The incidence rate of ectopic pregnancies is approximately one per 1000 users per year.[45] Immediate removal the IUD is recommended in the case of pregnancy.[39][40] No pattern of birth defects was found in the 35 babies for whom birth outcomes were available at the time of FDA approval.[46] Infection: The insertion of the IUD does have a small risk of pelvic inflammatory disease (PID). Concurrent infection with gonorrhea or chlamydia at the time of insertion increases the risk of pelvic inflammatory disease.[47] If PID does occur, it will most likely happen within 21 days of insertion. The device itself does not increase the risk of infection.[39] Ovarian cysts: Enlarged follicles (ovarian cysts) have been diagnosed in about 12% of the subjects using a hormonal IUD.