Metal on Metal Artificial Hip Replacement Products and Lawsuits
The metal-on-metal hip implant lawyers of Davis, Saperstein and Salomon, P.C., currently are investigating injuries and deaths that may be caused by faulty metal-on-metal hip implants.
According to recent research and U.S. Food and Drug Administration (FDA) warnings, these all-metal hip implants have potentially dangerous side effects, including a painful medical condition called “metallosis.” This condition is also called an “adverse local tissue reaction (ALTR)” or “adverse reaction to metal debris (ARMD).”
Samuel L. Davis, a founding partner of our firm, is an experienced New Jersey personal injury and products liability attorney who has litigated knee- and hip-replacement cases for many years and chairs the American Association of Justice’s Orthopedic Implant Litigation Group, which he founded.
If you believe that you have suffered injury due to an all-metal hip implant, or if you have lost a loved one who received one of these medical devices, contact our firm to receive a thorough, free and confidential consultation about your case. Our firm works with a full-time medical expert who can screen your case in conjunction with our legal team.
Davis, Saperstein & Salomon, P.C., represents people across the U.S. who have been harmed or placed at increased risk of harm by dangerous medical devices, including metal-on-metal hip implants. We can advise you of your legal options if you have received an all-metal hip implant.
Simply call us today at 1-800-LAW-2000 or complete our online form. You can also visit our special report website, MyMetalHip.com.
What Are Alleged Problems with Metal-on-Metal Hip Implants
Metallosis is caused by metal fibers that flake off when the moving parts of the artificial hip’s ball-and-socket joint rub together. Metallosis causes fibrosis (damage to or scarring of adjacent soft tissue) or local necrosis (death of tissue around the joint).
The FDA said in a January 2013 Safety Communication that the soft tissue damage due to metallosis in metal-on-metal hip implant patients could lead to pain, implant loosening, device failure and the need for surgery to replace the implant. Metal ions can also enter the bloodstream and damage other parts of the body. If you or a loved one has suffered any of these difficulties after receiving an all-metal hip implant, it’s important to get legal help.
Recognized Dangers of Defective Metal-On-Metal Hip Implants
Government researchers around the world have begun to call attention to the danger of metal-on-metal (MoM) hip implants. Recent developments include:
- In April 2010, the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that recommended blood tests and imaging for patients with painful MoM hip implants.
- In May 2012, Health Canada issued a public health communication to orthopaedic surgeons and patients, citing an increase in awareness of pain, adverse local tissue reactions and implant loosening in patients who had received MoM hip implants.
- In September 2012, the Therapeutic Goods Administration of Australia published safety information for healthcare professionals on MoM hips. It addressed metal ions from the devices having been reported to be associated with effects on the heart, nervous system, endocrine system and skin.
- In August 2010, the FDA issued a recall notice for the DePuy ASR XL Acetabular System based on data from the UK’s joint registry, indicating that 13 percent of patients needed replacement surgery within five years of receiving the implant. (Hip implants should last for 15 to 20 years.)
- Additionally, in June 2012, Smith & Nephew Orthopaedics issued a “market withdrawal” for the metal liners of its R3 acetabular system. In July 2008, Zimmer issued a voluntary recall of its Durom Acetabular Component, or “Durom Cup.” And, in November 2007, the FDA sent a warning letter to Stryker Corp. concerning its hip implants systems.
How Do Dangerous Metal-on-Metal Hip Implants Get on the Market?
The DePuy ASR Metal-on-Metal Hip Replacement System first became available in the U.S in 2005. The FDA gave Depuy Orthopaedics owner Johnson & Johnson special clearance through its 510(k) premarket submission program. The 510(k) program lets manufacturers circumvent the agency’s more stringent approval process by simply stating that a new medical device is “substantially equivalent” to a previously approved medical product.
The New York Times reported in January 2013 that hundreds of thousands of hip-implant patients in the U.S. had had corrective surgery because their metal-on-metal hip implants had failed prematurely. The report said problems with all-metal hip implants systems represented “one of the biggest device-related failures in decades.”
In January 2013, the FDA proposed removing metal-on-metal hip implants from the 510(k) process. The FDA said that makers of artificial hips with all-metal components should have to prove the devices are safe and effective before they can continue selling existing ones and must obtain approval for new all-metal designs.
If Your Metal-on-Metal Hip Implant Has Failed
Symptoms of a failed metal-on-metal hip implant include:
- Swelling or pain in the affected hip or surrounding areas
- Difficulty walking or pain in the hip when walking
- Grinding or popping noises in the hip area
- Inflammation or infection in the affected hip
- Dislocation or improper positioning of the implant.
If you are experiencing any of these symptoms, you should call your surgeon. Your surgeon should be able to provide you with:
- Your implant manufacturer’s name
- The model or model number of your hip implant
- Date of your surgery
- Hospital where the surgery was performed
- A copy of the operative report.
Next, you should have your primary care physician test your blood for metal content. If you have abnormal metallic content, you may need to have your implant removed.
If you have a metal-on-metal hip implant removed, keep it as evidence. It belongs to you. In fact, state clearly prior to surgery that you want it returned to you.
If you have had to have surgery to remove a metal-on-metal hip implant that has caused you to suffer problems, with or without a formal diagnosis of metallosis or another illness, you have a legal right to seek compensation for you expenses, pain and suffering.
Our Metal-on-Metal Hip Implant Lawyers are Ready to Help You
Samuel L. Davis, a founding partner of Davis, Saperstein & Salomon, P.C., is a New Jersey personal injury and products liability attorney who has litigated knee- and hip-replacement cases for many years. He founded and chairs the American Association of Justice’s Orthopedic Implant Litigation Group.
Davis, Saperstein & Salomon, P.C., represents people across the U.S. who have been harmed or placed at increased risk of harm by dangerous medical devices, including metal-on-metal hip implants. We can advise you of your legal options if you have received an all-metal hip implant.
For more details about your legal rights and information about metal-on-metal hip replacement systems, call us today at 1-800-LAW-2000 or take a moment to fill out our online form.
Our advice is free in an initial consultation. If we determine together that legal action is warranted in your case, there is no cost to you until your case is settled.
Sources
- Metallosis due to impingement between the socket and the femoral head in a total hip prosthesis. A case report, National Center for Biotechnology Information
- How Long Do Hip Replacements Last? Jonathan Cluett, M.D., About.com Guide
- 510(k) Submission Process, U.S. Food and Drug Administration
- FDA Safety Communication: Metal-on-Metal Hip Implants, U.S. Food and Drug Administration
- Warning Letter to Stryker Orthopedics Corp., U.S. Food and Drug Administration