However the recent FDA proposal does not address all the concerns with the devices. DePuy identified reasons for the failure of the hip replacement as component loosening, misalignment, infection, bone fracture, dislocation, metal sensitivity, and pain. Problems with the devices go beyond the risks of replacement surgeries. Additional complications may include:
- Residual - possibly deadly - metal fragments going undetected for years;
- Increased metal ion levels in the blood;
- Bone staining;
- Nerve, tissue and/or muscle damage or necrosis;
- Damage to the central nervous system including thyroid and heart;
- Poisoning of major organs causing genetic changes and increasing cancer risks, particularly to the kidneys and bladder.