What you need to Know About the Dental Implant Business
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 correct surgical technique, success rates have overtaken 95%. When the concept of osseointegration or even fusing titanium with bone was introduced to the dental community within the early 60s by an memory foam surgeon known as P. I. Branemark, the application of this concept was modified to dental use; implementing the process, however , into a dental setting had been seen as risky and unpredictable. Success at this point in time rarely approached 55-60%, and many clinicians felt that their introduction into a patient’s treatment plan might be too premature for predictable achievement of a particular prosthesis. To improve success rates, alterations in the design of the teeth implant surface were introduced most without sound, clinical evidence in order to back-up manufacturer’s claims of improved success rates. Through years of empirical experimentation, a titanium dental implant was created that looked much like that of a natural tooth root.
Some 40 years afterwards, technology within the dental implant field has facilitated their colloquial make use of among general dentists and professionals. When the market for implant dental care 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 in order to win market share over the major implant companies that currently hold 85-95% of US dental implant sales.
Sadly, there is an enormous amount of poorly written research that is being introduced in to the dental literature with false promises of improved success rates. In many instances, implant manufacturers have made changes to the type of their implant because of improved success rates seen with a competitor implant which has the proper research and clinical documents. With the dental implant industry expanding each year, this problem will never cease to exist.
Being a potential implant candidate, there are several things you should know about this industry prior to ongoing with treatment:
FACT: Doctors do not require formal surgical training on human beings to place dental implants.
In fact , a single 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 certification which states that they have formal learning surgical implant dentistry and therefore may place dental implants in a human being subject.
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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 neighborhood.
The US government has a governing body that oversees biomedical devices and their own potential implementation into the medical and dental local community. If, for example , a dental implant meets certain criteria necessary for medical placement into the human body based on earlier submissions by other manufacturers that have tested the device, then the governing body will grant 510K clearance towards the implant manufacturer. 510K clearance allows dental implant manufacturers (and some other biomedical device manufacturers) to market their particular device without the need for prior pet or human testing! If an additional biomedical device has been previously presented with similar intent, then the materials for the initial product can be used to formalize 510K clearance.
FACT: So many implants, so little time
The competition for the dental implant market is fierce, and after patents have expired on tested devices proven to be suitable for human use, a few implant manufacturers will duplicate the style 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 obvious, save for a minor change every now and then. These implants are known as imitations and are marketed to dentists in 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 books provided by the implant manufacturer through whom they are copying!
FACT: Implant manufacturers are introducing new designs into the market with false promises
To keep up with new implant producers that are having better overall success rates, some companies will copy a specific portion of the competitor’s implant and claim that results are similar with the newly added portion. Conceptually this is practical, but in most cases a combination of design features are responsible for some implant manufacturers’ enhanced success rates. By introducing a concept that has shown to improve success rates in an additional implant system (albeit with little if any clinical documentation), implant manufacturers can thereby retain their current clients, and therefore doctors need not worry about having to purchase another implant system.