Implanon NXT® (etonogestrel): Implants have been found rarely in the vasculature and lung. An update on possible risks and complications regarding insertion, localisation, removal and migration

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Date: 14 November 2016

 

Description:

There have been post-marketing reports of etonogestrel implants (non-radiopaque and radiopaque) found in the vasculature (including the pulmonary artery) and the chest wall. The package insert for Implanon NXT® has been updated to highlight possible risks and complications regarding insertion, localisation, removal and migration. Instructions for the correct insertion of the implant have been clarified in order to further minimise the risks. A Direct Healthcare Professional Communication (DHPC) has been approved by NPRA for distribution to relevant healthcare professionals to highlight these updates. Please contact the product registration holder, Merck Sharp & Dohme (Malaysia) Sdn. Bhd. for further information including support in training healthcare professionals on the use of Implanon NXT®.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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