FDA

New Rules for Troubled All-Metal Hip Implant Manufacturers

Many people have experienced injuries from their metal-on-metal (MoM) hip implants and many more are expected to experience similar instances. However, people are finally seeing some movement from the Food and Drug Administration (FDA) towards protecting the public from these dangerous medical devices. The MoM hip implants have been reported as causing serious injury to some patients when metal ions from the devices begins to wear off and enter the bloodstream and organs of patients.

The FDA has proposed new rules that will require manufacturers of all-metal hip implant devices to provide evidence that the devices are effective and safe for consumers. Valid evidence can include the results of clinical trials. Manufacturers who cannot produce such scientific evidence will not be allowed to sell the devices in the United States.

Several countries, including the United Kingdom, Canada and Australia, have issued safety warnings to the public regarding the issues surrounding the MoM hip implants. Some have recommended that less risky hip implant products be used, such as plastic or ceramic hip implant devices.

Potential Side Effects of MoM Hip Implants

While all implants come with inherent risks, the MoM hip implant devices were shown to carry additional, unique risks not found in other hip implant devices. Device wear-and-tear is not an uncommon occurrence; however, in the case of the all-metal devices, dangerous metal ions make their way into the body and organs of patients, leading to many systemic injuries including:

  • Swelling
  • Thyroid dysfunction
  • Eyesight deterioration
  • Skin rashes
  • Depression or cognitive impairment
  • Kidney problems

If you experience any of these health issues, and you have a metal-on-metal hip implant, it is advised that you talk with your physician immediately. Defective hip implant devices can lead to the possibility of hip revision surgery; a procedure in which the hip implant is either removed or replaced.

FDA Has Been Addressing Issues with Metal-on-Metal Hip Implants

In order to effectually address issues concerning the metal-on-metal hip implants, the FDA held the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee in June of 2012. The committee was convened in order to elicit scientific and clinical data as well as opinions surrounding the metal-on-metal hip implants and their potential safety issues from healthcare professionals on the front lines.

In an attempt to take action against the growing problem, the FDA recently issued a Safety Communication for patients and healthcare providers as well as new proposed rules for manufacturers.

While the latest action by the FDA is welcome, it may be a moot point. With the recent negative publicity surrounding the use of all-metal hip implant devices, the use in practice of these devices has decreased to nearly zero.

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

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html