It's one thing to recall a bunch of kids medicines that don't meet quality standards and quite another to announce a do-over on surgically implanted artificial hips.
But that's what Johnson & Johnson is up to now. The company's DePuy unit (rhymes with Pepe Le PEW) said new data show its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System are prone to early failure.
So the company has notified doctors and patients it's recalling the devices. For those keeping track, it's the 11th J&J recall since last September, the Associated Press reports.
What's up with these hips? Within five years of implantation, about 12 percent of people who got the ASR resurfacing device, available only outside the U.S., and 13 percent of people who got the ASR total hip replacement, available worldwide, have had them surgically removed and replaced with something else.
The signs of trouble include swelling, pain and even difficulty walking. Persistent symptoms can signal a loose implant, fracture of the bone around it, or dislocation of the implant's ball and socket, the company says.
We wondered how the failure rates of these hips stack up against other devices. A DePuy spokeswoman told us in an e-mail that "the generally accepted standards" are that no more than 5 percent of hip implants should need replacement withing five years — less than half the failure rate found by J&J.
The standard for so-called resurfacing devices, such as the DePuy ASR Hip Resurfacing System, is a little looser. DePuy, citing recent data from a U.K. registry, said the replacement rate for those devices is about 4.5 percent at three years compared with 1.9 percent for conventional hip replacement.
DePuy had already stopped selling the devices. But many doctors say that decision should have been made much sooner because of numerous reports of early problems, the New York Times reported in March.
Someone asked us this morning how exactly a company recalls devices that are stuck in people's bodies?
Very carefully, was our first response. But the real answer is that people who suspect they have the implants should talk to the orthopedic surgeons who fixed their hips to find out if they've got one of the affected models.
An X-ray or imaging scan may help the doctor see how the implant is doing. Blood tests can help figure out if metal particles coming from the implants are causing trouble.
If the problems are serious enough, surgery may be required to swap a new hip for the defective one. DePuy says it will pay for "reasonable and customary costs" of testing, treatment and replacement surgery. For more details, see the FAQ from DePuy here.