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Essure is a permanent sterilization procedure for women developed by Conceptus Inc and approved the use in the United States on November 4, 2002.

Procedure and assessment

Micro-inserts are placed into the fallopian tubes by a cathether passed from the vagina through the cervix and uterus. Once in place, the device is designed to elicit tissue growth (scarring) in and around the micro-insert to form over a period of 3 months an occlusion or blockage in the fallopian tubes; the tissue barrier formed prevents sperm from reaching an egg.

Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required. Somewhat similar to male vasectomy procedures, initially additional forms of birth control must be continued to prevent pregnancy until the method's effectiveness can be confirmed. For the Essure method, 3 months after insertion a physician performs a special type of x-ray test called a hysterosalpingogram to confirm that the fallopian tubes are completely blocked and the patient can rely on the Essure micro-inserts for birth control. Occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.

The reported insertional failure rates are: "failure to place 2 micro-inserts in the first procedure (14%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)." Following successful insertion and occlusional response, the Essure procedure is 99.80% effective based on 4 years of follow-up. The Essure procedure has been demonstrated in a small portion of the women undergoing clinical studies to be 99.74% effective based on 5 years of follow-up. Five year follow-up of all patients in clinical trials is ongoing.

Cautions and warnings

The micro-inserts do not prevent the transmission of sexually transmitted diseases. The procedure takes about 35 minutes for a trained physician to perform and can be performed in a physician's office. General anesthesia is not required. Unlike many temporary methods of birth control, the Essure micro-inserts do not contain or release hormones.

The micro-inserts being made from polyester fibers, nickel-titanium and stainless steel are safe to use with MRI equipment.

Risks

• Perforation, expulsion, or other unsatisfactory location of the micro-insert
• Pregnancy and increased risk of ectopic pregnancy
• Risks associated with anesthesia
• Pain, cramping, vaginal bleeding, menstrual pattern changes
• Nausea/vomiting, or fainting
• Vasovagal response

Notes

1. ^ "Essure™ System - P020014". Food and Drug Administration. 28 April 2003. Retrieved 2006-12-12.
2. ^ "Prescribing Information" (PDF). Essure. Conceptus. 8 September 2005. Retrieved 2006-12-12.
3. "Clinical Testing". Essure. Conceptus. Retrieved 2006-12-12.

External links

• Essure official site

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