TUESDAY, March 13 (HealthDay News) — There is “unequivocal
evidence” that stemmed metal-on-metal hip replacements fail at much higher
rates than other types of hip implants and should therefore be banned,
researchers say.
The failure rate is particularly high for stemmed metal-on-metal (MOM)
hip implants with larger head sizes and those implanted in women. In these
cases, failure rates are up to four times higher than other types of hip
implants, according to the study in The Lancet.
U.K. researchers analyzed data on more than 400,000 hip replacements
(including over 31,000 MOM implants) performed between 2003 and 2011. The
patients in the National Joint Registry of England and Wales were followed
for up to seven years after surgery.
Stemmed MOM implants had a five-year failure rate of 6.2 percent, which
was much higher than implants made from ceramic and polythene. Failure was
related to head size. Each 1 millimeter increase in head size was
associated with a 2 percent increased risk of failure.
The failure rate for ceramic-on-ceramic implants actually improved with
larger head sizes.
In women, failure rates for stemmed MOM implants were up to four times
higher compared to ceramic or polythene implants.
“Metal-on-metal stemmed articulations give poor implant survival
compared with other options and should not be implanted,” concluded
professor Ashley Blom, from the University of Bristol in the United
Kingdom, and colleagues. “All patients with these bearings should be
carefully monitored, particularly young women implanted with large
diameter heads.”
The study’s publication comes 10 days after the Medicines and
Healthcare products Regulatory Agency in the United Kingdom announced that
patients with stemmed MOM hip replacements require annual check-ups.
The use of stemmed MOM hip implants has declined in the United Kingdom,
but they are still used extensively in the United States, accounting for
35 percent of hip replacements in 2009. Large-head stemmed MOM implants
became popular because it was believed that they reduced the risk of
dislocation and were highly resistant to wear.
The situation involving stemmed MOM hip implants highlights the need
for careful evaluation of the safety and effectiveness of medical devices
before they’re approved by U.S. regulators, Dr. Art Sedrakyan, of Cornell
University’s Weill Cornell Medical College in New York City, said in an
accompanying editorial.
“The [U.S.] National Institutes of Health is interested in new
discoveries and, until recently, not in infrastructure for comparative
safety and effectiveness,” Sedrakyan wrote. “There is also substantial
pressure from Congress not to stifle innovation and to undertake faster
reviews…. [These practices] fail to recognize that only a large
national, or even worldwide, registry can address the needs when more than
10,000 products are on the market for the same purpose.”
Sedrakyan urged policy makers to require long-term testing of implants,
as some product malfunctions can take years to develop.
“In the case of the ASR and metal-on-metal implants, it took 45 years
before evidence was accumulated and reported,” he wrote. “We are left with
more than 500,000 patients with metal-on-metal prostheses in the United
States and more than 40,000 in the United Kingdom who are at elevated risk
of device failure, which will inevitably result in the burden of further
surgical treatment as well as billions of dollars in costs to
taxpayers.”
The ASR Hip System was recalled in August 2010, according to the
manufacturer’s website, DePuy Orthopaedics.
More information
The U.S. National Institute of Arthritis and Musculoskeletal and Skin
Diseases has more about hip replacement.
Views: 0