Sulzer Artificial Hips Recalled
What happens when an artificial part that's in your body gets recalled? Last month, Sulzer Orthopedics announced the recall of a hip replacement part that's inside more than 17,000 patients.
When you think of "recalls," you tend to think of cars, or tires, or appliances. But what happens when it's a medical device that's been surgically implanted inside your body?
Three months ago, Lindsay Low received an artificial hip. Today, it is virtually useless. Putting weight on it causes the hip to buckle - and Low to fall.
"I can only walk little short distances with my crutches," explains Low. "Right now I'm in a wheelchair. The pain is very severe, such that if I were to walk I would worry."
Low's natural hip bone is not growing into the new, artificial socket. Her doctor explains, while pointing to her X-ray, "The gap indicates the cup is loose and with the cup being loose, that means it's painful."
Last month, doctors discovered why. They got a letter from the Sulzer Orthopedics announcing a defect in the hip socket Low and thousands of other patients had received.
The company said that a production error had left traces of machine oil on the artificial joints and that the recall would begin immediately.
"I was frustrated. Part of me was angry," says Low. "Recalls are supposed to be for tires or something. They're really not supposed to be recalling things inside people."
What Happens Now?
At Summit Hospital in San Francisco, doctors have identified 254 patients who received the recalled hip.
"Surgeons are not going to remove every one of the recalled hips," says Summit's Dr. Mac Reynolds. "Patients not experiencing pain will simply be X-rayed every three months. Those who do have pain, we recommend replacing the implant."
No one knows how many of these operations will be needed - or how difficult they might be.
Replacing an artificial hip can take twice as long in the operating room as putting one in. That's because there's usually much more scar tissue. And then there are all the risks from another surgery: the potential for blood loss, and infection, and complications.
Low is scheduled to have her replacement operation later this month.
"I've got to have this thing out," says Low. "I've got to have a new one put in. And I've got to go through all the rehab again."
The company has offered to cover medical costs not paid by Medicare or other health insurance, but some patients are filing lawsuits for lost wages and what they see as unnecessary pain and suffering.
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