|Even advocates of the procedure have lodged
complaints. In February, the former president of
Canadian-based Lasik Vision, Michael Henderson, brought a
lawsuit against the company, claiming his eye surgery led to
Despite warnings on detailed consent
forms, few of the patients reporting problems from their laser
eye surgery say they understood that such severe complications
Leslie Woodlock says she thought if her
surgery didn't work, she could always return to wearing
"Now I can't drive at night because it's
so bright it's like putting your head in a bag of Christmas
lights," says Woodlock, 40, of Huntington Beach, Calif. "I
went to another doctor who said my corneas look like shattered
windshields. I've had four more surgeries in my left eye, but
it can't be fixed. It's important people know this can
To be sure, the operation is generally a
success and complications rare. Millions have been helped. But
some patients and doctors say advertisements touting laser eye
surgery, also known as LASIK (short for Laser-Assisted In-Situ
Keratomileusis), give the public dangerously unrealistic
"If you promote it as if it's a haircut,
then you're not being genuine. That's one of the reasons there
are more lawsuits, simply because people's expectations are
that it's low-risk," says Dr. Roy Rubinfeld of Chevy Chase,
Md., who's had the procedure himself and performed it on his
wife. "This is surgery. As with all surgeries, the results are
dependent on the skills, experience, judgment and ethics of
Problems with the surgery are getting
more attention because of an increase in malpractice lawsuits.
In addition, recent bankruptcies have prompted laser eye
clinics to close, causing scores of patients to scramble for
follow-up medical care.
What critics say:
- Profit pressures are leading to sloppy care. With
prices ranging from $499 an eye to more than $2,000, doctors
who see dozens of patients a day can earn tens of thousands
Profit pressures are prompting some
clinics to recycle equipment or rush screenings, critics
say. Lawyers say California-based LaserVue Eye Center
settled a lawsuit last year alleging it reused blades that
could have potentially exposed patients to infectious
diseases such as hepatitis and AIDS. LaserVue didn't return
calls seeking comment.
"A lot of these places are becoming
like mills, with patients literally getting in and out of
chairs," says Bryan Lentz, a lawyer in Philadelphia who has
represented a laser-surgery patient in another case.
- Patients are at risk because doctors fail to do
thorough screenings. With no standardization of
screening procedures, some doctors aren't conducting enough
tests on patients to determine risk of complications,
"They're doing the surgery on people
who should not be patients," says Aaron Levine, a Washington
lawyer. He estimates that there are about 100 malpractice
lawsuits involving laser eye surgery.
- Risks may not be known. The Federal Trade
Commission is now cautioning that LASIK surgery is "too new
to know if there are any long-term ill effects beyond 5
years after surgery."
Others also are raising concerns.
Canada's Medical Association last year added LASIK to a list
of 14 conditions considered risk factors when determining
whether a person can legally drive.
And in the USA, a Baltimore researcher
reported in a peer-reviewed journal in May that 41.5% of 176
LASIK patients surveyed said they had more difficulty driving
after the surgery. "It's not that they can't drive, but just
that some have glare that is worse than it was before," says
researcher Oliver Schein, a professor of ophthalmology at
Cathy Bishop-Clark, 37, a professor in
computer science and systems analysis at Miami University's
Middletown, Ohio, campus, underwent the surgery on Sept. 15,
2000, thinking it would be "neat to be able to see the clock
when I woke up in the morning."
"I cannot read for any amount of time
without experiencing substantial pain. I cannot go outside
without wearing goggles because the wind is too much to
tolerate," says Bishop, who spent $3,000 on her procedure. "I
have to close my eyes when people walk by me because I can
feel the breeze they create in my eyes, and it is
Growing number of patients
As complaints mount, the American Trial
Lawyers Association has started a laser eye committee, and
dissatisfied patients are forming support groups in
California, Florida and other states.
The number of people undergoing laser eye
surgery has grown each year since its inception in 1996, when
about 62,000 people had the procedure, according to Market
Scope, a marketing firm that concentrates on the optical
Last year, 835,000 people had the
procedure. This year, a projected 1.1 million will, hoping it
will correct their nearsightedness, farsightedness or
astigmatism enough so they can do without glasses or contact
In an operation that takes about 10 or 15
minutes, surgeons use a device to cut a flap from the front of
the eye and peel it back. A laser reshapes the cornea,
improving its focus. The flap is placed back over the
The surgery has become so routine that
some patients undergo the operation in malls while curious
bystanders look on. Ads promising "results you'll love" tout
the operation as a "miracle," "safe and effective" and
About 5% of patients — which would equal
50,000 people this year if 1 million have the surgery — face
some kind of complication, according to data commonly touted
by industry consultants. That may include temporary
inflammation, a reduction in vision quality, dry eyes, halos
and difficulty driving at night because of halos or severe
glare. Some complications go away within months. Others may be
"A 5% (complication rate) might be
correct early in a surgeon's experience, but later, it's more
like half a percent," says Dr. Howard Gimbel, medical director
of Gimbel Vision International, which runs surgery clinics in
Calgary and Alberta, Canada.
As a comparison, cataract surgery has
about a 3% complication rate, according to a study sponsored
by the federal Agency for Health Care Research and
Attention to problems within the LASIK
industry are welcomed by some who say consumers may have
"The turbulence in the industry is
needed. We need the reality check that this is a surgical
procedure," says Elias Vamvakas, CEO of TLC Laser Eye Centers,
whose U.S. headquarters is in Bethesda, Md. "The long-term
focus on quality is needed."
TLC, which performed laser surgery on
golfer Tiger Woods, also has clinics in Canada. Vamvakas says
equipment used there is more cutting edge than in the USA. And
he says patients are referred to his clinic by their own
doctors, which helps ensure fewer problems. He also says that
exaggerated advertising has added to patients' exaggerated
"Ninety percent of ads are done by
individual doctors. The vast majority bill it as easy and
quick. People say things that are out of line," he says. "It's
a huge issue. Consumers have no idea. They trust doctors.
Pressures in the industry have prompted some doctors to do
surgery on patients who aren't the best candidate."
Others say there should be more
regulation of the ads used to get patients in the door. The
Food and Drug Administration is warning consumers to be wary
of "slick advertising" and "deals that sound too good to be
Millard Stahle says that, based on the
advertisements he saw, he believed the surgery would improve
his vision. Instead, he says, it has dismantled his life.
Since undergoing laser eye surgery about a year ago, Stahle
doesn't sleep much. The procedure left him with such dry eyes
that he says he must awaken every few hours, peel his lids
open and apply lubricating drops.
He doesn't drive much anymore, either.
Night-vision problems mean the lights of an oncoming car can
be almost blinding, he says. Because he's unable to meet
clients in the evenings, the 54-year-old real-estate agent
gave up his job.
"I didn't know this could happen or be
this severe," says Stahle, of Fairfax, Va., who paid $2,400 to
have the surgery done. "For me, the night is the worst part. I
wake up every hour, and the pain is like someone threw acid in
there. I keep thinking, 'Millard Stahle, you ruined your
life.' Medicine should not be buyer beware. The ads, they're
Supporters say such bad outcomes were
more likely when the procedure was new. They say tales of bad
outcomes can too easily sway people from having a surgery that
may substantially improve their lives.
And they say that, in many cases,
problems can be fixed. For example, surgeons can redo
procedures to make vision sharper for patients who have failed
to come close enough to 20/20 vision. Wrinkles in the flaps
that can cause vision problems can be fixed if caught early
enough after surgery. Stray cells that get under the flaps can
also be brushed out.
"Somewhere between 50% and 70% of those
patients I can greatly improve," says eye surgeon Rubinfeld,
who is part of a growing new subindustry: doctors who care for
patients trying to correct laser eye surgery
"There are a number of problems that can
be helped a great deal or eliminated," Rubinfeld says.
But for some patients, nothing short of a
corneal transplant will help. "A transplant will repair almost
all LASIK problems, but it is not to be entered into lightly,"
Rubinfeld says. "It takes a long time for vision to heal,
about a year. And it has its own set of risks, of rejection
Patients with problems are increasingly
taking their stories to the courts — alleging medical
malpractice or consumer fraud.
Last year, Angel Bin Fang was awarded
$800,000 in her lawsuit against Kremer Laser Eye Center in
King of Prussia, Pa. She says the first surgery left her
farsighted in one eye. A second operation led to permanent
double vision and other problems. The case is under
She can read for only 15 minutes at a
time because of pain, she says. She can't play Ping-Pong,
peruse a menu in a dimly lit restaurant, read road signs at
night or spend any sustained period of time watching TV or
movies, she says. "It's constant. It will always be like
this," she says. "It's impacted everything in my daily
Officials at Kremer declined to
Some of the lawsuits could potentially
affect thousands of patients. Three sisters — Marie Harris,
Janet Janke and Sherry Stauffer — are suing Canadian-based
Lexington Eye Institute and Focus Eye Care, a company in
Washington. Lexington handled their surgeries, and Focus Eye
Care dealt with pre- and post-procedure care.
The lawsuit, filed in Seattle, seeks
class-action status. The sisters claimed they experienced
vision problems after their surgeries.
Steven O'Ban, a Seattle lawyer for
Lexington Eye Institute, says the company "categorically"
disputes the claims. He declined to comment, however, "because
of a confidentiality order the judge has put in place."
But some say such lawsuits are to be
expected. The increase in legal action against eye surgeons
who use lasers simply reflects an increased number of
procedures being performed, says Paul Weber, risk manager for
Ophthalmic Mutual Insurance, which insures about 2,200
doctors, about 850 of whom do laser surgery.
"There were more than a million
procedures done last year," Weber says. "Anytime you have that
volume of procedures done, there will be patients not happy
with the result. I don't think this procedure is any riskier
than any other ophthalmic procedure."
Last year, about 150 claims were filed
against the insurer. Of those, 19, or about 12%, were related
to laser surgery.
"It's something we're paying attention
to, but it's not a number that's shocking," Weber says.
Treatment issues can take on a different
twist for the scores of patients who go to Canada, which
approved the procedure before the USA. Critics say problems
arise because some Canadian centers have gone bankrupt, while
others use equipment not approved by the FDA. And they say
patients often return home right after surgery and are too far
away to go back to their doctor in Canada if complications
Other patients have been left without
follow-up care because dozens of clinics have closed. Lasik
Vision, a Vancouver, British Columbia, laser eye surgery firm
used by many in the USA, merged this year with another
Canadian firm, Icon Laser Eye Centers. In April, Icon placed
the subsidiary in bankruptcy and clinics closed throughout the
USA and Canada.
Some doctors in the USA report they've
been treating patients who developed complications after
having procedures done across the border.
"A large number of patients are coming in
with serious complications," says Dr. Steven Wilson, chair of
ophthalmology at the University of Washington in Seattle.
Some experts say complication rates are
likely to decline as surgeons and the industry learn more
about which patients make the best candidates for surgery.
Not good candidates
In the past few years, for example, many
surgeons have begun advising patients who need a great deal of
correction that they may not be good candidates, especially if
their corneas are thin or their pupils wide, because those
conditions increase the risk for problems, says Gimbel of
Gimbel Vision International in Calgary.
"Many of us have seen patients with
night-vision problems after LASIK," Gimbel says. "That's why
we are selecting patients differently now than early on. With
time and experience, we realize the limitations of a
procedure. Then we have to back away from those situations.
What's coming into the press now are those early results.
Unfortunately, that's making some people afraid of the
But Phyllis Knapp thinks a little fear
may be a good thing. Ads make the procedure seem so easy, so
safe. But more people considering the surgery also need to
know how bad the problems can be when things go wrong, she
Knapp, of Kalamazoo, Mich., says she
spent $4,400 for her laser surgery in January 2000. A proper
screening was never done, she says. Now she says she sees
double in her left eye. Driving at night with her husband, she
says the lights of oncoming cars appear to be spikes
stretching up into the black sky. At work, she says she
suffers from such painful dryness she spends breaks on a cot
in the lounge putting ice on her burning eyes.
"I'm struggling to work every day because
I can't see very well," says Knapp, 57, a secretary at
Kalamazoo Valley Community College. "I often have to wake up
every night to lubricate my eyes and put ointment in. It's
made me a whole different person. I find no joy in anything. I
had never envisioned it could be this bad. They're even doing
the procedure in malls now. It's sickening. It's a circus.
They're making a mockery of a serious medical procedure."
Contributing: Kate Morse