arznei-telegramm 2005; 36: 67


Unwanted pregnancies with the etonogestrel implant IMPLANON: The etonogestrel-containing flexible rod IMPLANON is implanted subcutaneously in the upper arm and is supposed to provide effective contraception for three years (a-t 2000; 31: 61). Since the beginning of this year, the Summary of Product Characteristics (SPC) "strongly recommends that physicians, prior to administering the insertion of IMPLANON, participate in training sessions organised by Organon" (Organon: IMPLANON SPC, as at Jan. 2005). The insertion details are also specified. For example, the presence of the implant as a white tip inside the metal part of the cannula has to be verified visually. The reason for these specific recommendations appear to be the numerous unwanted pregnancies that have occurred despite use of this contraceptive. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is assessing 101 reports of unexpected pregnancies and abortions associated with IMPLANON (BfArM: letter of 5 July 2005). In the Netherlands, 15 women have been granted financial compensation for pregnancies by court order. However, it remains to be clarified whether Organon and/or the doctors concerned will be liable for these sums, which are likely to be considerable. Neither the implant nor any trace of the active substance etonogestrel was found in any of the women's organs. The possibility that the rod might be expelled, unnoticed, from the implantation site through movement of the arm before wound healing was completed or whether the doctors made mistakes when inserting the implants is currently investigated (BMJ 2005; 330: 1467). Questions about the effectiveness of the contraceptive system have already been raised a year ago. When the IMPLANON study sites in Indonesia were inspected, falsifications of data relating to the clinical trial over a decade before emerged. If these pivotal data for the approval of the drug are excluded from the analysis, the effectiveness of the contraceptive in the third year of use is no longer sufficiently proven (BfArM: press statement on 21 Apr. 2004). Nevertheless, the European authorities continue to rate IMPLANON as "safe and effective" for the whole three-year period, provided that it is inserted in the appropriate manner according to the SPC (BfArM: press statement on 20 Oct. 2004). However, the reliability of IMPLANON as a contraceptive appears not to be guaranteed, considering the present state of knowledge we advise against its use, -Ed.

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