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John Darauche is fully awake sitting in an operating chair, head tipped back. His eyes are open wide, the lids spread apart with wire braces. Unable to blink, Darauche does his best to hold still as his doctor reaches in and uses a surgical spatula to peel back the cornea, the clear outer membrane covering Darauche's eyeball.
Unpleasant as this sounds, the procedure has only begun. Once Darauche's eyeball is laid bare, the doctor positions a computer controlled laser contraption 2 inches from the 32-year-old patient's wide-open peeper, steps on a trigger pedal and begins firing precisely controlled pulses of light at the surface of Darauche's eye vaporizing the tissue and filling the room with the smell of cooking cornea.
This delicate, and somewhat frightening, operation is the latest development in the laser revolution, a movement that's changing medicine with a speed that's, well, eye-popping. The futuristic device that helped Buck Rogers conquer the universe is now being used by doctors to correct nearsightedness, remove hemorrhoids and warts, treat snoring problems, erase wrinkles, vaporize cancer tisue and remove tattoos. And this is only the beginnning for what its proponents envision as a 21st-century superindustry of laser-based health care, with potential revenues running in to the billions of dollars.
You've no doubt picked up on the ads in the yellow pages, in newspapers, on radio, even on the Internet - touting a varety of minor ills that can be solved with laser surgery. And, if you're like most people, you probably assume that laser sugery is better, safer, less painful than conventional procedures.
You're partially right. In some fields, most notably dermatology and ophthalmology, the laser represents a significant improvement from conventional scalpel-based surgery.
For some physicians lasers are nothing more than marketing stunts designed to attract new patients in the face of cost-containment pressures from HMOs and the insurance industy. And some of these stunts can get dangerous [see "Careful with That Light Saber"]
Lasers can be inserted, via thin flexible filaments, deep into almost any part of the body to burn away diseased tissue without the traumatic side effects of invasive surgery. And by cauterizing tissues, laser cut down on bleeding. As a result, patients can be discharged from the hospital sooner, which holds down costs.
But the early discharge sometimes makes it necessary for the patient to be sent home wearing all sorts of tubes and drainage devices, says Alexander Sotiropoulos, M.D., a urological surgeon at New york's Lenox Hill Hospital. Patients may suffer significant discomfort, sometimes for weeks.
Moreover, says Dr. Sotiropoulos, when a doctor performs laser surger to, say, eradicate a bladder tumor, he misses a lot of information that could be vital for the appropriate follow-up and further management of the patient. The reason is that the laser doesn't remove, but burns off and 'vaporizees' diseased tissue. With conventional surgery, the doctor carves out the tumor and can then examine it to see how far it has progressed. "Unfortunately" say Dr. Sotiropoulos, "with a laser, you can't do any of that. All you can do is burn the tissue, period."
As little as two years ago, lasers were considered to be the most promising surgical solution to an enlarged prostate, a condition that inhibits a man's ability to urinate. And a lot of men began opting for the surgery. "Lasers have a lot of sex appeal, " says Joseph E. Oesterling, M.D., chariman of urology at the Univerity of Michingan Medical Center. "However, new does not always meean better."
But patients bought the hype, and they weren't the only ones. "Laser prostatectomy and other procedures have gained popularity mainly because they permit an earlier discharge from the hospital, which is what HMOs now stress," says Dr. Sotiropoulos. But in the long run, laser therapy can be more expensive notes Dr. Oesterling, and both doctors agree that lasers just don't improve the patient's urine flow as well as the current gold standard for surgery, TURP, or transurethral resection of the prostate.
And beyond the quesion of whether the technology itself is appropriate to the task comes the quesion of the training received by those who use it. With possible exception of ophthalmology (where laser-surgery experience is a standard part of the training), in no case can you walk into a private doctor's office, sign up for a laser procedure and be 100 percent confident that your physician has the training, experience and overall know-how needed to do the job well.
"This is a huge problem for all of medicine," says New York atttorney Samulel A. Abady, a general-practice lawyer whose client list includes patients allegedly injured by laser-wielding physicians. "There are no requirements of any kind - either in state or federal law or within the medical profession itself - regarding the minimum training required before a physician can use a laser to operate on a person."
Indeed, only the lasers themselves are regulated and controlled at the federal level. As for who's allowed to operate all this high-intensity firepower, well, that's where the regulation are clearly lagging behind the techonolgy.
After several years of clinical trials, the U.S. Food and Drug Administration last autumn approved a device known as the excimer laser. The laser is used in a procedure known as Photorefractive Keratectomy, or PRK - the procedure that was perfromed on John Darauche. This operation represents a signicant advance over conventional 'radial keratotomy," which was pioneered in the 1960s.
In conventional surgery to correct nearsightedness, a physician makes a series of minute incisions, radiating like pie slices, into the cornea. This alters the focal plane of the eye, enabling nearsighted patients to see distance objects more clealy. "[But] the incisions tend to weaken the structure of the eye and sometimes results in a person going from nearsightedness all the way to farsightedness," says Mark Speaker, M.D., who head a New York PRK facility owned by 20/20 Laser centers, a fast growing chain with branches in 10 cities nationwide.
Laser surgery doesn't have these drawbacks. The width of the beam can be preciesely adjusted to the cornea, and once the outer membrane, or epithelium, is peeled away, the beam can be adjusted to vaporise as little as one-quarter of a micron's worth of cornea at a time - about 1/300th the width of a human hair. The entire process takes about 30 seconds per eye, and requires only local anesthetic.
"Our field test have involved more than 1,100 patients," says Roger Steinert, M.D., an assistant professor of ophthalmology at Harvard Medical School. He helped monitor PRK clinical trials for Summit Technology, the first company to receive FDA approval to market its excimer laser in the United States. After three years, 95 percent of those tested had their vision improved to at least 20/40 without glases - good enough to pass a driver's test - and two thirds got all the way to 20/20. "Fully 98.7 percent of those questioned said they were very happy with the results," says Dr. Steinert.
Still, complications are a concern. "A laser is real surgery. It is invasive," warns Patricia Caton Reardon, M.D., an ophthalmologist and president of the Connecticut Society of Eye Physicians. "It vaporises human tissue, and the effects are permanent. The excimer laser has certain potential side effects such as infection, overcorrection and undercorrection. In 1 percent of cases, a haze develops in the cornea and can permanently distort vision." And this raisers concern over who should be allowed to operate with the laser.
The problem starts with the FDA, which only regulates medical devices and designates who can use them. When Summit reaceived FDA aproval, the only restrictions put on who could use its machine were that he or she be "experienced in the medical management and surgical treatment of the cornea" and be "trained in laser refractive surgery."
Come with us now to the state of Idaho where a coterie of ophthalmologists decided to buy themselves an excimer laser. Since the excimer costs about half a million dollars, they decided to sell shares in the laser, taking money from, among others, a group of optometrists (Optometrists are the guys in the back at Eyeglass Hut who examine your eyes and determine your prescription.) They reportedly recruited the optometrists with the promise that, if the state board of optometry ever granted permission, they would be able to perform the surgery themselves.
Little did they expect that a state board would grant them that right. But it did, purportedly because the Idaho optometry code didn't explicitly prohibit it. To date, optometrists have performed 43 percent of all of the PRK procedures done in Idaho - even though an optometrist's postgraduate work does not grant him a medical degree or include any surgical training.
"Optometrists simply do not have the medical training to do invasive surgery", Dr. Reardon argues. "Nobody in the back of an eyeglass store without a medical degree should be doing this."
Medical doctors have filed suit in Idaho to prevent optometrists from using the excimer. One of their concerns: If optometrists retain the right to perform the surgery, what's to stop other surgically inexperienced health-care providers from operating?"
Add it all up and laser surgery may or may not be the greatest medical breakthrough since the stethoscope and the x-ray. But before you put yourself in the line of fire, ask yourself three hard questions:
1. Is there a convetional surgery that's better? Lasers are a mainstay in dermatology and ophthalmology, but when it comes to other fields, the doctor with the flashiest tools doesn't always produce the best results.
2. Are you expecting too much from the procedure? Even physicians who praise laser PRK say perfect vision is not guaranteed. "For some it will just make it easier for them to find their glasses." says Richard Lindstrom, M.D., an ophthalmologist with the Phillips Eye Insitute in Minneapolis.
3. Does your doctor have operating privileges at an accredited hospital? Doctors who are approved to perform laser surgery in a hospital must at least meet that hospital's criteria for training. Doctors who perform surgery only in their offices may not meet anybody's training requirements.
Additional research by Carol Ann Shaheen.
Here are some mishaps reported by health care professionals to the FDA's MEDWatch system, as listed in the journal Minimally Invasive Surgical Nursing:
"[Laser was] resting on patient's abdomen, not activated. Doctor and staff noticed flames on patients's abdomen. Fire extinguished. Patient treated for burn on abdomen."
"During a knee orthroscopy procedure, a nurse, who was standing over the cord of the laser fiber being utilized, felt a burning in the area of her groin.... The nurse reported that laser burned through her clothing, leaving her with a burn..."
"Forty miutes into an orthroscopy procedure, the fiber broke at the connector end and burned the buttocks of a nurse"
Six patients were injured during laser hemorrhoid surgery. Doctor alleges that such patient injureies were caused by the design of the product."
"Laser fiber broke... while surgeon was using laser on male patient. Laser technician informed O.R. personnel that probe [fiber] was burning hole in the [patient's] drape"
"Laser fiber caught on fire whie treating BPH at 60 watts and 60-second bursts. This required an extinguisher and premature termination of the procedure."
"Handpiece unscrewed and became disconnected... redirecting the laser to the doctor, who received a small first or second degree burn on his temple."
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"Blinded By The Light" Article,by Chris Byron, Text Excerpt, Men's Health, Sept. 1996
"Blinded by The Light"
Laser surgery is changing medicine at lightning speed. But critics believe we're embracing this techology too quickly, while ignoring issues of safety and effectiveness
Sidebox Article
Careful with that light saber
What can go wrong with a laser? Apparently quite a bit.
Excerpted from Men's Health magazine,"Blinded By The Light", Sept. 1996, pp. 68, by Chris Byron. For the full text, please contact your central library. You can visit the Men's Health web site at http://www.menshealth.com.
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