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Published: Apr 10, 2006 12:00 AM
Modified: Apr 10, 2006 07:20 AM
With her dog Emily by her side, Franky McMahan, 62, of Raleigh exercises the resurfaced joint in her left hip. In early March, she returned from her surgery in India. Now, she says, she has stopped using crutches and is walking free of pain.

Hip patients find surgeons overseas

Delay in FDA approval for hip resurfacing means lost opportunity at Duke

Jeanne Bennett, just in her mid-40s, felt young and vital. But her arthritic right hip seemed like it was a thousand years old. Grit your teeth and endure the pain as long as you can, two different orthopedic surgeons advised. Then have a hip replacement.

That wasn't good enough for Bennett, who knew at her age she might wear through two or more prosthetic hips. That would mean multiple surgeries, each more complicated than the last.

Bennett, who lives in Raleigh, tried acupuncture, chiropractic adjustments, physical therapy and massage. Nothing worked. Finally, two years into her search for remedies, she found the answer: hip resurfacing.

The technique, which is being tested in clinical trials at Duke University Medical Center and a handful of other hospitals across the country, offers a fix for hip pain that is long-lasting and less invasive than traditional hip replacement.

The surgery is common in Europe and Asia but is late in arriving in the United States because it must first complete the lengthy process of winning the Food and Drug Administration's approval.

Without FDA approval, most insurers regard resurfacing as an experimental treatment and won't cover it. Bennett and others have obtained care in other countries -- at a huge savings.

In June of last year, Bennett and her husband, John, cashed in frequent-flyer miles and flew to Chennai, India, where Dr. Vijay C. Bose resurfaced Bennett's hip for $5,600, including all hospital fees. India's much lower overhead enables doctors and hospitals to charge a fraction of the cost of similar care in the United States. Bennett said hip resurfacing at Duke, which her insurance refused to cover, would have cost upward of $40,000.

Today, basic activities such as walking and rising from a chair are no longer agonies for Bennett, now 49. The full-time mother is back to hiking, biking and working out at the gym five days a week.

"I do set off metal detectors at the airport now," said Bennett, referring to the cobalt chrome implant in her hip. "That's the worst ramification from my operation."

Experts think resurfacing eventually could replace about 20 percent of hip replacement surgeries, or about 72,000 procedures a year. The market could be even larger, factoring in patients such as Bennett, who refused hip replacement.

Companies that make resurfacing implants are enrolling patients in clinical trials. About a dozen medical centers nationally are participating, and research sites can perform only a few surgeries a month.

Duke, for example, can do just four resurfacing procedures a month under the rules of the two trials in which it is participating. Diane Covington, a physician assistant in Duke's orthopedics department who coordinates the trials, said she gets up to 20 calls a month from patients seeking one of those slots. And that's in spite of the fact that many have to pay out-of-pocket.

"I certainly don't have to talk anybody into it," said Dr. Thomas Vail, the Duke orthopedic surgeon who performs resurfacing surgeries. "There is a lot of consumer interest."

For younger patients

Modern hip resurfacing implants are the latest attempt to provide a way to treat younger patients with disabling hip pain.

Younger patients are often reluctant to accept hip replacement, in which the upper part of the femur, or thighbone, is sawed away and replaced with metal rod attached to a prosthetic joint. Each time a worn implant is replaced with a new one, the surgeon has less bone to work with, making revision surgeries tricky, Vail said.

Hip resurfacing is far more appealing to younger patients, because most of their natural bone is preserved. Instead of removing the top of the femur, the surgeon smooths out the hip's damaged ball joint and covers it with a metal cap, much as a dentist would cap a damaged tooth. Then the hip socket is cleared of worn cartilage and lined with a metal cup. When the resurfaced joint is replaced, the patient's range of motion is restored, pain free.

Risks and past trouble

But resurfacing isn't without risk. In up to 2 percent of patients, the short length of bone that attaches the ball joint to the femur snaps, requiring patients to have a hip replacement. Surgeons try to minimize the risk by resurfacing only patients with strong bones.

Resurfacing itself isn't new. It was introduced in the United States in the 1970s, but the first implants were made with a plastic socket lining that didn't wear well, and the procedure fell out of use in the 1980s. Modern implants use a metal or ceramic socket and are considered much more durable.

If the implant wears out and the patient opts for a hip replacement later, the surgeon has plenty of bone to work with, Vail said.

Vail, who helped design a resurfacing implant for a subsidiary of Johnson & Johnson, said treatments for hip pain are evolving to meet patients' changing needs. Traditionally, hip surgery was for older people, and it was mainly to help them walk without pain, he said. Today, people stay active longer and are unwilling to accept that their aging bodies aren't up to the rigors of snow skiing, tennis, hiking or salsa dancing.

"What's changed is people's expectations," Vail said. "We can't rely on the old technologies to meet their needs."

Market going abroad

Resurfacing's slowness to win FDA approval frustrates Vail, who knows many patients are desperate for help now.

"If the technology is worthwhile and proven, it should be offered in the U.S.," Vail said. 'It seems like it's time [for FDA approval], but it's not our call."

Vail doesn't like to see patients going halfway around the world for a surgery he has been doing for more than five years. But he knows many aren't prepared to wait.

Bennett, for example, has helped two other Triangle residents -- a man in Cary and a woman in Raleigh -- get appointments with her surgeon in India, where both ended up having their resurfacing surgeries.

Responding to questions via e-mail, Bose, the surgeon who operated on all three patients, said he now does hip resurfacing on up to 15 Americans each month. Business picked up considerably after the television news program "60 Minutes" aired a segment last spring on medical tourism that featured an interview with him. Before then, Bose operated on Americans only occasionally.

Active again

Franky McMahan, 62, the woman Bennett encouraged to contact Bose, said it would have been difficult for her to afford surgery at Duke. She and her husband lost their health insurance a few years ago after the company covering them quit doing business in North Carolina. They never replaced it with a new plan.

Like Bennett, McMahan was eager to avoid multiple hip replacements. She was also eager to get back to a more active lifestyle. McMahan said pain often caused her to lag behind friends and family when she accompanied them on outings.

"I was last in line," she said. "People would forget about me."

McMahan returned from India in early March. Her pain is gone, and she recently stopped using the crutch her Indian nurse sent home with her. She exercises daily to build her muscles. And she is looking forward to showing companions she can keep up.

"Maybe I'll even set the pace," McMahan teased.

Staff writer Jean P. Fisher can be reached at 829-4753 or jfisher@newsobserver.com.

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