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Hip Implant Recall Affects Few

Certain artificial hips being recalled by FDA, but doctors say if there's no pain, don't worry

WEDNESDAY, Sept. 26, 2001 (HealthDayNews) -- First comes a pop, then the pain. Federal officials say that could be a nightmare scenario for patients whose hip implants may fail because a defective part. But a recall is underway, and the wide majority of implants aren't affected.

Even so, people should realize that hip implants always come with some level of risk, said Dr. William Tipton, executive vice president of the American Academy of Orthopaedic Surgeons. "A certain percentage are going to fail. These are man-made prostheses. They're not perfect, and they're not ever going to be without their complications."

With age, hip joints often deteriorate and lose the lubrication that helps them move smoothly. The result is pain and discomfort, which usually hits after the age of 50 or 55.

Hip implants replace the deteriorated ball-and-socket joints in the pelvis. The implants consist of balls, sockets and "stems" that stand in for the legs bones known as femurs.

At issue in the recall are ceramic balls -- also known as "heads" -- made by the French company, St. Gobain Desmarquest. According to the U.S. Food and Drug Administration, some zirconia ceramic heads that were made since early 1998 cracked at a higher rate than expected 13-27 months after they were installed.

If a ceramic head fractures, the hip implant will cause pain and have to be replaced.

The FDA, which announced the recall earlier this month, said the French company encountered problems after changing its manufacturing process.

Most hip implant balls are metal, but a small number are ceramic. They're estimated to be about 6 percent of the 150,000-200,000 hip implants placed in U.S. residents each year.

Some doctors prefer ceramic "because metal wears [down], and there's essentially no wear that occurs with the ceramic ball," Tipton said. "The problem with ceramic is that it can crack, or it can develop a weakness if it's scratched."

The companies that use the recalled ceramic heads are: Apex Surgical, Lakeville, Mass.; Biomet, Warsaw, Ind.; DePuy Orthopaedics, Warsaw, Ind.; Encore Medical Corporation, Austin, Texas; Osteoimplant Technology, Hunt Valley, Md.; Smith & Nephew, Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Warsaw, Ind.

Encore Medical Corporation, a small company based in Texas, said it is recalling all unused ceramic heads made by the French company in its implant kits. "We had never received any heads from the affected batches, but in an abundance of caution we did recall the ones that we had out in the field," said executive vice president Harry L. Zimmerman.

But heads made of metal are still available, Zimmerman added. "It did not affect our ability to serve our doctors and hospitals so they could serve their patients," he said.

Patients who have Encore hip implants with ceramic heads should not be worried, he said. "We'd definitely counsel you to not go back and have a second surgery to have it taken out," he said. "We've notified the doctors who are affected. It's obviously their call with their patients."

Tipton said he too is recommending that patients do nothing unless a problem arises. "Normally, my advice would be to wait, let's see what happens. If a patient said, 'I don't like living with this, I don't really care to be worried that something will happen to me even if it isn't that painful,' I would try to talk them out of it."

The recall brings another black eye to the hip implant business, which is already reeling from an admission by Sulzer Orthopedics that some of its implants are defective. The company, which is facing numerous lawsuits, is recalling the implants.

What To Do

If you think you have a potentially defective hip implant, contact your doctor. If it hasn't given you problems, a new surgery might not be recommended.

How do hip implants work? Learn the answers in this fact sheet from the American Academy of Orthopaedics.

If you'd like more information about the recall, read this fact sheet from the FDA.

SOURCES: Interviews with Harry L. Zimmerman, executive vice president and general counsel, Encore Medical Corporation, Austin, Texas; William Tipton, M.D., executive vice president, American Academy of Orthopaedic Surgeons, Chicago; FDA recall fact sheet
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