For years, patients have reported debilitating pain and swelling caused by metal-on-metal hip implants, and in many cases, metal implants have been removed because of failures. On June 27 and 28, the Food and Drug Administration (FDA) convened the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek the latest expert scientific and clinical opinion on the risks and benefits of metal-on-metal hip systems, including:
- Failure rates and modes
- Metal ion testing
- Imaging methods
- Local and systematic complications
- Patient risk factors
- Considerations for follow-up after surgery
Most of the problems associated with metal-on-metal hip implants involve the release of metal ions into the body as the metal parts of the implant rub together. Reactions to the metal particles can cause soft tissue damage, inflammation, bone loss, and other complications that compromise the implant, eventually necessitating its early replacement or repair. Replacement surgeries can be very hard on patients, especially if a person's joint has been further deteriorated as a result of the failed implant.
Once the FDA announced its plan to scrutinize the safety of metal-on-metal hip implants, CBS News spoke with people who sustained implant-related complications. One woman, who had both hips replaced with Johnson & Johnson ASR all-metal implants in 2007 and 2008, had her implants removed in 2011 due to increasing pain and elevated metal levels in her blood. Because of early failures and research showing metal ions leaching into the bloodstream at a high rate, Johnson & Johnson had already recalled the ASR implants in 2010.
Many people are frustrated because most prosthetic devices, like hip implants, do not undergo rigorous safety testing before being put on the market. Rather, the FDA's fast-track clearing program waives clinical testing requirements for devices that appear similar to others already in use. Almost all metal-on-metal hip implants were approved without new safety testing because plastic and ceramic hip replacements have been available since the 1950s. As one man put it, "[They] used my wife as a lab rat, along with 500,000 [other] people."
Contact Concerned Medical Malpractice Lawyers in Denver, Colorado
If you live in the Denver area and you or a loved one has suffered complications after a metal-on-metal hip replacement surgery, or if your hip replacement has required early repair, please contact the experienced Colorado medical malpractice lawyers at Paulsen & Armitage, LLC. We can help you recover the compensation you deserve from the manufacturers and distributors of dangerous medical devices.
