Women who sought permanent sterilization through a contraceptive implant called Essure were 10 times as more likely to be back for surgery within a year than women who had their tubes tied, according to a new study of 52,326 women sterilized in hospitals and ambulatory surgery centers in New York State from 2005 to 2013.
The findings add to growing concerns about the device, which has been on the market for over a decade. Thousands of women who claim they have been hurt by it have urged the Food and Drug Administration to warn the public about potential complications and pull the device from the market.
The new analysis found that 2.4 percent of the 8,048 women who had Essure implanted returned for an operation within a year. Only 0.2 percent of the 44,278 women who had more traditional, minimally invasive sterilization needed another operation. The analysis did not include women treated in private doctors’ offices.
Dr. Art Sedrakyan, the paper’s senior author and a researcher at Weill Cornell Medicine, said most of the repeat operations were required because of complications from the device, a small metal and polyester coil placed into a woman’s fallopian tubes, or because of a device failure. Many of them involved removing the fallopian tubes, though a precise breakdown of the follow-up operations has not yet been published, which some experts criticized as a weakness in the paper.
The study, published Tuesday in The BMJ, reported that Essure, which can be inserted vaginally without a surgical incision, was as effective at preventing pregnancy as laparoscopic tubal ligation. But the implant was associated with significantly higher hospital charges, with median charges of $7,832, compared with $5,068 for a surgical tubal ligation. More than half of the patients received general anesthesia, although Essure is promoted as an easy 10-minute office procedure that does not require anesthesia.
“This study is important because it looked at Essure women in the real world, not the more ideal world of clinical trials,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group. “The very high rate of reoperations — 10 times as high with Essure — is likely to add to concerns about the accuracy of the clinical trial data provided to the F.D.A.” when the device was approved.
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