FDA: Eye Surgery Centers Warned To Inform Patients of Risks


February 13, 2013
By Lee Law Offices, P.A. on February 13, 2013 2:04 PM |

Vision enhancement surgery, such as LASIK, was hailed as near miraculous when it became commonplace in the late 1990s. eye1.jpg

However, our South Carolina personal injury lawyers know there is a dark side to it as well, though risks and complications haven't been widely reported to the public or even patients, until recently.

Now, the U.S. Food and Drug Administration has issued a warning to five of the country's top surgery centers - two of those in nearby states - to immediately halt false advertising practices and begin appropriately advising patients of the potential adverse outcomes. The warning letters were sent to eye surgery centers in Indiana, California, Florida, Texas and Georgia.

A report by National Public Radio in the summer of 2010 indicated that some 17 million people globally had undergone LASIK eye surgery, with about 700,000 in the U.S. opting for the procedure each year.

Specifically, the goal of the surgery is to use lasers to reshape the cornea to improve or correct a number of vision-related problems, such as nearsightedness, farsightedness and astigmatism. While the American Academy of Opthalmology has reported that most patients are happy with the results, an increasing number of people have suffered serious side-effects. In a number of cases, the FDA has indicated patients may not have been adequately warned of those risks.

The regulator's Center for Devices and Radiological Health said patient awareness is paramount.

Among the most common risks posed by the procedure, some patients have reported severe dry eye syndrome, the need for contact lenses or glasses afterward and vision problems such as glare, double vision, starbursts and halos. In some cases, patients have been known to lose their vision entirely.

One of the greatest problems is that patients aren't being told when they are not a good candidate for the surgery, which could be the case for a number of reasons.

This most recent warning to those in the industry is by no means the first. The FDA first issued warning letters to 17 eye surgery centers in 2009 after they were found to have failed in adequately reporting patient complications to authorities. Similar problems prompted warning letters also in September 2011 and again in March of last year.

Those centers that don't follow the FDA's guidelines could face additional sanctions, such as monetary penalties or injunctions forcing them to close.

A $180 million federal class action lawsuit lawsuit was filed in South Carolina three years ago, alleging that some 30 branches of TLC LASIK Centers conducted the procedure on patients who should have been disqualified, causing them to suffer severe problems. The plaintiff alleged he had suffered vision loss and had to undergo a cornea transplant as a result of undergoing LASIK, which he said he should have never been allowed to have due to a pre-existing eye condition.

That case was initially dismissed, but is now pending appeal.

The bottom line for you is that if you are considering LASIK surgery, make sure your doctor thoroughly explains the procedure and potential risks and has conducted a thorough examination to determine whether you are in fact a good candidate.

Contact the South Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.

Additional Resources:
FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery, Dec. 18, 2012, News Release, U.S. Food and Drug Administration

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