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FDA Lasik Response to FDA
Webview Challenged |
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Reference:
www.fdaweb.com
09/14/2009 |
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LASIK Surgery Watch
says it disputes most of FDA’s response to FDA
Webview in our publication of an interview with
former FDA Division of Ophthalmic Devices Diagnostic
and Surgical Devices Branch chief Morris
Waxler, who said that FDA was mistaken in
approving excimer lasers for LASIK during his tenure
(see
story).
In a 9/13
letter to CDRH acting director Jeffrey
Shuren and other FDA and HHS officials and
members of Congress, LASIK Surgery Watch says that
FDA caveats that its guidance documents only provide
guidance “in no way exonerate [it] for approving
excimer laser devices for LASIK, a procedure with
complications in excess of 20%.” The group also
asserts that no number of subsequent meetings or
revisions to the guidance could justify such damage
to American eyes.
On the issue of LASIK re-treatments, LASIK Surgery
Watch says that while it agrees with FDA that such
re-treatments were never approved by the agency,
they still are common and speak to the lack of
efficacy of the initial LASIK procedure.
LASIK Surgery Watch also questions FDA’s comments on
adverse event reporting in its database. The
agency’s emphasis that most reports are not recent
only demonstrates that damaged patients have no idea
where to report adverse events, it says. It also
says that FDA statements about adverse events
reported in its own database are incorrect. It says
the agency mis-reported the number of voluntary
adverse event reports and asks why it is providing
misleading data to the public on its own adverse
event database.
The remainder of the letter reviews for Shuren all
of LASIK Surgery Watch’s concerns about the
procedure, including citation of a number of medical
journal studies. “LASIK is a medically unnecessary
surgery that carries with it permanent adverse
effects and substantial risk of permanent visual
impairment,” it says. “As evidenced, LASIK complications occur frequently. It is reasonable to
conclude that LASIK eye surgery has become a leading
cause of preventable visual impairment in the United
States.”
The letter calls on Shuren to immediately withdraw
FDA approval of LASIK devices.
Meanwhile, a Consumer Reports
survey
has found that 55% of Americans who had LASIK surgery continue to wear glasses or contact lenses
at some time. And many of them say they were misled
by advertising for the procedure that led them to
expect they would not need other eye correction
after surgery.
“Laser vision correction surgery is a largely
unchecked industry, and consumers need to know the
right questions to ask to be sure they’re protected
and that they’re getting good quality care for their
money,” says Consumer Reports Health Rating Center
director John Santa. “Vision
correction surgery is increasingly popular but there
is a concerning lack of unbiased, concrete evidence
about its safety and efficacy.”
Survey results showed that 53% of patients
experienced at least one side effect within the
first four weeks after surgery, and 22% experienced
them six months after surgery, especially dry eyes
and visual symptoms like halos, glare, and
starbursts around lights.
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