FDA Creates New Metal-on-Metal Warning Page After Recalls
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
The U.S. Food & Drug Administration (FDA) has set up a website for metal-on-metal hip implants, which among other things, details the potential risks posed by these devices. The new website comes months after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a worldwide recall of two ASR hip Implants, which were metal-on-metal hip components.
According to the FDA metal-on-metal hip implant site, because the metal ball and the metal cup on these device slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant and may even get into the bloodstream.
Additionally, it is believed that many of the complications linked to the DePuy ASR XL Acetabular hip implant are leading to tissue breakdown, bone loss, and even the formation of non-cancerous tumors. The shedding of metal shavings can cause cobalt poisoning, metallosis, and other disorders that, if left untreated, can put patients at risk of tinnitus (ringing in the ears), vertigo, deafness, blindness, optic nerve atrophy, convulsions, headaches, peripheral neuropathy, cardiomyopathy, and hypothyroidism.
FDA Warning About Implants
The FDA advises that recipients of metal-on-metal hip implants be aware of potential symptoms which may occur after surgery and indicate that their device is not functioning properly. Common symptoms may include:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
Metal-on-metal hip implant patients should also pay close attention to changes in their general health or new symptoms outside their hip including symptoms related to their:
- Heart (chest pain, shortness of breath)
- Nerves (numbness, weakness, change in vision or hearing)
- Thyroid (fatigue, feeling cold, weight gain)
- Kidney (change in urination habits)
If you have a metal-on-metal hip implant and have experienced any of these symptoms contact your doctor immediately to see if your hip implant could be failing. If you are already a client of Rheingold, Giuffra, Ruffo & Plotkin LLP, click here and enter your user name and password to view our client protected page.