| WASHINGTON, June 27
WASHINGTON, June 27 As concerns mount over the
safety of metal-on-metal hip implants, U.S. health regulators
are seeking advice on how best to minimize risks for the more
than 500,000 patients who have received the devices.
All-metal artificial hips were developed to be more durable
than traditional implants, which combine a ceramic or metal ball
with a plastic socket. Johnson & Johnson is the biggest
manufacturer of the all-metal devices, and other device makers
include Zimmer Holdings Inc and Wright Medical Group
J&J recalled its ASR all-metal hip implant in 2010, and has
since set aside $3 billion to cover legal costs related to
patient claims. Recent studies have shown such products may fail
at higher rates than their predecessors, and may leach high
concentrations of metal ions into the
The U.S. Food and Drug Administration will convene outside
experts for a two-day meeting starting on Wednesday, asking for
guidance from doctors, manufacturers, researchers and the public
on how to monitor patients who get the implants or need them
The discussion will not address whether to impose more
rigorous testing standards on companies who already make the
devices, the agency said in documents posted ahead of the
The FDA also does not plan to ask for guidance on changing
review requirements that must be met before the implants can be
sold in the United States, or whether to remove existing
implants from the market.
But these are some of the key questions for researchers like
Art Sedrakyan of Weill Cornell Medical College, who has written
extensively about the safety issues with the all-metal hip
implants. He believes the larger type of metal-on-metal hip
implants should no longer be used.
"Having a lot of alternatives to these implants, it's just
very clear that the potential harms outweigh any benefits that
are possible to imagine," he said in an interview.
The FDA said about 400,000 Americans get a hip replaced or
repaired each year in order to make it easier to walk and to
alleviate pain from joint problems, including arthritis.
In 2010, about 27 percent of those implants were all-metal,
a decrease from about 40 percent in 2008, the FDA said, likely
due to the increased attention on the devices' safety problems.
In April, British health regulators advised surgeons to stop
using a type of metal-on-metal hip implant because of the high
risk for patients needing repeat surgery compared to other
devices. They have also told doctors to conduct life-long tests
for some patients who get all-metal implants.
The warning was issued for implant cups or heads made by
Finsbury Orthopaedics, a unit of J&J, used in combination with
femoral stems made by Stryker Corp.
The devices can produce debris that can leak chromium and
cobalt ions into the blood, causing health problems and
potential damage to chromosomes.
The FDA's meeting follows a May 2011 order from the agency
requiring manufacturers of metal-on-metal implants to collect
more safety data on the devices.
But a recent article in the New England Journal of Medicine,
co-authored by Sedrakyan, highlighted the delays in the studies.
By mid-June, over a year since the order, the FDA and companies
had agreed on study design for less than a quarter of the