Metal-on-Metal Hip Implants - Consumer Justice Foundation

Metal-on-Metal Hip Implants

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Patients who receive metal-on-metal hip implants may be at risk for severe side effects like device fracture, loosening of the implant, metal blood poisoning, or the need for revision surgery.

Patients suffering from deterioration of the hip joint are sometimes advised by their physicians to replace the injured hip with an artificial hip implant, and among the various models and designs of artificial hips, metal-on-metal implants have been some of the most widely-used. Patients who opt for this method of treatment typically do so under the impression that the implant will repair the injury or relieve their pain without causing them any unnecessary harm. Unfortunately, the mounting number of defective hip implants on the market today has raised serious concerns about the safety of these medical devices and the adverse side effects defective hip implants may impose upon patients. As the makers of artificial hip implants continue to issue recalls for their devices, the public is finally being made aware of the adverse events recipients of defective hip implants may be exposed to. If you received a metal-on-metal hip implant and have since suffered from a serious side effect like implant loosening or device fracture, contact an experienced attorney today for legal help.

Metal-on-Metal Alternatives for Hip Implants

While all artificial hip implants carry a potential risk of complications, the FDA has warned that metal-on-metal devices have unique risks in addition to the general risks of all hip implants. In light of the potential for metal-on-metal hip implants to put patients at unnecessary risk for devastating complications, many patients are researching alternative hip replacement systems that may be safer and equally as effective, including the following artificial hip devices:

  • Metal-on-polyethylene implants
  • Ceramic-on-polyethylene implants
  • Ceramic-on-ceramic implants
  • Ceramic-on-metal implants

Other more conservative options for treating deterioration of the hip joint that don’t involve surgery to replace the hip may include pain medication and physical therapy. In light of the potential for metal-on-metal hips to cause serious side effects in patients, the FDA recommends that orthopaedic surgeons choose a metal-on-metal hip implant only after determining that the benefits and risks of using an all-metal device outweigh the benefits of using an alternative hip system.

FDA, Hip Implants and Side Effects

July 2008 – Zimmer briefly recalls the Durom Cup hip implant to revise the device instructions, but the artificial hip returns to the market.

December 2009 – DePuy withdraws the ASR hip implant from the Australian market, and details a plan to phase the device out worldwide by 2010, citing slow sales as the reason for its removal.

March 2010 – DePuy finally acknowledges in a letter to doctors that its ASR metal-on-metal hip replacement system is defective and prone to early failure. At this time, the FDA has already received hundreds of reports of early failure involving the ASR hip implant system.

August 2010 – The FDA recalls two metal-on-metal hip implants manufactured by DePuy Orthopaedics, the ASR XL Acetabular System and the ASR Hip Resurfacing System.

2011 – Johnson & Johnson estimates in an internal document that the ASR hip implant would fail within five years in 40% of patients who received the artificial hip.

February 2011 – Federal regulators launch an all-metal hip implant webpage to provide updated safety information and recommendations to consumers and medical professionals.

May 2011 – The FDA requires the manufacturers of metal-on-metal hip implants to conduct post-market surveillance studies on the safety and effectiveness of their artificial hips.

April 2012 – Stryker issues an Urgent Field Safety Notice to surgeons involving problems with the its Rejuvenate and ABG II implants, including “Excessive metal debris and/or ion generation” caused by “fretting and or/corrosion at or about the modular neck junction.”

June 2012 – Smith & Nephew recalls the metal liner components of its R3 Acetabular System, after thousands of patients in the U.S. received the implant from 2009 and 2012.

June 2012 – The Orthopaedic and Rehabilitation Devices Advisory Panel meets to discuss the safety and effectiveness of metal-on-metal hip implants, and finds that there is little reason for surgeons to continue using the controversial devices.

July 2012 – Stryker recalls two hip replacement systems – the ABG II and Rejuvenate modular-neck hip stems – both of which had been linked to complications like metallosis, tissue death and hip implant loosening.

September 2012 – Artificial hip manufacturer, Smith & Nephew, issues an “Urgent Field Safety Notice,” warning the public that the Birmingham hip device is tied to a higher rate of failure than is acceptable in the UK.

September 2012 – Health regulators in Australia recommend routine blood tests and soft tissue imaging for all patients implanted with a metal-on-metal hip implant.

January 2013 – The FDA issues a safety communication to provide updated information to patients and medical professionals about the safety and effectiveness of metal-on-metal hip implants.

January 2013 – The FDA issues a proposed order requiring the makers of all-metal hip implants to submit premarket approval applications.

May 2013 – DePuy removes its Ultamet and Complete all-metal hip implant liners from the market, and announces that it is phasing out its metal-on-metal products in favor of plastic and ceramic devices.

November 2013 – Hospitals in the UK ban metal-on-metal hip implant systems, due to higher-than-expected failure rates.

Artificial Hip Side Effect Studies

November 2010 – Researchers from the UK publish a study on the failure rate of the Ultima metal liner, designed to be used with DePuy’s Ultima Metal-on-Metal Acetabular Cup, and found that 13.8% of hips required revision surgery after failing. During the revision surgeries, doctors found a number of serious complications, including cloudy fluid pockets in the hip, ruptured tendons and necrosis (tissue death).

October 2011 – In a special report published in the Archives of Internal Medicine, researchers examined a Department of Justice settlement agreement with five major hip implant manufacturers – DePuy, Biomet, Smith & Nephew, Stryker and Zimmer – and found that orthopedic surgeons received payments from these five companies for consulting, research and clinical study work, as well as royalties on products they helped develop.

February 2012 – The BBC and the British Medical Journal launch an investigation into all-metal hip implant concerns, and report that there may be hundreds of thousands of patients who have faulty hip replacement systems that may expose them to toxic metal.

March 2012 – Metal-on-metal hip implants are significantly more likely to fail than other models of artificial hips, according to research published in The Lancet.

March 2012 – A study conducted by the National Joint Registry of England and Wales finds that 12% of patients who received the DePuy ASR resurfacing implant, and 13% of those who received the ASR total hip replacement, required revision surgery after five years, to remove or replace the faulty device.

June 2012 – The Journal of Bone and Joint Surgery publishes a study indicating that patients who receive all-metal total hip replacements may be ten times more likely to develop pseudotumors, or semi-solid masses that are greater than two centimeters in diameter.

December 2012 – The medical journal Orthopedics publishes a study highlighting the case of a 54-year-old woman who received the DePuy Pinnacle implant and developed soft-tissue growths called bursal cysts in her hip, due to metal debris shed by the implant. The cysts reportedly cut off circulation to her lower leg and she underwent revision surgery to replace the device with a ceramic-on-ceramic implant.

February 2013 – Research published in the Journal of the American Medical Association finds that women are 29% more likely than men to require revision surgery for artificial hip implant failure within three years.

Why We Think the Makers of Hip Implants Should be Held Liable for Side Effects

Many recipients of metal-on-metal hip implants have pursued corrective actions to repair or replace their damaged hip devices, including revision surgery, which can take both a physical and financial toll on patients. Many of these same patients have taken legal action against the makers of metal-on-metal hip implants, accusing the manufacturing companies of:

  • Manufacturing and selling defective devices
  • Failing to research the long-term effects of their products
  • Knowing that their hip replacement systems were defective
  • Failing to provide adequate warnings to consumers and the medical community about the risk of complications from all-metal hip implants
  • Knowing that their all-metal hips carried a higher-than-expected rate of failure within just a few years after being implanted
  • Willfully concealing problems with metal-on-metal hip implants from the general public

What should you do? If you believe you have been harmed by side effects of an artificial hip implant, you should contact an attorney as soon as possible to discuss filing a lawsuit against the device manufacturing company.

Receiving a defective hip implant can significantly affect the rest of your life, potentially resulting in debilitating injury to the bone or joint, restricted movement, and even damage to internal organs and the nervous system. If you or a loved one has suffered from adverse side effects allegedly associated with a metal-on-metal hip implant like DePuy’s ASR hip replacement system, contact a reputable product liability lawyer today. You may be entitled to financial compensation for your injuries, medical bills, lost wages, and pain and suffering, which you can collect by filing a defective hip implant lawsuit against the manufacturing company. You are not at fault for any injuries caused by a defective product, especially medical devices like hip implants that are designed to correct injuries, not cause them. With the help of a qualified defective product attorney, you can collect the compensation you deserve and protect yourself from further harm.

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