Does the Food and Drug Administration’s fast-track policy for new
medical devices help or hurt? According to
an article in the New York Times from October 27, 2008, the FDA approval process
for medical devices is simple at best. The FDA does not check for evidence
of effectiveness but only that the device performs as stated and is not
dangerous. After a medical device is approved, medical facilities are
free to use the devices and are not obligated to reveal information about
the newness of the technology to patients.
The example provided in the article is a breast cancer radiation device
known as MammoSite. The FDA approved it in 2002, but the new radiation
treatment administered by the MammoSite is still experimental and unproven.
One patient was referred to a radiation center that uses MammoSite but
was unaware of its experimental status until she opted for a second opinion.
The FDA argues that patients should have access to medical innovations
and stands by its approval policy. Critics say patients are the ones who
suffer, since the devices are not checked for effectiveness. Patients,
critics argue, believe devices are effective when they learn of FDA approval.
What it all comes down to is information. Be sure you are privy to all
information, and do your own research!