The safety of Sino-implant (II) for women with medical conditions or other characteristics: a systematic review.

OBJECTIVES

This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics identified by the World Health Organization for eligibility for contraceptive use.

STUDY

DESIGN

We searched PubMed, WEIPU, CNKI and Wanfang to identify all relevant evidence published in peer-reviewed journals from 1991 through 2014 regarding the safety of SI (II). We considered studies among women with medical conditions or other characteristics, such as age and parity, as direct evidence and studies among healthy women or a general population of women as indirect evidence.

RESULTS

We identified 108 articles of which 9 met our inclusion criteria. Among women with medical conditions, no evidence was identified for the outcomes of interest, including serious adverse events or outcomes related to medical conditions. Among healthy women, evidence regarding efficacy of SI (II) for women weighing ≥70 kg was conflicting; one study showed an increased pregnancy rate and another showed no relationship. Women with menorrhagia did not experience worsened symptoms and may benefit from SI (II) use. Healthy women using SI (II) were no more likely than users of other methods to gain weight, develop elevated blood pressure, have abnormal liver or bone density tests or develop ovarian cysts or uterine myomas.

CONCLUSIONS

Evidence among healthy women suggests SI (II) is safe and had health outcomes similar to those of other levonorgestrel implants. Studies were limited and conflicting regarding efficacy for women ≥70 kg. All included studies were conducted in China, limiting generalizability.