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Noncompliance is key to Essure-related pregnancies.(Gynecology)
CHICAGO -- Data indicate that most pregnancies in women who undergo the Essure hysteroscopic sterilization procedure could be avoided, Dr. John F. Kerin said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).
There have been no pregnancies with the Essure device (Conceptus, San Carlos, Calif.) in multicenter phase II or pivotal trials after 4 years of follow-up. But in post-marketing use, there have been 37 reported pregnancies following an estimated 29,736 procedures from 1997 to December 2004, said Dr. Kerin, a consultant and principal clinical investigator for Conceptus. As of October 2005, 52 pregnancies had been reported in 40,568 procedures worldwide.
Data analysis through 2004 suggests pregnancies are occurring after the device is put into general practice because of noncompliance with protocol by the physician or patient (21 cases, 57%); the patient was probably pregnant before the procedure (6 cases, 16%); or the hysterosalpingograms were misread (6 cases, 16%). Four cases (11%) were due to other etiologies: expulsion of the device with an earlier noncommercially available design, and a device expulsion. Two are still being investigated.
"The important thing is there were no confirmed Essure device-related failures resulting in pregnancy amongst tens of thousands of women so far who have had this procedure worldwide," Dr. Kerin said. "I think most pregnancies are avoidable, and we need to up-skill and use our care before the procedure, during the procedure, and in the follow-up."
Among the 21 noncompliance cases, 17 patients didn't return for follow-up at 3 months. ...
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Source: HighBeam Research, Noncompliance is key to Essure-related pregnancies.(Gynecology)