What You Should Know About the Dental Implant Industry
by Dr. Michael Gulizio
Advances in dentistry within the last decade or so have led to incredible technological developments. Dental implants have become the treatment of choice to replace lost or missing teeth, and when done under proper surgical technique, success rates have surpassed 95%. When the concept of osseointegration or fusing titanium with bone was introduced to the dental community in the early 60s by an orthopedic surgeon known as P.I. Branemark, the application of this concept was adapted to dental use; implementing the procedure, however, into a dental setting was seen as risky and unpredictable. Success rates at this point in time rarely approached 55-60%, and many clinicians felt that their introduction into a patient's treatment plan may be too premature for predictable success of a particular prosthesis. To improve success rates, alterations in the design of the dental implant surface were introduced most without sound, clinical evidence to back-up manufacturer's claims of improved success rates. Through years of empirical experimentation, a titanium dental implant was developed that looked much like that of a natural tooth root.
Some 40 years later, technology within the dental implant field has facilitated their colloquial use among general dentists and specialists. When the market for implant dentistry exploded not more than a decade ago, many implant manufacturers decided to alter the topographical surface of the implant fixture with unsubstantiated claims of improved success rates to win market share over the major implant companies that currently hold 85-95% of US dental implant sales.
Unfortunately, there is an enormous amount of poorly written research that is being introduced into the dental literature with false claims of improved success rates. In many instances, implant manufacturers have made changes to the design of their implant because of improved success rates seen with a competitor implant that has the proper research and clinical documentation. With the dental implant industry growing each year, this problem will never cease to exist.
As a potential implant candidate, there are several things you should know about this industry prior to continuing with treatment
FACT: Doctors do not need formal surgical training on humans to place dental implants.
In fact, one implant manufacturer in particular holds educational seminars for doctors wanting to place dental implants over the course of a single weekend. That's right, in just 2 days, doctors are given a surgical training certificate which states that they have formal training in surgical implant dentistry and therefore may place dental implants in a human subject. Unfortunately, the course does not train these doctors on human subjects, rather, on plastic jawbones.
FACT: The US government does not require FDA approval for a dental implant fixture to be marketed to the professional community.
The US government has a governing body that oversees biomedical devices and their potential implementation into the medical and dental community. If, for example, a dental implant meets certain criteria necessary for surgical placement into the human body based on prior submissions by other manufacturers which have tested the device, then the governing body will grant 510K clearance to the implant manufacturer. 510K clearance allows dental implant manufacturers (and other biomedical device manufacturers) to market their device without the need for prior animal or human testing! If another biomedical device has been previously introduced with similar intent, then the literature for the initial product can be used to formalize 510K clearance.
FACT: All implants are NOT the same
The competition for the dental implant market is fierce, and after patents have expired on tested devices proven to be suitable for human use, some implant manufacturers will duplicate the design of these devices. Implant manufacturers seeking a spot in the competitive dental implant market will copy the design of an implant that has an expired patent, save for a minor change here and there. These implants are known as clones and are marketed to dentists at a significantly reduced fee. In most instances, these implant clones have absolutely NO clinical documentation to substantiate their manufacturer's claims. In fact, these companies use literature provided by the implant manufacturer from whom they are copying!
FACT: Implant manufacturers are introducing new designs into the market with false claims
To keep up with new implant manufacturers that are having better overall success rates, some companies will copy a certain portion of the competitor's implant and claim that results are similar with the newly added portion. Conceptually this makes sense, but in most cases a combination of design features are responsible for some implant manufacturers' improved success rates. By introducing a concept that has shown to improve success rates in another implant system (albeit with little or no clinical documentation), implant manufacturers can thereby retain their current clientele, and therefore doctors need not worry about having to purchase another implant system.
FACT: Clone companies consistently falter and lose market share, resulting in withdrawal from the market place.
Dental implants are metals, and metals fatigue. A good number of implant manufacturers that have cloned other systems with adequate clinical documentation have gone bankrupt and as a result, can no longer offer their product to the dental profession. In many cases when components for these implant systems fail, it is very difficult or nearly impossible to purchase replacement parts. This could leave the patient who has had a cloned implant placed in their jaw with the unfortunate circumstance of not being able to have it restored.
FACT: The US FDA does not require dental professionals to inform their patients of the type of dental implant being placed.
There are more than 90 dental implant manufacturers currently competing for market share in the United States; within these 90 or so implant manufacturers, more than 340 different implant designs are available!!!! Unfortunately, this number is growing, and in the next 10-20 years when implant components are needed, it will be very difficult for dentists to discern the type of implant that has been placed.
What can you do to avoid these issues???
First and foremost
1. Do some research on the practitioner who is recommending the implant and whether he or she has experience in implant dentistry
2. Make sure that the individual placing the dental implant has surgical experience from an accredited specialty program or an extensive surgical course with proper training.
3. Prior to having the implant placed, consult with a general dentist or prosthodontist so that the implant tooth can be properly treatment planned and ultimately, properly restored.
4. At your initial surgical consultation visit, ask your dentist the type of dental implant he or she uses.
5. Finally, speak to your doctor at length and inquire as to the type of implant being placed and his or her reason for recommending that type of implant.