Copper T 380A IUD and magnetic resonance imaging

Area of Science:

• Medical Device Safety
• Magnetic Resonance Imaging
• Reproductive Health

Background:

• Women with implanted medical devices require safety data for MRI procedures.
• Previous testing of the Copper T 380A IUD was limited to 1.5 T MR systems.
• Higher field strength MRI necessitates updated safety evaluations for IUDs.

Purpose of the Study:

• To evaluate the safety of the Copper T 380A IUD at 3.0 T MR imaging.
• To determine potential risks associated with 3.0 T MR exposure for this IUD.
• To assess compatibility with current medical device safety standards.

Main Methods:

• In vitro safety testing of the Copper T 380A IUD.
• Utilized a GE Signa LX 3.0-T MR system for testing.
• Evaluated variables including deflection, torque, heating, and artifact generation.

Main Results:

• No significant deflection or torque was observed.
• No detrimental heating effects were detected.
• No significant artifact generation was found in the testing model.

Conclusions:

• The Copper T 380A IUD demonstrated no safety concerns at 3.0 T under tested conditions.
• Results align with new ASTM and FDA standards for MR Conditional devices.
• The IUD is considered safe for 3.0 T MR imaging based on these findings.