January 19, 2013 — A new study published by the Journal of the American Medical Association has found that women who receive a total hip implant (arthroplasty) are 29% more likely than men to need revision surgery. After an average follow-up time of 3 years, 2.3% of women and 1.9% of men had undergone revision surgery. The researchers also found that metal-on-metal hip implants were almost twice as likely to fail in women than men, which is consistent with data from several other large studies.
Past studies had indicated that the higher risk of revision surgery in women might be due to large femoral head-size. However, when the researchers controlled for head sizes, they found that women still had a 15% higher risk of revision surgery than men.
The study was one of the largest of its kind, based on the largest hip implant registry in the United States. It involved 35,140 patients who had hip replacement procedures at 46 hospitals by 319 surgeons between 2001 and 2010. The patients received metal-on-metal hip implants and other combinations of metal, ceramic, and various polyethylene materials.
In recent years, there has been growing concern about the risk of hip implants in women. Last year, the U.S. Food and Drug Administration (FDA) issued draft guidance for manufacturers to include sex-specific analyses in studies of new hip implants. The guidance is voluntary, however. Most new hip implants are approved under the 510(k) approval process, which rarely requires new clinical trials.
In an accompanying editorial to the paper, Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, recommended that this information could be important for designing new hip implants and making treatment choices for patients. She said:
“What is urgently needed is long-term comparative effectiveness research based on large samples sizes, indicating which [hip implant] devices are less likely to fail in women and in men, with subgroup analysis based on age and other key patient traits, as well as key surgeon and hospital factors.”
The lack of long-term research may be one reason why so many people have been injured by hip implants. Since 2010, there have been several high-profile recalls involving thousands of hip implants. Johnson & Johnson is currently facing litigation involving more than 10,000 lawsuits filed by people who were injured by the DePuy ASR hip implant.
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