Medical Devices: FDA's Approval of Four Temporomandibular Joint Implants Page: 2 of 30
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aAccountabiity Integrity Reliability
Highlights of GAO-07-996, a report to
Why GAO Did This Study
It is estimated that over 10 million
people in the United States suffer
from jaw joint and muscle
temporomandibular joint (TMJ)
implants have been used to replace
the jaw joint in some patients in an
effort to decrease pain and
increase jaw function. The safety
and effectiveness of these implants,
like other medical devices, is
overseen by the Food and Drug
Administration (FDA), an agency
within the Department of Health
and Human Services (HHS). Two
implants used in the 1970s and
1980s that were later removed from
the market caused severe side
effects for some patients. In 1998,
FDA began to require certain TMJ
implant manufacturers sponsoring
these devices to demonstrate the
implants' safety and effectiveness
before receiving approval. Since
1998, four TMJ implants from three
sponsors were approved.
In response to your request, GAO
described (1) the types of concerns
raised by FDA and how it
addressed these concerns for the
implants approved since 1998 and
(2) how FDA has monitored
sponsors' compliance with
conditions of approval. GAO
examined documentation related to
the four TMJ implants approved by
FDA since 1998 and sponsors'
annual reports, which FDA uses to
monitor compliance with
conditions of approval. GAO also
interviewed FDA officials, TMJ
implant sponsors, and patient
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Marcia Crosse
at (202) 512-7114 or firstname.lastname@example.org.
FDA's Approval of Four
Temporomandibular Joint Implants
What GAO Found
FDA officials raised concerns during the approval process that were similar
for all four TMJ implants. These concerns generally involved the adequacy of
the sponsors' clinical study protocols, patient follow-up, engineering testing,
and other matters, such as device labeling. FDA addressed many, but not all,
concerns upon approval. Some concerns were addressed by obtaining
additional information from sponsors to clarify and supplement data
contained in their device applications before approval. Other concerns were
addressed when FDA approved the implants but required sponsors to
comply with certain conditions of approval, such as continuing clinical
studies postmarket and collecting patient data. Because FDA staff, who
review the device applications, and FDA management, who approve the
devices for marketing, held differing views as to whether the implants'
health benefits outweighed its risks, they did not agree on the approval
decisions of two of the four TMJ implants. FDA management acknowledged
that the concerns raised about the implants were legitimate. However, they
ultimately concluded that the benefits provided by these two devices
outweighed the concerns and approved both devices to help patients obtain
relief from chronic pain.
FDA monitored sponsors' compliance with conditions of approval by
evaluating information contained in their annual reports. FDA often required
additional actions by the sponsors to resolve questions that were raised
through its review of these reports. However, GAO found that not all annual
reports were received by FDA. At the time GAO conducted its work, FDA
had only received 13 of 18 required reports. One implant sponsor did not
submit 5 of 7 required annual reports. FDA has requested these reports and
has issued draft guidance on annual report submissions to all medical device
sponsors. In addition, when reviewing the available annual reports to
determine if sponsors were complying with conditions of approval, many of
the submitted reports did not provide FDA with sufficient information to
assess compliance. FDA required these TMJ implant sponsors to provide
additional information to address this lack of sufficient information. In most
instances, once FDA received additional information from the sponsors, the
annual reports were considered adequate. However, one sponsor submitted
several annual reports for both of its devices that FDA said lacked sufficient
information regarding patient follow-up and also underreported problems
experienced by patients associated with the devices. FDA notified the
sponsor that it must address these concerns, but the sponsor repeatedly
provided inadequate responses. This situation ultimately led FDA to inspect
the sponsor's records and file an administrative complaint for civil monetary
penalties against the sponsor for failure to file certain reports with FDA. On
July 6, 2007, an administrative law judge ruled in favor of FDA.
In commenting on a draft of this report, HHS provided clarification on
postmarket requirements for approved devices and updated information on
the administrative complaint for civil monetary penalties.
,United States Government Accountability Office
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United States. Government Accountability Office. Medical Devices: FDA's Approval of Four Temporomandibular Joint Implants, report, September 17, 2007; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc296294/m1/2/: accessed April 22, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.