Proposed Consent Agreement In the Matter of Brain-Pad, Inc., FTC File No. 102-3073 #561790-00007 

Submission Number:
Paul Piccininni
Outside the United States
Initiative Name:
Proposed Consent Agreement In the Matter of Brain-Pad, Inc., FTC File No. 102-3073

On behalf of the various International Sport Dentistry groups which we represent, we are grateful for the opportunity to provide our input on and support for the recent settlement reached between the FTC and "Brain-Pad". The false and misleading claims regarding concussion prevention being made by various manufacturers over the past decade have been a constant source of both frustration and embarrassment with our other professional colleagues. Concussion is a serious and significant issue at all levels of sport, and many groups are working diligently to try to not only reduce the incidence of these serious injuries but also determine when it is safe for a concussed athlete to return to play. Most of the current guidelines on concussion definition, management and prevention have been developed during the three International Symposia on Concussion in Sport (Prague 2001, Vienna 2004 and Zurich 2008). These prestigious meetings have been sponsored by the IOC, IIHF (International Ice Hockey Federation), FIFA (governing body for world soccer) and IRB (International Rugby Board).and have redefined the standards for all aspects of concussion. At the very first of these meetings, Dr. Paul McCrory and his group from Australia presented a detailed review of all of the current and historical literature relating to the possible relationship between mouthguard use and concussion prevention. Their conclusion was simply that there is no scientific evidence to indicate any such relationship. There have been no posters, papers or presentations at either of the subsequent two international symposia that have drawn any additional research-based relationship between mouthguards and concussions. Three other prestigious and well-recognized meetings also addressed this issue. At the World Injury Congress in Monaco (2011) the importance of mouthguards in preventing dental and orofacial injuries was scientifically reinforced, but there was no additional evidence presented to change the position on their role in concussion prevention. Similar results were presented at the Concussion in Ice Hockey meeting at the Mayo Clinic (October 2010) and the AOSSM Symposium on Ice Hockey Injuries in Toronto (August, 2012). The Academy for Sport Dentistry (ASD) - in their February 2011 Position Statement on the use of Mouthguards and other Oral Appliances for the Prevention of Concussion and Enhancement of Strength and Performance - stated very clearly the following: "The Academy for Sports Dentistry has not yet (2011) identified any sound, independently peer-reviewed, published scientific research which either supports or refutes the wearing of any type of mouthguard or oral appliance for concussion prevention, or athletic performance and strength enhancement. The Academy for Sports Dentistry supports continued and future scientific dialogue and research which has been substantiated by sound, peer reviewed independent scientific data published in credible journals." The ISDST (International Society for Dentistry, Sport and Trauma), as well as the Dental Advisory Group for the International Olympic Committee Medical Commission Games Group, recognize and support the position of the ASD on both the performance and concussion issues. Properly designed and fitted mouthguards have been scientifically shown to play a key role in the prevention of thousands of dental and orofacial injuries every year. An argument can also be made in certain cases for the nomenclature "jaw-joint" protectors, as in certain cases the TMJ complex might be protected from various injuries while wearing a mouthguard. But claims of concussion prevention are totally unfounded and it is refreshing - after many years of being embarrassed by these claims - that the FTC has taken a stand to eliminate these false claims and protect American consumers from prematurely returning young athletes to play after a concussion with the false hope that they are being protected. We would strongly encourage the FTC to use this additional information in order to make its proposed consent order final. Should you require any additional information or clarification on any of the above discussion, please do not hesitate to contact any of the undersigned. Sincerely. Dr. Jean-Luc Dion Executive Member, International Society for Dentistry, Sport and Trauma Dr. Ray Padilla, Past President, Academy for Sport Dentistry Sport Medicine Staff, UCLA Dr. Anthony Clough Senior Dental Advisor, London 2012 Olympic Games Dr. Paul Piccininni IOC Medical Commission Games Group IIHF Medical Committee