Q:

8/26/2013
Many people have had implants and have had problems and are asking if the implant needs removal. I have been asked on more and more occasions to do the LTT-Melisa test at Elizabeth Valentine-Thon, PhD's lab as one test to base this decision and have done so as per request stating the test may not have clinical value. Reviewing your comments that the (to paraphrase) the jury is still out on this I wonder if you could suggest how we as a society/AAAAI could "collate" the data on this. I mean that those who do the test might send back to you or others the "outcomes" of removal of the metal knee, hip or other replacements and see if there is a clinical benefit to such testing. Does AAAAI have such a service?


A:

Thank you for your inquiry.

I am not aware of anyone, either in the Academy or the College, working on this project or any project similar to it, but it may be that such study is in planning. It also may be that other information has come forth since we last approached this problem. Dr. Luz Fonacier is an expert in contact dermatitis and has great experience with evaluating patients who have had possible contact reactions to implants. I am therefore going to ask Dr. Fonacier if she is aware of any ongoing research by either organization, and also for her to give us her opinion about the utility of this test. The last article that I could find in the literature dated back to 2011, and still, in my opinion, left a question as to the predictive value of lymphocyte transformation testing in this area.

In the meantime, both the Academy and the College do have venues that would be open to your suggestion. The interest section of the Academy that deals with dermatology, anaphylaxis, and drug reactions could be approached, and the drug reaction committee of College would also be an appropriate venue to open discussions in this regard.

Thank you again for your inquiry and I will get back to you with Dr. Fonacier's reply as soon as we receive it.

Sincerely,
Phil Lieberman, M.D.

We have received a response from Dr. Luz Fonacier. Thank you again for your inquiry and we hope this response is helpful to you.

Sincerely,
Phil Lieberman, M.D.

Response from Dr. Luz Fonacier:
We are currently accumulating data from literature regarding reactions to biomedical devices, Patch Testing and the LTT. The Workgroup on the Practice parameters will try to address this issue. The Lymphocyte Transformation Test measures lymphocyte proliferation (stimulation index) after 7 days incubation +/- allergen Some authors feel that the LTT better reflect immune reactions within the body, whereas PT reflects cutaneous reactivity. The problem with LTT is that there are limited allergens, its availability & rapid decay of T cells (meaning the need for rapid transportation). It may be useful in questionable cases, one study showed that 54/56 patients with Ti implants, (-) PT & (+) Ti LTT whose systemic symptoms resolved after implant removal. However, this needs validation.

References: (MELISA test: Health Diagnostics and Research Institute, South Amboy, NJ)
Muller K E, Valentine-Thon E. Hypersensitivity to titanium: clinical & laboratory evidence. Neuro Endocrinol Lett 2006: 27: 311-313

The bigger issue is really

  • Whether risk of allergic reaction to orthopedic implants increase in metal sensitized individuals
  • Whether supposed allergies to implanted devices really cause problems such as loosening or dermatitis
  • How to identify the subgroup of metal allergic patients with increased risk of complications from metal implant
  • Whether PT can truly detect reactions to implanted devices
  • Which is better, the Patch Testing vs. Lymphocyte Transformation Test


Based on the complex findings, it is difficult to make general principles for good clinical practice & prospective longitudinal studies are strongly needed. We are actually trying to get a prospective study done in our institution. Funding is the issue.

I will update you as soon as we have decided on what to include in the updated practice parameters for contact dermatitis. Hope this helps.

Luz Fonacier, MD

AAAAI - American Academy of Allergy Asthma & Immunology