Background
                Subdermal etonogestrel implants are highly effective contraceptive methods. Despite standardization of insertion technique by the manufacturer, some implants are inadvertently placed too deeply within or below the plane of the biceps brachii fascia. Placement of these implants in a deep tissue plane results in more difficult removal, which is not always possible in the office setting. In rare cases, surgical removal by an upper extremity surgeon is warranted.
              
              
                Case presentation
                Here we present 6 cases of etonogestrel implants located in a subfascial plane requiring removal by an upper extremity surgeon. Implants were all localized with plain radiography and ultrasound prior to surgical removal. All cases had implants located in the subfascial plane and one was identified intramuscularly. The average age was 28 years (19–33) and BMI was 24.0 kg/m^2 (19.1–36.5), with the most common reason for removal being irregular bleeding. The majority of cases (5/6) were performed under monitored anesthesia care with local anesthetic and one case utilized regional anesthesia. All implants were surgically removed without complication.
              
              
                Conclusions
                Insertion of etonogestrel contraceptive implants deep to the biceps brachii fascia is a rare, but dangerous complication. Removal of these implants is not always successful in the office setting and referral to an upper extremity surgeon is necessary to avoid damage to delicate neurovascular structures for safe removal

Castaño, Paula M.

Hellwinkel, Justin E.

Kadiyala, R. K.

Konigsberg, Matthew W.

Oviedo, Johana

Columbia University Academic Commons

CASE REPORT Open AccessSubfascial‐located contraceptive devicesrequiring surgical removalJustin E. Hellwinkel1*, Matthew W. Konigsberg1, Johana Oviedo2, Paula M. Castaño3 and R. Kumar Kadiyala1AbstractBackground: Subdermal etonogestrel implants are highly effective contraceptive methods. Despite standardizationof insertion technique by the manufacturer, some implants are inadvertently placed too deeply within or below theplane of the biceps brachii fascia. Placement of these implants in a deep tissue plane results in more difficultremoval, which is not always possible in the office setting. In rare cases, surgical removal by an upper extremitysurgeon is warranted.Case presentation: Here we present 6 cases of etonogestrel implants located in a subfascial plane requiringremoval by an upper extremity surgeon. Implants were all localized with plain radiography and ultrasound prior tosurgical removal. All cases had implants located in the subfascial plane and one was identified intramuscularly. Theaverage age was 28 years (19–33) and BMI was 24.0 kg/m^2 (19.1–36.5), with the most common reason forremoval being irregular bleeding. The majority of cases (5/6) were performed under monitored anesthesia care withlocal anesthetic and one case utilized regional anesthesia. All implants were surgically removed withoutcomplication.Conclusions: Insertion of etonogestrel contraceptive implants deep to the biceps brachii fascia is a rare, butdangerous complication. Removal of these implants is not always successful in the office setting and referral to anupper extremity surgeon is necessary to avoid damage to delicate neurovascular structures for safe removal.Keywords: Contraceptive implant removal, Etonogestrel complication, Subdermal etonogestrel, Subfascial implantremovalBackgroundSubdermal etonogestrel implants are highly effectivecontraceptive methods [1]. The manufacturer recom-mends subdermal placement of the implant overlyingthe triceps muscle in the medial upper arm using a pre-loaded insertion implant [2]. All healthcare practitionersproviding insertions are trained in proper placementtechniques, including immediate palpation to confirmsubdermal location, and in-office removal techniques.Deep placement can make removal particularlychallenging.Our institution is a referral center for complex implantremovals. After review of plain radiographs (XR) to con-firm upper-arm location of non-palpable implants,evaluation and in-office high-frequency ultrasonography(US), we refer patients with deeply-located implants notamenable to in-office removal to a single upper extrem-ity orthopaedic surgeon for operative removal.Case SeriesAfter IRB approval, we identified 6 cases of etonogestrelimplants referred for surgical removal from 2018 to2020 (Table 1). All patients had Nexplanon® implantsplaced within the preceding three years. The average agewas 28 years (19–33) and BMI was 24.0 kg/m^2 (19.1–36.5). The most common reason for removal was© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you giveappropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate ifchanges were made. The images or other third party material in this article are included in the article's Creative Commonslicence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commonslicence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtainpermission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to thedata made available in this article, unless otherwise stated in a credit line to the data.* Correspondence: jh4034@cumc.columbia.edu1Department of Orthopedics, Columbia University Irving Medical Center, 622W 168th St PH 11 – Center, NY 10032 New York, USAFull list of author information is available at the end of the article       Contraception andReproductive MedicineHellwinkel et al. Contraception and Reproductive Medicine            (2021) 6:13 https://doi.org/10.1186/s40834-021-00158-5irregular bleeding. We localized implants with XR(Fig. 1 a) and in-office high-frequency US to confirmdeep location prior to referral to orthopaedic surgeon.Each implant was identified through physical examin-ation by a qualified provider through palpation, XR andUS guidance to determine the location within the softtissue. For removal, a small incision and dissectionclamp were utilized in attempt to retrieve the implants.Reasons for failure of in-office removal included closeproximity to neurovascular structures, excessive painwith palpation concerning for neurologic irritation, andfailure to adequately visualize the implants. Surgeons ob-tained informed consent after discussing the risks ofmedial upper arm exploration. Surgeons positioned pa-tients supine with an arm table to allow adequatevisualization of the upper extremity. Surgeons utilizedconscious sedation and local anesthesia for all cases ex-cept one, where the patient preferred regionalanesthesia. Intraoperative fluoroscopic guidance aidedlocalization of the implant by its relative radiodensitywithin the soft tissue. Surgeons made a 2 to 7 centimeterincision longitudinally over the implant placement scar(Fig. 1b). Careful dissection was carried down throughplanes to expose the distal end of the implant. Implantswere all located deep to the biceps brachii fascia orwithin the muscle belly itself (Fig. 1 c, d). The fascia andoverlying soft tissue were then closed using suture. Nointraoperative or postoperative complications occurred.The average procedure time from skin incision to clos-ure was 14.3 min (Table 1).Discussion/conclusionThis series presents 6 cases of etonogestrel implants lo-cated in a subfascial location requiring complex surgicalremoval by an upper extremity orthopaedic surgeon.Other series have identified subfascial location of contra-ceptive implants; very few described surgical extraction[3–5]. In our series, none of the implants were able tobe retrieved in the office, despite subfascial exploration.Although not noted in this series, removal from subfas-cial planes has the potential for significant morbidityfrom larger incisions, anesthetic risk, and damage tonearby neurovascular structures [6, 7]. Rare cases de-scribe migration of implants to the axilla and pulmonaryvasculature, requiring more invasive surgical interven-tions [8–12].The rarity of this condition precludes identification ofspecific risk factors for deep location. We noted notrends in prior implant use or removal attempts but 5 of6 patients had normal BMI. Researchers theorize thatlow BMI may confer risk due to smaller distance be-tween tissue planes in the upper arm [3]. Whether sub-fascial location alters contraceptive efficacy, side effects(e.g., bleeding profile) or duration of use warrants futurestudy.Incorrect placement of etonogestrel implants occurs in12.6 per 1000 cases [13]. Alternate insertion sites in theskin overlying the scapula have been described [14]. TheFood and Drug Administration requires a training ses-sion before providers can order implants; this trainingallows for as many placement and removal attempts asdesired on a simulation arm. It is impossible to quantifywhether providers do not complete training or are infor-mally trained and how closely training mimics place-ment in a real arm. Adherence to recommendations toelevate the skin and perform placement at eye level mayhelp avoid deep placement. All certified implant pro-viders underwent mandatory retraining by June 1, 2019,to ensure placement in the ideal site 8–10 cm proximalto medial epicondyle and 3–5 cm posterior to the sulcusto avoid possible neurovascular injury [15]. All of theTable 1 Characteristics of 6 patients undergoing removal of subfascial etonogestrel contraceptive implant by orthopaedic surgeons,including the length of time each patient had their implants, any attempts at in-office removal and surgical duration. One patientwith prior implant transitioned to an alternative form of contraception before receiving her second implant and the other patienthad her implant removed at the time of replacement of the most recent one. (BMI: Body mass index reported in kilogram/meters^2;MAC: Monitored Anesthesia Care)AGE BMI Subfascial/IntramuscularDuration(years)First implant or prior? RemovalAttemptsAnesthesia Procedure Duration(minutes)31 19.1 Subfascial 2.96 First Once MAC/local 1526 22.0 Subfascial 2.68 First None MAC/local 1228 24.6 Subfascial 0.76 One prior (ipsilateral), removed inofficeNone MAC/local 1831 20.5 Subfascial 2.88 First Once MAC/local 1133 36.5 Subfascial 1.02 First None Regional 1019 21.5 Intramuscular 0.92 One prior (ipsilateral), removed inofficeNone MAC/local 2028 24.0 14.3 averageHellwinkel et al. Contraception and Reproductive Medicine            (2021) 6:13 Page 2 of 4implants reported in this series were placed prior to thischange in placement recommendation; future seriesshould explore whether these new guidelines have mini-mized complications in placement.Even with perfect technique, it is possible to insert theimplant too deeply and the clinician or patient may notknow until implant removal [9]. Informed consent attime of placement should include discussion of theserare complications. Initial attempt to remove the implantin the office setting is most optimized with plain radiog-raphy and ultrasound guidance, along with manual pal-pation to identify the location of the implant. Localanesthesia with lidocaine with epinephrine is typicallyadequate for this procedure, but providers may select alonger acting form of anesthesia if needed. If the implantis found to be within close proximity to neurovascularstructures or deep within the soft tissue, there is consid-erable risk for injury to delicate structures due to poorvisualization. These include superficial and deep sensorynerves, motor branches to muscles of the forearm anddelicate vascular structures that can be difficult tovisualize and control in a minimally invasive setting.Complex in-office removal and concern for neurovascu-lar injury or inability to adequately localize the implantbenefit from co-management with an upper extremitysurgeon to safely remove intra-/subfascial implants.AbbreviationsXR: X-ray; US: Ultrasound; BMI: Body Mass IndexAcknowledgementsNot applicable.Authors’ contributionsJEH contributed to data gathering, figure generation and manuscriptpreparation; MWK contributed to data analysis and manuscript preparation;JO contributed to manuscript preparation and editing; PMC contributed incare for each patient in the office prior to referral to the surgeon; RKK wasthe primary surgeon responsible for safe removal of the contraceptiveFig. 1 Radiographic identification of implanted contraceptive implant prior to incision in operating room (a). Incision and blunt dissection carrieddown to the fascial layer of the biceps brachii, which must be incised to retrieve the implant (b). Etonogestrel implant located deep to the bicepsbrachii fascia (c). Etonogestrel implant located within the muscle belly of the biceps brachii, surrounded by muscle fibers (d)Hellwinkel et al. Contraception and Reproductive Medicine            (2021) 6:13 Page 3 of 4implants in the operating room. All authors have read and approved thefinal version of the manuscript.FundingNo funding was required in generation of this manuscript.Availability of data and materialsThe data used to support the findings reported in this study are available bythe corresponding author upon reasonable request.DeclarationsAuthors’ InformationPMC is a board-certified associate professor of obstetrics and gynecology atColumbia University Medical Center. She serves as the director of the facultypractice and specializes in contraceptive use in medically complex patients.RKK is a dual fellowship-trained MD/PhD assistant professor of orthopedicsurgery at Columbia University Medical Center. He specializes in upper ex-tremity surgery and trauma.Ethics approval and Consent to participateInstitutional Review Board (IRB) approval was granted for this study byColumbia University IRB Protocol AAAS9878.Consent for publicationThis study qualifies for a waiver of consent, as outlined in approved IRBprotocol AAAS9878.Competing interestsThe authors declare that they have no competing interests.Author details1Department of Orthopedics, Columbia University Irving Medical Center, 622W 168th St PH 11 – Center, NY 10032 New York, USA. 2Department ofObstetrics and Gynecology, New York University Langone Health, 550 FirstAvenue, NY 10016 New York, USA. 3Department of Obstetrics andGynecology, Columbia University Irving Medical Center, 622 W 168th St, NY10032 New York, USA.Received: 10 September 2020 Accepted: 10 March 2021References1. Trussell J. Contraceptive failure in the United States. Contraception. 2011;83(5):397–404.2. Merck & Co. I. Whitehouse Station NJ. Nexplanon. (etonogestrel implant)prescribing information https://www.merckcom/product/usa/pi_circulars/n/nexplanon/nexplanon_pipdf .[Accessed 17 June 2020].3. Matulich MC, Chen MJ, Schimmoeller NR, Hsia JK, Uhm S, Wilson MD, et al.Referral Center Experience With Nonpalpable Contraceptive ImplantRemovals. Obstet Gynecol. 2019;134(4):801–6.4. Petro G, Spence T, Patel M, Gertz AM, Morroni C. Difficult etonogestrelimplant removals in South Africa: A review of 74 referred cases.Contraception. 2020.5. Xu L, Korotkaya Y, Rible R. Deeply Inserted Contraceptive Implants: WhereAre They Placed? Experience From a University Hospital Center. Obstetrics &Gynecology. 2020;135(p95S).6. Lefebvre R, Hom M, Leland H, Stevanovic M. Peripheral nerve injury withNexplanon removal: case report and review of the literature. ContraceptReprod Med. 2018;3:15.7. Jacques T, Henry S, Giraudet G, Demondion X, Cotten A. Minimally-invasivefully ultrasound-guided removal of nonpalpable single-rod contraceptiveimplant: Case report and technical description. Contraception. 2020;101(5):338–41.8. Diego D, Tappy E, Carugno J. Axillary migration of Nexplanon(R): Casereport. Contraception. 2017;95(2):218–20.9. Kang S, Niak A, Gada N, Brinker A, Jones SC. Etonogestrel implant migrationto the vasculature, chest wall, and distant body sites: cases from apharmacovigilance database. Contraception. 2017;96(6):439–45.10. Akhtar MM, Bhan A, Lim ZY, Akhtar MA, Sekhri N, Bharadwaj P, et al.Percutaneous extraction of an embolized progesterone contraceptiveimplant from the pulmonary artery. Open Access J Contracept. 2018;9:57–61.11. Gallon A, Fontarensky M, Chauffour C, Boyer L, Chabrot P. Looking for a lostsubdermal contraceptive implant? Think about the pulmonary artery.Contraception. 2017;95(2):215–7.12. Simon C, Maurier A, Gaboriau L, Vrignaud L, Dayani P, Vaillant T, et al.Incidence and characteristics of intravascular pulmonary migration ofetonogestrel implants: A French nationwide study. Contraception. 2020.13. Reed S, Do Minh T, Lange JA, Koro C, Fox M, Heinemann K. Real world dataon Nexplanon(R) procedure-related events: final results from the NexplanonObservational Risk Assessment study (NORA). Contraception. 2019;100(1):31–6.14. Pragout D, Darrouzain F, Marret H. Alternative insertion site in the scapularregion for etonogestrel contraceptive implant (Nexplanon((R))). Eur J ObstetGynecol Reprod Biol. 2018;224:207–8.15. Iwanaga J, Fox MC, Rekers H, Schwartz L, Tubbs RS. Neurovascular anatomyof the adult female medial arm in relationship to potential sites for insertionof the etonogestrel contraceptive implant. Contraception. 2019;100(1):26–30.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Hellwinkel et al. Contraception and Reproductive Medicine            (2021) 6:13 Page 4 of 4

Subfascial‐located contraceptive devices requiring surgical removal

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Subfascial‐located contraceptive devices requiring surgical removal

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