A decade of experience with TCu200.

Area of Science:

• Reproductive Health
• Medical Device Technology
• Clinical Gynecology

Background:

• Intrauterine devices (IUDs) are a common form of reversible contraception.
• Long-term data on the performance of specific IUD models is crucial for clinical decision-making.
• The TCu200 IUD has been in use, necessitating comprehensive evaluation of its extended efficacy and safety.

Purpose of the Study:

• To evaluate the ten-year performance of the TCu200 intrauterine device (IUD).
• To assess cumulative and yearly termination and continuation rates for the TCu200 IUD.
• To determine the long-term safety and efficacy profile of the TCu200 IUD.

Main Methods:

• Life-table analysis was used to calculate termination and continuation rates.
• Data from 2766 TCu200 IUD insertions over a ten-year period were analyzed.
• Patient follow-up included monitoring for pregnancy, expulsion, bleeding, pain, and removal for medical reasons.

Main Results:

• Cumulative ten-year rates: pregnancy (10.2%), expulsion (6.3%), bleeding/pain (32.3%), and medical removal (19.4%).
• First-year annual rates: pregnancy (1.8%), expulsion (2.4%), bleeding/pain (4.2%), medical removal (2.0%).
• Tenth-year annual rates: pregnancy (0.6%), expulsion (0.1%), bleeding/pain (4.4%), medical removal (2.8%).
• Continuation rates: 89.1% at 12 months and 33.2% at 10 years.

Conclusions:

• The TCu200 IUD exhibits good overall performance and a longer lifespan than initially anticipated.
• The device demonstrates sustained effectiveness and acceptable safety over a decade of use.
• These findings support the TCu200 IUD as a viable long-term contraceptive option.