Implanon Insertion Research Articles

Effect of etonogestrel implant on serum lipids, liver function tests and hemoglobin levels

BackgroundThis study aimed to assess the possible effects of etonogestrel implant (Implanon®, Organon, Oss, The Netherlands) on total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Hb levels in a sample of Turkish population. Study DesignHealthy women of childbearing potential who had applied to our Family Planning Clinic for a contraceptive method and had chosen to have an Implanon insertion after thorough counseling about all family planning methods and screening for eligibility for Implanon use were enrolled in the study. Serum concentrations of TC, TG, HDL-C, LDL-C, AST, ALT and Hb levels were tested before and at 3 and 6 months after insertion. Baseline mean parameters were compared with mean parameters at 3 and 6 months for statistical significance using paired-samples t test. ResultsEighty-two women eligible for the study were included. Mean age of the patients was 27.5±4.8 years. When compared to the baseline values, there was a statistically significant decrease in the TC (p<.001), HDL-C (p<.001) and TG (p=.006) at the end of the third month, while there was a significant increase in Hb values (p=.01). The decrease in TC (p=.001) and HDL-C (p<.001) and increase in Hb value (p=.03) persisted by the end of sixth month while the decrease in TG was transient. A statistically significant increase in mean ALT level was observed at 6 months (p=.03). ConclusionThe effect of Implanon on liver functions and lipid metabolism does not lead to unhealthy alterations. Increase in Hb can be attributed to the high frequency of amenorrhea in patients.

Prevensjonsimplantater – avvik ved innsetting og uttak

Contraceptive implants with progestogens are options for women who need long-term contraception. Implanon which contains etonogestrel (the active metabolite of desogestrel) effectively prohibits ovulation over a period of three years. This study presents aberrations from insertion and removal procedures for Implanon in the period 2 February 2002 - 30 June 2008. Information about sales of Implanon in Norway is taken from statistics provided by Farmastat Norway. Aberrations from procedures for insertion and removal of Implanon are based on reports from doctors to the producer. Non-palpable implants to be removed at Volvat Medical Centre in Oslo, were localized by ultrasound and removed surgically. In the period 2 February 2002 - 30 June 2008, the producer Organon AS (now Schering- Plough AS) sold 12 898 Implanon implants in Norway and recorded 112 aberrations from existing procedures, the first one 3 March 2003. 18 patients were referred for removal of implants (too deeply inserted) at Volvat Medical Centre in the period 19 January 2004 - 30 June 2008. The number of unsuccessful or wrongly inserted implants indicates that doctors should have practiced and be better informed about insertion and removal procedures before using this method. Localization and removal of implants inserted too deeply requires high-frequency ultrasound equipment and surgical experience.

Two-week postpartum Implanon insertion is not equivalent to immediate postpartum LARC

Two-week postpartum Implanon insertion is not equivalent to immediate postpartum LARC

Effects of the Progestagen-only Contraceptive Implant Implanon®on Transforming Growth Factor β1 and Endothelin-1

Progestagen-only contraceptives are often prescribed to women with an increased cardiovascular risk, despite the fact that only few data are available on the effect of these contraceptives on circulating biomarkers of inflammation and endothelial function. In our prospective case-control study, we aimed to investigate the influence of the low-dose etonogestrel-releasing contraceptive implant Implanon on endothelin-1 and cytokine transforming growth factor beta (TGF-beta1), both factors involved in the early phases of atherogenesis. We also were interested in searching for an interrelation between changes in these two parameters and changes in female hormones and plasma lipids. Cases (n=20) were women using Implanon for contraception, and controls (n=20) were females not using hormonal contraception. Baseline blood samples were taken during the early follicular phase of cycle 1 in both groups. A second sample was taken 12 weeks after Implanon insertion or, for controls, in the early follicular phase of cycle 4. In both groups no significant change in endothelin-1 or TGF-beta1 was observed. In Implanon users, cholesterol, high-density lipoprotein, low-density lipoprotein, sex hormone-binding globulin, and testosterone decreased significantly. No correlations were found between endothelin-1 or TGF-beta1 and the investigated parameters. The results suggest that Implanon does not exert a clinically relevant negative effect on endothelin-1 or TGF-beta.

Effects of the progestagen‐only contraceptive implant Implanon® on cardiovascular risk factors

Epidemiological studies on the cardiovascular risk of progestagen-only contraceptives are rare. With the present study we aimed to investigate the effect of the low-dose etonogestrel-releasing contraceptive implant Implanon on cardiovascular risk factors, including markers of inflammation. Longitudinal study. Family planning centre of a University Hospital. Thirty-six healthy, nonsmoking women with regular cycles (n = 18 controls without hormonal contraception; n = 18 cases requesting the insertion of Implanon. Blood samples for the determination of C-reactive protein (CRP), nitric oxide (NO), sex hormones and plasma lipids were taken in the early follicular phase of the cycle in both groups. A second sample was taken 12 weeks after Implanon insertion or in the controls during the early follicular phase of cycle 4. Implanon treatment caused a 36% decrease in CRP (P < 0.06) and a significant decrease in high density lipoprotein (HDL) (P < 0.007), low density lipoprotein (LDL) (P < 0.001), cholesterol (P < 0.001), testosterone (P < 0.05) and SHBG (P < 0.002). Levels of NO, oestradiol and progesterone were not affected in either group. The cholesterol/HDL ratio did not change in Implanon carriers. There was a significant correlation between the cardiovascular risk factors CRP, cholesterol/HDL ratio and NO. The progestagen-only implant Implanon does not exert a negative effect on the cardiovascular risk factors CRP, cholesterol/HDL ratio and NO. These results suggest that the use of a progestagen-only contraception does not increase cardiovascular risk factors in healthy young women.

Nerve injury caused by removal of an implantable hormonal contraceptive

Implanon insertion and removal are relatively uncomplicated procedures in the hands of medical professionals familiar with the technique. However, injury to branches of the medial antebrachial cutaneous nerve during Implanon insertion and removal can result in impaired sensibility, severe localized pain, or the formation of painful neuroma that can be quite devastating to the patient. The best way to avoid injury to the medial antebrachial cutaneous nerve is to better understand its position relative to the standard area of Implanon insertion. In the event that an injury to the nerve is recognized, immediate plastic surgical measures should be undertaken to avoid displeasing sequels of nerve injuries. Therefore, the benefit of this generally well-tolerated, highly effective, and relatively cost-efficient contraception is guaranteed only in the hands of medical professionals familiar with the technique.

Le suivi à long terme d'une cohorte de femmes porteuses d'un implant contraceptif (Implanon®) : analyse intermédiaire des données de l'observatoire OPNI

Describe the initiation and follow-up of Implanon insertion in current office-based practice in France and estimate the rate and causes of early removals. A prospective cohort study of 1000 women having been inserted with Implanon by a representative national sample of prescribers (gynaecologists and general practitioners) was designed. The follow-up period was 3 years and the enrolment was planned for 2 years starting July 2002 according to a naturalistic design. The results are related to an intermediate analysis describing the situation of the cohort at the date 31 December 2003. 872 women were enrolled, of whom 784 (89.9%) by gynaecologists and 88 (10.1%) by GPs. Implanon was inserted in 691 (79.2%) and 360 (52.1%) had at least one follow-up visit at this date. The mean follow-up period after insertion was 10.5 months. 38 early removals were recorded (actuarial rate at 16 months of 8.8% [CI 95% 5.0-12.7]), integrating the distribution of follow-up duration and the assumption that women with no follow-up visit the still had device. The estimated early removal rate was lower than the result of the meta-analysis of international clinical trials but this figure should be confirmed in the final analysis of the study.

Unintended pregnancies with the etonogestrel implant (Implanon): a case series from postmarketing experience in Australia

This paper describes a case series of over 200 unintended pregnancies associated with the etonogestrel implant, Implanon. These cases have been reported to the Australian Adverse Drug Reactions Advisory Committee during the first 3 years of marketing in this country. Of 218 cases included, 45 had insufficient data to assess the reason for contraceptive failure and 46 women were determined to have been already pregnant prior to Implanon insertion. Of the remaining 127 cases, the most common reason for unintended pregnancy was failure to insert the implant in 84 women. Other reasons included incorrect timing of insertion (19 cases), expulsion of Implanon (3 cases) and interaction with hepatic enzyme-inducing medicines (8 cases). The remaining 13 cases were classified as product/method failures once other reasons had been excluded. Using the 204,486 Implanon devices subsidized in this period to estimate the population exposed and the 218 pregnancies reported, the approximate failure rate in postmarketing use was 1 in 1000 insertions. These findings (and reports to medical indemnity insurers) have resulted in the development of guidelines and training for doctors inserting Implanon in Australia.

Assessment of Ease of Implanon Insertion and Removal

Assessment of Ease of Implanon Insertion and Removal

Assessment of ease of Implanon insertion and removal

Assessment of ease of Implanon insertion and removal

Insertion and removal of Implanon®: practical considerations

ABSTRACTImplanon®, 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.

Insertion and Removal of Implanon®: Practical Considerations

Insertion and Removal of Implanon®: Practical Considerations

Insertion and removal of Implanon®

Implanon® is a single-rod contraceptive implant containing the progestin etonogestrel. Implants require insertion and removal by medical professionals. Detailed and unbiased counseling before insertion is essential, and should include contraceptive efficacy, insertion and removal procedures, and possible adverse events. Insertion and removal times have been measured in six open studies and in seven comparative studies in which Norplant® (the six-capsule levonorgestrel implant) was used as the reference product. In comparative studies, the mean time needed for insertion of Implanon was 1.1 min and removal took 2.6 min. Insertion as well as removal of Implanon was four times faster than with Norplant. Complications with insertion and removal are rare in the hands of medical professionals familiar with the techniques.

Pharmacokinetics of Implanon®: An integrated analysis

The aims of this paper were to present data on the pharmacokinetics, clearance, bioavailability, and in vivo absorption of etonogestrel (ENG); to present the results of a longitudinal analysis of the plasma concentration-time curves of ENG; and to present the results of a cross-sectional analysis on the association of body weight with serum ENG concentrations. Implanon® had an absorption rate of almost 60 μg/day after 3 months, which slowly decreased to 30 μg/day at the end of 2 years. The bioavailability over this period of time was constant and close to 100%. The clearance remained around 7.5 L/h. With a bioavailability and clearance that remained constant, it was concluded that accumulation of ENG does not occur. After Implanon insertion, serum concentrations increased within 8 h to concentrations associated with ovulation inhibition. Maximum mean serum concentrations (C max) amounted to 813 pg/mL and the time (t max) to reach C max was 4 days. After reaching C max, ENG serum concentrations declined to about 196 pg/mL at the end of the first year, followed by a slow decline to 156 pg/mL at the end of the third year. After removal of Implanon, serum ENG concentrations declined to levels less than the detection limit of the assay (20 pg/mL) within 1 week. Lower body weight was associated with higher serum ENG concentrations.