Hand-held device to remove a single-rod subdermal contraceptive implant: Results of early trials in Sweden

Iwarsson, Karin Emtell; Sakaria, Ami; Bratlie, Marte; Hubacher, David; Gemzell‐Danielsson, Kristina

doi:10.1016/j.contraception.2020.07.005

Cited by 2 publications

(4 citation statements)

References 8 publications

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“…The version of the RemovAid™ product used in Uganda performed better than the previous versions used in pilot studies in Sweden ( Iwarsson et al , 2020 ) (note: the secondary efficacy definition in Uganda is comparable to the definition used in the Swedish study). In that previous trial, the device successfully removed the implant 58.5% of the time.…”

Section: Discussionmentioning

confidence: 85%

“…Our main aim in this study was to measure and compare safety and efficacy of an innovative, easy-to-use removal device versus the standard technique, in a population of Ugandan women seeking removal of a one-rod subdermal implant. The RemovAid™ device used in Uganda was an improved version of the earlier models used in pilot studies in Sweden ( Iwarsson et al , 2020 ).…”

Section: Introductionmentioning

confidence: 99%

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Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial

et al. 2022

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STUDY QUESTION Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users? SUMMARY ANSWER In terms of safety, the device is non-inferior to the standard technique for implant removal. WHAT IS KNOWN ALREADY 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. STUDY DESIGN, SIZE, DURATION 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. PARTICIPANTS/MATERIALS, SETTING, METHODS 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. MAIN RESULTS AND THE ROLE OF CHANCE 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. LIMITATIONS, REASONS FOR CAUTION 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. WIDER IMPLICATIONS OF THE FINDINGS 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. STUDY FUNDING/COMPETING INTEREST(S) 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. TRIAL REGISTRATION NUMBER NCT04120337 TRIAL REGISTRATION DATE 9 October 2019 DATE OF FIRST PATIENT’S ENROLMENT 23 December 2019

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Section: Discussionmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial

et al. 2022

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“…Some case reports have also explored patients' abilities to perform implant self‐removal, both successfully 31 and unsuccessfully 32 . A hand‐held implant device is also currently under development, which could aid in the facilitation of self‐removal 33 . Further research around LARC self‐removal including the possibility of LARC self‐insertion is needed.…”

Section: Reviewing Prior Research About Contraceptive Coercionmentioning

confidence: 99%

“…32 A hand-held implant device is also currently under development, which could aid in the facilitation of self-removal. 33 Further research around LARC self-removal including the possibility of LARC self-insertion is needed.…”

Section: Reviewing Prior Research About Contraceptive Coercionmentioning

confidence: 99%

Who gets to decide? Assessing contraceptive coercion in health care settings

DiCenzo

Gill

Brandi

2023

Health Services Research

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Contraception plays various roles in reproductive health. Not only is it vital for family planning, but it can also reduce transmission of sexually transmitted infections and help treat medical problems ranging from menstrual irregularity to endometrial cancer. 1 Contraception is a crucial aspect of reproductive justice and quality patient-centered care. 2 Contraceptive utilization and access are not only a personal decision but a human right. However, significant barriers to achieving contraceptive equity still exist. One example is the manipulation of someone's contraceptive use, known as contraceptive coercion. To alter someone's ability to use contraception, particularly if it happens within a patient-provider relationship, raises many ethical concerns of beneficence to the patient, justice, and human rights. | WHAT IS CONTRACEPTIVE COERCION?Control over another person's reproductive health and selfdetermination can be practiced in a variety of ways, both interpersonally and institutionally. Reproductive and sexual coercion refers to behavior that attempts to maintain power in a relationship related to reproductive health via tactics such as manipulation, emotional abuse, or physical violence. Reproductive coercion disproportionately affects communities of color. In one study, 37% of Black and 24% of Hispanic/Latinx cisgender women in San Francisco had experienced reproductive coercion compared to 18% of white women. 3 The

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Hand-held device to remove a single-rod subdermal contraceptive implant: Results of early trials in Sweden

Cited by 2 publications

References 8 publications

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial

Removal of a well-palpable one-rod subdermal contraceptive implant using a dedicated hand-held device or standard technique: a randomized, open-label, non-inferiority trial

Who gets to decide? Assessing contraceptive coercion in health care settings

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