FDA Seeking Comments on Excimer Ban Petition
The Food and Drug Administration (FDA) has received a petition to ban the use of excimer lasers for refractive surgery purposes. The citizens' petition was filed by the owner of lasikdisaster.com, and claims that "substantial deception in the labeling and an unreasonable and substantial risk of injury" represent sufficient grounds to ban the lasers.
The petition is not associated with the FDA's comprehensive investigation into the negative consequences of LASIK, including the psychological consequences of failed LASIK.
The FDA welcomes comments on the petition, which can be read online. Persons with a strongly positive or negative experience with LASIK surgery are encouraged to comment, since the FDA will consider all comments in evaluating the viability of the proposed ban.
Proponents of LASIK and related refractive surgeries claim the ban is uncalled-for. Glenn Hagele, executive director of the Council for Refractive Surgery Quality Assurance (CRSQA), says, "The suggestion that LASIK should be banned is not supported by science and ignores the vastly positive comments reported to the FDA" by his organization. In a CRSQA survey, 99 % of patients reported that their quality of life after laser vision correction is as good or better than expected, although 2 % report that complications from the procedure are frequently or always problematic (revealing that about 1 % of laser vision correction patients are very pessimistic.)
Laser vision correction is by far one of the most successful surgeries available, but there are a number of people who have experienced serious adverse effects. If you have had a positive or negative experience with laser vision correction, you are encouraged to respond to the petition.
The petition is not associated with the FDA's comprehensive investigation into the negative consequences of LASIK, including the psychological consequences of failed LASIK.
The FDA welcomes comments on the petition, which can be read online. Persons with a strongly positive or negative experience with LASIK surgery are encouraged to comment, since the FDA will consider all comments in evaluating the viability of the proposed ban.
Proponents of LASIK and related refractive surgeries claim the ban is uncalled-for. Glenn Hagele, executive director of the Council for Refractive Surgery Quality Assurance (CRSQA), says, "The suggestion that LASIK should be banned is not supported by science and ignores the vastly positive comments reported to the FDA" by his organization. In a CRSQA survey, 99 % of patients reported that their quality of life after laser vision correction is as good or better than expected, although 2 % report that complications from the procedure are frequently or always problematic (revealing that about 1 % of laser vision correction patients are very pessimistic.)
Laser vision correction is by far one of the most successful surgeries available, but there are a number of people who have experienced serious adverse effects. If you have had a positive or negative experience with laser vision correction, you are encouraged to respond to the petition.
posted by Dr. Candelaria at 12:09 PM
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