Jaw Implants Backed by Flawed Research, Conflicts of Interest, Investigation Finds

Medical devices used to treat Americans with a serious jaw joint disorder were approved by the Food and Drug Administration despite weak and incomplete research and conflicts of interest, an investigation by the Milwaukee Journal Sentinel found.

Since 1999, the FDA has approved four joint replacement implants for people with TMJ, or temporomandibular joint disorder, a group of ailments affecting the joint connecting the jaw to the head. Yet doctors involved in two of the clinical trials had a financial stake in the success of the devices, which may have biased the results.

In one of the trials, Dr. Peter Quinn of the University of Pennsylvania, tested the jaw replacement device he  invented for Biomet, a device maker based in Indiana, which paid him royalties later on.

Quinn said he assigned his patent rights to the company years before the device was approved, and only began receiving royalties in the last year.  “I sleep very well,” Quinn said. “I would put it in a family member.”

A trial for a device made by TMJ Concepts was conducted by Dr. Louis Mercuri, an Illinois oral surgeon who had helped to develop the device and later received stock in the company.

Mercuri acknowledged that the science behind the device was weak, but said the FDA decided TMJ patients with few other options could benefit from the treatment.

Studies were also marred by violations in study protocol, half-filled patient forms, and high dropout rates, according to the Journal Sentinel.

In a statement to the newspaper, the FDA said it stood behind the approvals.

More than 10 million Americans are afflicted by TMJ, and over the past two decades it’s estimated that more 1,000 per year have undergone implant surgery.

Christian Stohler, dean of the University of Maryland Dental School and adviser to the TMJ Association, a patient advocacy group, told the newspaper that the benefits of the devices outweigh the risks only in a few instances.

“There is very little science behind them,” Stohler said.

Print Print  
Lilly Fowler

About the author

Lilly Fowler is assistant editor at FairWarning.

7 comments to “Jaw Implants Backed by Flawed Research, Conflicts of Interest, Investigation Finds”

  1. Michael

    This is a very interesting debate to say the least. I certainly feel badly for those who may have had a bad outcome from a TM implant but would remind everyone that medicine is a science with no guarantees. On that point, the many disclosures and informed consents we are required to sign as patients make this point explicitly clear.

    I personally received bilateral Biomet joints approx seven years ago. That procedure was the culmination of a nearly 20 year treatment plan that was managed by Dr. Peter Quinn and his team at the University of Pennsylvania. Not a day or meal goes by that I do not reflect upon the care I received for many years and give thanks to Dr. Quinn’s commitment to improving the lives of everyone suffering from debilitating TM joint disorders.

    As a healthcare management professional I see far too many physicians who take advantage of patients and attempt to capitalize on their misfortune. Anyone who suggests that Peter Quinn falls into that category is either speaking from a position of ignorance or is subject to their own personal/financial bias. I consider myself lucky to be a patient of Peter Quinn’s and am thankful the hands that designed that joint were the same as those that performed my surgery.

    Thank you Dr. Quinn.

  2. Ruthie

    National Institute of Dental and Craniofacial Research’s TMJ Implant Registry and Repository
    The TMJ Implant Registry and Repository asked both patients and clinicians to contribute clinical information and biological specimens from patients who are having surgery with TMJ disorders.
    Why are they lacking data when they are both working with this institute. So many so called TMJ Specialist not acting very responsible.

  3. Ruthie

    I could not agree with you more. An estimated 100,000 alloplastic implants were placed in the TMJ joints during the TMJ Implant disaster. If they had performed a discectomy only, we had an outcome of 80-90% chance of living pain free today. http://www.aehf.com/articles/A75.htm
    How many implants are still being implanted a year? Christensen states that in a 19 month delay his company lost $6million After a 19-month delay during which the company lost $6 million and TMJ Concepts had gained a substantial lead. http://www.mddionline.com/article/predictability-competes-confidence-510k-revamp
    August 29, 1993 – Looks like it is still the money joint with no accountability. Tracking requirements of the Safe Medical Devices Act became effective. Manufacturers of certain devices, including TMJ implants, must establish tracking systems, which will enable them to promptly locate devices in distribution. Newly marketed devices subject to tracking are also subject to postmarket surveillance studies.
    How is this tracking working out??? Maybe you could give those patients lost in the above studies a call to see how they are feeling!
    I am disheartened to say the least and all I can ask is Why, Why, Why!
    TMJ Implant Victims are Brave Little Soldiers waiting for answers. Medical Insurance paid for our surgeries and then dropped us. Are we Medical or Dental? We are significant. May we all persevere on this unknown, uncharted territory of the TMJ joint.
    May we survivors never be afraid to entrust the unknown future to the all-knowing God. http://www.youtube.com/watch?v=Ht_AlpW1t0Q
    I am disheartened to see this

  4. Synergy463

    Thank you for publishing this, but the problem is far more complicated that what is being represented. Currently 35,000,000 people suffer from Temporomandibular Joint Disorder (TMJD). The stat cited, taken from the Mayo Clinic’s web content, is quite old.

    The fact is that neither the AMA nor the ADA recognizes TMJD as a condition and as a result, there are no established diagnosis/ treatment protocols past the “Wilkes” surgical staging which is dated. If there is a problem with the jaws functions, let’s just lump it under a catchall diagnosis and call it a day. This just isn’t working.

    People are suffering and don’t know where to go for help. If they are referred to an orthodontist, braces will more than likely be sold as curative intervention regardless of whether they will actually help or not. Diagnosing is too ambiguous. The disorder needs to be deconstructed and further defined and protocols established to ensure patient care. It’s been 20 years since the disaster. At the very least, this disorder should be defined so what happened to patients like me doesn’t happen again!

  5. Ruthie

    A silent FDA and Congress that have failed to make it clear to the TMJ Implant Survivors they failed to protect…And you want to control our health care..No Thank you!

  6. Ruthie

    I guess it can be said that No One is thinking and Articulating clearly. If the FDA and Congress kept their word and held manufacturers accountable then the patient would be protected. Because this clearly is not happening, patients continue to be injured with no recourse.
    We then try and pass through The Medical Device Safety Act? We need to spend more tax dollars to get the protection we are promised for negligent Medical Devices, fraud, misrepresentation? I question the word intended use! Looks to me the patient is being used. http://www.atla.org/cps/rde/xchg/justice/hs.xsl/12044.htm
    Nine Scientist from the FDA’S Medical Device Unit filed complaints concerning the safety of Medical Devices and the were intimidated and harassed only to have their complaints thrown out of investigation by federal officials???????
    Who really is in charge of the FDA and why do we sit back and allow them to continue to let corruption continue? http://www.youtube.com/watch?v=afX6VYn48KE

  7. Ruthie

    This taken from the 1992 Congressional Hearings…Nothing has changed!
    What can the FDA do to ensure that the research provided to the FDA is less biased and of better quality than some of the research evidence you have received in the past?

    Mr. Benson. One thing that we are doing is beefing up our bioresearch monitoring group within the center. This has not functioned in as strong a way in that past as it should.

    Ultimately, I think the way to assure that we get good data is to make sure that manufacturers understand the importance of that. We need to be very clear that we can’t allow fraudulent data, poor data, inadequate date, in support of approval for a product.

    To conclude, the development of Silastic sheeting in particular and other implant materials for the TMJ, which is one of the most critical joints in the body, is marked by a pattern of haphazard development, entrepreneurialism, unverified assertions in the absence of animal testing, and frankly, a silent FDA.

    “Are we now then to conclude that silastic/silicone is still being used in the TMJ joint today. Science is weak but still acceptable. The FDA is still allowing fraudulent data, half filled patient forms…poor data. High drop out rates? Or do you mean damaged goods..failures…pushed away and an FDA that continues to allow this 18 years later.

    Dr. Quinn may sleep well but many of his patients do not. Money over your own conscience and even family members?

    I know it is hard for me to look in the mirror when my face is swollen and looking deformed…How can you all look even look at yourselves.

    To much power in corporations is the greatest evil…How are we to trust the regulator when they play both sides of the fence. Protection? Do No Harm? What about the moral obligation to the patient and mankind? America’s tax dollars at work…and I don’t like what I see!

Leave a comment