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 suitable for anyone if someone is unsure about ending their fertility, may have only one insert in place, is or has been pregnant within the last 6 weeks, has had their tubes tied, has an active or recent pelvic infection, or has a known allergy to contrast medium.
A health care provider inserts soft, flexible coils into the fallopian tubes, the tubes that carry eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The buildup of tissue creates a barrier that prevents sperm from reaching the eggs, preventing conception. Essure is considered a permanent form of birth control and is therefore not intended to be phased out.
Two economic studies, one of which implemented Essure as an office procedure, suggest that Essure may be more cost-effective than laparoscopy (an operation performed on the abdomen or pelvis through small incisions (usually 0.5 to 1 .5 cm) with the aid of a camera It can 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 serious side effects leading to surgical removal, and activist Erin Brockovich hosts a website where women can share their stories after undergoing the procedure.
Process:
The procedure takes about 10 minutes,[citation needed] to be done by a trained doctor and can be done in a doctor’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 using a catheter passed from the vagina through the cervix and uterus. The insert contains internal polyethylene terephthalate fibers to induce inflammation that causes a fibrotic reaction and is held in place by a flexible stainless steel internal coil and dynamic nickel titanium alloy external coil. Once in place, the device is designed to cause tissue growth in and around the insert over a three month period to form an occlusion or blockage in the fallopian tubes; it is assumed that the tissue barrier formed prevents the sperm from reaching the egg.
Unlike other forms of tubal ligation, no general anesthesia or incision through the abdomen is required. As with other birth control methods, additional forms of birth control should initially be continued for 3 months to prevent pregnancy until the effectiveness of the method 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.
The Essure insertion is usually done 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 a day or two after the procedure.
Currently, Essure is the only non-surgical sterilization device approved or approved by the FDA for women who want permanent birth control in the United States. To see how Essure compares to other forms of birth control, you can check the product label.
Risks:
Short-term risks to patients include:
During and immediately after the Essure placement procedure, patients may experience mild to moderate pain. Immediately after the procedure, patients may also experience cramping, vaginal bleeding, pelvic or back discomfort.
Long-term risks for patients include:
1. Unwanted pregnancy, including ectopic pregnancy.
two. pelvic pan
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 a possible nickel allergy
Although scientific evidence shows Essure to be a highly effective means of sterilization when healthcare providers and patients follow proper instructions for use, no form of birth control is 100% effective.
The Agency has received reports of fetal complications including miscarriage in women who became pregnant after Essure placement. Women who have had the Essure placement procedure are more likely to have a pregnancy outside the uterus (ectopic pregnancy). Currently, clinical studies and individual cases of failed Essure sterilization reported in the scientific literature have not shown an increased risk of neonatal or pregnancy complications when the pregnancy is in utero after Essure placement. The FDA will continue to monitor the safety of Essure to ensure that the benefits of providing women with an incision-free sterilization option continue to outweigh its risks.
