Essure
| Essure | |
|---|---|
| Background | |
| Type | Sterilization |
| First use | 2002 |
| Failure rates (first year, after occlusion) | |
| Perfect use | 0.2% |
| Typical use | 0.2% |
| Usage | |
| Duration effect | Permanent |
| Reversibility | No |
| User reminders | Additional methods until 3 month check by hysterosalpingogram |
| Clinic review | None |
| Advantages and disadvantages | |
| STI protection | No |
| Benefits | Permanent contraception |
Essure is a permanent sterilization procedure for women developed by Conceptus Inc and approved for use in the United States on November 4, 2002.[1]
Procedure and assessment
Micro-inserts are placed into the fallopian tubes by a catheter 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.[1]
The reported insertional failure rates are "failure to place 2 micro-inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)."[2] Following successful insertion and occlusional response, the Essure procedure is 99.80% effective based on 4 years of follow-up.[3] 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 are made from polyester fibers, nickel-titanium and stainless steel are safe to use with MRI equipment. There is no data on reversing Essure and any attempt would require major surgery and likely be unsuccessful. Essure does not protect against sexually transmitted infections. Additional birth control must be used for 3 months after procedure. [2]
Risks
- Perforation, expulsion, or other unsatisfactory location of the micro-insert
- Pregnancy and increased risk of ectopic pregnancy
- Pain, cramping, vaginal bleeding, menstrual pattern changes
- Nausea/vomiting, or fainting
- Vasovagal response
- Allergic reaction to the materials
Notes
- ^ a b "Essure System - P020014". Food and Drug Administration. 2003-04-28. Retrieved 2006-12-12.
- ^ a b "Prescribing Information" (PDF). Essure. Conceptus. 2005-09-08. Retrieved 2006-12-12.
- ^ control methodsbyConceptus/Understanding/ClinicalTesting/tabid/58/Default.aspx "Clinical Testing". Essure. Conceptus. Retrieved 2006-12-12.
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External links
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