FDA Gets Involved as some hip replacements prove

Residents of Tennessee and others across the U.S .needing a hip replacement procedure in the coming months may want to consider alternatives to metal-on-metal devices. Recent scrutiny of this potentially unsafe product means that people may want to opt for metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic or ceramic-on-metal devices. In recent months, many patients have experienced negative reactions from metal-on-metal hip implants.

The Food and Drug Administration recently reviewed more than 100 studies of the metal-on-metal versions, determining they may cause problems for women and patients who received larger-sized hip implants. In an effort to protect patients from the effects of a defective product, the FDA issued a proposed order requiring either the filing of a premarket approval application or a notice of completion of a product development protocol. Because no PMA was previously mandated, no submission of safety and effectiveness data was required, potentially increasing product liability.

Additionally, the FDA recently posted on its website explaining that metal-on-metal hip replacements have risks beyond the risks associated with other types of implants on the market. Most concerning is that tiny particles of metal wear off the device around the implant, potentially damaging bone and/or soft tissue surrounding the implant and joint. This type of damage to the soft tissue may result in pain, implant loosening, device failure and the need for revision surgery. Furthermore, some metal ions released will enter the bloodstream and travel to other parts of the body, increasing the number of systems affected by the hip implant.

Patient reactions to the metal ions differ, and the FDA says it presently lacks sufficient scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to cause problems. Signs of possible adverse metal ion reactions in patients can include general hypersensitivity reaction (skin rash), cardiomyopathy, auditory or visual impairments, psychological status change (such as depression), renal function impairment or thyroid dysfunction.