OPEN LETTER TO THE DENTAL PROFESSION
Many of you have received a letter from Nobelpharma USA, Inc.* citing several allegations that constitute their lawsuit against Core-Vent Corporation. This suit seeks to prevent Core-Vent from interpreting the Brånemark research and other published research on the Biotes System in a manner that is contrary to Nobelpharma’s interests. Nobelpharma’s lawsuit before the United States District Court in Los angeles does not request one penny in damages.
Core-Vent Corporation believes that Brånemark’s published research belongs to the profession, not to the company marketing the hardware used in the clinical research. Core-Vent further believes that the proper forum for scientific debate is in published articles and professional symposiums.
It is impossible for Core-Vent to adequately respond to this letter, which continues to be widely distributed by Nobelpharma, since we do not know exactly who received it nor how many copies have been circulated. We do know that the members of the dental community who have received the letter now have a right to know the true nature of the lawsuit, and to be apprised of our position and counter suit. Therefore, we are sending this response letter to every oral surgeon, periodontist, and prosthodontist in this country and Canada.
1. Nobelpharma’s letter states: "The FDA has not approved Core-Vent’s device or material."
Core-Vent Corporation’s Response: "Core-Vent received the identical authority from the United States Food and Drug Administration (FDA) for the marketing of its endosseous screw implant, known around the world by its registered United States Trademark, Core-Vent®, as the Brånemark (Biotes) implant. FDA permission to
* The American subsidiary of a Swedish corporation known as Bofors Nobelpharma or Nobelpharma AB
market the Core-Vent Implant was granted on March 11, 1982 pursuant to Section 510K of the Federal Act –– Core-Vent No. K820163A. Core-Vent Corporation’s federal FDA registration number is No. 2025501, and the Department of Health Services, Food and Drug Branch of the State of California, has granted Core-Vent a device-manufacturing License No. 60611.
A Nobelpharma interoffice memo recently obtained by Core-Vent Corporation suggests that the FDA allegation in their letter was misleading: "...the FDA has approved use of titanium alloy for implants...at the present time, we cannot prove that the use of titanium alloy (as opposed to the use of pure titanium) has a negative impact."
2. Nobelpharma’s letter states that its legal action "does not seek to prevent Core-Vent from offering a competing system" but demands that Core-Vent "refrain from misusing the work of Dr. Brånemark and his colleagues."
Core-Vent Corporation’s Response:
The efforts by Nobelpharma and the Brånemark disciples to redefine and reinterpret the research results seem to be in direct response to Core-Vent’s increased professional acceptance. A recent article by Albrektsson, Zarb, Worthington and Eriksson in the first issue of the Journal of Oral and Maxillofacial Implants (Quintessence Publishing Co.) proposed the third definition of osseointegration by the same researchers in the last three years. This article supports my interpretation of the Brånemark research by acknowledging that: "...the Brånemark results...clearly underscore the basic concept of osseointegration as being the major, if not the exclusive, reason for a successful long-term dental implant attachment."
Core-Vent Implants have proven to be osseointegrated in both animal (JOMS, June 1986) and clinical studies (LSU Implant Symposium: Lubar and Katin –– 95% three-year success). A human specimen removed after two years in function for psychological reasons demonstrated osseointegration on light and scanning electron microscopy (see "Osseointegration" reprint enclosed).