A 5-year clinical evaluation of Norplant® implants in Senegal

The principal objective of this 5-year clinical study of Norplant(R) implants was to introduce these implants into the family planning program in Senegal and to determine their overall acceptability and safety in Senegalese accepters. A total of 300 subjects were enrolled into the trial from August 1986 to July 1991. All the women were followed-up for 5 years or until the implants were removed. The pooled cumulative discontinuation rate was 40.8 +/- 2.91 per 100 women resulting in a continuation rate of 59.2 +/- 2.91 per 100 women. Thirteen subjects (4.3%) were lost during the follow-up. Seven pregnancies were reported throughout the 5 years leading to a cumulative pregnancy rate of 3.3 +/- 1.25 per 100 women. Menstrual problems were the reason most often given for early removal during the first 2 years. After year 2, desire for another pregnancy was the main reason for implant removal. The results presented in this study show that the Norplant implant system is a safe, effective, and acceptable method that meets the needs of the Senegalese family planning program. (C) 1999 Elsevier Science. Inc. All rights reserved.