Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials

Darney, Philip D.; Patel, Ashlesha; Rosen, K.; Shapiro, Lena S.; Kaunitz, Andrew M.

doi:10.1016/j.fertnstert.2008.02.140

Cited by 206 publications

(169 citation statements)

References 13 publications

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“…More recently, as newer implantable contraceptives have been developed, complication rates have decreased [9,17,21,26] and removal times have shortened [22,26,28] owing to the single-tube, semi-rigid design [21], and standardization of techniques. A simple "pop-out" method using a 2-mm incision is commonly employed and has been described previously [21].…”

Section: Discussionmentioning

confidence: 99%

Ulnar Nerve Ligation after Removal of Norplant: A Case Report

Adkinson

Md²

2012

Hand (New York, N,Y.)

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Section: Discussionmentioning

confidence: 99%

Ulnar Nerve Ligation after Removal of Norplant: A Case Report

Adkinson

Md²

2012

Hand (New York, N,Y.)

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“…In any case, Darney et al, announced that the recurrence of adverse occasions (as far as regenerative issue) with implanon was 40.1% which was substantially higher than detailed earlier. 7 This information is increasing when contrasted with our review.…”

mentioning

confidence: 82%

“…However, questionable proofs has been seen in writing which make perplexity whether to actualize Implanon in future or not because of high recurrence of adverse reactions as said in study above. 7 So through this study we want to confirm the magnitude of problem, so that in future, we can update guidelines and can have other contraceptive method if complication rate is high with implanon otherwise use this method as this is most effective and safe method of contraception.…”

Section: Introductionmentioning

confidence: 97%

“…6 But Darney et al, revealed that the recurrence of adverse occasions (as far as reproductive issue) with implanon was 40.1% which was significantly higher than announced earlier. 7 Method of reasoning of this was to evaluate the recurrence of adverse occasions created by implantation of single-rod Etonogestrel embed (Implanon) in females looking for birth spacing after conveyance of past pregnancy. Implanon is a viable method of contraception in females looking for birth spacing and adverse reactions are likewise low.…”

Section: Introductionmentioning

confidence: 99%

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Etonogestrel Implant (Implanon); Frequency of Adverse Effects Caused by Implantation of Singlerod Etonogestrel Implant (Implanon) in Females Seeking Birth Spacing After Delivery of Previous Pregnancy

Sajid¹,

Mehmood²

2017

TPMJ

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ORIGINAL PROF-3935 ABSTRACT… Objective: To assess the frequency of adverse effects caused by implantation of single-rod Etonogestrel implant (Implanon) in females seeking birth spacing after delivery of previous pregnancy. Study Design: Descriptive case series. Setting: Unit V, Department of Obstetrics & Gynecology, and Lady Aitcheson Hospital Lahore. Period: One year from 01/04/2015 to 31/03/2016. Materials & methods: A total of 130 women fulfilling our selection criteria were selected. The ENG implant is a single (coaxial) rod made up of an ethylene vinyl acetate (EVA) copolymer core (40% EVA) containing 68mg ENG, surrounded by a 60mm skin of EVA copolymer (100% EVA). The implant was inserted during days 1 to 5 of spontaneous menses and left in place and adverse effects (abnormal vaginal bleeding or pregnancy) was measured (as per operational definition) for a period of 3 months. All this information was recorded in proforma (attached). Data was entered and analyzed in SPSS version 17.0. Results: The mean age of females was 29.08 ± 4.027 years with minimum and maximum age of 20 and 40 years. Adverse events were seen in 36(27.7%) of the females while other 94(72.3%) did not have any adverse effect of implantation of single-rod Etonogestrel implant (Implanon) in females seeking birth spacing after delivery of previous pregnancy. Abnormal vaginal bleeding was reported by 19(14.6%) and pregnancy was occurred in 17(13.1%) of the females. Conclusion: According to the findings of this study we found less adverse effects like abnormal vaginal bleeding in 19(14.6%) females and pregnancy was occurred in 17(13.1%) of the females. Hence we conclude Implanon is an effective mode of contraception in females seeking birth spacing and can be adopted in females seeking family planning. Keywords:Family planning, inter pregnancy interval, Implanon, side effects, abnormal vaginal bleeding and pregnancy Article Citation: Sajid A, Mehmood T. Etonogestrel Implant (Implanon); Frequency of adverse effects caused by implantation of single-rod etonogestrel implant (implanon) in females seeking birth spacing after delivery of previous pregnancy.

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“…This single-rod implant is inserted subdermally under local anesthetic in the medial aspect of a patient's upper arm using a specialized needle applicator. The implant provides highly effective contraception for up to 3 years [1][2][3][4]. As a condition of etonogestrel implant approval by the Contraception 95 (2017) 205 -210 US FDA, the Sponsor (Organon USA, Inc., now Merck & Co., Inc.) instituted a comprehensive and mandatory clinical training program (CTP) to ensure provider proficiency with insertion and removal procedures.…”

Section: Introductionmentioning

confidence: 99%

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

et al. 2017

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Objective: The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP). Study design: US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localizationor removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA. Results: Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization-or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal. Conclusion: Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant. Implications: This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.

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Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials

Cited by 206 publications

References 13 publications

Ulnar Nerve Ligation after Removal of Norplant: A Case Report

Ulnar Nerve Ligation after Removal of Norplant: A Case Report

Etonogestrel Implant (Implanon); Frequency of Adverse Effects Caused by Implantation of Singlerod Etonogestrel Implant (Implanon) in Females Seeking Birth Spacing After Delivery of Previous Pregnancy

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

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