Susanna Derham, a resident of Surrey, England, was just 34 years old when she was implanted with an all-metal hip made by DePuy Orthopaedics. Her natural hip had plagued her with arthritis for years, so receiving a sturdy, state-of-the-art metal hip designed to last up to 25 years offered her hope for a better, less painful future. But she was wrong.
Dr. Stephen Tower, an orthopaedic surgeon from Anchorage, Alaska, knew the artificial hip device he wanted when he required hip replacement surgery for his arthritic hip. He chose the ASR XL, a metal-on-metal device made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The all-metal device was constructed with chromium and cobalt, and appeared to be the best option for someone who wanted to get back to vigorous physical activity.
What he didn’t realize is that the DePuy device he chose had not been tested for safety and efficacy before it was approved by the Food and Drug Administration (FDA). The device was grandfathered into the market through a process that allows medical devices to be approved by the FDA if they are similar to ones already on the market.
A new study funded by the National Joint Registry of England and Wales and published this month in the British medical journal The Lancet calls on surgeons to stop using metal-on-metal hip implants completely, saying that evidence shows patients who receive the implants are much more likely to need revision surgery to have the implants repaired or replaced.
Johnson & Johnson decided to phase out one of the hip implants made by its subsidiary DePuy Orthopaedics and sell off its inventory shortly after receiving an inquiry from the Food and Drug Administration (FDA) that questioned the device’s safety and efficacy. The federal agency was asking the drug and medical device manufacturer for safety data on its metal-on-metal ASR XL Acetabulator hip replacement and hip resurfacing systems, and informed the company that blood tests in patients who had received the implants showed “high levels of metal ions.”
In an email blast to one million subscribers, Consumer Reports President Jim Guest wrote that medical devices that receive U.S. Food and Drug Administration (FDA) approval through its fast-track process have created a “nightmare scenario” for public safety. The fast-track approval process, or 510(k), is a shortcut designed to speed low- and moderate-risk medical devices to market when their designs are similar to already approved devices, bypassing costly and time-consuming clinical safety trials.
“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to one million Americans earlier this year. He was warning consumers that medical devices they assume are safe may not be fully vetted before being approved by the Food and Drug Administration (FDA), and that the federal government needed to change this process that is putting the lives of millions of people at risk.
Terri Wagner-Morley’s artificial hip seemed like an answered prayer. In just one year, she regained mobility lost from chronic arthritis, and was able to exercise again. She shed more than 50 pounds and was enjoying life again. “It felt great,” she told the Star Tribune. But shortly thereafter problems began to surface. It started with a popping sensation in her right hip, then came the pain. Soon, Terri wasn’t moving around like she had been. The exercising stopped, and the weight came back.
Terri, a mother of twin college-age daughters and a grown son, told the Minnesota StarTribune that the DePuy ASR artificial hip she received in 2008 to counter the chronic arthritis in her right hip gave her a new lease on life. As she recovered from replacement surgery, the pain subsided and her mobility improved dramatically.
Surgeons should stop using metal-on-metal hip implants because they are prone to failure and may seep toxic metals into patients’ blood, say researchers who conducted safety studies on various hip replacement systems. The study was published this week in The Lancet.