This article is being republished on The Concussion Blog with permission from Paul D. Anderson of http://www.nflconcussionlitigation.com. Paul is @PaulD_Anderson on twitter and has been a huge asset to this awareness campaign, make sure you also have his website in your rotation.
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Can a helmet, mouth guard, helmet shell, or other sporting equipment prevent or reduce concussions? Absolutely not! Whenever sufficient forces are transmitted to the brain–via a hit to the head or body–nothing can prevent the brain from slamming against the skull.
Unfortunately, companies are taking advantage of the concussion crisis by marketing their products as having the capability to reduce or prevent concussions.
The Federal Trade Commission (FTC) recently slapped Brain-Pad with an administrative complaint for violating Section 5(a) of the FTC Act. The FTC found that Brain-Pad’s marketing was false and misleading.
Some examples of the marketing used by Brain-Pad consisted of the following:
- “Reduces risk of CONCUSSIONS!”
- “Reduces the risk of concussion from: facemask impact, chin cup forces & direct lower jaw impact.”
- “Creates new brain safety space!”
- “Tested and proven to reduce risk of internal head injuries and concussion from lower jaw impacts”
- “BIOMECHANICALLY TESTED & PROVEN.”
- YouTube: “Brain Pad Protective and Performance Mouth Guards”
Brain-Pad and its President, Joseph Manzo, entered into a proposed consent order with the FTC, which will require Brain-Pad to cease making unsubstantiated claims that the mouth guards can prevent or reduce concussions. Once the order becomes final, and if Brain-Pad continues to make false claims, it will be hit with monetary fines of up to $11,000 for each violation.
Although this is a step in the right direction, other companies continue to make similar claims. Furthermore, the settlement does not provide a remedy to the consumers that were injured by Brain-Pad’s false and misleading conduct.
Probably the most outlandish example of false claims comes from MaherCor Laboratories, LLC.[1] MaherCor provides an expensive, moldable orthotic-type mouth guard allegedly designed as “an aid in the prevention of concussion.”
Aids in Concussion Prevention To help reduce the chances of suffering from a concussion, it is important to always wear a Maher product while participating in sports. The implementation of this properly-fitted mouth guard with the prescribed thickness separates the mandible (lower jaw) from the maxilla (upper jaw). This limits the chance of obtaining a concussion via a direct blow to the jaw. This, as well as wearing properly fitted protective head gear and chin straps allows for the utmost protection from dangerous head trauma. Mahercorlabs.com/concussions
John Gonoude had a promising athletic future entering into his freshman year of high school football. He was the captain of the squad, and his peers looked up to him as the next leader to take his team to the state championship.
Tragically, numerous concussions sidelined John’s football dreams.
During the summer of his sophomore year, a new coaching staff was put in place and John’s goal was to show the coaches he deserved a spot on the varsity squad. He suffered his first concussion during training camp and was required to sit out for a week.
In the interim, John’s father explicitly told his coach not to allow him to return to practice until a medical professional cleared him to play.
John believed he had to get back on the field or else he would lose his shot at making the varsity squad. Despite his father’s directive, the coach allowed him to return to play.
Later that day during line drills, John said he felt “like his brain was creeping out of his skull,” and he began screaming in pain on the ground. After his father shared a few choice words with the coach, his family decided it would be best if John sat out for the remainder of the season.
John experienced constant headaches, he couldn’t bear bright lights, and he had trouble reading — symptoms of post-concussion syndrome — which, according to John, made him “scared as hell.”
He and his father began researching concussions and looking for equipment that would allow him to return to play. His father came across the MaherCor website which promised a quick fix to prevent concussions. In fact, numerous professional athletes endorsed Maher’s mouth guard as effectively preventing concussions.
I previously had 3 concussions. I started wearing The Maher Mouth Guard 3 years ago and have not had a concussion since. I feel very comfortable wearing The Maher Mouth Guard and recommend it for any contact sport. It is perfect! Asante Samuel[2]
John said he and his dad were entirely convinced the mouth guard would keep him concussion free. His father dropped a coupled hundred dollars so that his son could be properly fitted with the Maher B-Protect Splint.
John was ecstatic. He told his friends and coaches that he was fitted with a mouth guard that would prevent concussions.
Cloaked with a shield of security, John felt that he could hit harder because he was protected with the mouth guard.
During the first week of training camp, prior to his junior year, John took another blow to his head, causing his third concussion. This time, ending his hopes of ever playing tackle football again.
John said other than giving him “a false sense of confidence,” the mouth guard was utterly worthless. “I wish people didn’t have to deal with this; especially once consumers find out the investment backfires.”
Leading neurologists and experts on sport-related concussions agree.
Dr. Jeffrey Kutcher, American Academy of Neurology’s chairman of sports neurology, testified that, “The simple truth is that no current helmet, mouth guard, headband, or other piece of equipment can significantly prevent concussions from occurring…Concussion prevention is much more about teaching proper technique, playing by the rules, and limiting the overall dose of impacts.”
Boston University’s team of experts, Dr. Cantu, Dr. Ann McKee, and Chris Nowinski, recently did a study of “concussion prevention devices.” The conclusion: “there is currently no evidence that standard or fitted mouth guards decrease the rate or severity of concussions in athletes.” Further, there was “no statistically significant results” to show that the custom mouth guard, which can cost up to $600, was any more effective at preventing or reducing concussions than a standard $5 boil-and-bite mouth guard.
Additional studies concur and conclude that the studies performed by Dr. Maher are flawed in multiple respects because they were based on “limited case series studies and retrospective, nonrandomnized, cross-sectional surveys.”
Though John still battles the cognitive effects of concussions, he has become a beacon for concussion awareness and frequently contributes to The Concussion Blog. John’s goal is to educate others about the severity of concussions, and that it’s ok to sit out if you are still showing signs of concussions.
There is no question the mouth guard negatively affected John, “As much as I love football, football scares the living hell out of me.” And John warns, “The fact that we have companies profiting and perpetuating the concussion crisis, sickens me.”
One of the main principles of concussion awareness is ensuring coaches, athletes and parents are educated about the symptoms of concussions. The false sense of security that the mouth guards, and other “concussion prevention” devices, provide undercuts this. An athlete who believes his equipment can prevent concussions is much less likely to report symptoms, dismissing them as a regular headache. Likewise, a coach and parent will put their guard down because they believe the athlete is less susceptible to concussions.
At bottom, MaherCor and other companies should not convey false messages that their product can effectively reduce or prevent concussions. Manufacturers would be wise to take note of the FTC’s recent actions and change their marketing schemes, or else they will be sued for violating consumer protection statutes.
If you have purchased any of the following products – Brain-Pad, Maher Mouth Guard, Guardian Caps, Full90, Shock Strips, etc. – please send me an email, at PaulD_Anderson@me.com, expressing your thoughts on the products effectiveness.
[1] The founder of MaherCor is also the New England Patriots’ dentist.
[2] Dustin Fink at The Concussion Blog scrutinized this comment and several other claims made by MaherCor and its employees. http://theconcussionblog.com/2011/09/30/mouth-gear-comments/#more-4775
Dustin, Once again throwing the baby out with the bath water. U.S. Army research is moving forward with the investigation of a protocol designed to balance the Temporal mandibular joints, prior to the construction of the mouth guard. No other company is doing this in the region where CTE is found, the medial Temporal lobe. This procedure has been recognized with a USPTO patent for this purpose. The U.S. Army Sbir has gotten the attention of Dr. Robert Cantu, a neurologist with a lengthy history in boxing. Much like an orthotic in the shoe of a person with one leg longer than the other, these guards may be made thicker on one side or the other to help balance the jaw joints in those with slipped meniscus, a diagnosable condition. Not all athletes have this condition, many do and our data shows, those with recurring “events” are candidates for fitting.
NFL research has failed to investigate this, even though it’s been used in the league since 1980 and Dr. Shaefer reports the Patriots have the lowest concussion rate annually in peer reviewed data.
No other guard on the market takes a medical approach. In fact Jeff Nixon president of the NFL retired players will tell you the latest NFL produced research on common mouth guards, finding show fitting some athletes with non adaptive, randomly positioning guards like Brain pad, may elevate the chances of getting a concussion. Ignoring Temporal mandibular joint dysfunction in athletes with concussion history is a fatal flaw. Most NFL players wear no oral protection or randomly positioning guards, their is no Tmd oversight or mandates for use.
As a trainer, you do have not the educational background in determining right from wrong in such medical cases as this you should be interviewing some of the Tmd experts I have suggested before dismissing the recommendation’s to the military of Dr. Jeffery Shaefer a Harvard/MGH Tmd expert and peer reviewer of our Dental Traumatology publication is your fatal flaw or Dr. Noshir Mheta, head of Tufts dental research on the effects of Tmd who suggests this may be appropriate for our troops. Obviously you have an agenda on the marketing as the guardian of all that is concussion. Clearly John Gonoude was not a candidate for this procedure, provided he actually was fit with this type of gaurd, many dentist pirate this idea. More than likely he may have had some sort of physiological issue other than his jaw, that may be the issue in his case. We have made it clear from the beginning other issues, blows to the neck, poor helmet fitting/design or blows to the top of the head may be the issue and no oral appliance can address these types of forces. Once again, our messaged and focus is Tmd in athletes, it should be corrected prior to play. Much of the concussion rhetoric you cite was put online 5 to 6 years ago, prior to the existence of watch dogs like yourself. Protecting kids with Tmd and concussion history, that is all we are claiming.
Mark most military injuries in OIF/OEF do not result from blows to jaw or face. These injuries result from differential pressure from a blast event.
Receiving a 100K Phase I SBIR from DoD is not a validation or endorsement of your dental appliance. It is some money to conduct some research.
I can’t exactly follow the connection between your product to the medial Temporal lobe.
Robert Cantu, MD is a neurosurgeon. His research dating back three decades involves injury to brain resulting from athletic exposure among other things.
You say many athletes have this condition but you show no data, AGAIN!
Does Shaefer own your company or is compensated by your company?
How does Shaefer explain such a low rate of concussion with Patriots? Perhaps it was not your appliance. Perhaps the Patriots just did not bother to diagnose them or record them. Maybe give Ted Johnson a call he might have some thoughts. He has his career ended because of the cavalier attitude of the Patriots medical staff toward concussions.
“May be appropriate” a qualified statement without supporting data.
Dustin is not qualified,OK. He may not be a dentist but since you present nothing but hype he is qualified to call BS.
The statement regarding John Gonoude representations are irritating. You should prove you did not supply the appliance before you make accusations. Maybe your product simply did not work. As usual, we can’t really say whether the product works or not because you never present any independent data.
Prove your claims or stop posting nonsense. At some point, a federal agency is going to make you. Saying a guy from Harvard or Tufts thinks it might work is not sufficient to please the FTC.
Re: my qualification, research what my education entailed and get back to me… Then do all the research and reading and classes post school then get back to me…
I am not a doctor, not a dentist, not even a trainer. I am an athletic trainer who has nearly 7,000 hours of post graduate research and supplemental education about concussions…
If you tout your product as a TMJ problem fixer then fine… Don’t confuse or muddy the waters by saying it relates to mTBI or concussions, because it doesn’t…
Stop.
Dr. Shaefer is not an owner, completely independent. He peer reviewed the Dental Traumaology paper that has data on athletes and Tmd. Military blast forces related to the chin strap are the focus of the Army investigation, something Dr. Cantu is not endorsing, just collaborating. The Gonoude case is Hippa protected, no idea who made the guard. The Sbir is for $700k in a phase 2. Again, not claiming to prevent concussion only address Tmd symptoms found to be similar to mtbi symptoms, nausea, dizziness, the sensation of seeing stars. These questions being addressed should have been investigated years ago, focus on helmets has overshadowed this and its relation to the football helmets anchoring system, the chin strap. We are re adjusting the marketing, no issues there. Tufts and Harvard are the pioneers in Temporal mandibular joint diseases and should be consulted for info on what it is.
http://nflconcussionlitigation.com/?p=1056
Dustin, this post is getting around. Can you send me the name of the dentist who made John Gonoude the mouth guard. mpicot@mahercorlabs.com
Thanks
Nope you can contact John Gonoude…
Dustin,
What’s your thoughts on ImPakt Protective’s “Shock Box” sensor? I know my thoughts. Want to hear yours. One of my coaches called me because he was approached from someone who was willing to shed the dough to outfit the whole team with them. 1,2,3….GO!
Dustin and Tommy can you guys start getting copies of all the equipment data and posting. Since NATA is keeping up with things, maybe you should start the equivalent of consumer reports site for seeing if any of these products are good.
Too many schools and parents are getting fleeced trying to do the right things. NATA should be able to find you a grant and you can buy some experts.