On May 6, the U.S. Food and Drug Administration (FDA) mailed 145 post market surveillance orders with the intentions of reaching 21 different hip replacement manufactures. Among the recipients were world renowned corporations including Zimmer and Stryker orthopedic companies. The intentions of the letter were resilient in their request that each of the companies conduct post market studies to gather data on the levels of metal in the blood of people who have received their hip implants and what health effects those implants might have.
Recent indications in the healthcare community have officials worried that there is a severe risk of metal poisoning in patients who have received a metal-on-metal hip replacement. Many hip replacement systems consist of metallic (cobalt and chromium) ball and socket components that utilize each others movements to generate a wide range of motion. Currently these metal-on-metal hip replacements make up one-third of the 250,000 surgeries preformed annually in the U.S.
However, metal pieces like the ones just described, can potentially wear and diminish over a period of time and create minute shavings that can cause excruciating pain and potentially lead to metal poisoning (metallosis). If left untreated or neglected, these microscopic particles of cobalt and chromium may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or any number of complications that may only be cured through painful revision surgery.
The risks associated with metal-on-metal hip replacements have become so prevalent that the American Academy of Orthopaedic Surgeons (AAOS) decided to issue a warning that acknowledged the risks that coincide with the whole process.
According to the FDA’s concerns regarding metal-on-metal hip implant systems:
Because the metal ball and the metal cup 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. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream. However, it is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).” Such a reaction may cause the implant to become loose or cause pain. Ultimately this can require a revision surgery where the old device is removed and replaced with another one.
In addition to these reactions to metal near the joint and implant, there are some case reports in the literature of a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.
Do I Have a Hip Replacement Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in hip replacement lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by a hip replacent, you should contact us immediately. You may be entitled to compensation and / or refund by participating in a class action lawsuit and we can help.