FDA Rules that Metal-on-Metal Hip Replacements Create Problems

For many patients, a hip replacement is the best option for a healthy future. Options for hip replacement devices include metal-on-plastic, metal-on-polyethylene, metal-on-metal, and metal-on-ceramic. Until recently, about 1/3 of all patients receiving a hip replacement have been receiving an all-metal device.

While all hip replacement devices carry risks, the FDA has found that metal-on-metal devices have additional unique risks. The metal parts rub against each other as a patient moves, creating friction between the metal parts which allows tiny particles to enter into the body’s bloodstream; which causes inflammation, allergic reactions, and pain. It is estimated that 1 in 1,000 patients have exhibited sensitivity to these metals (e.g. cobalt and chromium).

Reports found that metal hip replacement parts are also failing earlier than those that are made of other materials such as plastics, ceramics, or a mix of metal and plastic. If metal hip replacement parts fail early, a need for revision surgery to correct the problem may be necessary.

Metal-on-metal hip parts have been the subject of criticism for several years. In 2010, DePuy recalled their all-metal hip replacement device, the Articular Surface Replacement (A.S.R.). There have been several international studies warning against the use of metal on metal hip replacement parts. DePuy is facing over 13,000 lawsuits related to all metal replacement hips in two models, the ASR and the Pinnacle.

The FDA has not ruled that companies cannot manufacture the all-metal hip replacement devices but the agency is requiring companies to conduct intensive studies with patients in order to sell the devices. DePuy has decided not to conduct these studies and instead, it will discontinue selling all metal hip replacement parts. The company will also stop selling metal parts that are used in Pinnacle and Complete systems which combine ceramic and metal components.

Metal-on-metal replacement hips once accounted for one in three hip implants used in the United States. However, more recently few doctors are choosing to replace their patients’ hips with metal-on-metal devices.

The following symptoms may indicate that the hip replacement device is not working correctly:

  • pain in groin, leg, or hip
  • swelling in area of hip joint
  • limp or other change in walking ability
  • sounds such as popping, grinding, clicking, or squeaking

Recommended Reading:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

http://healthletter.mayoclinic.com/editorial/editorial.cfm/i/262/t/
Choosing%20the%20right%20total%20hip%20replacement/

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/
ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm