CHICAGO (CBS) — They trusted that the hip replacement device approved by the Food and Drug Administration was safe and would help them. Instead it made the already painful condition for some patients worse.
And as CBS 2’s Pam Zekman reports, after it was voluntarily recalled, serious and painful health problems still plague patients even after the device is removed.
“I had a job and a career that I loved,” Mary Ann Doornbos, 53 said. “I went around the world doing things.” But she also had osteoarthritis and needed hip replacement surgery in 2007.
Doornbos recalls her doctor told her, “there was a hip replacement that was new, innovative and geared towards younger people and that I would be back to work in a very short period of time.”
It was known as the ASR made by DePuy Orthopaedics. The ASR was first introduced in 2004 outside the United States, and then approved for sale in the U.S. in 2005.
That approval came under the FDA’s 510K regulatory process which does not require clinical trials on patients. Under that process, manufacturers can get an expedited FDA approval if their device is “substantially similar” to another already on the market.
But the ASR differed from other metal models because it had a shallower socket.
Dr. James Kudrna, an orthopedic surgeon at NorthShore Glenbrook Hospital, implanted about 400 of them.
“It lent for great mobility so patients could get the motion back in the hip,” he said.
But like others, he later learned that also reduced lubrication of the bearing causing excessive wear. As a result tiny particles of chromium and cobalt flaked off.
“It can lead to the destruction of muscles tendons and ligaments surrounding the hip area,” Dr. Kudrna said.
That’s what happened to Doornbos, who had an ASR implanted by another doctor in 2007. After two other surgeries to repair a mass that formed around her hip bone and damaged tissue that doctor replaced the ASR in 2009. But she’s still in constant pain, cannot walk without a cane, and unable to return to work.
There have been case reports of a small number of patients who had high levels of metal ions in their bloodstream that effected their nervous system and heart, which worries Doornbos.
Now she’s suing Depuy Orthopaedics charging the ASR had “dangerous design defects.”
“DePuy knew or should have known in Europe, in Australia these devices were failing at a ridiculously high rate,” said her attorney, Peter Flowers, who represents hundreds of patients who have had adverse reactions to the metal debris generated by normal use of the ASR.
“This device never should have been released in the United States.” Flowers said.
Then, in 2010, after the United Kingdom National Joint Registry reported the ASR had a 13 percent failure rate after five years, DePuy voluntarily recalled it saying the action was “in the best interests of patients.”
“The United Kingdom has an outstanding registry of every prosthetic device implanted in their citizens,” said Attorney Thomas Prindable, who also represents Doornbos and others suing DePuy. “The United States doesn’t track that,” he said, and it should. “The FDA trusts the manufacturers too much to do their own policing.”
Now, in a study published last August in the Journal of Bone and Joint Surgery, a group practice of orthopedic surgeons in the United Kingdom reported a 48.8% failure rate after 7 to 8 years.
“That’s huge.” Said Dr. Kudrna. “Based upon that certainly there is an ominous future for this device.”
Like other doctors after the recall, Kudrna contacted all of his patients for follow up examinations and tests. Those who had elevated metal levels or other symptoms of tissue damage underwent revisions. Patients who do not have problems now, “need to be followed essentially the rest of their lives,” he said.
As for Doornbos, “Even before I get out of bed it’s just pain, constant pain,” she said. “And I can’t understand how or when it’s going to stop.”
A DePuy spokeswoman said the company is now facing 4,500 lawsuits and will not comment on any pending litigation. In a written statement, she noted that the recently reported 48.8 percent failure rate was from just for one medical practice, cannot be verified, and is out of line with previously reported failure rates.
She said all orthopedic implants, “no matter what materials are used,” experience generate debris. Particles from metal on metal hip implants “do not cause problems for most patients, but a small number of patients have an adverse reaction to them,” she said.
She said DePuy monitors data from a variety of sources and “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
“Depuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall,” she said.
The company encourages patients to visit the DePuy website or call its help line at 888-627-2677.
Meanwhile, the FDA has asked manufacturers of all metal on metal hip replacements to research how well their devices are performing and monitor adverse reactions.
For more information you can log on to the FDA website.