Following the FDA’s January 2013 Safety Communication on the concerns with metal-on-metal (MoM) hip replacement implants, a number of lawsuits have centered on these implants. Concern has focusd on the the higher than normal incidence of complications, including the need for removal of the all-metal devices. These devices have been implicated in over 16,800 adverse events since their introduction in 2000, after coasting through the FDA’s 510k “fast track” approval process, which allows manufacturers to skip normal testing protocols if a new device is similar to others already in use.
Medical manufacturers, such as Johnson & Johnson and Zimmer Holding, Inc., promoted metal-on-metal implant implants as a more reliable and long-lasting alternative to traditional polyethylene plastic or ceramic and metal combination devices. Between 2006 and 2007, metal-on-metal implants were used in 30% of all hip replacement procedures, but that number has fallen to approximately 10% in the years since. The decrease comes as a result of registries in both the United States and abroad reporting higher incidences of complications with the all metal implants, which have a revision (replacement) rate of six percent, three times higher than the replacement rate for the older ceramic or plastic devices. Additionally, authorities in Great Britain are now recommending that patients with all-metal implants undergo annual blood screenings to insure that metal ions produced by friction between device components is not leaking into surrounding tissues.
Some of the other complications linked to metal-on-metal devices include:
- Decreased mobility and even hip joint failure
- Severe pain in the hip, groin or thigh
- Inflammation and swelling
- Loosening of the device
- Bone damage
Approximately 500,000 people currently live with the metal-on-metal devices. These developments have prompted product recalls from companies like Johnson & Johnson, which recalled its ASR hip replacement system in 2010, and has allotted $3 billion to cover potential lawsuits related to its use. Other manufacturers' products that are currently being investigated include:
- Stryker Rejuvenate ABG II
- Depuy PInnacle
- Depuy ASR
- Biomet Magnum
- Wright Medical Conserve.
The FDA’s advisory panel will provide recommendations on the continued use of metal-on-metal implants. Patients who underwent hip replacement surgery with any of the above mentioned devices, who may be suffering complications, should seek the advice of an experienced attorney immediately.