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Metal-on-Metal Hip Implants: Updated Safety Recommendations

Metal-on-Metal Hip Implants: Updated Safety Recommendations

The FDA recently provided updated safety information and recommendations to both patients and health care providers about metal-on-metal hip implants. This new safety assessment includes updated risks of metal-on-metal joint replacement devices. This information also takes into account all new medical published literature, as well as the results of the June 2012 Orthopedic and Rehabilitation Devices Advisory Panel Meeting.

Metal-on-Metal Hip Device Complications:

Metal-on-metal hip implants include a metal ball and cup joint that replace the existing hip joint in patients with severe hip deterioration. The metal ball and joint slide against each other as patients go about their daily lives. Unfortunately, several studies have shown that metal is often released from the implant where the device’s metal pieces connect. These metal particles can cause severe damage to bone and soft tissue surrounding the implant and joint. This damage can be incredibly painful and can potentially lead to implant loosening and complete failure of the device, requiring additional surgery and recuperation time. Some of these metal particles can travel through the bloodstream and affect other parts of the body, resulting in illness and additional painful reactions. The FDA does not presently have enough scientific evidence to specify the exact concentration of metal particles that need to be in a patient’s blood to produce these adverse effects. Reactions appear to be specific to individual patients, with some patients experiencing severe and life-altering reactions to very small concentrations of the particles.

Safety Assessment Recommendations and Link:

Surgeons are recommended to review all of the FDA safety information before recommending and implanting any metal-on-metal hip implant at the following link:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm335775.htm

Here patients can also find information if they are facing hip replacement. Patients who currently have metal-on-metal hip devices will also find recommendations about the safety of their devices, as well as what to do if they are experiencing symptoms.

Report Complications to the FDA:

If you have had a metal-on-metal hip replacement, it is extremely important to report any adverse symptoms to the FDA at the following website database:

https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Reporting your complications will help the FDA gain a better understanding of the risks associated with these metal devices, and in the future could lead to the banning of metal-on-metal implants altogether.

Current FDA Reports about adverse symptoms related to metal-on-metal hip systems include:

  • pain,
  • malposition,
  • adverse local tissue reaction,
  • metallosis,
  • hypersensitivity (allergy),
  • loosening, and dislocation.

To help FDA learn more about the adverse reactions associated with metal-on-metal hip implants, include the following information in your reports, if available:

  • Date of implantation
  • Date of implant removal (if applicable)
  • Clinical cause for revision (if available)
  • All symptoms and reactions

Healthcare professionals are also urged to report adverse events or side effects related to the use of these products.

If You or a Loved One Have Been Injured:

If you or a loved one have experienced any complications or injury as the result of a metal-on-metal hip implant, it is imperative you contact the skilled personal injury attorneys at Graves McLain, the Tulsa Personal Injury Law Firm, for a free confidential consultation at 918-359-6600. An experienced lawyer will review your situation at no cost to you. Graves McLain will be able to get to the facts to help ensure you get the compensation you deserve for your medical bills, pain and suffering, lost wages, and loss of quality of life.  We represent victims and their families in serious injury and death cases arising from medical mistakes, vehicle collisions, and other accidents.

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