Essure is intended to provide women with permanent birth control. Essure is inserted through the vagina and cervix into the fallopian tubes. The procedure does not require a skin incision or general anesthesia.
Essure is not right for anyone if anyone is uncertain about ending your fertility, can have only one insert placed, are or have been pregnant within the past 6 weeks, have had one’s tubes tied, have an active or recent pelvic infection, or have a known allergy to contrast dye.
A health care provider inserts soft, flexible coils into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.
Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic (an operation performed in the abdomen or pelvis through small incisions (usually 0.5-1.5 cm) with the aid of a camera. It can either be used to inspect and diagnose a condition or to perform surgery) bilateral tubal ligation.
Since 2013, the product has been the subject of controversy with women complaining of severe side effects leading to surgical extraction, and campaigner Erin Brockovich hosting a website where women can share their stories after having the procedure.
Procedure:
The procedure takes about 10 minutes,[citation needed] for a trained physician to perform and can be performed in a physician’s office.[citation needed] General anesthesia is not required. Despite this, some women have reported considerable pain during the procedure.
Small, flexible inserts are placed into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. The insert contains inner polyethylene terephthalate fibers to induce inflammation causing fibrotic reaction and is held in place by flexible stainless steel inner coil and a dynamic outer nickel titanium alloy coil. Once in place, the device is designed to elicit tissue growth in and around the insert over a period of three months to form an occlusion or blockage in the fallopian tubes; the tissue barrier formed is supposed to prevent sperm from reaching an egg.
Unlike other forms of tubal ligation, no general anaesthetic nor incision through the abdomen is required. Similar to some other methods of birth control, initially additional forms of birth control must be continued for 3 months to prevent pregnancy until the method’s effectiveness can be confirmed.
Benefits:
Essure is intended to provide women with permanent birth control. Essure is inserted through the vagina and cervix into the fallopian tubes. The procedure does not require a skin incision or general anesthesia.
Essure inserts do not contain or release hormones.
Essure insertion is typically performed in a doctor’s office and can be completed in 10 minutes. The recovery period is not long. Most women return to normal activity within one to two days after the procedure.
Essure is currently the only FDA-approved or cleared, non-surgical sterilization device for women who want permanent birth control in the United States. To see how Essure compares to other forms of birth control, you may refer to the product labeling.
Risks:
Short-term risks to patients include:
During the Essure placement procedure and immediately following, patients may experience mild to moderate pain. Immediately following the procedure, patients may also experience cramping, vaginal bleeding, pelvic or back discomfort.
Long-term risks to patients include:
1. Unintended pregnancy, including ectopic pregnancy.
2. Pelvic pain
3. Migration of Essure inserts through the fallopian tubes into the lower abdomen and pelvis
4. Perforation of the uterus or fallopian tubes
5. Rash and itching associated with possible nickel allergy
While scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100% effective.
The Agency has received reports of fetal complications including miscarriages in women who became pregnant following Essure placement. Women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy). At present, clinical studies and individual cases of Essure sterilization failure reported in the scientific literature have not demonstrated an increased risk of neonatal or pregnancy complications when pregnancy is in the uterus following Essure placement. The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks.