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Difficult removal of subdermal contraceptive implants: a multidisciplinary approach involving a peripheral nerve expert.

ABSTRACT: We aim to describe our experiences and identify patients who may benefit from referral to a peripheral nerve surgeon for removal of contraceptive subdermal implants in which neurovascular injury may occur, and describe a treatment pathway for optimal care.We reviewed the charts of 22 patients who were referred to the Division of Family Planning for difficult removal of etonogestrel contraceptive implants between January 1, 2014, and April, 1 2016. Of these, five were referred to a peripheral nerve surgeon due to pain or location of the implant. We evaluated and described these cases and, from our findings, developed recommendations for care in a multidisciplinary team approach.Two patients reported pain, including one with four previous failed removal attempts. In the two patients with pain, the implants were adherent to a sensory nerve. In another, the implant was within the biceps muscle and difficult to locate. In all cases, ultrasound imaging, general anesthesia and a wide exposure allowed for safe removal and good outcomes. Our multidisciplinary care approach has elucidated important referral and technical considerations that improve patient care and safety.When necessary, multidisciplinary care with a Family Planning expert and possibly a peripheral nerve surgeon may be beneficial in safely removing etonogestrel contraceptive implants that would be difficult or risky to remove in an ambulatory setting.

SUBMITTER: Odom EB

PROVIDER: S-EPMC5555624 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Difficult removal of subdermal contraceptive implants: a multidisciplinary approach involving a peripheral nerve expert.

Odom Elizabeth B EB Eisenberg David L DL Fox Ida K IK

Contraception 20170603 2

<h4>Objectives</h4>We aim to describe our experiences and identify patients who may benefit from referral to a peripheral nerve surgeon for removal of contraceptive subdermal implants in which neurovascular injury may occur, and describe a treatment pathway for optimal care.<h4>Study design</h4>We reviewed the charts of 22 patients who were referred to the Division of Family Planning for difficult removal of etonogestrel contraceptive implants between January 1, 2014, and April, 1 2016. Of these ...[more]

PMID: 28583591

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Project description:Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? In terms of safety, the device is non-inferior to the standard technique for implant removal. An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world's first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product. From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique. We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons. We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique. We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology. The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique. Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS. NCT04120337. 9 October 2019. 23 December 2019.

Project description:BACKGROUND:US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. OBJECTIVE:We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. STUDY DESIGN:We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. RESULTS:Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). CONCLUSION:Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention.

Dataset Information

Difficult removal of subdermal contraceptive implants: a multidisciplinary approach involving a peripheral nerve expert.

Publications

Difficult removal of subdermal contraceptive implants: a multidisciplinary approach involving a peripheral nerve expert.

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