnancy, fetal malformation, or impaired infant health in pregnancies conceived either during implant use or after removal.

Age Factors↗