Reports of unintended pregnancy related to etonogestrel implant (Implanon®)

Implanon® (SOL limited) is a sub-dermal contraceptive implant which contains 68mg of etonogestrel and has been licensed in Singapore since May 2002.

Background

Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that there have been reports of problems with inserting and removing Implanon® and that in some women who have had an unintended pregnancy, Implanon® was found not to have been inserted at all.

Based on statistics provided by the company, the distribution of Implanon® in Singapore is estimated to be 6,597 implants between May 2002 to September 2010. During this period, the company has received four medically confirmed spontaneously reported unintended pregnancies (0.06 unintended pregnancies per 100 implants distributed).

The correct technique of Implanon® insertion

Implanon® should be inserted subdermally using a sterile disposable applicator at the inner side of the non-dominant upper arm about 8-10cm above the medial epicondyle of the humerus. There is a possibility of the implant falling out of the needle prior to insertion. The applicator should therefore always be held in the upward position until the time of insertion. To ensure proper insertion, the doctor must first visually verify the presence of the implant in the applicator while keeping the shield on the needle and then confirm the successful insertion by palpation of the implant. The presence of the implant should be verified by palpation and women should be shown how to feel its location at the time of fitting.

In cases where the implant cannot be palpated or when the presence of the implant is doubtful, it is recommended that other suitable methods such as ultrasound or magnetic resonance imaging be used to confirm its presence. If imaging methods also fail, it is advisable to verify the presence of the implant by measuring the etonogestrel level in a blood sample of the women.

Advisory and call for reports of unintended pregnancies

The proper insertion of Implanon® is crucial for its efficacy. An implant that is not inserted on the correct day or not inserted properly can result in an unintended pregnancy. Pregnancy should also be excluded before the insertion of Implanon®.

Implanon® should be inserted by someone who is familiar or trained with the proper technique of insertion. Healthcare professionals are advised to follow the instructions on the package insert on the proper insertion of Implanon® and to attend training sessions organised by the manufacturer (MSD) on the proper technique of Implanon® insertion.

Published: 4 Apr 2011

Safety Alerts