(Reuters) – the food and drug administration of
United States ( FDA) responded to the growing concern about
the safety of metal hip prosthesis saying that
undergo the devices to a review of two days of
length by experts, which could lead to fix
more rigorous standards.
The FDA announced that a panel will be meeting on 27 and 28 June
integrated Advisor by scientists, researchers, patients and
medical assisting regulators to decide if they are imposed
new standards of assessment and review requirements to
must be met before that one of these prostheses may
sold in United States.
“we are consulting with experts, doctors and scientists
“
external to discuss the recent information on these
devices, so that the Agency can continue to
“
reliable recommendations in terms of security”, indicated in
a release Dr. William Maisel, Deputy Director of science
of the Center for devices and health radiation of the FDA.
The actions of manufacturers of Orthopedic devices
-including Stryker Corp, Zimmer Holdings Inc and Johnson &
Johnson – fell after the announcement, made on Thursday.
Hip replacement surgery is a common procedure
and expensive that it seeks to provide greater mobility and pain relief to
persons with problems joints, including arthritis.
Each year, United States, occur in about
270,000 hip replacements, which represents almost 40 by
cent of all replacements joints, according to British
Medical Journal. Analysts point out that the procedure
can cost as much as $17,000.
But for years there has been growing evidence that the
totally metal implants fail in greater proportion than
systems using other materials. Patients that the
are also have been showing to have older
concentrations of ions of metal in their blood.
A recent study of the whole national register of
England and Wales showed that about 6 percent of the
people that they implanted the variety exclusively
metal needed additional surgery to replace or repair the
prosthesis after five years, compared with the 1.7 to the 2.3 by
% of who carried plastic or ceramic systems.
The announcement of the FDA follows an order of May 2011 from
the Agency required manufacturers of metal implants
collected more data on the safety of their devices.
The FDA said that the meeting posted on the Advisory panel
it will look at rates of failure, evidence of metal ions
methods for images, risk factors for patients,
follow-up surgeries and complications associated with the
hip with metallic prosthesis replacements.