Proposed Consent Agreement In the Matter of Brain-Pad, Inc., FTC File No. 102-3073 #561790-00009 

Submission Number:
Albert Gusenbauer
Oral and Maxillofacial Surgeon
Outside the United States
Initiative Name:
Proposed Consent Agreement In the Matter of Brain-Pad, Inc., FTC File No. 102-3073
Re: Brain-Pad ruling I am an Oral and Maxillofacial Surgeon with 20 plus years of experience on the Regional Trauma unit in Hamilton Ontario, serving five hospitals including University teaching hospitals. I have provided my services in instances of head trauma to the maxillofacial area and became acquainted with the products of Brain-Pad after treating a patient who had the condylar head (jaw joint) displaced into the cranial cavity (skull) following impact to the lower jaw, via the chin. The case was published in the Journal of the Canadian Dental Association co-authored by the consulting neurosurgeon (Dr. Hollenberg) on the case along with a dual trained Plastic and Craniofacial Surgeon/ Oral and Maxillofacial Surgeon (Dr. Sandor). The case provides irrefutable proof that impact to the lower jaw can create injury to the TMJ, skull base and brain by posterior and superior displacement of the lower jaw during impact. No dentist or doctor with even a rudimentary understanding of anatomy and trauma would have any difficulty in understanding this concept even in the absence of the well documented clinical cases, a few of which are referenced in the article. The Brain-Pad product line is the only intra oral appliance to address lower jaw impact by stabilizing the lower jaw to prevent posterior or superior displacement caused by blows to the lower jaw. This is accomplished by locking the lower jaw in position with respect to the upper jaw, through coverage of both the upper and lower jaw dentition. Reducing energy transmission to the skull base and brain in lower jaw impact can reduce the risk of diffuse brain injury (concussion) and focal (localized) brain injury. No other mouthguard includes this dual arch design (locking the lower jaw to the upper jaw dentition). The Brain-Pad design stands alone in protecting the TMJ and skull base during lower jaw impact, reducing the risk of concussion, focal brain injury, and TMJ injury. Other mouthguards are in effect designed to protect only the teeth. The effectiveness of the Brain-Pad design concept is well documented in the literature submitted to the FTC. The concept of locking the lower jaw in position to prevent displacement during lower jaw impact is effective with or without jaw positioning in the appliance to create additional protective space in the TMJ area. This is simply and additional level of protection. The amount of anterior positioning of the jaw to create this space is minimal and well within physiological limits utilized in many dental appliances including "snore guards", TMJ appliances etc. Any persons who may have made submissions to the FTC describing this as a "dislocation" positioning are completely in error and totally lacking in understanding of TMJ anatomy. The design concept of Brain-Pad products is also well understood by the boxing and martial arts communities. Combatants understand that a blow to the chin or lower jaw is known be the prime target for incapacitation of an opponent. The chin-lower jaw-TMJ-skull base route of energy transmission is one of the most efficient roots of delivering energy and hence injury and incapacitation to the brain in combat sports. Only the BrainPad product can minimize the risk associated with impact to the lower jaw. Lower jaw and chin blows are not restricted to the martial arts and can and do occur in the majority of contact sports with varying degrees of frequency. Any decision or statements by the FTC that even imply that the Brain-Pad products can be categorized alongside conventional mouthguards (teeth guards in effect) only serves to deny the public of the necessary information needed to make a proper choice in maximizing protection against the effect of trauma via blows to the lower jaw. I am certain that this cannot be the intention of the FTC whose mandate is to serve the public and would urge that the FTC reconsider their decision as relates to the ruling re: Brain-Pad products.