Yourlawyer.com (LASIK News)

LASIK Surgery Study to Look at Potential Quality of Life Issues

Tue, 20 Oct 2009 00:00:00 -0700

The potential impact on quality of life from LASIK surgery is the subject of a study just launched by the Food & Drug Administration (FDA). According to an agency press release, the study is to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense.

LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

LASIK is not for everyone, especially those with misshapen or excessively thin cornea, early cataract formation, big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. LASIK risks include lost vision, painful dry eye, glare, and night-vision problems. Serious complications affect about one percent of the cases and FDA estimates place customer dissatisfaction at five percent. Unfortunately, aggressive marketing campaigns often lead patients to believe clear sight is guaranteed, even though one in four patients seeking LASIK is deemed a poor candidate.

According to the FDA, the goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems. The federally funded study will consist of three phases:

Phase 1, which began in July 2009, is to design and implement a Web based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.
Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.
Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

According to the FDA, the results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

The announcement of the LASIK study came at the same time the FDA issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.

How to Avoid LASIK Surgery Injuries

Tue, 06 May 2008 00:00:00 -0700

How to Avoid LASIK Surgery Injuries

LASIK eye surgery holds great appeal for those looking to rid themselves of bothersome eyeglasses and contact lenses. However, LASIK surgery is not without risk, and some people with certain pre-existing conditions should avoid the procedure entirely.

Despite the white coats they often wear, the front office staff at many eye surgery centers are not always medical professionals, and many LASIK eye surgery candidates might not even meet their surgeon until the day of their procedure. What's worse, the staff at a majority of these centers are often paid a commission based on the number of surgeries they "sell." Unfortunately, this set-up can create a situation where screening staff play down the risks of LASIK surgery, and hype its positive outcomes. There have also been cases were patients who have conditions that should have disqualified them for LASIK have been cleared for the procedure anyway by staff too eager to make a sale.

One of the best ways to avoid LASIK surgery side effects, as well as disappointment with results, is to become an educated consumer. LASIK surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown. Very often, the side effects of LASIK surgery are permanent, and will affect a person for the rest of their lives.

It is first of all important to remember that not everyone is a candidate for LASIK surgery. Those considering LASIK should be fully evaluated in advance for conditions such as dry eye, which affects an estimated 10 million Americans. Contact lenses, birth control pills, antihypertensive medications, and antihistamine use can lead to dry eye. Those with moderate-to-severe dry eye should be advised prior to LASIK surgery since the eye will certainly be drier afterward.

Misshapen or excessively thin corneas, early cataract formation or big pupils, and underlying conditions such as lupus or rheumatoid arthritis, often result in bad LASIK outcomes. In patients who are far-sighted, the level of improved vision after LASIK surgery may decrease with age.

Even patients who are ideal candidates for LASIK surgery can experience complications. Typical side effects of LASIK include halos, starbursts, and poor night vision. All of these side effects are extremely debilitating, as they impact a person's ability to drive, play sports, and engage in other daily activities.

Anyone considering LASIK should look for a physician who is fellowship-trained in corneal diseases, and speak to the prospective surgeon well in advance of the procedure. If front office staff insists that this be done the day of surgery, it is a good idea to find a more cooperative eye surgery center. When speaking with a surgeon, ask how many LASIK procedures the surgeon has conducted and when.

It is also important to ask a LASIK surgeon what equipment he or she is using. Not all LASIK lasers are of the same quality, and some have higher complication rates than others. Some LASIK lasers have been subject to recall, and in some instances, doctors have used lasers not approved for use in the US. Once the make and model of a LASIK laser are known, a brief internet search will reveal if it is a defective or unapproved device.

Eye sight is precious, and permanent LASIK side effects can have a devastating impact on quality of life. Anyone considering LASIK surgery should be their own advocate, and arm themselves with the information they need to help them avoid these life-altering injuries.

More Warnings for Lasik Surgery, FDA Panel Says

Mon, 28 Apr 2008 00:00:00 -0700

At a meeting of the U.S. Food and Drug Administration's (FDA) Ophthalmic Devices Panel Friday where post-LASIK quality-of-life issues were discussed, it was recommended the FDA ensure clearer warnings outlining the risks of LASIK, according to the Associated Press. LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism. Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery. The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of Lasik remains unknown.

The FDA has received 140 letters of complaints. "The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center. FDA advisers recommended the agency clarify warnings regarding LASIK, including: Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be disqualified from LASIK, such as large pupils or severe nearsightedness.

According to the Associated Press, David Shell of Washington, D.C., had LASIK in 1998 and said he has "not experienced a moment of crisp, good quality vision since. Matt Kotsovolos worked for the Duke Eye Center when he had a more sophisticated LASIK procedure in 2006 and said his doctors classified him as a success because he has 20-20 vision, but Kotsovolos said, "For the last two years, I have suffered debilitating and unremitting eye pain.”

Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions. Colin was told he wasn't a good candidate for LASIK, but got the surgery at a Lasik center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself…. I can't and won't continue facing this horror," he wrote in a his suicide note, adding, "I have other problems like most people do. But this is something else. As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it." On Friday, Colin’s father, Gerald, detailed the six years of eye pain and blurred vision experienced by his son.

Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City, says that LASIK is not for everyone, especially those with a misshapen or excessively thin cornea, who have early cataract formation or big pupils, who have dry eyes, or underlying conditions such as lupus or rheumatoid arthritis. Side effects can include glare and halos around lights at night and some patients have had corneal transplants, Starr said.

FDA to Hear from Lasik Surgeons, Unhappy Patients

Thu, 24 Apr 2008 00:00:00 -0700

The US Food and Drug Administration (FDA) is finally going to review complaints from patients who underwent Lasik eye-correcting surgery and who have suffered from a variety of issues, including blurred vision and dry eyes. The FDA received 140 reports of Lasik surgery injuries between 1998 and 2006, according to an agency spokeswoman. Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery. The surgery permanently reshapes the cornea; there are no guarantees of 20/20 vision and the long-term safety of Lasik remains unknown.

The FDA will hear from Lasik eye surgeons and dissatisfied patients at a meeting Friday with its outside panel of eye experts and will ask the panel whether educational materials provided to patients considering Lasik require change or update. Regulators agreed to hold the meeting after years of complaints from some patients who say their eyesight has been permanently damaged by Lasik. "My life is a blur," Dean Kantis said. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them." Kantis is one of Friday’s scheduled speakers.

Double vision, night-vision disturbances and dry eye are among the side effects listed in literature given to Lasik patients; however, Kantis and others argue that physicians don’t generally focus on these risks. "Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.

An FDA spokeswoman said the FDA has no authority over physician handling of patients; however, regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' post-surgical quality of life. As part of the study to examine the relationship between Lasik complications and quality of life issues, are plans to look at psychological problems such as depression. When patients undergo vision-correcting laser eye surgery—such as Lasik—they sign a release form with an extensive list of risks; however, researchers and former patients say a potential complication is not mentioned: Depression leading to suicide. While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe. For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions. The surgery was conducted at a Lasik center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do. But this is something else. As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb are under analyst radar as Lasik procedures are expected to decline five to 15 percent this year because it cost—between $1,500 and $5,000—may not be affordable to many consumers.

LASIK Surgery to Undergo FDA Review

Tue, 18 Mar 2008 00:00:00 -0700

US health regulators plan to review whether LASIK—laser-assisted in situ keratomileusis— surgery is actually improving patients' lives. Last month, in response to patient complaints, the US Food and Drug Administration (FDA) discussed plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression. According to Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, those discussions have now led to plans for a public meeting to talk about the issue. Schultz said a number of concerns have been raised concerning patient satisfaction with the LASIK vision correction procedure.

Schultz did not give a date when the meeting will occur. Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc. and LASIK providers such as TLC Vision Corp and LCA-Vision Inc. "Obviously, it's a technology that has caught on and is used very, very widely. And there have been questions raised in terms of ... quality of life and what does it actually do for the patient as opposed to the technology itself," Schultz said adding that the meeting will focus on the quality of patients' lives following surgery. Although FDA spokeswoman Karen Riley said the meeting date has not been made public, some analysts have said it could happen as early as next month. Meanwhile, the agency's eye-related panel has tentatively scheduled meetings for April 24-25, May 15-16, September 18-19, and November 20-21.

When patients undergo vision-correcting laser eye surgery, such as LASIK, they sign a release form with an extensive list of risks. Known complications can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness. However, researchers and former patients say a potential complication is not mentioned -- depression leading to suicide.

In July 2007, the FDA responded to petitions from an individual requesting that LASIK procedures be stopped and for a withdrawal of their approval. The agency responded by saying the LASIK devices were safe and effective but advisory panel discussions "could complement" its other safety monitoring. "The post-market information found within our databases, regarding the devices mentioned in your petitions, does not suggest that at this time, there are adverse events that are unanticipated or occurring at an unexpected rate," the FDA said then.

In a research note, analyst Larry Biegelsen—from Wachovia Capital Markets—said the planned FDA meeting could result in a couple of different outcomes. Either doubt could be cast on affected companies because of an uncertain outcome or it "could ultimately be positive for companies" if the panelists decide the surgery does helps patients, especially those which were done with newer technologies, he said.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed. A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country.

LASIK Surgery - Depression Link To Be Studied by FDA

Tue, 26 Feb 2008 00:00:00 -0800

LASIK surgery - a procedure that can sometimes lead to life-altering complications -- has caught the eye of federal regulators. When patients undergo vision-correcting laser eye surgery—such as LASIK—they sign a release form with an extensive list of risks. However, researchers and former patients say a potential complication is not mentioned: depression leading to suicide. In response to patient complaints, the US Food and Drug Administration (FDA) plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, says the limited clinical data "failed to suggest significant problems following LASIK surgery." Confirming that the FDA wants a broad and systematic review, she said, "We also noted that quality of life issues related to LASIK had not been evaluated consistently and there were few reports of well-designed studies." While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe. For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after LASIK surgery left him with visual distortions. The surgery was conducted at a LASIK center in Canada that has since closed. "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do. But this is something else.
As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but don't believe LASIK complications are the root cause, arguing that patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand. "There's no cause and effect," said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from LASIK. Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, has encountered the psychological effects that patients experience when they have trouble seeing. "Depression is a problem for any patient with a chronic vision problem," she said. In the case of post-LASIK patients, depression is compounded by remorse, "It's not just that they lose vision. They paid somebody [who] took their vision away," she said. Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications and said people at risk of depression or anxiety are generally not good LASIK candidates.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.  A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country. The FDA is also planning a public meeting to discuss experiences with LASIK devices since their introduction to the U.S. market.

New York City Jury Awards Man $7.25 Million for LASIK Surgery Gone Bad

Fri, 05 Aug 2005 00:00:00 -0700

Although LASIK eye surgery is rapidly becoming one of the most common and safest forms of surgery, it should not be taken lightly as it is still a delicate surgical procedure.

Thus, the potential exists for some very serious post-operative problems to occur if the procedure is not performed correctly or if a patient’s medical history is not properly evaluated to first determine if the surgery is contraindicated and should not be done.

Unlike some other surgical procedures which, if done improperly, may be corrected, LASIK surgery that results in serious vision problems is very often beyond repair.

This is what appears to have occurred in the case of a 32-year-old former investment banker whose LASIK surgery left him with distorted and blurred vision that forced him to leave a high paying Wall Street career.

The allegation made by the plaintiff, Mark Schiffer, is that Dr. Mark Speaker, a well-known LASIK surgeon with thousands of procedures to his credit, should never have performed the operation because Mr. Schiffer suffered from a degenerative corneal condition called keratoconus which made laser surgery unsafe.

It was claimed that doctors affiliated with Dr. Speaker failed to diagnose this condition before the surgery because the high-volume practice was what Mr. Schiffer’s attorney referred to as the “McDonalds of LASIK surgery.”

On the day Mr. Schiffer was operated on, Dr. Speaker performed procedures on 10 other patients. This was claimed to have been a factor in the failure to determine that Mr. Schiffer was not a suitable candidate for laser eye surgery.

Defense counsel argued that Mr. Schiffer did not suffer from keratoconus and that his injuries were far less severe than claimed.

The $7.25 million jury award represented $4.5 million in lost income and $2.75 million for conscious pain and suffering. Previously, the highest award in a LASIK eye surgery case was believed to be $4 million in an Arizona case involving a former United Airlines pilot.

There was no immediate word if the defendants intended to appeal the verdict in the Schiffer case.

Eye Surgeon Sued Over Lasik Work

Fri, 23 May 2003 00:00:00 -0700

A jury has been seated and testimony may begin today in a civil lawsuit against an eye surgeon by a former Indiana County woman whose Lasik procedure went badly.

Common Pleas Judge Max Baer, who is presiding, will meet this morning with attorneys before the jury is sworn in and lawyers make their opening statements.

Kashmira Karanjia is suing TLC Laser Centers of Wexford and Dr. Mark Whitten, claiming her eyes were damaged by Lasik surgery, a laser procedure used to correct vision and allow the patient to see without eyeglasses.

Karanjia, 31, had been an elementary school teacher in Tampa, Fla. She said she had to quit her job because of problems after the 10-minute operation.

The suit also claims that Whitten doctored her medical records to indicate, falsely, that she was a good candidate for the procedure.

Although the surgery corrected Karanjia's visual acuity she said that she can see close to 20-20 it caused severe visual aberrations or side effects of glare and ghosting that are present during the day and worse at night, limiting what she can see.

These are common side effects for people who have had complications with Lasik.

Karanjia, whose father is a physician, has lived in Orlando for seven years. She chose to have the surgery performed locally, in March 1999, after a consultation with her optometrist, Dr. Charles M. Tarnoff of Indiana, Pa.

She said Tarnoff measured her pupils and found them to be 8 mm in diameter. Candidates for Lasik should have pupils no larger than 6 mm, according to the suit.

Karanjia claims that Whitten and Tarnoff should have known that she would suffer complications. She said that Whitten changed her records to indicate that her pupils were within the acceptable range.

Whitten has said he does thousands of Lasik procedures a year. It is a 10-minute outpatient procedure, approved by the Food and Drug Administration in the 1990s.

During the operation, a surgeon cuts a small flap of the cornea and pulls it back to allow a computer-controlled laser to sculpt the eye to correct vision impairments like nearsightedness and farsightedness. The procedure also can correct astigmatism, a misshapen cornea that causes blurred vision near and far. After the operation, the cornea flap is then folded back to heal.

Whitten has said he did the surgery on golfer Tiger Woods and other celebrities, and is considered a national expert in Lasik.

He has been quoted as saying that during an 18-month period he did 11,000 of the procedures.

LASIK Surgery Isn't for Everybody

Tue, 04 Jun 2002 00:00:00 -0700

Considering laser surgery to improve your eyesight? New guidelines should help determine if you're a good candidate or might be prone to vision-harming side effects.

One key: The guidelines explain what tests are needed before getting zapped, so if your doctor skips these steps, consider picking another surgeon.

"There is a major need for credible, reliable information," says Dr. Roger Steinert of Harvard Medical School, who co-wrote the guidelines for the American Society of Cataract and Refractive Surgery.

"You need to be aware of the complications and the risks," adds John Jeter of Reston, Va., who may have narrowly escaped injury. He was scheduled for surgery by one LASIK center but — nervous because workers repeated his eye test six times before okaying him — got a second opinion from another doctor who said Jeter's cornea was too thin to be zapped safely.

Americans will undergo more than a million LASIK procedures this year to correct blurry eyesight. It's quick and painless: Doctors cut a flap in the cornea, aim a laser underneath it, and with a zap, reshape the cornea for sharper sight.

While the vast majority of patients get better vision, it's not for everybody — a message often lost in the hoopla of ads promising that people can "throw away your glasses" or offering bargain-basement prices for surgery that usually costs more than $1,000 an eye.

Side effects include double vision, glare, halos or starbursts of light. Occasionally, patients actually lose vision, unable to see as well even with glasses or contact lenses after LASIK as they could before. Others are left with painfully dry eyes, despite eye drops.

The Food and Drug Administration, which approved laser surgery, cannot tell consumers just how big those risks are. It's not tracking them. Recent studies estimate 1 percent to 5 percent of patients suffer various side effects, although Steinert says experienced surgeons can have lower rates.

That's a small risk, yet with millions undergoing LASIK, it means thousands may suffer some problem.

The FDA has long offered general LASIK warnings, such as to know the risks and consider treating one eye at a time. The American Academy of Ophthalmology recently concluded LASIK is best for moderate, not severe, vision problems. SurgicalEyes, a group of injured patients, created a Web site that illustrates what it's like to see through various LASIK-caused side effects.

The new guidelines, to be unveiled Tuesday by the surgeons' new Eye Surgery Education Council, offer consumers a different approach — steps to determine if they're good candidates.

A key is knowing what eye tests to get. Among the most important: Finding out if the cornea is too thin or the pupil is too big. Most patients need half their original cornea thickness — at least 250 microns — remaining after surgery, Steinert explains. Avoiding glare and other vision distortions partly depends on the laser-treated area not overlapping a dilated pupil, so doctors must measure pupils in low light.

Side effects aside, you may need multiple LASIK treatments over months, and not everybody gets perfect vision. You're not an appropriate candidate for LASIK if you need a new prescription for glasses every year, or have certain medical conditions that affect vision or surgical healing.

Basic LASIK won't eliminate that middle-age need for reading glasses. Some doctors offer a variation called monovision, where one eye is focused for near vision and the other for far vision. Test this by wearing different-strength contact lenses first, stresses Steinert. While monovision works well for many people, including him, others never get used to it.

One patient offers additional advice: Visit LASIK centers to watch the procedure, get second opinions, and call former patients.

"I was willing to invest a little money to hopefully ensure I got a good result," said Rick Robertson of Houston, who spent $250 on two eye exams before undergoing LASIK last year — and has almost perfect vision.

LASIK Surgery: Hidden Risks and Regrets

Wed, 18 Jul 2001 00:00:00 -0700

The advertising and infomercials suggest LASIK surgery is painless and foolproof. The surgeon cuts a tiny flap on the surface of the eye and a few blasts from a laser burn away part of the cornea in hopes of giving patients perfect vision.

When we first reported on LASIK surgery last year we met Sherie Wong, who shared a horrifying memory. The surgeon started cutting before her anesthetic had taken effect.

"So you felt this blade begin to cut your cornea?" Blackstone asks. Wong says, "Oh, it was awful. It was so swift, you could feel it was a razor blade just slicing over your eyeball. Just slicing it."

Then after the surgery Wong had other problems including eyes that became painfully dry.

"My eyes were as dry as the Sahara desert," says Wong.

Wong needed additional surgery on her tear ducts to keep her eyes moist.

"People think I'm constantly crying," she says.

Medical research just published this month suggests that many LASIK patients are at risk for developing severely dry eyes. The research suggests that the cutting and burning in LASIK surgery disturbs delicate nerves on the surface of the eye, upsetting the intricate mechanism of tear production.

"You're taking away one-third of the structural integrity of the eye," says Aaron Levine. Levine isn't an eye surgeon. He's a malpractice attorney. Though the vast majority of LASIK patients are happy, Levine is seeing a growing number with problems.

"The more surgery that you do that's unneeded that's done under sloppy conditions--the more people are going to knock on lawyers' doors," says Levine.

The problem, Levine says, is that LASIK surgery is driven by marketing and not by medical necessity.

"Well, you never heard an advertisement on television for gall bladder surgery or a hysterectomy I don't think," says Levine.

When we first investigated the marketing of LASIK surgery last year, we watched with others from a San Francisco sidewalk as a surgeon operated in a storefront window.

It was one way for a fast-growing national chain called LASIK Vision to get attention, although LASIK Vision didn't like our attention and chased away our cameras.

A year later, the storefront clinic is closed and empty. LASIK Vision has gone bankrupt--largely a victim of its own price-cutting.

And a growing number of LASIK patients regret having surgery.

"I'm never touching these eyes ever again," says Wong.

LASIK Lawyer Cornea Replacement Blurry Vision Double Lawsuit Fuzzy Glare Halo Night Drive Attorney

Wed, 18 Jul 2001 00:00:00 -0700

Keywords: LASIK Lawyer Cornea Replacement Blurry Vision Double Lawsuit Fuzzy Glare Halo Night Drive Attorney

LASIK Surgery Injury Lawyers

The lawyers and attorneys at our firm our currently offering free case evaluations to victims of botched LASIK eye surgery. Approved a decade ago, LASIK is one of the most popular elective surgeries in the US, and an estimated six million Americans have undergone LASIK surgery. Unfortunately, LASIK surgery is no guarantee of perfect vision - in fact, the procedure often goes horribly wrong and leaves patients with serious and debilitating vision problems. If you or a loved one suffer vision problems as a result of LASIK surgery, we urge you to contact our LASIK injury lawyers immediately to discuss your case.

LASIK Side Effects

The promise of LASIK surgery is often oversold by the physicians performing it, and patients are usually ill-prepared for LASIK side effects. Doctors have also been known to perform LASIK surgery on people who had pre-existing conditions that should have barred them from the procedure. What's worse, in the vast majority of these cases, LASIK surgery complications cannot be corrected with either eyeglasses or further surgery. In extreme cases, some LASIK patients have become so depressed over the deterioration of their vision that they attempt, and sometimes, commit suicide. Our LASIK injury lawyers believe many such injuries are avoidable, and we intend to hold accountable the LASIK doctors who fail their patients.

LASIK surgery can result in myriad complications. Dry eyes are one of the most common. This painful condition can last for months, or it can be permanent. In both cases, patients are forced to use expensive eye drops - which they often purchase from the LASIK surgeon - to mitigate the symptoms of dry eyes. Other common LASIK side effects include halos, starbursts, and poor night vision. All of these side effects are extremely debilitating, as they impact a person's ability to drive, play sports, and engage in other daily activities.

It is unknown how many patients suffer LASIK side effects. For instance, some doctors say dry eyes occur in 31 percent of LASIK patients, while others put that number higher, at 48 percent. It is also thought that many LASIK side effects and complications are never reported, so the true number could be much higher. In the future, the issue could become clearer, as the Food & Drug Administration (FDA) is set to begin a major study in 2009 to better understand who has bad LASIK outcomes. But for now, no one knows how many people suffer LASIK injuries, or how serious they typically are.

Causes of LASIK Side Effects Injuries

Though LASIK surgery is unpredictable, there are a number of factors that can make it more likely that a patient will experience LASIK side effects or injuries. In some cases, doctors are less then forthcoming about possible LASIK risks, or they encourage patients who are more likely to suffer LASIK side effects to have the surgery anyway. Another is the use of use of faulty or unapproved LASIK equipment.

The equipment used in LASIK surgery is more important to the outcome than even the physician's skill. Unfortunately, not all LASIK equipment is of the same quality. In recent years, several media reports indicated that one type of laser was more likely than others to cause serious LASIK side effects. According to a 2003 article in the journal "Ophthalmology", the LADARVision Laser manufactured by Alcon Laboratories was twice as likely to be associated with LASIK complications. Some LASIK doctors say the LADARVision's complication rate is as high as 40 percent. According to FDA reports and court documents, hundreds of patients suffered permanent blurred vision, glares and halos, and sometimes the need for additional surgeries to improve their vision because of the LADARVision laser.

Alcon is aware of the LADARVision's problems. Nearly a dozen doctors are known to have communicated their concerns about the defective laser. One Chicago TV news program even obtained a transcript of a phone conference where several surgeons tell Alcon administrators they’ve reported their concerns over malfunctions. They say their concerns have been “ignored” and that they are “not comfortable with the laser."

Some LASIK surgeons have been known to use laser equipment not approved by the FDA. Such lasers are called black box lasers. Many LASIK injuries have been traced to unapproved devices. Unfortunately, the FDA does not monitor LASIK physicians to insure they use only approved lasers, and the agency will only seized such equipment if it receives complaints. Incredibly, the FDA has no power to discipline LASIK doctors if they use black box lasers. For that reason, anyone considering LASIK surgery needs to ask their doctor about the type of laser they use, and research that equipment before they undergo LASIK surgery.

Some LASIK surgeons also contribute to LASIK side effects by failing to fully communicate the risks of this surgery. In many instances, they reassure patients that LASIK side effects and complications can be fixed, but this is not always the case. Others perform LASIK on people who are not good candidates for the surgery.

Not everyone should have LASIK surgery. LASIK surgery is not recommended for those with refractive instability - generally anyone who required a change in their eyeglass prescription in the year prior to surgery. People with diseases like HIV or diabetes that can prevent healing are not candidates for LASIK surgery. People with large pupils or dry eyes can also experience complications from LASIK surgery. In patients who are far-sighted, the level of improved vision after LASIK surgery may decrease with age. Unfortunately, there are many documented cases of LASIK side effects in people with such pre-existing conditions. In some instances, LASIK surgeons did not even bother to ask about these factors, or ignored them when they did.

FDA LASIK Surgery Investigation

In April 2007, the FDA held a meeting of its Ophthalmic Devices Panel to look into LASIK surgery after the agency received 140 complaints about the procedures. According to media reports, the doctors who sat on the FDA advisory panel were all eyeglass-wearers. One of them blamed LASIK surgeons for hyping patients' expectations, while at the same time downplaying risks.

The FDA advisory panel ultimately recommended stronger warnings for LASIK surgery. The panel's recommendations included allowing prospective patients to see photographs that illustrate what people suffering certain LASIK side effects actually see. The panel also said the warnings should make clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness. The panel also called for an effort to clarify how often patients suffer different LASIK side effects.

Legal Help for Victims of LASIK Surgery Side Effects

If you or a loved one suffer from chronic dry eyes, decreased night vision, halos or other LASIK side effects, you have valuable legal rights. Please fill out our online form or call us at 1-800-LAW-INFO (1-800-529-4636) to speak with a qualified LASIK injury lawyer about your case.