FDA Cites New Concerns About Metal-on-Metal Hip Implant Systems

DePuy Lawsuit Information

Attorney Fred Pritzker has represented people injured by defective hip replacements. He is heading up our team of lawyers representing people who had a DePuy ASR XL Acetabular System implanted during hip replacement surgery. Our investigation has found evidence that all patients who had the DePuy hip implanted may have a claim for money damages...

On February 10, 2011, the FDA issued an update on the concerns related to metal-on-metal (MoM) hip implant systems, similar to the DePuy ASR hip system that has been recalled. They have devoted an entire section of their website to address the associated risks and supply information to patients and health care professionals.

All artificial hip replacement systems have risks related to the surgical procedure itself and the function and wear of the implant. The metal-on-metal hip replacement systems have unique risks in addition to the general risks of a hip replacement procedure. Any prospective metal-on-metal hip implant patient should be informed of these additional risks:

Elevated metal ion levels in and around the joint.

Elevated metal ion levels in the blood.

Potential development of allergic reaction to the metal, which could include rash, lesions, lumps and tissue necrosis (cell death).

Development of systemic events related to elevated metal ion levels, including symptoms related to heart, nerves, thyroid and kidneys.

The potential for and risks of revision surgery.

The FDA also enumerated reasons for disqualification from receiving the metal-on-metal hip implant system.

Patients with chronic kidney disease or kidney failure

Patients with known metal sensitivity (e.g. cobalt, chromium, nickel)

Patients with suppressed immune systems

Patients currently receiving high doses of corticosteroids

Females of childbearing age

Last year the U.K. recommended blood tests and imaging for patients with painful MoM hip implants. Because some of the devices available in U.K. are not marketed in U.S. and the FDA does not know the frequency of the severe reactions described above, the FDA is not recommending checking metal ion levels in the blood or special imaging if U.S. patients with MoM hip implants have none of the adverse symptoms described above.

The FDA is in the process of gathering additional information about adverse events in people with metal-on-metal hip implants.

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