Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study.

OBJECTIVE

The present study examines the safety, effectiveness, and local tissue response for a new transcervical fallopian tube permanent contraceptive device, the STOP device (Conceptus, Inc., San Carlos, CA).

DESIGN

Nonrandomized prospective evaluation of tubal occlusion and histologic response.

SETTING

Inpatient, university and university-affiliated medical centers in the United States and Mexico.

PATIENT(S): Premenopausal and perimenopausal women with benign indications for hysterectomy who were able to defer their hysterectomy for 1 to 13 weeks.

INTERVENTION(S): A transcervically placed microcoil (STOP device) was inserted into the fallopian tubes of women who were scheduled for hysterectomy, and the device was worn for 1 to 12 weeks. At hysterectomy, hysterosalpingography was done to determine tubal occlusion; subsequently, the tubes containing the STOP devices were processed, sectioned, and evaluated to determine the histologic response.

MAIN OUTCOME MEASURE(S): Ability to place a device and evaluate tubal occlusion and tissue response.

RESULT(S): Devices were placed in 33 women, representing 57 tubes; the women wore the devices from 1 day to 30 weeks. Histology on 27 women (47 tubes) showed an acute inflammatory and fibrotic response in the short term that, over time, became a chronic inflammatory response with extensive fibrosis.

CONCLUSION(S): The localized tissue response and notable absence of any normal tubal architecture in the segment of the fallopian tube containing the STOP device supports the postulated mechanisms of action of the device. Prehysterectomy study findings suggest the usefulness of the STOP device for pregnancy prevention, this is being evaluated in long-term safety and effectiveness studies.