FDA warns that advertisements of Lasik surgeries should not be misleading and have to be truthful regarding associated risk factors.
For quite some time the Food and Drug Administration (FDA) is investigating the complaints of the patients regarding Lasik procedure. The FDA have asked the healthcare providers that commercials and other promotions that do not convey necessary warnings, side-effects and other precautions are deceptive.
According to a letter issued by FDA in Friday, from now on health care providers and Doctors is required to give detailed information about the associated risks of Lasik surgery.
Timothy Ulatowski, head of the Office of Compliance for the FDA's Center for Devices and Radiological Health, says that Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.
From now on if the FDA deems LASIK advertising misleading, it can issue warning letters as well as take stronger action such as imposing fines or making referrals for criminal investigation.
Reactions from experts:
- FDA could have done more than send a "vague" letter that does not help "patients in any meaningful way.
- The agency should instead require doctors and clinics to give potential patients a simple, easy-to-understand booklet that lays out all the possible risks
- Many people think LASIK is some kind of miracle and that's just not true.
- The problem is there are certain people who are unlikely to benefit (from LASIK) and they don't know about that.
- The "reminder" from the FDA is highly appreciated and would give the letter to its members. Other industry groups either could not be immediately reached or had no comment.
Meanwhile FDA have decided to updating its website and making it easier for people to report problems to the FDA.
However, as per experts, presently Lasik complications rates are decreasing. It is true that complications were generally more common in the early years of LASIK, when studies in the late 1990s indicated that up to 5 percent of people undergoing laser vision correction experienced some type of problem.
As per the report of experienced LASIK surgeons now serious complication rates can be held well below 1 percent, but it is required to select surgical candidates very carefully.
It is very important that patients should carefully mention their health conditions and the medicines they are consuming at the time of per operative consultation. For example patients having certain pre-existing conditions such as diabetes might be eliminated as a good Lasik candidate.
The finally you must keep in mind that the most important step you should take to decrease any risks associated with Lasik is choosing the right eye surgeon.
Source: Yahoo News
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