Laser Eye Surgery: US federal panel urges FDA to make LASIK risks clearer

Laser Eye Surgery: US federal panel urges FDA to make LASIK risks clearer

The U.S. Food and Drug Administration should take more steps to advise LASIK patients about potential risks of the laser eye surgery, an advisory panel said on Friday, following pleas from those who suffered from glare, dry eye and even suicidal tendencies.

“I think we need better screening, better information and in some cases better doctors,” said panel chairwoman Jayne Weiss, a Kresge Eye Institute ophthalmologist in Detroit.

The panel’s recommendation followed hours of testimony by some LASIK patients who said that blurriness, double-vision and other problems led to depression and in some cases suicidal tendencies.

Panelists agreed with the FDA that LASIK is safe and effective, but said the agency could offer clearer information about side effects. They also suggested the FDA provide photos on its website to give patients a better idea of what halos and other visual complications look like.

Millions of Americans have successfully undergone LASIK, or laser-assisted in-situ keratomileusis, which cuts a flap in the eye then uses a laser to reshape the cornea, making people less dependent on glasses or contact lenses.

Roughly 700,000 Americans have had LASIK since it was approved in 1998, according to industry estimates.

Still, the FDA is taking another look at the procedure after a 2006 internal review concluded that while available data did not point to widespread problems, there was not enough information on rare but serious complications.

The agency also is set to begin a LASIK study on patient satisfaction next year along with the National Eye Institute and two groups: the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology.

The panel urged the FDA to take more action upon the study’s conclusion, although some patients pointed to the medical groups’ involvement as a conflict of interest.

At Friday’s meeting, patients told the panel that their sight never recovered after LASIK surgery.

“Since LASIK, I am visually handicapped,” said David Shell, adding that he has near constant eye pain and depression. “My eyes never feel comfortable … 10 years have passed, and I still suffer from this problem.”

Others said the complications were simply overwhelming.

Gerald Dorrian said his son Colin killed himself after getting LASIK during law school and wrote in a suicide note that overlapping images and other problems “drives me more and more crazy every day.”

Surgeons and other industry representatives told the FDA’s outside advisers that most LASIK patients are satisfied with their vision. They said depression was a complex condition and that no studies show a direct link between depression and laser eye surgery.

New York University Medical Center ophthalmologist Eric Donnenfeld defended the surgery as a way to improve patients’ lives.

“The reality is that, following LASIK, the great majority of our patients see as well or better than they ever saw with their glasses or contact lenses with which they were unhappy,” Donnenfeld said. Less than one percent of patients had severe complications like some of those testifying Friday, he added.

Other patients, including military personnel and those confined to wheelchairs, also lauded LASIK’s ability to help them see in difficult or hectic circumstances.

FDA’s panelists pointed to heavy marketing of the procedure and said not all doctors took adequate precautions, echoing several patients at the meeting who faulted surgeons for not ruling out poor candidates or stressing possible risks.

But the FDA, which has said the surgery is safe and effective, regulates LASIK devices but not surgeons or clinics. “We cannot regulate the practice of medicine,” said Malvina Eydelman, head of the FDA device center’s ophthalmic division.

Most of the physicians on the FDA panel, including Weiss, had not undergone LASIK, choosing to stick to glasses.

“I would not tolerate any risk for myself,” Chairwoman Weiss said.

Stock analysts have said the FDA panel’s examination could further hurt LASIK-related companies, including device makers Advanced Medical Optics Inc , Alcon Inc , and Bausch & Lomb as well as clinics such as TLC Vision Corp and LCA-Vision Inc .

The companies have already seen weaker earnings as a softening U.S. economy dampens demand for the elective surgery. Most health insurers do not cover LASIK, which can costs several thousand dollars per eye.

Advanced Medical Optics shares closed up 1.4 percent to $20.33, while Alcon shares closed off nearly 1 percent to $153.49, both on the New York Stock Exchange.

TLC Vision shares closed down about 1.6 percent at $1.20, while shares of LCA-Vision closed up 3 percent at $12.47, both on Nasdaq.

Laser Eye Surgery: US federal panel urges FDA to make LASIK risks clearer. Editing by Tom Swan

Donate for Kindness

Hi man, if you find this article useful, please donate a few bucks to help the one in need.


Topics: ,,,