Patient compliance with HSG after Essure is high.
"Since the introduction of Essure in 2003, physician uptake has been substantially less than expected, despite the obvious advantages in terms of no incisions, no general anesthesia, and no hospital stay," Dr. Glazerman said at the annual meeting of the AAGL. "One of the expressed concerns is that the [Food and Drug Administration] requires a 3-month confirmatory hysterosalp-ingogram [HSG] after the procedure, before the patient is allowed to rely on the device for contraception. In my personal discussions with physicians, I hear all the time that 'my patients don't want to come back for the HSG. They'd rather know right away that they are sterile.'"
Dr. Glazerman disclosed that he is a preceptor, speaker, and consultant for Conceptus Inc., which developed the Essure procedure. He is also a preceptor for Karl Storz Endoscopy-America Inc.
To determine the rate of compliance with the FDA recommendation for the hysterosalpingogram, Dr. Glazerman studied the medical charts of 130 consecutive patients who underwent Essure hysteroscopic sterilization in his former private ob.gyn. practice in Allentown, Pa., from December 2003 through May 2008.
Of those patients, 128 were at least 3 months post procedure and 2 were not, said Dr. Glazerman, who is now director of minimally invasive surgery in the department of obstetrics and gynecology at the University of South Florida, Tampa. Of the 128 patients, 116 (91%) underwent hysterosalpingography, and 100 (86%) of those 116 showed bilateral tubal occlusion on their first hysterosalpin-gogram. Of the 16 patients who failed their initial HSG, 13 had documented tubal occlusion on their second HSG; 2 had a previous unilateral salpingectomy; and 1 had unilateral placement, and subsequently conceived.
Based on the findings, Dr. Glazerman concluded that concern about noncompliance with HSG "should not deter physicians from offering hysteroscopic sterilization. The way I present the Essure procedure to patients is like this: 'If they have a laparoscopic tubal failure (a rate of 0.5%-l%), the only way they know if it fails is if they get pregnant. On the other hand, if they have a hysterosalpingogram after the Essure that shows bilateral occlusion, there's a pregnancy rate of less than 1 in 200,000 cases. My patients seem to like that. In addition, they like the fact that there's no hospital stay, no incision, and no general anesthesia."
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|Publication:||OB GYN News|
|Date:||Apr 1, 2009|
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