Essure's first year results in only five pregnancies.
After approval by the FDA in 2002, Conceptus Inc. of San Carlos, Calif., shipped 9,000 units of Essure in the first year of commercial availability, said Dr. Brill, professor of ob.gyn and director of gynecologic endoscopy at the University of Illinois, Chicago.
"Essure and other hysteroscopic sterilization methodologies are quickly becoming a standard option for patients seeking permanent sterilization and probably will become the norm, by my prediction, in 2 or 3 years," Dr. Brill said. "The effectiveness rate remains high in the commercial marketplace."
The rates of various adverse events reported in that first year were lower than those reported during the pivotal premarket clinical trials, but Dr. Brill acknowledged that the actual number of adverse events--and pregnancies--may be higher than the number voluntarily reported to the company by clinicians.
For example, the rate of expulsion of the Essure microinserts was 0.16% in commercial experience, compared with 2.9% in the clinical trials. Tubal perforation was 0.31% in commercial experience and 1.1% in clinical trials.
Clinicians also reported that 0.97% of the insertion devices had bent tips, resulting in deployment difficulties.
Although Dr. Brill did acknowledge receiving consulting and grant support from several companies, including TAP Pharmaceuticals, Gynecare, SurgRx, Gyrus Medical, and ACMI, this list did not include Conceptus, which distributes Essure.
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|Title Annotation:||Women's Health|
|Publication:||Internal Medicine News|
|Article Type:||Brief Article|
|Date:||Jan 15, 2005|
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