Hip replacement devices can restore mobility and allow you to lead an active life, but unfortunately for some, hip replacements led them down a road of pain and medical complications. Over the course of an eleven year period beginning in 2002, there were nearly 600 recalls issued by the six major manufacturers of hip replacement devices, including Biomet, DePuy, Smith & Nephew, Stryker, Wright, and Zimmer. For many, the recall was issued once their device was in place and did little to prevent the pain and need for follow-up surgical procedures.
Despite the innovations in joint replacement devices, there is still a great deal of risk with hip implants. This is especially true for those with metal-on-metal implant devices. One hip replacement manufacturer, DePuy, spent more than $800 million on a recall of one of its metal-on-metal implant devices after friction caused metal components to break down, causing device failure and reactions to the metal fragments released into the body of users.
Many believe these metal-on-metal devices should have never made it to market, and they blame the FDA approval process for the misery these devices have caused. Many were cleared through the FDA’s 510(k) program that allows manufacturers to sell their devices without formal testing, provided there is already a “substantially equivalent” product on the market.
After a rash of recalls involving metal-on-metal replacement devices, the FDA assembled a panel in June 2012 to discuss the risk. Data was provided by surgeons and researchers, and after review, the panel’s chair stated he no longer saw a reason why metal-on-metal implants should continue to be in use, but did not issue an official ban on all metal-on-metal devices. The panel did call for further investigation and encouraged doctors to educate patients concerning the risks associated with the devices.
Types of Hip Recalls
Should the FDA choose to eventually issue a recall for all metal-on-metal hip replacement devices or any additional brand or model specific devices, it has three options:
It can issue a Class I recall, which is the most urgent and used for the most harmful devices or drugs. It is issued when there is reasonable probability using a product will cause serious adverse health conditions or be fatal.
A Class II recall is the second most serious and issued when the use of or exposure to a product could cause temporary or medically reversible adverse health conditions, or when there is a remote chance of serious health consequences. Most brand and model specific hip replacement recalls fall into this category.
Finally, the FDA could issue a Class III recall which is an option when it is unlikely to harm will be done by product.
Recalls: Always Too Little Too Late
Regardless of the severity and timing of a recall, for many it will always come too late, as is the case with the brand and model specific recalls issued so far by manufacturers of hip implants and the FDA. Hundreds of thousands of people were already dealing with complications, injuries, and the need for revision procedures by the time the recall for their device was issued.
Hip Implant Devices Recalled So Far
There have been several voluntary hip replacement devices recalled so far, including:
DePuy Articular Surface Replacement (ASR) Hip (2010)
Acetabular Hip System (2010)
ASR Hip Resurfacing System (2010)
Stryker Rejuvenate (2012)
Stryker ABG II (2012)
Smith & Nephew R3 Acetabular System Recalls (2009 in the United States)
Recipients of metal-on-metal hip replacement devices suffer from pain, loss of mobility, damage to the bone and tissue surrounding the joint, complications from the release of metal fragments into the bloodstream, inflammation, infections, and pseudotumors. There are still several metal-on-metal implants on the market, so additional recalls are likely. Many recipients are also pursuing legal action against the manufacturers of these devices.