As more and more metal hip
implants are being recalled, those who were implanted with a Stryker hip
device—believing it to be safe—are dismayed to find that Stryker cobalt
toxicity is just one health risk associated with the Rejuvenate and ABGII. The
Rejuvenate and ABGII Stryker implants are not “true” metal-on-metal implants
due to the fact that they use a ceramic ball. Unfortunately, the Stryker
implants share the same risks of fretting and corrosion. In fact, at the time
of the recall, Stryker stated a higher-than-normal risk of implant failure from
the fretting, corrosion and excess metal debris shedding into the body.
When Stryker introduced the
ABGII and the Rejuvenate, there were no safety risks relayed to patients,
particularly concerning Stryker cobalt toxicity.
Both devices gained FDA approval through a controversial process known as the 510(k), which does not require clinical trials, only that the device be substantially equivalent to a device already on the market. From the time of approval, in 2008 and 2009, adverse reports began coming in to the FDA regarding both Stryker cobalt toxicity and metallosis symptoms. Symptoms of metallosis can occur when tiny metal shards of cobalt and chromium lodge into the tissues surrounding the hip. Severe inflammation, infection, chronic pain, bone loss and tissue degradation can all occur when the body sees the metal shards as a foreign body and attempts to “fight” them.
Both devices gained FDA approval through a controversial process known as the 510(k), which does not require clinical trials, only that the device be substantially equivalent to a device already on the market. From the time of approval, in 2008 and 2009, adverse reports began coming in to the FDA regarding both Stryker cobalt toxicity and metallosis symptoms. Symptoms of metallosis can occur when tiny metal shards of cobalt and chromium lodge into the tissues surrounding the hip. Severe inflammation, infection, chronic pain, bone loss and tissue degradation can all occur when the body sees the metal shards as a foreign body and attempts to “fight” them.
Stryker cobalt toxicity can
result in cardiovascular problems, loss of vision and hearing, neurological
disorders, chronic headaches, irritability, depression, memory loss, vertigo,
gastrointestinal disorders, skin rashes, DNA disruption and the formation of
pseudo-tumors. Cobalt is found in miniscule amounts in the body naturally—less
than 1 part per million. When cobalt ions shear away from the metal hip device,
those ions can lead to Stryker cobalt toxicity due to levels of cobalt in the
bloodstream which are many times those considered safe.
Some physicians believe any
cobalt levels above 2 parts per million are dangerous, while others put the
number at 7 parts per million. Stryker cobalt toxicity can affect different
implant recipients differently. Some people are especially sensitive to heavy
metals and may suffer serious symptoms of Stryker cobalt toxicity at relatively
low levels, while others could test as high as 20 parts per million while not
experiencing any serious side effects. It’s
important that those experiencing Stryker cobalt toxicity discuss those
symptoms with their physician and have regular blood work done.
No comments:
Post a Comment