On January 17, 2013, the Food and Drug Administration issued a safety communication to health care providers, surgeons and patients who have received or are contemplating having a metal-on-metal hip implant. The FDA notice concerns two types of metal-on-metal hip implants: total hip replacement systems and hip resurfacing systems.
Who is at risk?
Anyone who has received a metal-on-metal (MoM) hip implant is at risk for medical complications beyond the general risks associated with all types of hip implants. Normal risks include those associated with any type of major surgery and hip surgery patients are advised to notify their doctors if they experience symptoms – three or more months post-surgery – such as:
- Pain in the leg, hip or groin area
- Swelling near or at the location of the hip implant
- Changes in walking ability
- Squeaking, snapping, popping or grinding noises from the replaced hip joint
A person who has or is contemplating having a MoM hip implant is also subject to increased health risks caused by the metal parts of the implant rubbing against each other during the patient’s normal activities. When the metal ball and cup of the implant rub together, the friction causes small fragments of metal to wear off and release into the area surrounding the implant. These metal particles may cause damage to bone and tissue and the resulting damage can lead to such problems as:
- Severe pain
- Loosening of the implant
- Failure of the implant
- Adverse reactions due to metal sensitivities
Metal ions are also released from the metal-on-metal rubbing and may enter the bloodstream causing metal poisoning, also called metallosis. Recipient patients must pay close attention to general health changes due to the presence of these metal ions in their bodies. Systemic symptoms may include:
- Neurological changes including impairment of the senses or numbness and tingling
- Depression, anxiety or cognitive impairment
- Skin rash
- Heart issues such as breathlessness, leg swelling or irregular heartbeat
- Impaired renal function
- Symptoms associated with thyroid dysfunction
- Persistent pain or malaise
What can you do?
The FDA is in charge of overseeing the safety and efficacy of surgical devices used in humans. Its safety communication outlines risks and problems with metal-on-metal hip implants that were uncovered last year by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The administration is proposing to require premarket approval (PMA) applications for manufacturers of these medical devices which would, in effect, bar their use in patients.
However, this does not help those who already have a MoM hip implant. If you do not suffer from any of the above symptoms, maintain regular follow-up appointments as established by your doctor.
If, however, you have concerns about your health due to your hip implant, first contact you doctor and then contact a medical malpractice attorney. A lawyer experienced with hip implant lawsuits can investigate your claim and may be able to help you obtain compensation for your pain and suffering, medical expenses and other losses.
