The intrauterine contraceptive device, "Multiload Cu 250": a regulatory problem

Area of Science:

• Reproductive Medicine
• Medical Device Safety
• Pharmacovigilance

Background:

• Reports of fractures and thread ruptures with the Multiload Cu 250 intrauterine contraceptive device prompted safety reviews.
• Fractures were reported in 15 countries, with low reporting rates to authorities.

Purpose of the Study:

• To review the safety of the Multiload Cu 250 intrauterine contraceptive device.
• To analyze the incidence of device fractures and thread ruptures.
• To evaluate the impact of device modifications on safety.

Main Methods:

• Analysis of 1516 returned Multiload Cu 250 devices.
• Examination of fracture and thread rupture incidence.
• Stress testing of explanted devices.

Main Results:

• Overall incidence of device fracture was 1:405; broken threads occurred at 1:8.
• Modifications in 1983/1984 significantly reduced fracture and thread rupture rates.
• Fracture risk may increase with longer duration of intrauterine placement.

Conclusions:

• Device modifications improved safety, reducing fractures and thread ruptures.
• Regulatory actions included updated physician and patient information and device withdrawal.
• Long-term in utero presence may increase fracture risk.