Adverse responses to products or treatments

Orthodontists are blessed in many ways. One of our blessings involves the safety and high quality of the products that are now available for our use. Another is the relative predictability of good treatment results when the doctor and patient work in concert toward the desired and well-planned end.

Past problems

Unfortunately, this state of affairs did not exist in all ways over all times; not all commercial products have been safe and effective. As some easy examples, I can recall the days when plastic or metal brackets would bend or break when wires were tied in. Bands would sometimes snap when placed because the bands were “sized” too many times during the manufacturing process. The very early days of direct bonding were also exciting (in a negative sense) because some of the first adhesives did not adhere well at all, and later-developed versions of the adhesives were thought to be mutagenic or cytotoxic. Another example relates to various forms of headgear that initially were used without serious consideration of safety until cases of ocular and facial lacerations were reported in small but significant numbers.

More contemporary issues are also well remembered. The early versions of ceramic brackets would adhere to the teeth very well—in some cases, too well. When debonding was attempted, the bracket might debond, the bracket might fracture (like splintered glass), the enamel might tear, or the crown might fracture in part or in whole. This too was exciting (also in a negative sense). In a related specialty, the use of Teflon-coated Proplast implants used in temporomandibular joint surgery produced a disastrous result for a significant number of patients; the Teflon caused a giant cell reaction, the patients became ill, and the Proplast caused bone resorption so that the implants had to be removed in a second surgery.

Present problems

Some challenges today speak to product safety, but in different ways. One of these challenges addresses products in an indirect way but more directly addresses human factors. A case in point is the allergic reaction to nickel. Nickel is the most common cause of metallic allergy and is seen in as many as 1 in 500 patients. This condition is more common in females (11%) than males (2%) and changes with age. A reaction could stem from costume jewelry, body piercing, trace-element exposure, environmental pollution, and dental appliances. Fortunately, the allergic reaction to nickel is usually mild (ie, runny nose, swollen tissues, rashes, sores, or ulcers on the lips or the oral cavity mucosa). Similar reactions can be elicited by some types of stainless steel, acrylics, latex, and adhesives.

A relatively new concern is gluten. Gluten can be found in many products; for example, it might be added to plastics as a filler and to some personal home-care products (eg, some toothpaste formulations). It has also been used as a powder on latex gloves. Of consequence is celiac disease; a report in 1 patient links gluten in the plasticized methacrylate polymer used in the retainer to the course of the disease.

Perhaps the greatest current threat to product safety in the United States, though, is the gray market. Gray-market products can be those manufactured legitimately by a company in the United States that are intended for export and sale elsewhere, but are redirected back to the United States. Alternatively, gray-market products might be those that are counterfeited to look and perform like the real items. A third form of gray market involves a reseller who purchases goods from various sources (sometimes stolen) and then repackages, relabels, and resells the goods. In these situations, products make their way into U.S. markets and are sold to practitioners through unauthorized channels.

Unfortunately for practitioners and patients alike, such products might be defective, diverted from destruction, recalled, expired, improperly labeled, poorly packaged, subject to poor shipping and handling practices, contaminated, and underperforming. Practitioners who buy gray-market products will find that they do not come with a warranty, they might not comply with U.S. laws, and they can hurt the patient and expose the purchaser to certain liabilities (professional misconduct, ethics violations, and so on). The willful use of gray-market products might even void malpractice insurance contracts.

As an extension of this problem, fashionistas in Thailand have been purchasing black-market braces for about $100 as an attractive status symbol. These are affixed to the teeth in local beauty salons. Even cheaper versions can be had at open-air stalls in local markets and through online sources. Many styles of braces are available, even some that look like cartoon characters. Government officials, however, have warned that some of the wires may contain lead and cause sores on the gums and inside the mouth, and that some glues can cause blood poisoning and nerve damage. Such fake braces have also been linked to 2 deaths in Thailand; as a result, the Thai government banned the production and sale of fake braces; those who violate the law could receive a steep fine and a sentence of up to 6 months in jail. Still, this practice goes on and has expanded to other parts of Asia (mainly Indonesia and China).

Finally, in the world of stupid, you might see fake braces fabricated out of paper clips and butterfly clips (the part of a pierced earring that clips onto the post behind the ear) all affixed to the teeth with glue or left loosely affixed to the teeth. Judging by what’s on the Internet, this involves children and adolescents seemingly with the permission of their parents. In this case, besides the risks of swallowing, choking, or aspirating the fake braces, allergic reactions are quite possible. Of course, if a member of the public wants “real braces” of any kind to stick on their own teeth, they can be had cheaply via the Internet. You may see these people in your practice when they get into trouble.

Present problems

Some challenges today speak to product safety, but in different ways. One of these challenges addresses products in an indirect way but more directly addresses human factors. A case in point is the allergic reaction to nickel. Nickel is the most common cause of metallic allergy and is seen in as many as 1 in 500 patients. This condition is more common in females (11%) than males (2%) and changes with age. A reaction could stem from costume jewelry, body piercing, trace-element exposure, environmental pollution, and dental appliances. Fortunately, the allergic reaction to nickel is usually mild (ie, runny nose, swollen tissues, rashes, sores, or ulcers on the lips or the oral cavity mucosa). Similar reactions can be elicited by some types of stainless steel, acrylics, latex, and adhesives.

A relatively new concern is gluten. Gluten can be found in many products; for example, it might be added to plastics as a filler and to some personal home-care products (eg, some toothpaste formulations). It has also been used as a powder on latex gloves. Of consequence is celiac disease; a report in 1 patient links gluten in the plasticized methacrylate polymer used in the retainer to the course of the disease.

Perhaps the greatest current threat to product safety in the United States, though, is the gray market. Gray-market products can be those manufactured legitimately by a company in the United States that are intended for export and sale elsewhere, but are redirected back to the United States. Alternatively, gray-market products might be those that are counterfeited to look and perform like the real items. A third form of gray market involves a reseller who purchases goods from various sources (sometimes stolen) and then repackages, relabels, and resells the goods. In these situations, products make their way into U.S. markets and are sold to practitioners through unauthorized channels.

Unfortunately for practitioners and patients alike, such products might be defective, diverted from destruction, recalled, expired, improperly labeled, poorly packaged, subject to poor shipping and handling practices, contaminated, and underperforming. Practitioners who buy gray-market products will find that they do not come with a warranty, they might not comply with U.S. laws, and they can hurt the patient and expose the purchaser to certain liabilities (professional misconduct, ethics violations, and so on). The willful use of gray-market products might even void malpractice insurance contracts.

As an extension of this problem, fashionistas in Thailand have been purchasing black-market braces for about $100 as an attractive status symbol. These are affixed to the teeth in local beauty salons. Even cheaper versions can be had at open-air stalls in local markets and through online sources. Many styles of braces are available, even some that look like cartoon characters. Government officials, however, have warned that some of the wires may contain lead and cause sores on the gums and inside the mouth, and that some glues can cause blood poisoning and nerve damage. Such fake braces have also been linked to 2 deaths in Thailand; as a result, the Thai government banned the production and sale of fake braces; those who violate the law could receive a steep fine and a sentence of up to 6 months in jail. Still, this practice goes on and has expanded to other parts of Asia (mainly Indonesia and China).

Finally, in the world of stupid, you might see fake braces fabricated out of paper clips and butterfly clips (the part of a pierced earring that clips onto the post behind the ear) all affixed to the teeth with glue or left loosely affixed to the teeth. Judging by what’s on the Internet, this involves children and adolescents seemingly with the permission of their parents. In this case, besides the risks of swallowing, choking, or aspirating the fake braces, allergic reactions are quite possible. Of course, if a member of the public wants “real braces” of any kind to stick on their own teeth, they can be had cheaply via the Internet. You may see these people in your practice when they get into trouble.

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Apr 6, 2017 | Posted by in Orthodontics | Comments Off on Adverse responses to products or treatments
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