Essure
Encyclopedia
Essure is a permanent transcervical sterilization procedure for women developed by Conceptus Inc. It was approved for use in the United States on November 4, 2002.
Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic bilateral tubal ligation
.
through the cervix
and uterus
. The insert contains inner polyethylene terephthalate fibers to induce benign 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 to form over a period of three 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.
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.
The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)". Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.
is not required. Unlike many temporary methods of birth control
, the Essure inserts do not contain or release hormones.
The inserts are made from polyester
fibers, nickel
-titanium
and stainless steel
and are safe to use with MRI equipment.
The Essure procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed.
Additional birth control must be used for three months after procedure.
Two economic studies, one of which implemented Essure as an in-office procedure, suggest that Essure could be more cost-effective than laparoscopic bilateral tubal ligation
Tubal ligation
Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for fertilization...
.
Procedure
Inserts are placed into the fallopian tubes by a catheter passed from the vaginaVagina
The vagina is a fibromuscular tubular tract leading from the uterus to the exterior of the body in female placental mammals and marsupials, or to the cloaca in female birds, monotremes, and some reptiles. Female insects and other invertebrates also have a vagina, which is the terminal part of the...
through the cervix
Cervix
The cervix is the lower, narrow portion of the uterus where it joins with the top end of the vagina. It is cylindrical or conical in shape and protrudes through the upper anterior vaginal wall...
and uterus
Uterus
The uterus or womb is a major female hormone-responsive reproductive sex organ of most mammals including humans. One end, the cervix, opens into the vagina, while the other is connected to one or both fallopian tubes, depending on the species...
. The insert contains inner polyethylene terephthalate fibers to induce benign 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 to form over a period of three months an occlusion or blockage in the fallopian tubes; the tissue barrier formed prevents sperm
Spermatozoon
A spermatozoon is a motile sperm cell, or moving form of the haploid cell that is the male gamete. A spermatozoon joins an ovum to form a zygote...
from reaching an egg.
Unlike other forms of tubal ligation
Tubal ligation
Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for fertilization...
, no general anaesthetic nor incision through the abdomen is required.
Similar to some other methods of birth control
Birth control
Birth control is an umbrella term for several techniques and methods used to prevent fertilization or to interrupt pregnancy at various stages. Birth control techniques and methods include contraception , contragestion and abortion...
, initially additional forms of birth control
Birth control
Birth control is an umbrella term for several techniques and methods used to prevent fertilization or to interrupt pregnancy at various stages. Birth control techniques and methods include contraception , contragestion and abortion...
must be continued for 3 months to prevent pregnancy
Pregnancy
Pregnancy refers to the fertilization and development of one or more offspring, known as a fetus or embryo, in a woman's uterus. In a pregnancy, there can be multiple gestations, as in the case of twins or triplets...
until the method's effectiveness can be confirmed.
Follow-up
For the Essure method, three months after insertion a physician performs an x-ray test called a hysterosalpingogram to confirm that the fallopian tubes are completely blocked and that the patient can rely on the Essure inserts for birth control. A contrast agent (dye) is injected through the cervix, and an x-ray technologist takes photos of the Essure coils to ensure that they are in place.Efficacy
Following successful insertion and occlusional response, the Essure procedure is 99.74% effective based on 5 years of follow-up, with zero pregnancies reported in clinical trials.The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)". Upon follow-up, occlusion is observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months.
Cautions and warnings
The inserts do not prevent the transmission of sexually transmitted diseases. The procedure takes about 10 minutes for a trained physician to perform and can be performed in a physician's office. General anesthesiaAnesthesia
Anesthesia, or anaesthesia , traditionally meant the condition of having sensation blocked or temporarily taken away...
is not required. Unlike many temporary methods of birth control
Birth control
Birth control is an umbrella term for several techniques and methods used to prevent fertilization or to interrupt pregnancy at various stages. Birth control techniques and methods include contraception , contragestion and abortion...
, the Essure inserts do not contain or release hormones.
The inserts are made from polyester
Polyester
Polyester is a category of polymers which contain the ester functional group in their main chain. Although there are many polyesters, the term "polyester" as a specific material most commonly refers to polyethylene terephthalate...
fibers, nickel
Nickel
Nickel is a chemical element with the chemical symbol Ni and atomic number 28. It is a silvery-white lustrous metal with a slight golden tinge. Nickel belongs to the transition metals and is hard and ductile...
-titanium
Titanium
Titanium is a chemical element with the symbol Ti and atomic number 22. It has a low density and is a strong, lustrous, corrosion-resistant transition metal with a silver color....
and stainless steel
Stainless steel
In metallurgy, stainless steel, also known as inox steel or inox from French "inoxydable", is defined as a steel alloy with a minimum of 10.5 or 11% chromium content by mass....
and are safe to use with MRI equipment.
The Essure procedure is reported to be permanent and not reversible by the manufacturing company. Notwithstanding the manufacturer's position, several Essure reversals have been performed.
Additional birth control must be used for three months after procedure.
Risks
- Perforation, expulsion, or other unsatisfactory location of the insert
- Pregnancy and increased risk of ectopic pregnancyEctopic pregnancyAn ectopic pregnancy, or eccysis , is a complication of pregnancy in which the embryo implants outside the uterine cavity. With rare exceptions, ectopic pregnancies are not viable. Furthermore, they are dangerous for the parent, since internal haemorrhage is a life threatening complication...
- Pain, cramping, vaginal bleeding, menstrual pattern changes, light periods at first then longer, heavier periods lasting up to 6–8 weeks due to changing birth control methods to a non-hormonal solution
- Nausea/vomiting
- Vasovagal response (fainting)
- Allergic reaction to the materials