- Medicines and Healthcare products Regulatory Agency
- 15 June 2016
- Therapeutic area:
- Obstetrics, gynaecology and fertility
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the earliest opportunity. If an implant cannot be located within the arm, perform chest imaging. Correct subdermal insertion reduces the risk of these events.
Updated advice for healthcare professionals:
- An implant should only be inserted subdermally and by a healthcare professional who has been appropriately trained and accredited
- Do not insert over the sulcus (groove) between the biceps and triceps.
- Take care to avoid insertion close to any blood vessels or nerve bundles eg the ulnar nerve
- Immediately after insertion, verify the presence of the implant by palpation
- Show the woman how to locate the implant and advise her to do this frequently for the first few months; if she has any concerns she should return to the clinic for advice
- Locate an implant that cannot be palpated (eg, using imaging of the arm) and remove it at the earliest opportunity
- If an implant cannot be located in the arm by palpation or imaging, perform chest imaging
- Surgical or endovascular procedures may be required to remove an implant from the chest
- Review the updated instructions on how to correctly insert the implant, including an amended diagram that illustrates:
- the correct angle on the arm for insertion
- how to view the needle to avoid deep insertion
Nexplanon is a highly effective, long-acting contraceptive implant which contains the active ingredient etonogestrel, a synthetic progestogen. Nexplanon acts by preventing ovulation and is usually effective for 3 years. Safety and efficacy have been established in women between 18 and 40 years old. For maximum effectiveness Nexplanon needs to be correctly implanted by someone who is trained to fit it.
Reports and potential risk factors
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. The number of reports of Nexplanon implants in the vasculature received by the licence-holder is estimated to be approximately 1.3 per million implants sold worldwide.
No definitive set of adverse reactions have been associated with these events. However some cases have reported:
- haematoma at the insertion site
- excessive bruising at the insertion site
- a combination of the above
No specific risk factors have been identified. Potential risk factors include:
- deep insertion
- insertion in an inappropriate site
- insertion in thin arms
Evidence from the literature shows that implants found in the vasculature can become endothelised into the pulmonary artery1 2 3. If they are located early enough it is possible to remove them by an endovascular procedure4 5. Women should therefore be shown how to locate the implant immediately following insertion and advised to check the position of the implant frequently for the first few months.
Expert removers’ network
A network of healthcare professionals who are experienced in implant localisations and difficult removals is available for consultation. To request additional information on implant insertion and removal, contact the network by calling 01992 467272.
Reporting of suspected adverse reactions
Report any suspected side effects to Nexplanon, or any other medicine or medical device, to us on a Yellow Card, including difficulties with insertion or removal of Nexplanon.
Letter sent to healthcare professionals in May 2016
Article citation: Drug Safety Update vol 9 issue 11, June 2016: 2.
D’Journo XB, et al. Intravascular pulmonary migration of a subdermal contraceptive implant. Ann Thorac Surg 2015; 99: 1828. ↩
Patel A, et al. Contraceptive implant embolism into the pulmonary artery. Ann Thorac Surg 2014; 97: 1452. ↩
O’Brien A, et al. Subdermal contraceptive implant embolism to a pulmonary artery. Ann Thorac Surg 2015; 2254–55. ↩
Heudes P-M, et al. Migration of a contraceptive subcutaneous device into the pulmonary artery. Report of a case. Case Reports in Women’s Health 2015; 8: 6–8. ↩
Published: 15 June 2016
Therapeutic area: Obstetrics, gynaecology and fertility