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Device Legislation...... Now Tread Cautiously

Judy, Kenneth W. M. DDS, FACD, MICD

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doi: 10.1097/ID.0000000000000926
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The Food and Drug Administration (FDA) has come under fire recently for approving new drugs, devices, and/or techniques without long-term meaningful clinical data from multicenter sources. Ergo, clinicians can be harming patients with resultant class action lawsuits. Are we, as dentists, both generalists and specialists, now immune from such problems? We only need to look at our history, especially regarding dental and maxillofacial implantology.

I can remember that just a few decades ago, endosteal implants made from vitreous carbon as well as aluminum oxide were complete failures even though prominent lecturers with multidegree credentials rushed to endorse them on a well-advertised but biased lecture circuit. Titanium or titanium alloy implants seemed to save the day. But, what about basic designs, different coatings, or prosthetic connection methods? In fact, many endosteal implants were “pulled from the market.” Some manufacturers hushed things up by silencing lecturers who were openly critical. Authors who disagreed with manufactures had their articles repressed. Hush money unfortunately talks.

What is our role as practitioners? Is it similar to the FDA's? Are we coming together for public benefit or tolerating issues which we feel are beyond our control? When new products are introduced and too rapidly brought to market, do innovative manufacturers bear any responsibility? Shouldn't the FDA do all it can to strengthen their premarket approvals? We are used to automobile recalls as a part of life. But, what about breast implants, hip implants, intrauterine contraceptive devices, etc.? Clearly when patients' health is compromised, because of regulatory oversight and lack of long-term studies, we should be concerned. As dentists we need only think of Proplast, a material that was used for temporomandibular disc implantation beginning in the late 1980s. By 1992, the FDA and American Association of Oral and Maxillofacial Surgeons (AAOMS) agreed that all patients had to have their Proplast TMJ implants removed. This was not a simple or pain-free procedure.

Does the American Dental Association (ADA) adequately protect its members? Shouldn't materials as well as procedures be thoroughly vetted? Dental implantology is now a mature area of practice. However, we have diverse opinions about many procedures. It took years for sinus lifts to be accepted. Yet, considerable controversy exists about basic related bone graft filler materials. Many of my colleagues feel “All on 4” procedures in the maxilla are too destructive of existing bone. In the mandible, there is concern about encroachment on the mandibular nerve with resulting loss of sensation. Partial Extraction Theory or Technique (PET) is a concept that many colleagues feel should be limited to anterior maxillary teeth, which are ankylosed. Others would like to expand the concept. The profession is cautioned that a dental license, basic skill, and specific knowledge about the technique and a related armamentarium, and implants, in general, are all needed to be successful. Are such statements adequate legal protection against future poor or questionable PET results?

I have mentioned some controversial areas. What interests me more is whether there exists a clear policy that actually protects all my colleagues, generalists as well as specialists? Are there programs in most dental school curricula that address new materials and techniques or just a few? Sometimes the fact that many diseases are widespread drives the rapid development of “cures.” Dr. Ignaz Semmelweiss proved that correct sanitary procedures greatly reduced puerperal fever that had a 25% mortality rate. His Austrian colleagues were not convinced. More than 1000 cures for syphilis were published in England by honored Fellows of the Royal Academy of Medicine. None worked. Both of these medical issues plagued Europe for hundreds of years. But, was there a litigious environment then like there is today? I am haunted by some of our health care history and plead that we do not repeat similar mistakes as dental implants become more and more widely used. We should insist in this coming age, when health care might become a “right for all,” that evidence-based science is its fundamental foundation.

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