The FDA Tightens Regulations On All-Metal Hip Implant Companies
In January 2013, the U.S. Food and Drug Administration (FDA) tightened regulations on the manufacturers of all-metal hip implants. Metal-on-metal hip replacement manufacturers are now required to prove that their devices are safe before they can receive approval to put new designs on the market or continue to sell metal-on-metal hip implants already in existence.
This was a big step toward patient safety, which came a few years after the FDA began investigating complaints about the all-metal hip implants and urged manufacturers to issue recalls (such as the DePuy ASR XL Acetabular System recall in 2010).
A Reversal From The Lax Requirements Implant Companies Once Enjoyed
In the past, hip implant companies were required to show only that their designs were similar to ones already on the market to obtain accelerated status and, thus, market the new implants. They did not have to conduct clinical studies to determine whether their devices were, in fact, safe for consumers.
When the DePuy ASR hip implant went on the market, for example, Johnson & Johnson only had to show that it was similar to other hip implants to receive accelerated status, even though the ASR was significantly different from the other implants on the market. It did not have to go through clinical studies or the battery of tests that other new medical products must go through. And the results were telling: One in eight DePuy ASR hip implants failed within five years of implantation.
Now, Johnson & Johnson has begun to pull its ASR hip implants and other metal-on-metal hip implants from the market, in large part because doctors and consumers questioned the safety of the implants.
Take Action, Find Justice
Metal-on-metal (MoM) implants are leaving the market precisely because of consumer action. Without consumer complaints, the FDA could not have known the extent of the problems with the metal-on-metal hip implants. Consumer complaints led to recalls, convincing some manufacturers to take the defective and dangerous hip implants off the market.
Your voice matters. If you have been injured by a metal-on-metal hip replacement, take action to hold your manufacturer accountable for putting an unsafe medical device on the market. Contact Girardi | Keese by calling 800-401-4530 or sending us an email.