A prospective study on the effects of reformulated 2-rod Norplant implant on haemostasis after five years of use.

OBJECTIVE: To evaluate the long-term effects of the new reformulated 2-rod Norplant implant on haemostasis in a prospective group of subjects who have completed 5 years of use. METHODS: Data from 11 women who have completed 5 years' use of the new reformulated 2-rod subdermal implant from the original 16 women who were recruited and randomized to receive this new improved implant in a comparative study were analysed. Clinical assessment and serial blood sampling were done prior to insertion of implant and after 1, 3, 12, 18, 24, 36, 48 and 60 months of implant use. Each subject served as its own control and Analysis of Variance with Student-Newman-Kuels test was used for statistical analysis. The following parameters were determined: plasminogen activators (t-PA, u-PA), plasminogen activator inhibitor-1 (PAI-1), D-dimer, beta-thromboglobulin (beta-TG), thrombin-antithrombin (TAT)-complex, fibrinogen, Factor VII, platelets, haematocrit and haemoglobin levels. RESULTS: No significant change was observed for t-PA levels in prolonged implant use. u-PA antigen showed a significant decrease whilst D-dimer were significantly elevated at only 24 months of implant use compared to pre-implant level. PAI-1 levels were not significantly changed but fibrinogen and FVII levels increased at 36 months and 42 months of use with enhanced platelet activation shown by beta-TG levels at 24 months. Platelet numbers were not affected by prolonged implant use. Haemoglobin concentration and haematocrit level showed significant fluctuations and then return to pre-implant level by 54 and 60 months. CONCLUSION: Enhanced fibrinolysis with platelet activation at 24 months of implant use were seen during the 60 months of 2-rod reformulated Norplant implant use. Hypercoagulable state was not observed although fibrinogen and FVII levels remain above the pre-implant levels as coagulation activation was not enhanced. The increased haemoglobin and haematocrit levels seen indicate enhanced bone marrow activity. There was no association between the use of reformulated 2-rod Norplant implant over 60 months of use and prothrombotic state.