Pregnancy with Implanon: a report on three cases

We explored the potential causes associated with pregnancies occurring in patients using an etonogestrel contraceptive implant (Implanon). Three cases of treatment failure were reported where no predisposing factors were found (i.e. Body Mass Index, hepatic inducing therapy). Etonogestrel plasmatic detection was positive in two cases whereas in the third case with negative endocrinological makers, neither palpation nor ultrasonography identified the device. Therefore, true contraceptive failure can be considered in two of the reported cases. Furthermore, pregnancies associated with Implanon use warrant additional attention including notification to drug monitoring centers and Organon SA.     

Ultrasound localisation and removal of non-palpable Implanon implants

BACKGROUND: Implanon is the trade name for a contraceptive implant that releases etonogestrel over a 3-year period. The rod is inserted into the subdermis of the upper arm. The implant should be palpable and easily removed through a small incision. AIMS: To determine whether ultrasound is an accurate means of localising and guiding removal of non-palpable Implanon implants. METHODS: All patients referred to The Northern Hospital, between March 2002 and October 2005, for localisation and/or removal of their non-palpable Implanon implants were included in this study. Ultrasound was used to locate the implants, the implant was considered localised when a linear echogenic rod with posterior acoustic shadowing was identified. When removal of the implant was requested and the implant was clear of neurovascular structures, blunt dissection was performed under ultrasound control and the implant was extracted. If the implant was considered too close to major neurovascular structures, the position of the implant was marked and the patient was referred for surgical removal. RESULTS: Thirty-four women were included in the study. In 33 patients the implant was identified. In one patient no implant was found and its absence was confirmed by serum assay. Twenty-four patients were referred for implant removal. In 20 patients the implant was successfully removed under ultrasound guidance. In the other four patients the implant was close to neurovascular structures. The position of the implants was marked and surgical removal was successfully performed. CONCLUSION: Ultrasound is highly accurate at localising and guiding removal of non-palpable Implanon implants.     

Ultrasound localisation of non-palpable Implanon

BACKGROUND: Localisation of the non-palpable Implanon is useful to confirm its presence or to assist the surgeon with its removal. Previous studies have suggested that almost all non-palpable Implanon implants can be located with ultrasound in phantoms. AIM: To determine whether diagnostic ultrasound is a reliable method for localising non-palpable Implanon implant in-vivo. METHODS: Ultrasound was carried out to localise the non-palpable Implanon implant. To ascertain the accuracy of the ultrasound findings, all patients were followed-up until the implant was removed or until it was proven absent by serial progesterone levels confirming ovulation or by negative etonogestrel levels. RESULTS: In 22 out of 23 patients the Implanon was correctly identified as present. The specificity is 95.7% (95%CI 79.0-99.2%), the positive predictive value is also 95.7%. In six out of seven patients the Implanon was correctly identified as absent. The sensitivity is 85.7% (95%CI 48.7-97.4%), the negative predictive value is also 85.7%. Four patients were excluded due to incomplete follow-up. CONCLUSION: Ultrasound is a reliable first line method for localising non-palpable Implanon. When the Implanon is localised on ultrasound, it is very likely present. When the Implanon is not seen on ultrasound, etonogestrel determination should be carried out to confirm its absence.     

Implanon: user views in the first year across three family planning services in the Trent Region, UK.

OBJECTIVE: Implanon (NV Organon, Oss, The Netherlands) was released in the United Kingdom towards the end of 1999. This survey elicited the experiences of women who had the new implant inserted in three family planning services in North Trent, UK during the first year after its introduction. METHOD: A previously piloted questionnaire was sent to all Implanon users who had the devices fitted in the three services between December 1999 and December 2000. Returned questionnaires were analyzed. RESULTS: Health-care providers and friends or family were the main sources of information about the single-rod contraceptive implant for the survey population. Women considered themselves informed about the method prior to insertion irrespective of whether they continued to use the method or requested early removal. Ease of use was the most common reason for choosing Implanon and one of the best-liked features. Bleeding irregularities were the most commonly reported side-effect, followed by weight gain, moods and headaches. Bleeding problems led to the majority of removal requests; the wish for pregnancy was not stated at all. The single-rod implant compared favorably with most responders' experiences with other methods of contraception. Further research into motivation and perceptions regarding modern contraceptives may be required in different populations.     

A long-term study of the efficacy and acceptability of a single-rod hormonal contraceptive implant (Implanon) in healthy women in China.

OBJECTIVE: To investigate the contraceptive efficacy, cycle control and acceptability of Implanon, a new single-rod, progestogen-only contraceptive implant. METHODS: In a non-comparative, open, multicenter study, a contraceptive implant containing the progestogen etonogestrel was inserted into 200 healthy women. The study duration was 2 years, with an optional extension up to 4 years. RESULTS: Women were exposed to Implanon for 644.6 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days ranged between 18 and 21 and the median number of bleeding-spotting episodes was two. The mean overall incidence of prolonged bleeding fell markedly during the study, from 69% in the first reference period to 26% in the 16th period. The most common adverse events were related to disturbed bleeding pattern and amenorrhea. Heavy or prolonged bleeding caused 18 subjects to withdraw from the study. Only a few subjects discontinued the study early due to irregular bleeding (2%) or amenorrhea (2%). A slight increase in mean body weight was observed. The implant was removed in an average time of 2.9 min. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy for 4 years of use and was well tolerated. The incidences of prolonged bleeding and amenorrhea both fell markedly with continued implant use. Because of its single-rod design, Implanon was quickly removed with few complications and proved to be a highly acceptable method of contraception.     

The contraceptive implant

Contraceptive implants provide long-acting, highly effective reversible contraception. Currently, the only subdermal implant available to women in the United States is the single rod etonogestrel implant, Implanon (N.V. Organon, Oss, the Netherlands) approved by the Food and Drug Administration in July 2006. Implanon is currently approved for 3 years of use, provides excellent efficacy throughout its use, and is easy to insert and remove. Similar to other progestin-only contraceptives, Implanon can cause irregular vaginal bleeding. Implanon has been shown to be safe to use during lactation, may improve dysmenorrhea, and does not significantly affect bone mineral density, lipid profile, or liver enzymes.     

Ectopic pregnancy with etonogestrel contraceptive implant (Implanon): first case

We describe the first case of ectopic pregnancy occurring in a patient with an etonogestrel contraceptive implant (Implanon). There was no factor predisposing to a failure of the technique (implant in place for less than 2 years and normal BMI). In addition there was no risk factor for an ectopic location of the pregnancy. We discuss the role of the micro progestative in the location of the pregnancy. This case report emphasizes the fact that ectopic pregnancy should not be ruled out in women taking this contraception, however efficient it is otherwise.     

Contraceptive implants

In response to the need of some women for long-acting, effective and safe contraceptives, the scientific community developed non-biodegradable progestational subdermal implants that act by making the cervical mucus viscous, with ovulation inhibition and thinning of the endometrial lining. The contraceptive protection is within 24 hours and the cumulative failure rate is low. Contraceptive implants require little or no motivation following adequate counselling. In current use are multirod implants (Norplant I and Norplant II Jadelle) and single rod implant (Implanon and Uniplant). Although menstrual symptoms associated with progestational regimens are the major compliance and acceptability factors within the first year of use, menstrual disturbance generally improves. Continuation rates for implant use are high among those who have had adequate pre-insertion counselling because the perceived advantages greatly outweigh the nuisance effects. Other side effects of implants are similar to those observed with hormonal pills--headache, weight changes, mood swings and abdominal bloating. Training of physicians and nurses in the art of insertion and removal techniques is a pre-requisite for a successful implant programme. This should also be backed by integration of implants into the national commodity logistics systems to ensure adequate local budgetary provision for contraceptive implant procurement rather than reliance on donor supply.     

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.     

Experience with Implanon in a northeast London family planning clinic.

AIM: The primary objective of the study was to evaluate the continuation rates of a relatively new long-acting method of contraception, Implanon. The secondary objective was to study discontinuations related to bleeding problems and their management. METHOD: A retrospective review of records of women fitted with Implanon was undertaken during February 2000--January 2003. RESULTS: Results from the secondary objective will be the subject of a separate communication. Of the 147 implants fitted, 132 records could be retrieved; of these, 97% of the women had pre-insertion counselling by the clinician. The most common indications for Implanon usage were choice of a long-acting method, unhappy experience with other contraceptive methods and suboptimal compliance with contraceptive pills and injectables. The median age of fitting was 25 years and 36% of the women were nulliparous. No problems were experienced with fitting or removal of implants. Twenty (15%) women were lost to follow-up. Twenty-two implants were removed by the end of the study period, with 12 (60%) removals attributed to prolonged heavy/light bleeding. There were no known pregnancies during the study. Given that 15% of the women could not be followed up or contacted, the assumed lifetimes of Implanon using the Kaplan-Meier method are 0.90 (95% confidence interval 0.82-0.95) at 12 months, 0.80 (0.67-0.88) at 24 months and 0.75 (0.58-0.85) at 35 months. The confirmed lifetimes are 0.84 (0.71-0.91) at 12 months, 0.63 (0.42-0.78) at 24 months and 0.53 (0.28-0.73) at 35 months. CONCLUSION: Although not free of side-effects, Implanon can be a good choice for women who are properly informed and counselled and seek long-term 'forgettable' contraception.     

Acceptability and side-effects of Implanon in Switzerland: a retrospective study by the Implanon Swiss Study Group.

DESIGN: A multicenter, retrospective study of the single-rod contraceptive implant, Implanon (NV Organon, Oss, The Netherlands), was carried out in Switzerland in 1183 women. METHODS: Assessments included duration of use, bleeding pattern, side-effects and subjective acceptability and satisfaction with the method. RESULTS: A total of 991 women (84%) had at least one follow-up visit and 306 (26%) had two visits with a mean duration between insertion and follow-up of 224 days (7.4 months) and 347 days (11.4 months), respectively. Implanon was removed prematurely in 235 women (24%), primarily because of side-effects (20%) and for family planning reasons (4%). Side-effects leading to discontinuation were mainly bleeding disturbances (45%), acne (12%) and other reasons (15%). The mean duration between insertion and removal for discontinuers was 280 days (9.2 months). Side-effects related to bleeding (visit 1) included infrequent bleeding (28%), amenorrhea (33%), prolonged bleeding (15%), and metromenorrhagia (frequent and heavy bleeding) (16%). Other reported side-effects at visit 1 included dizziness (12%), acne (11%), mood swings (8%) and headache (5%). The incidence of side-effects reported at visit 2 was generally comparable to that at visit 1. CONCLUSIONS: The results of this study show that early discontinuation of implant use is primarily due to bleeding problems. Extensive counseling before implant insertion may help to prevent this. It is also important to develop an easy solution to successfully treating progestogen-induced bleeding disturbances.     

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.     

Experience with Implanon® in a north-east London family planning clinic

Aim The primary objective of the study was to evaluate the continuation rates of a relatively new long-acting method of contraception, Implanon®. The secondary objective was to study discontinuations related to bleeding problems and their management.

Method?A retrospective review of records of women fitted with Implanon was undertaken during February 2000–January 2003.

Results?Results from the secondary objective will be the subject of a separate communication. Of the 147 implants fitted, 132 records could be retrieved; of these, 97% of the women had pre-insertion counselling by the clinician. The most common indications for Implanon usage were choice of a long-acting method, unhappy experience with other contraceptive methods and suboptimal compliance with contraceptive pills and injectables. The median age of fitting was 25 years and 36% of the women were nulliparous. No problems were experienced with fitting or removal of implants. Twenty (15%) women were lost to follow-up. Twenty-two implants were removed by the end of the study period, with 12 (60%) removals attributed to prolonged heavy/light bleeding. There were no known pregnancies during the study. Given that 15% of the women could not be followed up or contacted, the assumed lifetimes of Implanon using the Kaplan–Meier method are 0.90 (95% confidence interval 0.82–0.95) at 12 months, 0.80 (0.67–0.88) at 24 months and 0.75 (0.58–0.85) at 35 months. The confirmed lifetimes are 0.84 (0.71–0.91) at 12 months, 0.63 (0.42–0.78) at 24 months and 0.53 (0.28–0.73) at 35 months.

Conclusion?Although not free of side-effects, Implanon can be a good choice for women who are properly informed and counselled and seek long-term ‘forgettable’ contraception.     

Insertion and removal of Implanon®: practical considerations

ABSTRACT

Implanon®, a novel contraceptive implant containing the progestogen, etonogestrel (68 mg), provides highly effective, well-tolerated contraception for up to 3 years. Its single-rod design, semi-rigid polymer base and convenient pre-loaded presentation mean that Implanon® has potential insertion and removal advantages over the six-capsule Norplant® implant. Insertion of Implanon® is simple: the applicator needle is positioned subdermally and the cannula is withdrawn, leaving the implant rod in place. Implanon® is removed using the ‘pop out’ technique, involving a 2-mm incision. A meta-analysis of data from seven open-label, randomized studies in 1378 women compared the ease of insertion and removal of the Implanon® and Norplant® implants and the frequency of associated complications. It was approximately four times quicker to insert and remove Implanon® than Norplant® (mean insertion times 1.1 vs. 4.3 min, respectively; mean removal times 2.6 vs. 10.2 min, respectively). Insertion complications were very rare with both Implanon® (0.3%) and Norplant® (0.0%). However, Implanon® was associated with a significantly lower frequency of removal complications (0.2 vs. 4.8% with Norplant®; p < 0.001). Implant site abnormalities were uncommon. The simplicity of the insertion and removal procedures with Implanon® may have significant implications for contraceptive implant training programs and user counselling.     

Hands-On Training in a Digital World: A Novel Simulation-Based Virtual Training Program for Placement and Removal of the Subdermal Contraceptive Implant

ObjectiveThe COVID-19 pandemic necessitated a shift from traditional in-person instruction for learning new technical skills to virtual delivery of medical education training. The objectives of this study were to develop and evaluate a virtual simulation-based training program for Canadian health care professionals (HCPs) on the insertion, localization, and removal of the etonogestrel subdermal contraceptive implant.MethodsA scientific committee of Canadian family planning experts developed a 2-part virtual training program during the COVID-19 pandemic. Core educational content (part 1) was provided in an asynchronous, self-directed, online format. Part 2 consisted of synchronous, simulation-based training using web conferencing. The HCPs were provided with model arms and placebo applicators; the trainers demonstrated implant insertion and removal techniques, and trainees received individual feedback. All trainees were asked to complete an online evaluation upon completion of the program.ResultsBetween September 22, 2020, and December 31, 2021, 83 trainers conducted 565 virtual training sessions. A total of 3162 HCPs completed part 1 of the training program, of whom 2740 had completed part 2 by December 31, 2021. Participants reported high levels of satisfaction with virtual simulation-based training; 96.5% of respondents (1570/1627) agreed that the virtual format was effective. Additional training prior to inserting the implant in clinical practice was requested by 4.5% of respondents (75/1671).ConclusionVirtual simulation-based learning provides effective education and technique training for etonogestrel implant insertion and removal. Online training for implant use can be scaled, as needed, to reach professionals in remote or underserved locations. This virtual training approach may be appropriate for other technical or minor surgical procedures.     

Clinical experience and acceptability of the etonogestrel subdermal contraceptive implant

Objective: To evaluate efficacy, adverse effects, and user continuation rate of an etonogestrel subdermal single-rod contraceptive implant. Methods: A total of 417 healthy volunteers of childbearing age were included in this multicenter trial. After implant insertion, the women were followed up during the 3 years of contraceptive action. At each visit, clinical findings, side effects, and bleeding patterns were recorded. Efficacy and continuation rates were analyzed using the Pearl Index and Kaplan–Meier life tables, respectively. Results: The observation period totaled 958.5 woman-years (27.5 months per woman). The Pearl Index score was 0. Side effects were reported by 44.4% of users, but the proportion had decreased to 16.5% by the end of the study. The continuation rate was 61.4%. The most common reason for early discontinuation (in 21.1% of the participants) was menstrual disturbances. Conclusions: Etonogestrel subdermal contraceptive implants demonstrated high efficacy and an acceptable continuation rate. Counseling potential users explicitly about the side effects will optimize patient success with this long-acting contraceptive.     

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.     

Effect of cost on early removal of contraceptive implants: a prospective cohort study

Objectives: To evaluate the effect of the cost of subdermal etonogestrel implant (SEI) on the continuation rate one year after insertion, and to assess the reasons given by users to remove the implant before the expiration date.

Methods: Prospective cohort study conducted among 265 women who chose the SEI as a contraceptive method in a sexual and reproductive health center in the eastern region of Spain, between October/2012 and October/2017. The sample was divided into two cohorts depending on the cost of the implant for the user (free-of-charge or requiring partial payment). Kaplan–Meier survival curves were used to compare the cumulative removal rates of free implants with partially paid implants within the first year of insertion. Cox proportional hazards models were used to control for confounders.

Results: After adjusting for confounders, no significant associations were found between the cost of the implant and its removal within a year of insertion. No significant associations were found in the reasons given for implant removal and for the duration of implant use.

Conclusions: Cost was not associated with SEI continuation rates within the first year of use. No other significant variables were found to explain implant removal within one year of use.