Medical device maker recalls artificial hip part after new study suggests increased risk of some cancer.
The US Food and Drug Administration (FDA) said SGACD recalled the unimplanted inventory of a total of 9 batches of its zirconia ceramic femoral heads worldwide due to a higher-than-expected fracture rate. In the United States, where the part is used in less that 6% of the estimated 150,000 to 200,000 hip prostheses implanted annually, the recall is being handled by manufacturers that use the component in their hip prostheses. These include Smith & Nephew, Zimmer, Biomet, Apex Surgical, DePuy Orthopaedics, Encore Orthopedics, Osteoimplant Technology, and Stryker Howmedica Osteonics. The FDA has cautioned surgeons not to implant any artificial hips that contain zirconia ceramic femoral heads made by SGACD since 1998, when a manufacturing process change occurred that may be responsible for the problem. But the FDA also stressed that it is not recommending the removal of these hip replacements in patients who are doing well. The agency is advising that doctors monitor the performance of these implants more closely than usual and be alert to patient complaints of sudden pain.
Patients and physicians can call the FDA for more information at 888-Info FDA (888-453-6332). A complete copy of the FDA notice can be obtained on the agency's web site at www.fda.gov/cdrh/recalls/zirconiahip/html.
Although the recall is limited to this particular SGACD component, a new study conducted by researchers at the International Epidemiology Institute in Rockville, MD has raised concerns that patients with any type of artificial hip may be somewhat more likely to develop skin, prostate, and blood cancers. Since several materials used in artificial hips and knees, including chromium, lead, cobalt, and acrylic, are known or suspected carcinogens, Lisa Signorello, MD and colleagues evaluated cancer rates in nearly 117,000 patients who had hip replacement surgery in Sweden between 1965 and 1994. They found that compared to the general population, those with artificial hips had a 16% increased risk of developing prostate cancer, a 15% increase for melanoma, and an 8.6% increase in multiple myeloma.
"Overall, the results of our study are largely reassuring that hip implant patients have similar rates of most types of cancer as the general population," wrote Signorello and coauthors in the September 19 issue of the Journal of the National Cancer Institute. Nonetheless, the results, "while potentially attributable to chance or bias, should be considered carefully and warrant further in-depth study," the investigators concluded.
Interestingly, the researchers found that patients with hip implants had a 17% decrease in the rate of stomach cancer, possibly attributable to long-term antibiotic therapy. Antibiotics, they theorized, could be destroying the ulcer-causing bacterium Helicobacter pylori, which has been linked to stomach cancer.
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|Title Annotation:||Saint Gobain Advanced Ceramics Desmarquest|
|Comment:||Medical device maker recalls artificial hip part after new study suggests increased risk of some cancer.(Saint Gobain Advanced Ceramics Desmarquest)|
|Article Type:||Brief Article|
|Date:||Oct 15, 2001|
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