Site necrosis at the insertion place of the single-rod subdermal contraceptive implant: report of five cases.

OBJECTIVE: Implant-site necrosis is a rare complication. We present a case-series of a necrosis as an adverse effect after the etonogestrel (ENG)-subdermal contraceptive implant placement. MATERIAL AND METHODS: Five women with site necrosis after the ENG-implant placement and their clinical manifestations and treatments. RESULTS: Local pain was the main symptom, appearing within 35 days of placement. Outpatient multidisciplinary treatment was undertaken. Local debridement and implant removal was performed in four out of the five women. Time to complete healing varied from 45 days to 12 months. CONCLUSION: Early diagnosis and multidisciplinary treatment are essential to avoid severe aesthetic or functional damages and major life-threatening complications.

We presented five cases with necrosis at the ENG-implant site of placement in which we proposed an early diagnosis and multidisciplinary treatment to avoid severe aesthetic or functional damages.

One-year follow-up of immediate postpartum contraceptive implant insertion in adolescents.

PURPOSE: Our study aimed to evaluate the acceptability, adverse effects and continuation rates among adolescents who accepted the etonogestrel (ENG) subdermal implant and compared to adolescents who chose other methods during the immediate postpartum period before hospital discharge, with one year follow-up up. MATERIALS AND METHODS: We conducted a cohort non-randomised study at the Women's Hospital, University of Campinas. All women up to 19 years of age, who gave birth at the hospital between July 2019 and April 2020, were invited to participate and were offered the ENG-implant or the routine contraceptive methods. They were followed for one year postpartum. RESULTS: We included 100 teenagers and 72 accepted the ENG-implant. Students are more likely to accept the ENG-implant than non-students (PR: 1.25 [95%CI 0.99-1.59]). Up to one year of follow-up, survival analysis showed that the time of adherence to the method was longer for the ENG-implant users (p = 0.0049). More than 90% of the adolescents were satisfied with the implant; however, five requested early removal due to menstrual irregularity and local discomfort. CONCLUSION: Provision ENG-implant for adolescents in the immediate postpartum demonstrated high acceptance and ensured effective contraception. After one year, most of them were satisfied, with a high continuation rate and without unplanned pregnancies.

SURGICAL REMOVAL AFTER IATROGENIC SUBRETINAL INJECTION OF AN INTRAVITREAL DEXAMETHASONE IMPLANT.

PURPOSE: To report a rare case of subretinal migration of an intravitreal dexamethasone implant to treat macular edema secondary to diabetic retinopathy in a vitrectomized eye and the surgical outcome. OBSERVATIONS: A pars plana vitrectomy and a retinotomy were performed to remove the implant and restore vision. CONCLUSION AND IMPORTANCE: Subretinal dislodgement of intravitreal implants is a rare and preventable complication. In the current case, we speculated that this complication might have been related to the injection technique, a possible unrecognized retinal perforation before the injection of the implant, or delayed treatment with the implant. Because a retinal detachment and vitreoretinal proliferation were observed, surgical management was required. Increasing widespread application of any technology may lead to a more significant risk of complications, and ophthalmologists should be aware of this potential risk.

Efectos adversos y motivos de retiro de implante subdérmico Jadelle® en usuarias de Policlínica de salud Sexual y Reproductiva del Hospital de Clínicas en período junio 2015- diciembre 2017 / Adverse effects and reasons of remove of subdermico implant Jadelle® in users of Sexual and Reproductive Health Clinics of Hospital de Clinicas in period june 2015-december 2017

INTRODUCCIÓN: La anticoncepción hormonal, a través de implantes subdérmicos, es uno de los métodos anticonceptivos reversibles de larga duración más eficaces en la actualidad que está disponible en nuestro país en forma gratuita en el sistema público. OBJETIVO: Reconocer los efectos adversos y los motivos de retiro del Implante Jadelle® en usuarias del Hospital de Clínicas, así como evaluar la información recibida por las usuarias al momento de la colocación. MATERIAL Y MÉTODOS: Un total de 160 pacientes participaron en el estudio a través de una encuesta previo consentimiento informado. Se utilizó la estadística descriptiva en números absolutos y porcentuales. Resultados: Previo al uso, recibieron información sobre los probables efectos adversos del método el 83% de ellas, y acerca de la efectividad del método el 89 %. En cuanto a efectos adversos los presentaron el 80,6% de las usuarias, siendo la irregularidad de la menstruación la causa más frecuente constituyendo un 61%. CONCLUSIONES: Es alta la frecuencia de pacientes que presentan efectos adversos y que solicitan retiro del implante antes del tiempo a causa de ello, 35% de las usuarias, siendo el principal motivo la irregularidad menstrual en un 43% de los casos. Es recomendable realizar un correcto asesoramiento previo a la colocación e incentivar a las pacientes a concurrir a los controles médicos, luego de la colocación, para brindar asesoramiento y tratamiento si se presentara algún efecto adverso, con el fin de obtener una mejor continuidad de uso del método.

INTRODUCTION: Hormonal contraception, through subdermal implants, is one of the most effective long active reversal contraceptive methods currently available in our country for free in the public system. OBJETIVE: Recognize the adverse effects and the reasons for its withdrawal in users of the Hospital de Clínicas as well as to evaluate the information received by the users at the time of placement. METHODOLOGY: A total of 160 patients participated in the work with prior informed consent through a survey. Descriptive statistics were used in absolute and percentage numbers. They received information on the probable adverse effects of the 83% pre-use method, about the effectiveness of the 89% method. RESULTS: Regarding adverse effects, they were present in 80.6% of the users; the being irregularity of menstruation is the most frequent, constituting 61%. Concluding that the frequency of patients presenting with adverse effects and requesting removal of the implant before the time is high because of it, 35% of the users who requested removal menstrual irregularities were the main reason for 43% of patients. CONCLUSIONS: It is advisable to make a correct advice prior to placement and encourage patients to attend medical controls, after placement, to provide advice and treatment if any adverse effect occurs, in order to give better use in terms of method time.

Twelve-month Continuation of the Etonogestrel Implant in Adolescents With Polycystic Ovary Syndrome.

STUDY OBJECTIVE: To identify why adolescents with polycystic ovary syndrome (PCOS) chose the etonogestrel (ENG) contraceptive implant, to determine the 12-month continuation rate, and to characterize factors related to discontinuation. DESIGN, SETTING, AND PARTICIPANTS: Retrospective chart review of adolescents seen at a tertiary care children's hospital between July 1, 2008, and August 30, 2019, with PCOS diagnosis confirmed per National Institutes of Health criteria and ≥12-month ENG follow-up. INTERVENTIONS AND MAIN OUTCOME MEASURES: Demographic characteristics, reasons for ENG insertion and removal, and information on other hormonal/contraceptive therapies were collected. Patients were categorized as ENG continuers (use ≥12 months) or discontinuers (removal at <12 months), and groups were compared. RESULTS: A total of 96 patients met inclusion criteria (age 17.7 ± 2.2 years, body mass index 34.8 ± 8 kg/m2). Reasons for ENG were documented in 74% (51% contraception, 32% ease of use, 15% other, 13% estrogen avoidance). In all, 27% had never been sexually active, and 67% had had prior sexual activity. Treatments prior to ENG placement included 74% combined hormonal contraception, 20% medroxyprogesterone acetate withdrawal, and 17% depot medroxyprogesterone. A total of 77% continued ENG at 12 months. The main reasons for discontinuation were bleeding (41%), concern about weight gain (23%), and mood changes (18%). No preimplantation characteristics were independently predictive of continuation, although 100% of patients with type 2 diabetes (n = 11) continued. Patients who sought additional care, including telephone calls (41% vs 12%, P = .006) and clinic visits (64% vs 20%, P < .001) were more likely to discontinue. CONCLUSIONS: The ENG implant was well tolerated in adolescents with PCOS and similar to published 12-month continuation rates.

ENG-releasing subdermal implants in postpartum teenagers - an open-label trial study protocol.

BACKGROUND: Higher than expected adolescent pregnancy high rates continue globally, with repeated unplanned pregnancy (UP) in this age group is a public health problem. In Brazil, 16% of pregnancies occur in adolescents under 18 years old, with high maternal morbidity and mortality rates in this age group. Effective and safe contraception is required to reduce UP rates. The objective of our study is to evaluate acceptance of etonogestrel (ENG)-releasing subdermal contraceptive implant after childbirth, before discharge, as well as clinical performance up to one year after placement. Comparison between teenagers who opt for ENG-implant versus other contraceptive methods after childbirth will be also evaluated, specifically regarding UP, continuation and discontinuation rates and reasons, body composition, pelvic ultrasound characteristics and user satisfaction. METHODS: A non-randomized open-label trial will be conducted with teenagers after childbirth and followed up to one year at the Women's Hospital, University of Campinas (UNICAMP), Campinas, Brazil. The study group will consist of patients who accepted to use ENG-implant and placed before discharge. The comparison group will include adolescents who choose to use other contraceptive methods at the first postpartum visit (42 ± 3 days after childbirth). All women will follow-up at 40-60 days postpartum, as well as, at 6 and 12 months post-enrollment. Patient satisfaction, contraceptive effectiveness, reasons of discontinuation, continuation rate and body composition will be evaluated. Transvaginal ultrasound and electric bio impedance tests will be performed at all follow-up appointments. A 5% significance level was assumed, as well as, a sampling error (absolute) for 10% prevalence. The sample size was calculated at n = 100, obtaining an estimate of 50 to 70 adolescents who would accept the method offered, according to the prevalence and sample error assumed. DISCUSSION: Long-acting reversible contraceptive (LARC) methods include subdermal implants and intrauterine contraceptives, are considered first line contraception for teenagers. Immediate postpartum use is a safe option, which significantly reduces rates of repeated UP and all the undesirable consequences inherent to this process. TRIAL REGISTRATION: This study was approved by the Ethics and Research Commission of UNICAMP (CAAE: 92869018.5.0000.5404) and the Brazilian Registry of Clinical Trials (REBEC): http://www.ensaiosclinicos.gov.br/rg/RBR-4z7bc6, (number 2.901.752).

INTRAVITREAL DEXAMETHASONE IMPLANT MIGRATION INTO THE ANTERIOR CHAMBER: A Multicenter Study From the Pan-American Collaborative Retina Study Group.

PURPOSE: To establish the prevalence and risk factors for intravitreal dexamethasone implant migration into the anterior chamber in eyes with macular edema. METHODS: This was a multicenter, retrospective, observational chart review of data that included patients with macular edema who had been treated with at least one intravitreal dexamethasone injection. Patients with incomplete chart information during the follow-up period were excluded. RESULTS: The prevalence of implant migration in 468 patients, considering the number of injections, was 1.6%, with significant associations between implant migration and cataract surgery (P = 0.043) and intraocular lens status (P = 0.005) and a trend toward statistical significance (P = 0.057) with vitrectomy. A higher rate of implant migration into the anterior chamber was observed in vitrectomized eyes (4.8%) when compared with patients who did not undergo a vitrectomy (1.6%). The implants that migrated were removed with forceps with/without viscoelastic expression or with 20-gauge cannulas connected to the vitreous cutter machine. CONCLUSION: The risk of implant migration into the anterior chamber was 1.6%. Risk factors were a history of cataract surgery or vitrectomy and aphakia. When anterior migration occurs, rapid removal is advised, especially if corneal edema is present.

Pseudoaneurisma traumático em artéria braquial após retirada de implante contraceptivo subdérmico / Traumatic pseudoaneurysm in brachial artery after removal of a subdermal contraceptive implant

Resumo Os procedimentos terapêuticos invasivos têm aumentado frequentemente com a evolução da medicina, consequentemente aumentando o número de complicações decorrentes deles. O dispositivo contraceptivo subdérmico (DCS) tem um benefício para a contracepção feminina, mas o implante e a retirada apresentam uma taxa de complicações em torno de 3%. Neste artigo, relatamos e discutimos um caso de pseudoaneurisma traumático da artéria braquial após tentativa de retirada do implante, complicada com a compressão do nervo mediano.

Abstract The frequency of invasive therapeutic procedures has increased as medicine evolves, and the number of complications related to them has increased as a consequence. Subdermal contraceptive implants (SCI) offer benefits for female contraception, but implant and removal are associated with a complication rate of around 3%. In this article, we report and discuss a case of traumatic brachial artery pseudoaneurysm after an attempt to remove an SCI, complicated by compression of the median nerve.

Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

OBJECTIVES: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use. STUDY DESIGN: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.1 starting at Day 29 and ending at Day 118. We dichotomized bleeding patterns as "favorable" (amenorrhea, infrequent bleeding and normal frequency bleeding without prolonged bleeding) or "unfavorable' (prolonged and/or frequent bleeding) and tracked user groups based on these bleeding patterns in reference period 1.1 through Year 1 and from Year 1 through Year 2, respectively. RESULTS: We evaluated data from 537 and 428 women with up to 1 and 2 years use, respectively. Of the 325 (60.5%) women with favorable bleeding in reference period 1.1, 275 (84.6%) reported favorable bleeding also in reference period 2, 197 (60.6%) reported favorable bleeding throughout Year 1, and favorable bleeding in 75-85% of reference periods in Year 2. Among 212 (39.5%) women with unfavorable bleeding in reference period 1.1, 118 (55.7%) continued with unfavorable bleeding in reference period 2, while about 40%-50% reported favorable patterns in RP 2, 3 and/or 4. Initial favorable bleeding resulted in lower discontinuation rates than initial unfavorable bleeding in years 1 (3.7% vs 12.7%, p≪.0001) and 2 (2.5% vs 16.5%, p≪.0001). CONCLUSION: Implant users with favorable bleeding in the first reference period are likely to continue with favorable bleeding over the next 2 years. Initial bleeding patterns predict overall continuation rates in years 1 and 2. Implications Statement When evaluating vaginal bleeding in any 90-day reference period over 2 years of etonogestrel implant use, approximately 80% of women with favorable and 40% with unfavorable bleeding patterns will have favorable bleeding in the next reference periods. These findings can facilitate counseling regarding bleeding for women using the etonogestrel implant.

Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial.

OBJECTIVES: To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates. STUDY DESIGN: This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity). RESULTS: We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9). CONCLUSION: Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion. IMPLICATIONS: Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.

TRActional DIabetic reTInal detachment surgery with co-adjuvant intravitreal dexamethasONe implant: the TRADITION STUDY.

AIM: Main failure of diabetic tractional retinal detachment (TRD) surgery is the development of proliferative vitreoretinopathy (PVR), causing higher re-detachment rates. We investigated whether the use of dexamethasone (DEX) implant at the end of pars plana vitrectomy (PPV) with silicone oil tamponade might have an impact on these outcomes. DESIGN: Comparative, nonrandomized, retrospective study. PARTICIPANTS: A total of 148 eyes from 148 patients that underwent PPV with silicone oil tamponade for diabetic TRD (with DEX implant, n = 52; without DEX implant, n = 96). METHODS: Consecutive patients' records were reviewed for time between TRD diagnosis and surgery; lens status before surgery and after 6, 12, and 24 months; retina attachment rate after primary PPV; change in postoperative PVR severity; rate of re-detachment at 6, 12, and 24 months; use of IOP lowering treatment after 6, 12, and 24 months; surgery details; intra- and postoperative complications. Correlations between outcome measures, postoperative PVR severity, and re-detachment rates were analyzed. MAIN OUTCOME MEASURES: Change in postoperative PVR severity and retinal re-detachment rates with and without the adjuvant use of DEX implant. RESULTS: Retinal re-detachment rates were significantly higher in the group of patients that did not receive DEX implant [11/96 (11.5%) vs. 0/52 (0%), p = 0.049; 11/84 (12.9%) vs. 4/52 (7.7%), p = 0.007; 14/71 (19.7%) vs. 5/52 (10%) p < 0.001 at 6, 12, and 24 months, respectively]. PVR severity correlated with retinal status at 12 and 24 months (p = 0.018 and p = 0.027, respectively). The difference in PVR severity between the two groups was statistically significant at 6, 12, and 24 months (p < 0.001). CONCLUSIONS: DEX implant at the end of PPV in patients with diabetic TRD improves PVR severity and decreases re-detachment rates. This should be considered as an option in the customized treatment of TRD.

Impact of a progesterone-releasing intravaginal device and inflammatory reaction on ovarian activity in embryo-recipient anestrus mares.

This study aimed to correlate the inflammatory reaction (IR) caused by a progesterone-releasing intravaginal device (P4) with ovarian activity and pregnancy rate (PR) in embryo-recipient anestrus mares (to decrease the spring transitional period). 50 animals were assigned to three groups: GP4 (P4 group; n = 16), GP4OH (P4 + oxytetracycline hydrochloride and hydrocortisone sprayed onto the device; n = 14), and GNP4 (no intravaginal P4; n = 20). The administration protocol for GP4 was: Day 0, 750 mg P4 + ovarian examination by ultrasonography (US) + vaginal sample collection; Day 8, US; Day 11, P4 removal + 7.5 mg PGF2α + US + second vaginal sample collection; Days 13 to 16, US; Days 17 to 21, US + 750 IU hCG to mares with follicles 35 mm or more in diameter; Days 19 to 23 US (ovulation check); Days 24 to 28, embryo transfer + intravenous flunixin meglumine; and Days 30, US pregnancy diagnosis. The GP4OH and GNP4 mares received the same administration protocol as GP4, except that no P4 device was administered to the GNP4 group on Day 0. Although neutrophil-mediated IR occurred in the GP4 and GP4OH groups, the IR was significantly reduced in GP4OH as compared with that in GP4 (P < 0.0001). From Day 0 to Day 17, the GP4 and GP4OH mares developed a greater number of follicles per animal than did the GNP4 mares (P < 0.05), and the average diameter of the follicles was larger in the GP4 and GP4OH mares. The ovulation rates in GP4, GP4OH, and GNP4 mares were, respectively, 43.7%, 64.3%, and 30.0%, and ovulation occurred at 6.8, 6.5, and 23 days after P4 removal (P < 0.05). On Day 17, endometrial edema was verified in 50%, 64.2%, and 35.0% of the GP4, GP4OH, and GNP4 mares, and the PRs after embryo transfer were 80%, 100%, and 66.6%, respectively. Although intravaginal devices caused IR in both the device-recipient groups (P = 0.0001), IR and vaginitis had no negative impact on follicle diameter, ovulation rate, period to ovulation after the removal of P4, endometrial edema, or PR. In addition, P4 reactivated the ovarian function and the IR eliminated a large percentage of bacteria (Bacillus spp., Enterobacter spp., Proteus spp., Pseudomonas spp., and Staphylococcus spp.), especially in GP4; the application of oxytetracycline hydrochloride and hydrocortisone on the devices reduced the severity of vaginitis.

A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

STUDY QUESTION: Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER: The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY: ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN, SIZE, DURATION: This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. PARTICIPANTS, SETTING, METHODS: The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE: ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). LIMITATIONS, REASONS FOR CAUTION: Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS: Findings of the study can inform policy makers and clinicians about choice of implant, but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTERESTS: UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION: ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 2003.

Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial.

OBJECTIVE: To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)]. STUDY DESIGN: We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use. RESULTS: At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9-1.9; 3-month: 25.6% vs. 23.1%, PR= 1.1, 95% CI=0.8-1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of .15). CONCLUSIONS: Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. IMPLICATIONS: Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant.

Efeitos adversos em usuárias de implante contraceptivo / Adverse effects on contraceptive implant users

A gravidez indesejada continua a ser um grave problema de saúde pública em todo o mundo. Uma das explicações para a manutenção de altas taxas de gestações não planejadas relaciona-se com os efeitos adversos provocados por grande parte dos métodos contraceptivos disponíveis que levam as usuárias a descontinuar seu uso. Nos últimos anos, tem se visto um aumento nas opções de contracepção para garantir métodos mais eficazes, com maiores taxas de continuação e níveis elevados de satisfação da paciente. Entre os métodos contraceptivos de longa ação e com rápida reversibilidade, o implante é considerado um dos mais eficazes e mais seguros. Dentre os efeitos adversos relacionados com esse tipo de contracepção, estão incluídos: alterações no padrão do sangramento, cefaleia, aumento do peso, acne, mastalgia, labilidade emocional e dor abdominal. Portanto, no presente estudo, fez-se uma atualização sobre os possíveis efeitos colaterais desse contraceptivo, visando a um melhor aconselhamento pelos profissionais de saúde antes da inserção desse método, a fim de garantir melhor adesão a ele. Estudos demonstram que um aconselhamento claro antes de iniciar um método de longa duração como o implante subdérmico é imprescindível para melhorar a satisfação e a adesão ao método contraceptivo.

Unwanted pregnancy remains a serious public health problem worldwide. An explanation for keeping high rates of unplanned pregnancies is related to the adverse effects caused by most of the available contraceptive methods that lead users to discontinue its use. In recent years, it has been seen an increase in contraceptive options to ensure the most effective methods with higher continuation rates and high levels of patient satisfaction. Among the long-acting contraceptive methods with rapid reversibility, the implant is considered one of the most effective and safest ways. Among the adverse effects associated with the drug are included: changes in the pattern of bleeding, headache, weight gain, acne, breast pain, emotional lability and abdominal pain. Therefore, in our study it was made an update review on possible side effects of contraception, seeking a better counseling by health professionals before insertion in order to ensure better adherence to the method. Studies show that clear advice before starting long duration method as subdermal implant is essential to improve the satisfaction and adherence to contraception.

Endometrial histology, microvascular density and caliber, and matrix metalloproteinase-3 in users of the Nestorone-releasing contraceptive implant with and without endometrial breakthrough bleeding.

OBJECTIVE: This descriptive study evaluated endometrial histology, microvascular density and caliber, and quantification of matrix metalloproteinase (MMP-3) expression in long-term users of the Nestorone (NES)-releasing implant who presented or not endometrial breakthrough bleeding (BTB). METHODS: Endometrial biopsies were obtained from 32 healthy women with unpredictable BTB. The quantitative analysis was performed only in 20 samples. RESULTS: The mean duration of use of the implant among the 14 women with BTB was 19.6+/-1.0 months, and the other six women had used the implant for 17.7+/-2.3 months (mean+/-S.E.M.). Histological analysis of the endometrial tissue showed a predominance of progestogenic pattern followed by atrophic and proliferative endometrium in both groups. Mucosal breakdown and glandular pseudostratification were observed in half of the cases. Endometrial vascular density was 73.1+/-10.0 and 57.5+/-24.1 vessels/mm(2), and maximum vessel diameter was 923.3+/-86.0 and 1038.0+/-404 microm (mean+/-S.E.M.) in the group with and without BTB, respectively, without significance, and the rate of cells expressing MMP-3x1000 counted stromal cells was 155.8+/-24.8 and 127.0+/-19.0 (mean+/-S.E.M.) in both groups, respectively, without significance. CONCLUSIONS: This study provides information about some endometrial aspects of women using NES in contraceptive implants. In addition, the endometrium was similar during long-term use of NES-releasing contraceptive implants in women with and without endometrial bleeding.

Local side effects observed among long-term users of norplant contraceptive implants.

The prevalence of local signs and symptoms related to the site of insertion of implants, and the association of these signs and symptoms with time of use, skin color and body mass index (BMI) was evaluated among users of the Norplant implant system. Three hundred and three Norplant users attending at the reproductive health clinic of PROFAMILIA in Santo Domingo, Dominican Republic, were asked if they had ever had any discomfort at the site/arm of implant insertion and the implant insertion area was examined and hyperpigmentation and hollowing of the surface was recorded. Half of the subjects reported either pain or paresthesia or both, in almost equal numbers, some time since insertion. Hyperpigmentation was observed in 35.6% and hollowing in 22.4% of the subjects. Report of pain and paresthesia was inversely associated to time of use and to BMI. Hyperpigmentation was directly associated to time of use and darker skin, and hollowing of the arm surface in the implants area with time of use and BMI. Local signs and symptoms were more frequent than previously reported, although they were of mild nature and appeared not to worry most of the users.

Enlarged ovarian follicles in users of a levonorgestrel-releasing intrauterine system and contraceptive implant.

OBJECTIVE: To evaluate the prevalence of enlarged ovarian follicles among users of a 20 micrograms/d levonorgestrel-releasing intrauterine system (Mirena, Leiras Oy, Turku, Finland), of subdermal contraceptive implants releasing Nestorone (Population Council, New York, New York) and of the TCu 380A intrauterine device. STUDY DESIGN: A cohort study was conducted at the Universidade Estadual de Campinas, Brazil. Three hundred women were enrolled, with 100 participants in each group. Bimanual pelvic examination and vaginal ultrasound were performed during routine gynecologic examinations in women without complaints. In women with enlarged ovarian follicles (> or = 25 mm), estradiol and progesterone levels were assessed weekly until disappearance or reduction of the ovarian image. RESULTS: Enlarged ovarian follicles were detected in 19%, 10% and 5% of users of the levonorgestrel system, implants and intrauterine device, respectively. Most of the enlarged ovarian images disappeared after 2 weeks of follow-up. Progesterone levels showed that the intrauterine system and TCu 380A IUD (FEI, North Tonawanda, New York) users had presumably ovulated before the first ultrasound examination in contrast to the implant users. CONCLUSION: Physicians and users should be aware that findings of enlarged ovarian follicles during the use of progestin-only contraceptives are transient and that no medical interventions are necessary.

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.