Dental
Malpractice Lawyer Services
Dental
Amalgams Overview
FDA
and other organizations of the U.S. Public Health Service
(USPHS) continue to investigate the safety of amalgams
used in dental restorations (fillings). However, no
valid scientific evidence has ever shown that amalgams
cause harm to patients with dental restorations. FDA
is aware that some manufacturers have advised in their
labeling against using amalgams in very young children
and pregnant or nursing women.
The safety of dental amalgams has been reviewed extensively
over the past ten years, both nationally and internationally.
In 1994, an international conference of health officials
concluded there is no scientific evidence that dental
amalgam presents a significant health hazard to the
general population, although a small number of patients
had mild, temporary allergic reactions . The World Health
Organization (WHO), in March 1997, reached a similar
conclusion. They wrote: "Dental amalgam restorations
are considered safe, but components of amalgam and other
dental restorative materials may, in rare instances,
cause local side effects or allergic reactions. The
small amount of mercury released from amalgam restorations,
especially during placement and removal, has not been
shown to cause any other adverse health effects."
Similar conclusions were reached by the USPHS, the European
Commission, the National Board of Health and Welfare
in Sweden, the New Zealand Ministry of Health, Health
Canada and the province of Quebec.
In January 1993, the USPHS published a broad scientific
report about the safety and use of dental amalgam and
other materials commonly used to fill dental cavities.
These conclusions were reaffirmed by USPHS in 1995 and
1997. Since then, the National Institutes of Health
(NIH), the Centers for Disease Control and Prevention
(CDC), and the Food and Drug Administration (FDA) have
continued to study the issue. The National Institute
of Dental & Craniofacial Research at NIH has also
provided money to study the safety of dental amalgams
and to develop non-mercury alternatives. This effort
includes research and clinical studies of dental amalgam
use in children. These studies are ongoing and will
require several years of follow-up in order to detect
possible subtle and long-range health effects.
Also, USPHS scientists analyzed about 175 peer-reviewed
studies submitted in support of three citizen petitions
received by FDA after the 1993 report. They concluded
that data in these studies did not support claims that
individuals with dental amalgam restorations will experience
problems, including neurologic, renal or developmental
effects, except for rare allergic or hypersensitivity
reactions.
Although there is international agreement that the scientific
data do not confirm the presence or absence of a significant
health hazard, several countries and the state of California
restrict the use of dental amalgams or have recommended
limitations on their use. Some manufacturers now include
these "contraindications" (against using)
in their labeling of dental amalgams sold in those countries.
If a manufacturer wishes to make a similar labeling
change in its dental amalgam sold in the United States,
FDA will require the manufacturer to submit a new marketing
application with data supporting the change.
FDA plans to uniformly regulate dental mercury, amalgam
alloy, and pre-encapsulated dental amalgam. To reduce
allergic reactions from restorative materials, FDA will
propose in labeling guidance that the product's labeling
list the ingredients in descending order of weight by
percentage and include lot numbers, appropriate warnings
and precautions, handling instructions and expiration
dating. The labeling guidance will be most useful with
new restorative materials.
While research, regulatory changes, and educational
efforts are underway, the use of dental amalgams in
the U.S. is declining. Pediatric dentists, in particular,
are using resin (plastic); tooth-colored materials that
are bonded to the tooth may release fluoride and are
mercury-free. Other reasons for the decline in amalgam
use include increasing use of sealants and community
fluoridation, an expanding selection of fluoride-containing
dental products, improved oral hygiene practices, and
greater access to dental care.
For the foreseeable future, patients will continue to use amalgam
dental fillings. The USPHS will continue
gathering data about possible risks of dental amalgams
and other restorative products and pursuing new methods
of dental treatment and oral health. As an important
part of this plan, USPHS will continue working with
the dental profession to bring about changes in the
delivery of oral healthcare based on valid scientific
research.
Dental Sealants Overview
Dental
sealants are usually applied to the chewing surfaces
of the back teeth where decay most often occurs. They
are primarily used in children between the age of 6
and the onset of puberty, as this is the time when most
cavities are likely to form. The sealant is applied
to cover the uneven surfaces of the teeth where bacteria
develop and multiply. Sealants are painted onto the
teeth and then set with a special light. According to
the American Dental Association (ADA), about 20% of
American children have sealants in their mouths.
Concerns have surfaced regarding the use of sealants.
Studies conducted in Spain found that sealants released
a chemical known as BPA into the saliva. BPA is classified
as an endocrine disruptor, a chemical that interferes
with the body's production and utilization of certain
hormones. These disruptors are associated with an increased
risk of testicular and prostate cancer in men, and breast
cancer and endometriosis in women. Endocrine disruptors
may also suppress the immune system .
The ADA maintains that sealants are safe and effective.
See a doctor if you or your child have experienced serious
health problems after receiving dental sealants. In
addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep
in mind that there may be time limits within which you
must commence suit.
Dental
Amalgams Overview and Dental
Sealants Overview information provided by InjuryBoard.com
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