Management and localization strategies for the nonpalpable Implanon rod

PURPOSE: The goal of this paper is to review the imaging methods required for localizing nonpalpable Implanontrade mark. METHOD: Different localization methods for nonpalpable Implanon rods are summarized, and clinical guidance is provided as to how best to localize such implants. RESULTS: In the great majority of cases, optimal visualization of the single-rod Implanon rod is obtained with ultrasound using a high-resolution linear array transducer (10-15 MHz). An implant located just under the skin, under the fascia muscularis or one located deep in the muscle can most often be localized with ultrasound. In rare cases where ultrasound does not definitively locate the implant, magnetic resonance imaging is usually the next best choice. Measurements of serum etonogestrel levels may be necessary to confirm the presence or absence of the implant when it cannot be visualized by either of the two imaging methods. DISCUSSION: Close clinical coordination between women's health care providers and radiologists is required to minimize or prevent removal complications and to facilitate subsequent contraceptive management of the patient.     

Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance

BACKGROUND: Implanon insertion appears to be an easy procedure, but in a small minority of cases difficulties have been encountered with removal if the rod is impalpable. METHODS: Patients were referred to the contraceptive and sexual health service with non-palpable Implanon. Following a clinical assessment and examination of the arm where the implant had been inserted, an ultrasound examination was carried out to identify and locate the implant. These implants were subsequently removed, some under general anaesthesia and others under local anaesthesia. RESULTS: Twenty-seven patients were referred to the unit with impalpable Implanon rods. In four cases the rods were palpable and were removed in the clinic setting without the need for further intervention. Positive identification of the implants was achieved in 21 of the remaining 23 cases using ultrasound. No implant was detected in two cases and etonogestrel was not demonstrated serologically in either woman, suggesting non-insertion. All 21 Implanon rods identified by ultrasound were successfully removed. In just over 52% of women a previous attempt at removal had been undertaken prior to referral. CONCLUSIONS: It is possible to identify and locate impalpable Implanon rods with the aid of ultrasound, facilitating their subsequent safe removal. Although previous reports have identified the position of 'lost' implants using ultrasound, this is the first case series to discuss measuring the skin/implant depth. This parameter, together with the precise position of the implant (in muscle or fat), aids removal. All health professionals inserting and removing contraceptive implants should have been appropriately trained.     

US referral center experience removing nonpalpable and difficult contraceptive implants with in-office ultrasonography: A case series

ObjectivesTo assess referral center outcomes with removal of difficult or nonpalpable contraceptive implants using high-frequency point-of-care ultrasonography.Study DesignWe present a case series examining patients referred to our specialty center from January 2019 through September 2020 for difficult or nonpalpable implant removal.ResultsOf the 54 referrals, 6 had palpable implants and 48 required ultrasonography. We localized 46 (96%) implants in-office, including 13 located subfascially; 2 Implanon implants could not be localized. We successfully completed 50 (96%) of 52 attempted in-office removals, including 12 (92%) subfascial implants.ConclusionHigh-frequency point-of-care ultrasonography can effectively localize nonpalpable contraceptive implants leading to successful in-office removal.ImplicationsSpecialists can use high-frequency point-of-care ultrasonography to localize nonpalpable implants without formal radiology scans and skilled technologists, optimizing patient time and convenience. However, the probe is expensive, and providers may need to consider this cost in the context of reimbursement for these highly specialized procedures.     

Removal of etonogestrel contraceptive implants in the operating theater: report on 28 cases

OBJECTIVES: We describe removal procedures for etonogestrel contraceptive implants in the operating theater. In addition, we discuss the management of removal of contraceptive implants that are difficult to palpate or are impalpable. DESIGN: We conducted a retrospective single-center case series analysis of Implanon removals conducted at a university hospital between January 2002 and April 2005. MATERIALS AND METHODS: We analyzed case notes for 28 patients who had their contraceptive implant removed in the operating theater. RESULTS: Intermenstrual bleeding was the principal reason for removal (52.4%). Ten patients already had one attempted removal of their implant. Preoperative ultrasound localized the implant in all cases. Half of the removals were done under local anesthetic, with three cases progressing to general anesthesia (11%). Thirty percent of the implants had migrated from their initial implantation, 37% were in intramuscular tissue and 11% were in the humeral neurovascular sheath. The only postoperative complications were one small seroma and transient paresthesia in the territory of the ulnar nerve. The implant was not found in one case. CONCLUSIONS: The removal of an implant that is not palpable or difficult to palpate should take place in the operating theater following localization by ultrasound. Patients must be fully informed about the procedure, including its complications and the risk for failure.     

Ovarian cysts in users of Implanon and Jadelle subdermal contraceptive implants

OBJECTIVE: To evaluate the prevalence of ovarian cysts in users of two contraceptive implants compared to users of intrauterine contraceptive (IUC). MATERIALS AND METHODS: A total of 344 women were enrolled at 3 months of use of the etonogestrel-releasing implant (Implanon), the levonorgestrel-releasing implant (Jadelle) or the TCu380A IUC. Bimanual pelvic examination and vaginal ultrasound were performed during routine 3-, 6- and 12-month visits of asymptomatic women. Women with ovarian cysts (or enlarged ovarian follicles > or = 25 mm) were assessed weekly until disappearance or reduction of the image [including estradiol (E2) and progesterone (P) measurement], and women with no ovarian enlargement underwent the same evaluation for the same period of time. RESULTS: Ovarian cysts were detected in 5.2%, 13.0% and 1.9% of users of Implanon, Jadelle and IUC, respectively, at 3 months. At 6 months of use, prevalence was 7.2%, 8.0% and 2.1%, whereas 12-month rates were 26.7%, 14.6% and 1.2% in the three groups, respectively. E2 levels were significantly higher among users with ovarian cysts than controls. The time until disappearance of the ovarian cyst was similar in all three groups. There were more cases of menorrhagia in users of implants who had ovarian cysts than in those with no ovarian enlargement. CONCLUSIONS: The finding of ovarian cysts or enlarged ovarian follicles during the first year of use of Implanon and Jadelle implants is common and transient and should not be interpreted as a pathologic ovarian cyst. No further medical interventions are necessary.     

Continuation rates of Implanon in the UK: data from an observational study in a clinical setting

BACKGROUND: Long-acting reversible methods of contraception can potentially reduce unintended pregnancy. There are few data on "real-life" continuation rates of the contraceptive implant Implanon. MATERIALS AND METHODS: Three hundred twenty-four women choosing Implanon in a community family planning clinic in Scotland were followed up by case note review (n=236) or postal questionnaire (n=87) 3 years after insertion of the implant (1 woman chose not to disclose her home address). RESULTS: Data were available for 85% of the women. Continuation rates were 89% (CI 84-91) at 6 months, 75% (CI 69-79) at 1 year, 59% (CI 52-63) at 2 years and 47% (CI 40-52) at 2 years and 9 months. Of the 68 women who discontinued Implanon within 1 year, 62 (91%) did so because of unwanted side effects, the most common being frequent and/or unpredictable bleeding (n=42, 62%). Almost half changed to a less-effective method of contraception; however, one third (n=99, 39%) chose to use a second implant when the first one expired. CONCLUSIONS: Continuation rates of Implanon in this clinic setting in the UK make it a cost-effective method of contraception and justify its widespread provision.     

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.     

Spontaneous snapping of an Implanon in two halves in situ

A 30-year-old woman presented at our family planning clinic for Implanon removal and reinsertion. At the time of presentation the patient's weight was 148 kg. The Implanon was fitted in July 2000 (i.e. 35 months previously) when her weight was 138.5 kg. The patient was very happy with the contraceptive method. She was aware that her Implanon had snapped in half about 2 months ago. There was no aggravating factor such as weightlifting associated with this incidence.     

Persistent vaginal bleeding in a patient with a broken Implanon

A 29-year-old woman with an Implanon contraceptive device in situ presented with persistent and prolonged vaginal bleeding. The implant had been inserted 2 years previously; the patient had been happy with it and had been mainly amenorrhoeic with the occasional light period. She was concerned that the implant had broken during a game of 'rough and tumble' with her son in August 2000. Since the trauma to her arm her bleeding pattern had changed, and she began bleeding heavily for 3 weeks every month. The rod was removed and found to be fractured halfway across its width. A new Implanon device was inserted and the bleeding settled.     

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.     

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.     

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.     

Implanon users are less likely to be satisfied with their contraception after 6 months than IUD users

Background

The study was conducted to perform a direct comparison of the satisfaction of intrauterine device (IUD) users and Implanon users after 6 months.

Study design

Women were recruited to this study in the contraception clinics of Southern Health and Family Planning Victoria. Each woman completed a questionnaire at the time of starting her contraception with either an IUD or Implanon. Women were sent a follow-up questionnaire after 6 months to assess their satisfaction with their chosen method of contraception.

Results

A total of 439 participants were recruited for this non randomized cohort study; 211 choosing an IUD and 228 choosing to use Implanon. The main reason patients in both groups chose their contraceptive method was recommendation by the doctor. Follow-up was achieved in over 84% in both groups. More than 50% of women in both groups reported at least one side effect. The most commonly reported side effect in both groups was abnormal bleeding and this was also the most common reason for having the contraceptive device removed. The IUD users reported a higher rate of satisfaction with their chosen method of contraception, although there was no difference between groups in the removal rate or whether the women would recommend the contraception to others.

Conclusions

IUD users reported a higher level of satisfaction than did Implanon users at 6 months. Side effects in women using IUDs and Implanon are common. The range of likely side effects should be included in counseling women about long-term reversible contraception.     

81例皮下埋植剂依托孕烯使用后临床分析

目的：收集我院近2年使用皮下埋植剂依托孕烯的81例患者临床资料，分析影响皮下埋植剂使用的因素，为推广皮下埋植剂的使用提供临床依据。方法：回顾性收集2017年1月—2018年9月于我院计划生育科就诊，自愿选择要求放置或取出皮下埋植剂依托孕烯的81例患者临床资料，于2018年12月集中电话随访放置后是否出现与皮下埋植剂相关的不良反应以及后续处理和目前在用状态，探讨皮下埋植剂放置时机、放置原因、放置后出现的月经改变不良反应以及处理效果与目前是否在用的关系。结果：皮下埋植剂是高效的长效避孕措施；放置后发生闭经和不规则阴道出血情况的患者在皮下埋植剂放置时间上比较，差异无统计学意义（P＞0.05）；皮下埋植剂取出组与在用组在放置原因、出现月经改变不良反应是否治疗、放置后是否发胖方面比较，差异无统计学意义（P＞0.05）；2组在针对月经改变的用药治疗效果方面比较，在用组好于取出组，差异有统计学意义（P＜0.05）；皮下埋植剂用于避孕和同时用于缓解腺肌病痛经症状时，两者放置皮下埋植剂的时间长短比较，差异无统计学意义（P＞0.05）。提前终止皮下埋植剂使用的人群后续避孕方法以避孕套为多。结论：皮下埋植剂避孕效果可靠；皮下埋植剂对改善腺肌病痛经症状有一定效果；皮下埋植剂对月经模式的改变随着放置时间的延长趋于固定化；影响皮下埋植剂取出的主要因素是患者对月经改变的治疗效果是否满意；后续针对出血模式改变的机制进行研究与治疗可能提高皮下埋植剂使用的满意度，提高皮下埋植剂作为长效安全避孕措施的使用效果。     

Implanon use in Thai women above the age of 35 years

A prospective study of Implanon implant use in women older than 35 was conducted in Bangkok, Thailand. The purposes of this study were to evaluate the menstrual pattern and side effects of Implanon in 51 women followed for 6 months. Their mean age was 39.7 years. Most acceptors had completed primary school. No accidental pregnancies occurred in 6 months of use. The most common menstrual pattern in these acceptors was irregular bleeding followed by amenorrhea. The major side effect was irregular bleeding. There was no significant change in body weight, body mass index and diastolic blood pressure during the 6-month follow-up period, but systolic blood pressure declined. Implanon implant use is a safe and effective contraceptive method and should become another choice for contraception in women aged above 35 years who have contraindications for oral contraceptive use.     

Effect of etonogestrel subdermal contraceptive implant (Implanon) on liver function tests -- a randomized comparative study with Norplant implants

OBJECTIVE: The study aimed to assess the possible differences in effects of Implanon and Norplant implants on liver function over 2 years of use. METHODS: This is a 2-year open randomized study of 80 implant (Implanon and Norplant) acceptors. Selected parameters of liver function were tested in the serum before implant insertion and at 6, 12 and 24 months after implant insertion. RESULTS: In both the implant groups, the mean total and unconjugated bilirubin and the gamma-glutaryl transferase levels were significantly raised during implant use. For none of the subjects, at any sampling period, did the levels exceed the normal range in our population. There was no significant elevation of any other liver enzymes in either group. CONCLUSION: It appears that there may be mild hepatocellular dysfunction associated with the use of both Implanon and Norplant, which is possibly of no clinical significance to the healthy acceptor.     

A pilot efficacy study with a single-rod contraceptive implant (Implanon) in 200 Indonesian women treated for < or = 4 years.

In this 4-year open-label, noncomparative, single-center pilot efficacy study, the contraceptive efficacy, safety, bleeding pattern and acceptability of Implanon was studied in 200 sexually active women of proven fertility in Indonesia. All subjects received the single-rod subdermal implant Implanon, which contains 68 mg etonogestrel (3-keto-desogestrel), with an initial release rate of 67 micrograms etonogestrel/day. Contraceptive efficacy was analyzed by calculation of the pregnancy rate, bleeding patterns were determined by the 90-day reference period method, and acceptability by the discontinuation rate. No in-treatment pregnancies were reported during 658.4 women-years of exposure, resulting in a Pearl Index of 0.0 (95% CI 0.0-0.6). The overall bleeding pattern was acceptable, with no discontinuations because of irregular bleeding. Incidence of irregular bleeding was highest during the first two reference periods and decreased thereafter. Amenorrhea was experienced by 7%-12% of subjects during years 1 and 2, by 5%-7% during year 3, and by 2%-5% during year 4, with one discontinuation because of amenorrhea. No clinically significant changes were reported for systolic and diastolic blood pressure, body mass index, and hemoglobin level. Three adverse experiences were related to treatment and resulted in discontinuation (two headaches and one dyspnea). One difficult implant removal was reported. In conclusion, this pilot efficacy study indicates that Implanon provides excellent contraceptive reliability and an acceptable bleeding pattern. Overall safety and acceptability are good, as suggested by the low incidence of adverse experiences and the low discontinuation rate.     

Effects of the etonogestrel-releasing implant Implanon and a nonmedicated intrauterine device on the growth of breast-fed infants

The study objectives were to compare the effects of an etonogestrel-releasing implant (Implanon) and a nonmedicated intrauterine device (IUD) on parameters of lactation in breast-feeding women and on the growth of their breast-fed infants over a 3-year period. Healthy lactating women (28-56 days postpartum) chose either the implant (n=42) or the IUD (n=38). Infant growth during a 3-year follow-up period is reported here. Total duration of breast-feeding coinciding with the mothers' treatment was 421.0 and 423.4 days in the Implanon and IUD groups, respectively. There were no differences between the infant groups in terms of body length, biparietal head circumference and body weight. No abnormalities were reported in psychomotor development or during physical examination. No treatment-related side effects were observed in either group. In conclusion, there were no differences in the growth of breast-fed infants of women treated with Implanon or a nonmedicated IUD. Implanon, therefore, appears to be a safe contraceptive option for breast-feeding women and their infants.     

A risk management approach to the design of contraceptive implants

This article assesses the risks associated with the insertion and removal of contraceptive implants. Risks to patient safety relate to the way the insertion device is designed and used, rather than to the pharmacological properties of the implant itself. Risks associated with removal are not amenable to thoughtful design. A systems approach is taken, the assumption being that human errors are symptoms of underlying systems deficiencies rather than causes of adverse events. The insertion procedure is broken down into five key steps. Errors in these steps contribute to non-insertion and deep insertion of implants. The design of the Implanon(?) applicator is critically examined and suggestions made as to how it could be improved in such a way as to reduce errors in its use. The exercise undertaken has coincided with the imminent launch of the redesigned applicator of the new contraceptive implant, Nexplanon(?). Preliminary comments are made about the new features of Nexplanon.     

“pop-out” method of levonorgestrel implant removal

The “pop-out” technique is a method of levonorgestrel implant removal that uses digital pressure to direct implants through a small skin incision. This technique was developed, theoretically, to cause less bruising and patient discomfort by avoiding the use of instruments. The pop-out technique is the primary method used for levonorgestrel implant removal in the Magee-Womens Hospital resident clinic. We performed a retrospective analysis of levonorgestrel implant removals performed between July 1, 1995, and December 31, 1998. Of the 168 removals included in this analysis, 38 were performed by one of two attending physicians, and 130 were performed by the residents with attending supervision. The average time for removal was 12 ± 5 min (range 2.25–27 min) when the “pop-out” method could be used to remove all six implants, and 14 ± 7 min (range 2.25–59 min) for all removals. The removal time for residents was inversely proportional to the anticipated level of difficulty of the removal and to the number of previous removals performed. The removal time was significantly faster when residents were supervised by one of the attending physicians as compared with the other attending physician. Only 0.7% (7/1,008) of levonorgestrel implants were fragmented during removal. This review shows that the “pop-out” method is a reasonable alternative to other proposed methods of primary implant removal. The difference in the level of expertise of the attending physician may significantly influence removal time when training clinicians in levonorgestrel implant removal.