The Stryker Rejuvenate and
ABGII were both recalled this past July after it was found the implants had a
higher-than-normal risk of causing fretting, corrosion and the potential for
metal ion debris to enter the body. Up until now, the focus regarding those
metal ions has been on the cobalt and chromium shards which can lead to a
variety of serious health issues including metal toxicity. The neck of the
Rejuvenate and ABGII is constructed of the harder cobalt and chromium while the
stem is constructed of titanium.
Titanium has generally been
considered a “safe” metal therefore little attention has been given to the
possible side effects of titanium. Titanium, over time, binds completely to
bone and living tissue, minimizing the need for adhesives. The titanium
component of the hip replacement device is also more flexible and lightweight
than the cobalt and chromium component. Despite these “pluses” there may be
risks inherent in a titanium hip implant component which few recipients are
aware of.
Titanium Allergies Could Cause Problems in Rejuvenate Recipients
Metal allergies have been
researched as they relate to metal hip implants because some thirty percent of
the population have a metal sensitivity to nickel, and the cobalt and chromium
implant contains at least 1% nickel. Titanium allergies, on the other hand, are
a barely recognized problem. It is a fairly recent occurrence that a test known
as MELISA® can test
for titanium sensitivity although the test cannot measure serum levels of
titanium in the bloodstream as tests for cobalt and chromium can do. Labs using
the MELISA® test
report that 4% of all patients tested for titanium sensitivity test positive.
Titanium Allergies Cause a Variety of Health Problems
Titanium sensitivity can be
very frustrating for those who have the allergy as their symptoms can be
somewhat vague and may be wrongly attributed to other health issues. Skin
rashes in the hip implant area, muscle pain and fatigue, Chronic Fatigue
Syndrome and chronic thigh pain may all indicate an allergy to titanium.
Titanium is not only used in metal hip implants such as the Stryker Rejuvenate
and ABGII, it can be found in many everyday articles including certain food
coatings, cosmetics, sunscreen, medicine coatings, paint, certain whitening toothpastes,
jewelry, vitamin supplements and even the hard candy coating found on Skittles
and M & M’s.
Stryker Rejuvenate Patients May Be Subject to Titanium Corrosion
Like most all metals,
corrosion causes a release of metal ions which bind with body proteins. A
person with an allergy to titanium may find their body will attempt to attack
the foreign particles of titanium when sensitivities to the metal are present. This
attack will cause inflammation in the hip area and likely pain to the victim.
The MELISA® test is
currently the only test which has been proven to diagnose titanium
sensitivities. Additionally, several studies have concluded that titanium
metals frequently contain small amounts of nickel as a result of the
processing. Therefore a person who is sensitive to both titanium and nickel
could have extremely strong reactions to a Stryker Rejuvenate or ABGII hip
implant.
Studies on Titanium Allergies
A study done in 2006 tested
fifty-six recipients of a titanium-based hip implant device after each patient
experienced a variety of adverse health issues following the implantation.
Testing was done on each patient to determine whether they had sensitivities to
any of the ten metals including titanium. Of the 56, 21 tested positive for a
titanium allergy, 16 patients tested “ambiguous,” and the remainder tested
negative for a titanium allergy. Of the 56, all but two underwent revision
surgery to replace their titanium-based hip implant with a different implant
material and all 54 showed “remarkable” improvement of their adverse symptoms.
The conclusion of the article was that titanium, in those who are sensitive to
the metal, can cause “clinically relevant hypersensitivity in a subgroup of
patients exposed to titanium implants.”
A 2004 study detailed in the
Journal of Bone and Joint Surgery followed nine patients with titanium-based
hip replacements who all suffered from severe thigh pain which worsened at
night despite a well-fixed implant and no sign of infection. Eight of the nine
underwent revision surgery after x-rays showed deterioration of the femur at
the tip of the titanium stem. Following revision, the tip of the removed
titanium stem was found to be highly acidic with considerable evidence of
corrosion. As to whether the cobalt and chromium ions react negatively with the
titanium ions, this same article did note that galavanic corrosion is more
likely to occur in a hip implant using dissimilar metals.
Two specific case studies done
in England determined titanium allergies were the culprit for the adverse
health issues and one of the patients also suffered from a nickel allergy as
well. Fatigue, exhaustion, fevers, headaches, suppressed appetite, pain,
swelling, neurological disturbances and even confusion were noted by the two
patients, yet once their titanium-based implant was removed, the symptoms
disappeared completely.
Patients with Suspected Titanium Allergies and a Rejuvenate Implant
Those who have suffered pain,
fatigue, and other adverse symptoms following their Rejuvenate hip implant
should request that a MELISA test be performed to determine whether they have
an allergy to titanium. While science has not yet determined whether the cobalt
and chromium ions can react negatively to the titanium ions, it is definitely a
possibility. Despite the titanium hip replacement recall of the Rejuvenate and
ABGII in July, 2012, many of those implanted with the devices continue to
experience serious health issues.
