1. Foreword
_____June 2003, the US Government Accounting Office (GAO) has issued a report that in the past several years, large increases in medical malpractice insurance premium rates have raised concerns that physicians will no longer be able to afford malpractice insurance and will be forced to curtail or discontinue providing certain services. Additionally, a lack of profitability has led some large insurers to stop selling medical malpractice insurance, furthering concerns that physicians will not be able to obtain coverage.
_____Since 1999, medical malpractice premium rates have increased dramatically. GAO found that losses on medical malpractice claims—which make up the largest part of insurers’ costs—appear to be the primary driver of rate increases in the long run. According to theWashington Post, July 26, 2004, the Governor of Maryland, Robert L. Ehrlich Jr. (R), while talking about how to head off a potential health care crisis, called it “the number one issue in Maryland right now”.
_____Most insurance companies have given up providing malpractice insurance: St. Paul Federal before quitting has lost $1 billion, with other suits pending. Such facts have called the attention of a major magazine. Thus, Time magazine has entitled one of its covers “The Doctor is Out”, while Chicago Dental Soc. Bulletin of May-June 2002 has entitled its editorial “Doctor, You are being sued!”. In its April 18, 2000 issue, the Chicago Tribune reported that doctors are fleeing their posts due to the skyrocketing malpractice insurance costs. In his wake-up keynote address at the 104th Annual Convention of the American Association of Orthodontists, Orlando 2004, entitled “Doctor, you too will be sued!” and editing the recent, basic book Risk management in orthodontics,1 , Professor T. M. Graber took over the problem. As one can see from Fig. 1 taken from the meeting, the legal targets he pointed out are the rich doctors and insurance companies. According to this presentation, only in 1993, in the US were registered no less than 53,000 malpractice suits, of which the dentistry related were 9,000.
_____The median verdict in Illinois in 2004 was over half a million dollars, and the percent of the payouts over $750,000 were over 35%, and this while the liability insurance has increased from $60 million in 1960 to 10 billion in 2000. Well aware of the problem, the American Association of Orthodontists’ Bulletin publishes frequent reviews, alerts and warnings related both to procedures and materials, of which some may sound too ridiculous to be printed, as it can be seen from the following lawsuit on toothbrush abrasion to which the American Association of Dentists had to take a position:
“Res. 60-99 H: The Board of Trustees is to review a lawsuit recently filed against the American Dental Association. This lawsuit addresses toothbrush abrasion. According to the ADA News, the lawsuit “alleges that toothbrushes are ‘unsafe and unreasonably dangerous’ and should carry package warnings on the ‘risks of toothbrush abrasion,’ as well as instructions on how to use the brushes to avoid abrasion.” If appropriate, the Board of Trustees will take supportive action.
_____Malpractice suits are sprawling and the number of devices and materials used exceed the authorities’ possibility for control. As a result, it has become quite likely that a clinician who exerts the best practices may be sued for his use of materials he has no control of. Benjamin Franklin’s adage that “an ounce of prevention is worth a pound of cure” should be updated, as the amount of prevention needed today has significantly increased.2
_____1.1. A device can be a weapon
_____An average practitioner uses instruments and attaches to his patients devices made of stainless steel, alloys containing nickel, chromium and cobalt, metals known not only as generating allergies, but also as carcinogenic to humans. If he prefers, he may attach ceramic brackets that can cause enamel abrasion and tooth fracture at debonding time. To attach these, he uses resins based upon bis GMA, compound that has been found to be toxic, mutagenic, carcinogenic and oestrogenic. During treatment, he is obliged to use surgical gloves: the best of these may kill him (anaphylactic shock). As far as we know, there are no books or guides to help him to do his job without hazards for him and his patients.
_____Understanding orthodontic biomaterials’ behavior helps in the delivery of a better treatment as well as in the patient’s education. Their proper selection, handling and sometimes testing should avoid not only failures, but also reasons for litigious claims. As far as we know, there are no books concerned with the last aspects. The many books dedicated in general to dental materials and the only one on orthodontic materials3 provide non-specific information regarding an important aspect of clinician’s activity. With the exception of a book dedicated to dental materials, which is now over two decades old4 , these do not have the goal to inform and protect the general practitioner against the problems he may encounter as he attempts to use an array of new devices.
_____In the absence of an orthodontics specifically dedicated book, should the orthodontist rely on the information provided to the general practitioners of dentistry?
_____The answer is a decided NO: the “materia technica” involved is different, as shown by an experiment we made in two major meetings, one dedicated to general practitioners and one to orthodontists. A list of devices taken from the index of the only comprehensive book on dental and orthodontic materials, The Clinical Handling of Dental Materials, 3rd edition5 was given to twenty clinicians from each group, all being asked to mark from 0 to 10 the extent of their usage of each device. It was found that each group marked from 8 to 10 the tools they were using, i.e. specific to their domain, and with 0-1 the others. The test showed a lack of common ground. The vast majority of the devices and the materials, to which the mentioned book dedicated ~95% of its pages, were marked with 0 by the responding orthodontists. Specific preferences were obvious even in the field of impression materials, where only alginates were selected. This doesn’t only show the clear difference between the materials the orthodontist and the dentist use, but also the disproportionate attention given to dentistry to the detriment of its first specialty, orthodontics. This can be seen also from the fact that in the US, out of 67 American Dental Association (ADA) Specifications, only two address orthodontic materials (No. 18 - Alginate Impression Materials and No. 32 - Orthodontic Wires); the one on dental brazing alloys refers to cast restorations only! Dentistry is fortunate to have Gordon J. Christensen, who along his wife, Rella, started in 1976, Clinical Research Associates (CRA) in Provo, Utah. Today, CRA is an international organization counting more than 380 clinicians and 43 on-site basic scientists and staff, all dedicated to evaluate dental biomaterials6 . There is almost no issue of the Journal of American Association of Dentists (J.A.D.A.) without one of their contributions, and the CRA newsletter is widely read. Unfortunately, to date, there is no parallel organization in the US or other countries dedicated to orthodontic biomaterials.
_____Materials lead to progress. Today’s development of technology has allowed the manufacture of large amounts of an incredible diversity, a sharp difference from the past. The importance given to materials in the past can be best illustrated by T. A. Edison who, when honored at a grand dinner for his achievements in the use of electricity, was asked what he would like as a gift. To the general surprise, he asked for “A cubic foot of copper”.(Today, the 559 pound cube can still be found at the Edison Laboratory Museum in West Orange, NJ.)
_____Having to handle an enormous data base resulted from both analyses and practice, concerned organizations have to convey independent and reliable information to the practitioner as fast as possible, preferably long before the release of the new materials (like a radio traffic report, it has to come early enough to allow you to change your route: if you are already stuck in the backup, it becomes useless). The lack of interest in manufacturing and product information may often result in thousands of wasted dollars, hours of additional chair time, or even in lost court battles. As a result, the biomaterials’ behavior is of concern to many journals, among which Biomaterials (Elsevier, Chicago); Journal of Biomaterials Applications (SAGE Publications, Thousand Oaks, CA); Journal of Materials Chemistry (Royal Society of Chemistry, Piccadilly, London); Journal of Materials Science: Materials in Medicine (Springer, The Netherlands); Journal of Biomaterials Science. Polymer Edition (International Science Publishers, Zest, The Netherlands); Trends in Biomaterials & Artificial Organs (Society for Biomaterials, Thiruvan anthapuram, India).
_____According to a study made by the US National Materials Advisory Board and the National Research Council7 , only in the last 25 years, and especially in the last decade, has the foundation of what we call materials science begun to take shape and to achieve recognition.
_____Orthodontic biomaterials are no exception. While the design of most orthodontic appliances is a century old, from the edgewise bracket to the palatal expansion screws, and from bands to arch wires and headgears, the biomaterials used are new. Half a century ago, the major problem was the devices and the materials in their making. According to J. V. Mershon, who was reminiscing the meetings his group had in Angle’s time, the bulk of the discussions were directed toward “plain molar bands versus screw bands, German silver arches versus gold arches, different types of band materials and ligatures”.8
_____Since then, the problem has reversed: today thousands of products are offered in an incredible variety, puzzling the clinician. The speed with which new materials are picked up by the orthodontic suppliers has multiplied several times within less than a century. Compare the time elapsed since the discovery of stainless steel (Maurer, 1912), until its use by Angle (1930), or with that of super elastic alloys (Buehler, 1961) till their use in arch wires (Andresen, 1971). Furthermore, compare the few years elapsed between the commercial release of partially stabilized zirconia (Imperial Chemical Industries, 1985) and its use in direct bonding brackets (Lee, 1990). Recently, even this interval has shrunk, if we consider the time elapsed since the development of diamond-like carbon bracket coating through plasma source ion implantation on arch wires. Although orthodontic materials manufacturers have succeeded in bringing forth a variety of superior materials, not all had the patience to wait for years of clinical use before launching their products. While this may have advantages, this presents also a negative aspect: to save detailed and expensive pre-testing, some manufacturers have responded to the problems only after these were encountered in vivo. As shown in Table 1.1, it takes just few years to have new materials or procedures transgressing into orthodontics, often without concern regarding health problems.
_____The problems raised by orthodontic materials are to some extent the same as those of dental materials in general. Quite often, however, like in the case of wires, these deserve an extensive and at the same time differentiated approach. Highly dependent on sophisticated materials, orthodontics uses relatively few categories, but in an incredible variety. Aware of the problems, The Bulletin, a voice of the American Association of Orthodontists, often publishes related risks management reviews and briefs.
_____The other face of the coin. While the problems raised by orthodontic materials are to some extent the same as those of dental materials in general, they deserve a differentiated approach. Highly dependent on sophisticated materials, orthodontists uses relatively few categories, but in an incredible variety. To give an example, there are today hundreds of thousands of different types of direct bonding brackets...
_____In the U.S., according to the Medical Device Amendments of 1976, the non-customized orthodontic products are either drugs (if metabolized), or devices (if non-metabolized). Devices can be short acting (e.g. instruments, rinses, etching gels, impression materials) or used for an extended period of time (e.g. brackets, bands, wires, adhesives). Especially in the last case, the devices have to be biocompatible, i.e. not only have a harmless shape, but be made of materials that do not interfere with the body’s normal functioning.
_____Some of the products on the market not only do not properly fulfill the needs, while others can even harm. Cases in point include the detachment en masse of some direct bonding brackets from bases due to poor brazing, the leaking of nickel from corrosion susceptible attachments or the abrasion or fracture of enamel by ceramic brackets, to name only a few. Concerns about iatrogenically inflicted ailments grew, first addressed being the devices which interfered with the normal body function and generated responses like allergies or tissue necrosis. Unfortunately, far from being able to check ineffectiveness, these organizations can barely keep abreast with the toxicity testing of flood of new products released yearly in many countries. Consequently, shoddy workmanship and the use of mechanically or chemically inadequate materials has been therefore considered of secondary importance, especially for the least intrusive Class III devices within which comprise most of the orthodontic devices used in the U. S
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_____In contrast, in Germany, alloys containing palladium (Pd), indium (In), gallium (Ga) and tin (Sn) were either banned, or controlled.9,10 Devices containing beryllium (Be), cadmium (Cd), lead (Pb) or their derivatives were also phased out, as were these containing a larger amount of nickel (Ni) or using lower grades of stainless steel.11
_____In the last few years, in the U.S. the pressure mounted to properly evaluate and understand biomaterials, especially after “Proposition 65”12 became law in California. This strict law has enjoyed widespread support and may expand all over the world. Proposition 65 further enforces the already existing Title 21, Code of Federal Regulations of the Food and Drug Administration that states “Clinicians are held responsible for the materials they use”. This law has already led to suits in court against major orthodontic manufacturers and to severe warnings to many dental offices. Also known as the Safe Drinking Water and Toxic Act of 1986—this law has no equal anywhere in the world, as it simply states that the physician should not use products that are toxic, mutagenic, carcinogenic and oestrogenic. According to its paragraph 25249.6 (entitled Required Warning Before Exposure To Chemicals Known to Cause Cancer or Reproductive Toxicity), “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual”.
_____Since 1988, thousands of 60-Day Notice letters have been filed with the California Attorney General, affecting thousands of businesses including dental offices. Many Proposition 65-related lawsuits have been formally litigated, including hundreds of enforcement actions. Hundreds of cases have been resolved through either court approved or out-of-court settlements and hundreds of million dollars in fines have been levied through various applications of Proposition 65. Its unique requirements, extreme penalties, and national and international reach make it one of the most important and dynamic environmental laws in existence today. Among its provisions, which extend way outside the borders of California, is also the following:
_____“Any company with ten or more employees that operates within the State or sells products in California must comply with the requirements of Proposition 65”. Under Proposition 65, businesses are:
“1) Prohibited from knowingly discharging listed chemicals into sources of drinking water,
"2) Required to provide a ‘clear and reasonable’ warning before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, by posting signs at the workplace, or by publishing notices in a newspaper.”
_____According to the “Prop 65 news”13 , many dentists and several orthodontic manufacturers from Los Angeles have been sued, as one can see from a list of the latter:
• Consumer Cause v. Acme Monaco Corporation, Case 243041: Orthodontic Dental Bands
• Consumer Cause v. Ortho Organizers, Case 243040: Orthodontic Dental Bands
• Consumer Cause v. Ultimate Wireforms Inc., Case 243038: Stainless Steel Orthodontic Products
• Consumer Cause v. Darby Dental Supply, Case 243039: Stainless Steel Orthodontic Products
• Consumer Cause v. Western Dental Centers; American Orthodontics, Lancer Orthodontics, Case 225425, Orthodontic Products.
_____It is common knowledge that not all the cases are brought to trial or have led to penalties: a good number of these have settled out of court. However, because a dental auxiliary has used a diamond burr to remove excess adhesive (illegal staff service), an office had to pay in 2003 a settlement of $80,000 that did not include the legal services.
_____According to Professor T. M. Graber’s keynote speech mentioned above, there is a National Register that lists not only the clinicians found guilty of malpractice, but also those who settled the cases out of court. As a result, the problem has stirred an increased interest. Two books published recently have focused on what happens with the dental materials in the oral environment and the related dangers. The first examines thus the disintegration of orthodontic appliances in general (metal, resin-based, ceramics)14 , of the orthodontic brackets15 and of the orthodontic utilities and auxiliaries16 , while the second the potential iatrogenic responses and the orthodontics’ related malpractice and risk management issues. Among others discussed are the release products from metals17 and the dangers posed by the polymers used in orthodontics18 .
_____1.2 Standards and regulations.
_____The concerns about iatrogenically inflicted ailments were first addressed whenever the devices interfere with the normal body functioning, generating from allergies to tissue necrosis. Taking the place of mutual, friendly contacts, national or international organizations took on themselves the task of testing product and conveying the information to the practitioner as fast as possible, preferably long before the release of the new materials (like a radio traffic report, it has to come early enough to allow you to change your route).The lack of interest in manufacturing and product information may often result in thousands of wasted dollars, hours of additional chair time, or even lost court battles.
_____Although orthodontic materials manufacturers have succeeded in bringing forth a variety of superior materials, not all had the patience to wait for years of clinical use before launching their products. Cases in point include the detachment en masse of some direct bonding brackets from their bases due to poor brazing, the leaking of nickel from corrosion susceptible attachments or the abrasion or fracture of enamel by ceramic brackets, to name only a few.
_____As a result, regulatory organizations were charged with the protection of the patients. Either national or international, such organizations are controlled by public or private organizations concerned with general or specialized interest. In the U.S., the Food and Drug Administration (FDA) has the regulatory authority to protect the public against hazardous and ineffective medical and dental devices. According to the Medical Device Amendments of 1976, the non-customized orthodontic products are either drugs (if metabolized), or devices (if non-metabolized). Devices can be short acting (e.g. instruments, rinses, etching gels, impression materials) or used for an extended period of time (e.g. brackets, bands, wires, adhesives). Especially in the last case, the devices have to be biocompatible, i.e. not only have a harmless shape, but be made of materials which do not interfere with the body’s normal functioning, respecting Hippocrates’ dictum “Primum non-nocere”.
_____The American Dental Association (ADA) Acceptance Program provides guidelines and provides initial evidence that a certain product is safe and effective as claimed by the manufacturer. Similar agencies can regulate materials in groups of countries (like Nordisk Institutett Odontologisk Material, NIOM) or individual countries (like the German Bundesgesundheitsamt). Many other countries have dental specifications or standards and governmental regulations. Two international organizations, the Federation Dentaire Internationale (FDI) and the International Organization for Standardization (ISO), whose TC 106 (Dentistry) Committee is located in Germany, are attempting to unify and simplify the mass of regulations. While ISO encompasses a large field of standards in general, FDI deals only with the dental materials. To be sold in Europe, these products have to carry the CE marking on their packaging, symbol of the European Union (CE stands for Conformite Europeene).
_____Far from being able to check ineffectiveness, these organizations barely can keep abreast with toxicity: indeed, it is quite difficult to judge the flood of new products which are released every year in tens of countries. Consequently, shoddy workmanship and the use of mechanically or chemically inadequate materials, while important for liability, are not properly inspected. Thus, if these are listed in the FDA’s least intrusive Class III devices (most orthodontic devices that are comprised in it), the tests needed for market approval shown in Table 1.2 are only seldom performed.
References
1. Graber TM, Risk management, in: Risk management in orthodontics. Experts’ guide to malpractice, Graber TM, Eliades T, Athanasiou AE, ed., Risk Quintessence Publishing Co., Chicago, 185: 2004
2. Matasa CG, Biomaterials in orthodontics, in: Orthodontics, Current Principles and techniques, Graber TM, Vanarsdall R, Vig KW, ed., IVth Ed. Mosby/Elsevier, St. Louis 2005
3. Brantley WA, Elides T, ed., Orthodontic materials. Scientific and clinical aspects. Thieme, Stuttgart, New York 2001
4. Smith DC, Williams DF. Biocompatibility of dental materials. Vol. 1, Characteristics of dental tissues and their response to dental materials. 1st ed., Boca Raton, FL, CRC Press, 1982: 10-20; 179-80
5. Smith BGN, Wright PS, Brown D, The Clinical Handling of Dental Materials, IIInd ed., Butterworth-Heinemann Ltd., Oxford 1994
6. www.cranews.com; accessed August 2004
7. Materials Science and Engineering for the 1990s, Committee on Materials Science and Engineering, the National Materials Advisory Board and the National Research Council, National Academy Press, Washington DC, 1989
8. Mershon JV, The significance of the Angle school, Am. J. Orthod. Oral Surgery, 1939; 25 971-5
9. Kappert HF, Das spezielle Problem der PdCu-Legierungen, Phillip Journal (Germany), 1993; 10: 411-3
10. Peters KP, Heese A, Allergie gegen Metalle in der Zahnheilkunde, Tagung der DGKMZ (German Academy for Dentistry), Wiesbaden, 1995
11. Bundesgesundheitsamt, Legierungen in der zahnartzlichen Therapie, 1993, BGA, Hellmich KG, Germany
12. www.calprop65.com; accessed August 2004
13. http://www.prop65news.net; accessed August 2004
14. Hensten-Petteresen A, Jacobsen N, Disintegration of orthodontic appliances, in: Eliades G, Eliades T, Brantley WA, Watts DC, ed., Dental materials in vivo. Aging and related phenomena, Quintessence Publishing Co., Chicago, 125: 2003
15. Matasa CG, Characteristics of used orthodontic brackets, Idem, 139
16. Eliades T, Eliades G, Brantley WA, Watts DC, Aging of orthodontic utilities and auxiliaries, Idem, 155
17. Eliades T, Eliades G, Brantley WA, Athanasiou AE, Release of wear and corrosion products from orthodontic alloys: a review of mechanisms and biologic properties, in: Graber TM, Eliades T, Athanasiou AE, ed., Risk management in orthodontics, Quintessence Publishing Co., Chicago, 97: 2004
18. Matasa CG, Polymers in orthodontics: a present danger? Idem, 113