Hip replacement surgery, first performed in 1960, has long been considered an important advance in modern medicine.1 People suffering from joint pain, loss of mobility, and degenerative disease have been given hope for an improved quality of life. However, these surgeries sometimes cause serious complications. As recently as summer 2012, metal-on-metal hip implant recalls have been in the news.
Hip implant recalls
Since 2008, the U.S. Food and Drug Administration (FDA) has been managing recalls2 of partial and total hip implants. In 2008, the federal agency monitored a voluntary recall of a hip replacement part, the Zimmer Durom® cup. In 2010, another voluntary recall involved a metal-on-metal hip replacement implant made by British drug manufacturer DePuy. In June 2012, American company Smith and Nephew withdrew their metal-on-metal hip replacement device, while another company, Michigan-based Stryker, voluntary recalled its hip replacement implant, a metal stem.3
The recalls were prompted by medical studies showing that some hip replacement devices, DePuy’s devices specifically, were replaced or removed almost 30 percent of the time after just six years.4 Since then, a number of metal-on-metal hip replacement implant lawsuits and class actions have been filed.
Complications linked to metal-on-metal hip replacement devices
Complications5 from metal-on-metal hip implants have increased over the years. Some of these complications include the following:
- Severe Infection
- Metal in blood stream
- Loose implants and loss of mobility
- Damage to tissues around the hip area
- Damage to bones around the hip area
- Additional surgeries6
- Damage to organs due to metal in bloodstream
On Jan. 17, 2013, the FDA issued an updated Safety Communication7 to doctors and surgeons who regularly advise hip replacement surgery for their patients. In the notice, the federal agency, which created a metal-on-metal hip implant web page in 2001, explained unique risks associated with total and partial metal-on-metal hip replacement surgery. The FDA cautioned doctors to follow patients closely to prevent major complications from these devices.
Manufacturers of medical devices have a duty to create a safe and effective product. The same is true of the makers of metal-on-metal hip replacement parts and systems. When consumers are injured as a result of a manufacturer's possible negligence, they may be eligible to file a lawsuit or join a class action.8