In-Office Placement of Essure Feasible and Fast, Study Shows


CHICAGO — Essure hysteroscopic sterilization may be performed in an office setting with minimal analgesia, Dr. Gil A. Weiss said at the annual meeting of the AAGL (formerly the American Association of Gynecologic Laparoscopists).

Physicians reported a 94% placement rate, which is comparable to the 86% rate seen in previous phase II and pivotal trials of the Essure device (Conceptus Inc., San Carlos, Calif.).

“It's reassuring that we had comparable success rates,” Dr. Weiss said in an interview. “Once the learning curve is achieved, I believe that the office placement offers unique benefits that a hospital-based procedure cannot.”

He presented data from a prospective study in which 155 women underwent bilateral hysteroscopic placement of the Essure device in an office setting at the Montefiore Medical Center, Bronx, N.Y.

A paracervical block and NSAIDs were provided for pain and for control and reduction of tubal spasm. The average patient age was 36 years, parity 2.7, and body mass index 30, which is classified as obese.

The rates of the confounding factors included the following: 34% of the patients had undergone cesarean section, 14% had a history of pelvic infections, and 44% had prior abdominal or pelvic surgery, which would have confounded a laparoscopic approach.

Of the 155 patients, 146 (94%) had successful bilateral placement and 9 had anatomic considerations that prevented placement, said Dr. Weiss, a fellow at the Albert Einstein College of Medicine, Bronx, N.Y., who participated in the study and presented the data on behalf of the authors, Dr. Mark D. Levie and Dr. Scott G. Chudnoff, both of Montefiore Medical Center.

To date, hysterosalpingographies performed on 106 of the 155 women revealed bilateral occlusion in 104.

Three patients had initial unilateral occlusion. One patient had another device placed with confirmed bilateral occlusion, one is awaiting a repeat hysterosalpingography, and one aborted the device into the uterus and underwent subsequent laparoscopic sterilization.

No patient required hospitalization or narcotic analgesia, and most left the physician's office within 1 hour.

Pain data that was collected on 114 women showed the average procedural pain level was 2.65 on a scale of 1 to 10, with the average menstrual pain 3.28 on a similar scale.

Follow-up on 73 women showed 95% would undergo the procedure again, 99% would recommend it to a friend, and 90% would choose the office setting again.

Dr. Weiss and Dr. Chudnoff have no financial disclosures related to Conceptus.

Dr. Levie is a consultant for Conceptus.

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