BIOMET 3i SLActive implants

Dec. 17, 2010
BIOMET 3i’s Italian distributor, Straumann Italia ,admitted in vourt that flawed clinical conclusions were drawn from the preclinical study it sponsored by Dr. Frank Schwarz that compared SLActive Implants to BIOMET 3i NanoTite Implants.

PALM BEACH GARDENS, Florida--After being confronted with a suit before an Italian court brought by Biomax, BIOMET 3i’s Italian distributor, Straumann Italia, admitted in court that flawed clinical conclusions were drawn from the preclinical study it sponsored by Dr. Frank Schwarz that comparead SLActive Implants to BIOMET 3i NanoTite Implants.

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In addition, Straumann Italia admitted that it falsely identified BIOMET 3i NanoTite Implants in its marketing literature that referenced Dr. Schwarz’s preclinical study. Straumann admitted that the preclinical study, which was published in the Journal of Clinical Periodontology, entitled “Influence of Titanium Implant Surface Characteristics on Bone Regeneration in Dehiscence-Type Defects: An Experimental Study in Dogs”, concerns dehiscence-type defects artificially created in animals.

Straumann Italia admitted that if such dehiscence-type defects created during the preclinical study should be found in humans, it would be correct to follow a bone reconstruction procedure. In addition, while the SLActive and BIOMET 3i NanoTite Implants have several design differences, Straumann also admitted that these other design differences were not evaluated by Dr. Schwarz and that the comparison made by Dr. Schwarz concerned only one of several issues that can determine an implant’s success.

Straumann Italia’s marketing piece that highlights Dr. Schwarz’s preclinical study included a comparative photo of two implants, one of which Straumann identified as a BIOMET 3i NanoTite Implant that had allegedly failed. However, Straumann Italia now admits that this allegedly failed implant in its photos was not, in fact, a BIOMET 3i NanoTite Implant.

“We are very pleased with the outcome of the litigation concluded with this admission made by Straumann Italia in favor of Biomax and continue to stand behind our NanoTite Implant product line and its strong global growth," said BIOMET 3i President Maggie Anderson.

"We are confident that outcomes such as this will encourage industry to focus on credible, evidence-based science rather than inaccurate comparisons. BIOMET 3i will continue to support clinical research that is accurate and evidence based and let the results speak for themselves.”

Clinicians are reacting to the recent judgment.

“I have placed hundreds of BIOMET 3i NanoTite Implants and have experienced consistent success in my practice,” said Dr. PO Östman, a global key opinion leader in the dental implant market and a clinician and researcher in Sweden. "The flawed comparisons in the study surely tainted the results in this article.”

To view Straumann’s retraction, log on to To read the retraction in English, click on the title on the screen.

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