Surgical Guides & Your Liability

I think that with todays computer guided surgeries, we are seeing some amazing results. In fact, with the high success rates of these cases, and the ability to anticipate and pre-plan bone augmentation, sinus grafting, tissue modeling and even the simplified incorporation of zygomatic implants, computer guided implantology is rapidly becoming the standard of care. Practitioners can even download free planning and surgical guide software off the internet, so cost is no excuse.


The thing I find frightening is the number of labs who are fabricating model based surgical guides without the benefit of a CT Scan, or any other way of identifying and avoiding anatomical interference from adjacent root tips to the inferior alveolar nerve, or peforating the buccal plate due to angulation problems.


I think labs who are doing this kind of thing, are facing some serious issues when and if these cases go bad. A California Jury recently awarded 1.7 million dollars for a botched implant case where cone beam imaging could have avoided injury. What lessons do you think the insurance industry learned from the painful mistake?


Ask yourself a few questions if you are doing these guides. How will you answer these questions if you are drug into the lawsuit by an overzealous attorney working for the patient (and possibly the dentists' malpractice company):


  • Were you competent to manufacture this guide?
  • Even though the doctor asked you to make it, what made you feel qualified to accept the challenge? Were you given all the information you needed and did you ask for more?
  • Have you got documentation of your specialized education and experience in this area?   
  • Does the manufacture of this device require FDA registration?
  • Is your lab FDA GMP Compliant?
  • Did a competent authority (besides the defendant in the case) review your design?
  • Will your product liability insurance cover this product, or are you in violation of the policy?
  • Do you need professional liability in addition to your product liability insurance?

The work we are doing is much more sophisticated and technically challenging than the work we were doing just a few short years ago, and the dental technician performing these particular tasks and others like them need a whole new level of skill sets.


Please note that when a customer orders a surgical guide from Nobelbiocare and Simplant, they are signing a release that protects that manufacturer from any liability involving the use of that guide. What contractual protection do YOU have?


A case like this gone bad could cause you more grief that you'll ever know. Not only could it put you out of business, it could put your family out of their home, and could leave you owing a nondismissable debt to a patient and their attorney.


If you think all the responsibility lies with the dentist, please understand that when you started making surgical guides, you crossed over into a whole new world where fitness for use isn't measured with contact paper and an explorer.

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  • The dentists insurance company would love to hang the responsibility on the lab, and the plaintiffs attorney will be looking for the deepest pockets, and these days, as labs run towards bigger and bigger operations, our pocketbook is looking better and better to them. It's the perfect storm.

    Glad to hear you are buttoning things up John. Smart move. Our customer agreement went from over 14,000 words to close to 20,000, and we had our product liabilityt insurance policy rewritten to cover this. We also added a professional liability policy and a patient release when the surgical guide originates from a scan taken with our cone beam unit. Expensive as you said, but well worth the cost.

    I would also make sure you are FDA compliant, as that is another huge liability, and will certainly be used against you.
  • Really good points Mark,

    Ironically we are working with an attorney now drawing up a disclaimer for the surgical guides we fabricate in my laboratory. It certainly is a slippery slope and costly as well

    Often times we underestimate the actual scope of the procedure we are actually performing in the lab. It is certainly easy to fall back on the belief that we are just filling orders and are sheltered from any prosecution. Labs need to realize in this litigious society we live in there are no get out of jail free cards. Certain procedures need to have more information than we often receive. Documenting this and having a policy in place is one way to let me sleep better at night.

    Nice to see you here.
  • Thanks Mark,

    Excellent post and information!
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