Appendix - Sending Specimens for Research

Sending Specimens for Research

Type of Research Specimens:

The knowledge base on implant performance is at present incomplete. Many implant types used over several decades have not been studied in detail. Performance information is scarce. Failure modes are uncertain and there is minimal information published on the retrospective performance of devices which are currently promoted and where use is rapidly expanding.

Most clinical institutional pathology laboratories are over-committed and understaffed. They are rarely interested or equipped to deal with implant failure analyses. Their interests are habitually limited to basic tissue studies in support of the surgical activities and the medico-legal requirements of the institution. In some cases, costs and time constraints may further restrict their mandate to detection of specific diseases such as cancer, as is the case for breast surgery.

Innoval Failure Analysis has been involved in large scale implant studies for nearly ten years and is interested in all implant types, in particular long term implants for ophthalmic, cardiovascular, neurological, urologic and maxillofacial devices and their associated tissue. The work is dependent on availability of clinical material with implant or implant fragments which can be studied exhaustively and, when possible, using destructive analysis techniques.

There is a need for implants suitable for this type of detailed study. Medico-legal investigations generally preclude destructive evaluation of evidential material; research specimens suitable for destructive analyses can supplement the information base.

The receipt of implants as ‘donations for research’ is appreciated and can contribute significantly to the knowledge base on the performance of long term medical and dental implantables.

There is no cost levied for the study of such specimens. However, it is not generally possible to issue a written report in such cases. When such specimens are sent to Innoval, they must be accompanied by a covering letter authorizing destructive testing, if applicable. Additional material indicating the background of the device, and if available, copies of surgical and pathological reports would also be valuable and can accompany the shipment.

All material for research must be sent prepaid or billed to the sender (mail or courier). Duties and taxes must be indicated as billed to the sender or third party. The "Description of Contents" section on the courier waybill or the mailing manifest sticker must be indicated exactly as shown on the label below. The nominal value of $1.00 is particularly important. Duties and taxes will not be applicable and the package will not be delayed if the labelling is as shown.

Typical Mailing and or Courier Label:

Inoval Inc.

Adresse: 496 Westminster Ave.

Ottawa, Ontario

K2A 2V1, Canada

Or Contact delphine1939@videotron.ca

Micheline B. Lambert

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