One-year clinical experience with FlexiGard

Area of Science:

• Gynecology
• Reproductive Health
• Medical Devices

Background:

• Intrauterine devices (IUDs) are a common form of reversible contraception.
• Copper-containing IUDs (ICC) offer long-term, highly effective birth control.
• Innovations in IUD design aim to improve user tolerance and retention.

Purpose of the Study:

• To evaluate the performance of the novel frameless copper-containing IUD, FlexiGard.
• To assess the device's retention, expulsion, and complication rates over a 12-month period.
• To determine the contraceptive efficacy and continuation rates of the FlexiGard IUD.

Main Methods:

• A prospective clinical study involving 344 parous women.
• Insertion of the FlexiGard IUD within the first seven days of the menstrual cycle.
• 12-month follow-up to record usage, expulsions, removals, and pregnancies.

Main Results:

• A net continuation rate of 89.7% was observed after 12 months.
• Cumulative expulsion rate was 1.5%, and cumulative removal rate for bleeding/pain was 4.4%.
• A low cumulative pregnancy rate of 0.6% was recorded at 12 months.

Conclusions:

• The FlexiGard IUD is well-tolerated and highly effective, with results consistent with previous multicenter studies.
• Its frameless design and anchoring system contribute to good uterine retention.
• The device offers an easy and safe insertion and removal process, making it a viable contraceptive option.