In many respects, North Hollywood gynecologist Dr. Ara Poladian considered the 42-year-old patient’s problems to be typical.
For almost a year, the woman had suffered from endometriosis, a painful condition in which the wall of the uterus thickens. Over time, uncontrolled bleeding had left her anemic. Sexual intercourse had been excruciating. Drug therapy had had little or no effect.
Finally, when all other treatment options had been exhausted, the woman chose to undergo a hysterectomy. With 600,000 to 700,000 such procedures performed each year, it is one of the most commonly performed surgeries in the United States.
But this particular hysterectomy, performed recently at the Medical Center of North Hollywood, was anything but common.
On a television screen above the operating table, Poladian viewed the source of the woman’s pain through a laparoscope, a thin metal tube equipped with a small camera that was inserted through the woman’s navel. He then inserted two similar-looking instruments through pen-size incisions in her pelvic area.
It was the beginning of a technique that he and a growing number of gynecologists nationwide say will revolutionize the way hysterectomies are performed.
“Instead of making an incision in the abdomen, which is the traditional way, we use the laparoscope to remove the uterus through the vagina,” said Poladian, an assistant clinical professor of gynecology at the USC School of Medicine and head of the American Fertility Institute in North Hollywood.
The different approach, he and other doctors familiar with the technique believe, has distinct advantages over abdominal hysterectomies.
“Instead of spending four to five days in the hospital, a lot of patients are discharged the same day,” he said. “There also is less pain and no big scar afterwards. In another five years, this will be standard.”
Dr. Fred Quevedo, a gynecologist with St. Joseph Medical Center in Burbank where 12 of the operations have been performed, also has seen advantages.
“Normally, women go back to work in about six weeks after a hysterectomy. But with this technique, I had a woman who returned to work in 10 days,” he said. “There definitely is reduced recovery time.”
But the procedure--which is performed by only a small percentage of physicians nationwide and at three hospitals in the San Fernando Valley--still faces obstacles to its widespread use.
Skeptics have voiced concern that not enough data has been gathered about risks versus benefits.
The agency responsible for approving medical devices has not yet approved the laparoscope for use in hysterectomies.
And women’s health care groups, which claim that there already is an abundance of medically unnecessary hysterectomies, worry that the incision-free technique may actually increase the problem.
Developed in Germany, laparoscopic hysterectomies were reportedly first performed in this country in 1988 by Dr. Harry Reich, a Philadelphia gynecologist. Reich then taught the technique to a handful of surgeons at seminars, including one at Cedars-Sinai Medical Center in Los Angeles.
Among the physicians who learned it from Reich were Poladian and Dr. Rafael Del Valle, a Northern California gynecologist.
“Last year there was no other course for surgeons to learn the technique. This year, though, physicians are scrambling to learn it,” Del Valle said, adding that courses--which physicians generally pay for out of their own pockets--are now available in “just about” every state.
Del Valle doesn’t disagree with critics who say that not enough is known about the operation. But he said that doesn’t mean he is any less enthusiastic about it.
“It’s true that we don’t know everything about it yet, because it takes a long time afterward to know how it will be for the public,” he said. “The operation is still in its infancy. . . . But so far, in the cases we’ve done, the patients have done well.”
The U.S. Food and Drug Administration, however, is apparently not so ready to pronounce the operation safe.
Although the agency has no jurisdiction over surgical procedure--its only regulating power is over drugs and medical devices, and not over techniques physicians use--it still has not approved the laparoscope for use in hysterectomies.
The laparoscope, which has been used by gynecologists for more than 20 years, has been cleared by the FDA for use in general surgery, including one of its newest uses--gallbladder removal. Although OB/GYNs have used it for two decades as a diagnostic tool, it has not been approved for obstetrical, gynecological or cardiovascular surgeries.
“When a device is approved, it is for a particular indication,” said Rosario Vior, public affairs specialist with the federal agency’s Los Angeles office.
Under law, she said, a physician can use “anything he thinks will be of assistance to a patient,” including unapproved drugs and medical devices. But if an approved medical device is to be used for another purpose, she said, “it would still have to be reviewed for the new use. If it’s not approved by the FDA, there is a risk it’s not safe for that use.”
For patients, that lack of approval has even wider implications.
Since most insurance companies require FDA approval of a drug or medical device before they will pay for it, some patients may be surprised to learn that the cost of the operation has to be borne on their own.
“As far as we are concerned, this is still considered investigational,” said Paulette Williams, a utilization review representative with Blue Cross in Woodland Hills. “Once it is approved by the FDA, we would cover it. Right now we don’t.”
Physicians familiar with the technique reject the view that it is investigational. Hysterectomies have been performed for decades, they say, and using the laparoscope is just a different surgical technique.
Doctors do agree, however, that not every woman is a candidate for the new operation. Women with cancer, who are significantly overweight or who have had multiple abdominal surgeries may fare better with the traditional operation, they say.
“This is not experimental. It’s a new way of doing it,” said Dr. Stephen Pine, chief of obstetrics at Tarzana Regional Medical Center, which he said has performed four laparoscopic hysterectomies.
“The surgery that is being performed is the same that has always been performed, except that we are accomplishing it a different way.”
Pine said he is unaware of any doctors who have had medical claims for laparoscopic hysterectomies rejected by an insurance company. He said his hospital has submitted bills to insurance companies for the procedure and experienced no problems with payment.
Whether the procedure is covered by insurance is of secondary importance to some women’s health care advocates.
A spokeswoman for the Hysterectomy Educational Resources and Services Foundation, a nonprofit organization in Pennsylvania, said the operation could be promoted as less serious than abdominal surgery--and thus increase unnecessary hysterectomies.
By focusing on the minimal scarring and faster recovery time, she said, women may be led to believe that the operation is not as serious.
It is a concern that is shared by some physicians.
“I think it’s a possibility,” said Dr. Scott Sanborn, chief of obstetrics at Kaiser Permanente Medical Center in Woodland Hills. “I have some reservations, too, about the way the concept is being publicized by the medical community in general.
“Purposely or not,” he said, “some people are capitalizing on the confusion. . . . They may think that they will have a same-day procedure, and the only surgery is a dime-size hole in their belly button.”
Sanborn said some physicians also may be more apt to perform the operation if they have just spent time and money learning the technique.
“There is a natural tendency to want to use things that are new . . . particularly to use a skill you have just paid $2,000 to acquire,” he said.
But, like many other doctors who perform the operation, Poladian rejects the notion that the procedure will be used inappropriately. Although he said one or two doctors may perform more operations because of it, the majority are interested in the well-being of the patient.
“It is possible that the number of hysterectomies will increase, since more patients may be willing to have it done instead of putting it off because they can’t take time off of work,” he said. “But that, I think, isn’t the issue.
“With this technique there is less pain, less time in the hospital and you’re back at work faster,” he said.
“The bottom line is: If you have to have a hysterectomy, this is a better way to do it.”