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Patients recovering from surgery expect to get better, and with the claims made by manufacturers of cold therapy machines and the doctors who recommended them, they assumed this would be the case. However, the quicker recovery and faster healing became, instead, nerve and tissue damage, frostbite, hypoxia, skin necrosis, or another significantly-damaging condition requiring reconstructive surgery.
Warnings and recalls go back several years. In April 2004, the American Journal of Pain Management described the potential effects of these devices with “Cryotherapy Can Cause Permanent Nerve Damage.” In November 2005, the FDA issued a warning regarding the EB Ice 10b cold therapy system and, in 2008, followed with a Patient Safety Advisory and Class A Recall for BREG Polar Care 500, 500 Lite, and 300 devices.
Nevertheless, many such devices remain on the market and continue to be recommended for therapy: DonJoy Iceman, Game Ready, Aircare Cryo/Cuff Cold Therapy Unit, De Royal Cold Therapy Unit, Bledsoe Cold Central and bMini, and Ice Cooler Machine, among others.
Doctors recommend cold therapy after a patient undergoes foot, knee, shoulder, lower back, or joint surgery. The device combines a cooler, which gets filled with ice and water, with a motor pump and hose, which attaches to a compression pad the patient wraps around the area. The swollen or injured area then can receive up to eight hours of consistently-applied near-freezing temperature.
Several functional issues cause a cold therapy device to potentially result in nerve damage, even with medical recommendations. Certain systems do not have sufficient temperature selection, time controls, an emergency shutoff switch, or warning alarm. Thorough warning about potential dangers and instructions about correct usage do not accompany products.
Along with these factors, a patient desensitized from surgery may find determining if the device has been on too long or is too cold to be difficult. Similarly, malfunctioning thermometers or temperature regulation devices may not provide the user with accurate information.
Several conditions may result from prolonged usage of cold therapy:
- Nerve damage
- Tissue damage
- Immersion syndrome
- Skin necrosis
- Skin damage
- Complex Regional Pain Syndrome 1 and 2
- Reflex Sympathetic Dystrophy Syndrome
- Shoulder-Hand Syndrome
Resulting conditions appear similar to trench foot, burns, and frostbite and may require skin grafts, surgery, or amputation. In certain cases, such as with nerve damage, it may take months or years for the patient to notice the damage. When physical signs aren’t visible, an electroencephalogram (EEG) test can determine if the cold therapy device caused damage.
Filing a Claim
While most cold therapy machines have not been recalled, ramifications resulting from defects and ill-informed usage have potential to result. Claimants who have taken their cases to court have been awarded compensation for pain and suffering, medical expenses, future medical care, loss of income or employment, decreased quality of life, disfigurement and scarring, permanent injuries, and punitive damages against the manufacturer.