HYSTEROSCOPIC TUBAL STERILIZATION - ESSURE SYSTEM
Although tubal ligation is often referred to as "tying the tubes," actually, the
fallopian tubes may be tied, cut, clamped or blocked, permanently preventing eggs from
leaving the fallopian tubes. In no-incision sterilization, coils are inserted through
the vagina, cervix and uterus, and then placed in the fallopian tubes.
Tubal ligation is a surgical procedure that requires anesthesia. Depending
on the type of procedure performed, a woman may go home the same day or may be hospitalized.
If you are considering undergoing this irreversible procedure, first see your
health care provider or clinic and make sure you understand the risks.
Women are sometimes pressured into getting sterilized, especially if they have just
experienced a trying pregnancy or abortion. Many people are under the impression that
sterilization is easily undone; however, sterilization should be considered permanent.
Reversals can cost over $10,000 and may not be successful. One in three sterilized
women regret their decision at some point in their lives, mostly due to a change in
marital status, the death of a child, or a renewed desire to have children. For this
reason, sterilization is not recommended unless you have a medical condition that would
make pregnancy difficult or dangerous.
Now you can have a tubal ligation, permanent contraception, with a simple outpatient
procedure. This procedure can be done with local anesthesia. You can also have light
sedation or general anesthesia, if you desire. The best part - No Incisions and most
patients can go back to work the same day. This method is called Hysteroscopic Tubal
Sterilization with the Essure System.
Your health care provider will gently insert two small implants (one in each fallopian
tube) through a tiny (3.5millimeters) hysteroscope. The Essure procedure is a sterilization
procedure for women that is performed by an Essure trained doctor. Unlike the standard
tubal ligation and vasectomy, there are no incisions. Instead, micro-inserts are passed
through the body's natural pathways (vagina, cervix, and uterus) and placed into your fallopian tubes.
During the first 3 months following the procedure, your body and the micro-inserts work
together to form a tissue barrier that prevents sperm from reaching the egg. During
this period, you will need to use another form of birth control.
After 3 months, your health care provider will perform a special type of x-ray test
called an HSG to confirm that your tubes are completely blocked and you can rely on
the Essure micro-inserts for birth control.
Follow Up: If you experience any complications after your surgery, be sure to contact
your health care provider.
For more information about the Essure System, visit their website:
Essure System Home Page
ESSURE PROCEDURE ADVANTAGES
Effective: The Essure procedure is 99.80 percent effective based on 4 years of follow-up.
No incisions: The Essure micro-inserts are passed through the body's natural pathways
and inserted into the fallopian tubes. Unlike a tubal ligation (for a woman) or a
vasectomy (for a man) there is no cutting into the body.
Quick recovery: The Essure procedure takes very little time out of women's busy lives
and most women return to their normal activities within one day.
No general anesthesia required: There are risks and side effects associated with
general anesthesia. Although some physicians may offer general anesthesia, this is not
a requirement of the procedure. You should discuss your anesthesia options with your
Essure health care provider.
Short procedure time: The Essure procedure only takes about 35 minutes for an
Essure trained health care provider to perform. Most women are on their way in an average
of 45 minutes.
No hormones: Unlike many temporary methods of birth control, the Essure micro-inserts
do not contain or release hormones and are made with the same kind of safe materials that
have been used in other medical devices (such as heart stents and valves) for many years.
Can be performed in a health care provider's office: Because there is no cutting or
general anesthesia required the Essure procedure can be performed safely and comfortably
in a health care provider's office.
Covered by insurance: The Essure procedure is covered by most health insurance plans.
Check with your health insurance company to see if the Essure procedure is covered for you.
ESSURE SYSTEM DISADVANTAGES
Irreversible.
Can be expensive, costing between $1,000 and $3,000.
Tubal ligation requires exacting abdominal surgery and anesthesia, both of which carry health risks.
Surgical complications can include infection and uterine perforation.
Long-term health risks of sterilization can include ectopic pregnancy, cervical
cancer, menstrual cycle disturbances, increased bleeding and pain, and gynecological
problems necessitating hysterectomy.
Does not protect you from STIs, including HIV.
Dispenses with the need for planning or forethought, sometimes enabling risky sexual behavior.
RISKS OF THE ESSURE PROCEDURE
As with all procedures, there are risks associated with the Essure procedure:
Perforation, expulsion, or other unsatisfactory location of the micro-insert.
Possible problems include expulsion, in which the device moves out of place, and
perforation of the uterus- this is very rare.
Pregnancy & theoretical increased risk of ectopic pregnancy.
Risks associated with anesthesia.
Pain, cramping, vaginal bleeding, menstrual pattern changes.
Nausea/vomiting, or fainting.
Vasovagal response
During the implantation procedure, a health care provider uses a special catheter to insert one of
the devices into each of a woman's two fallopian tubes. The device works by causing scar
tissue to form over the implant, blocking the fallopian tube and preventing fertilization
of the egg by the sperm. It is an irreversible procedure.
During the first three months, women cannot rely on the Essure implants and must use
alternate contraception. At the three-month point, women must undergo a final X-ray
procedure to confirm the device is in the right place.
Women with a history of tubal or uterine disease or who have enlarged fallopian tubes
may not be good candidates for the procedure.
In the studies, 643 women who were implanted with Essure reported no pregnancies over
either one or two years. No serious side effects were reported from either clinical
study. Mild side effects include short-term cramps, pain, and nausea.
In the second study, doctors failed to implant the device successfully in 14 percent of the
patients. So the FDA is requiring Conceptus to conduct a post-approval study to document
how well the devices are being implanted by newly trained physicians and to identify
factors associated with placement failure.
Because women will rely on this device for permanent sterilization for many years
after placement, Conceptus also will be required to follow all study participants from
both clinical studies for at least five years to evaluate long-term contraceptive effectiveness.
Amy Allina, program and policy director at the National Women's Health Network, testified
before an FDA advisory panel on Essure. She says the device does have the potential to
expand contraceptive choice and advance women's health but there are some concerns about
its long-term safety and effectiveness.
"It has not been tested in many women and not for a great extent of time," says Allina.
"It's important to convey the limits of what we know about it."
About 700,000 women in the U.S. undergo tubal ligation each year, which makes it one of
the most common methods of contraception. The procedure requires general anesthesia and
two incisions in the abdominal area. A four- to six-day recovery period is recommended
before the patient can return to normal activities.
Patients should be counseled that this product does not protect against HIV
infection (AIDS) or other sexually transmitted diseases.
IMPORTANT NOTE - This information is a BRIEF SUMMARY of the complete prescribing
information (Instructions for Use) provided with the product and therefore should not
be used as the basis for prescribing the product. This summary was prepared by deleting
from the complete Instructions for Use certain text, tables and references. The health care provider
should be thoroughly familiar with the complete Instructions for Use before using or
prescribing this product.
INDICATIONS FOR USE: The Essure System is indicated for women who desire permanent birth
control (female sterilization) by bilateral occlusion of the fallopian tubes.
CONTRAINDICATIONS:
The Essure System should not be used in any patient who is:
- Uncertain about her desire to end fertility.
- Patients in whom only one micro-insert can be placed (including patients with apparent
contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus).
- Patients who have previously undergone a tubal ligation.
Or any patient with any of the following conditions:
- Pregnancy or suspected pregnancy.
- Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement.
- Active or recent upper or lower pelvic infection.
- Known allergy to contrast media or known hypersensitivity to nickel confirmed by skin test.
WARNINGS:
The patient must use alternative contraception (cannot rely on the Essure micro-inserts
for contraception) until an HSG performed three months post-micro-insert placement
demonstrates satisfactory micro-insert location and tubal occlusion. During this time
frame, the patient may be at an increased risk of ectopic pregnancy.
The Essure procedure should be considered irreversible. There are no data on the safety or
effectiveness of surgery to reverse the Essure procedure. Any attempt at surgical reversal
will likely require utero-tubal reimplantation. Pregnancy following such a procedure
carries with it the risk of uterine rupture and serious maternal and fetal morbidity
and mortality.
The Essure micro-insert will conduct energy if directly or closely contacted by an active
electrosurgical device. If this occurs, then there is a risk of patient injury. Therefore,
electrosurgery should be avoided in procedures undertaken on the uterine cornua and
proximal fallopian tubes without either hysteroscopic visualization of the micro-inserts,
or visualization of the proximal portion of the fallopian tube via open surgical procedures
or laparoscopy. During LAVH and other procedures in which electrosurgical instruments
could contact the serosa of the fallopian tube, instruments should not be placed more
proximal than the ampullary portion of the tube.
Bench studies suggest that endometrial ablation using radio frequency (RF) energy will
cause significant damage to surrounding tissue if an active RF instrument comes into direct
contact with the Essure micro-inserts. Consequently, if using RF energy to perform
endometrial ablation, direct contact with the Essure micro-inserts should be avoided.
Global auto-ablative systems that employ RF energy should not be used in women with the
Essure micro-inserts in place.
Bench studies suggest that endometrial ablation of the uterus with thermal (heated fluid)
techniques can be done with the Essure micro-inserts in place without significant tissue
damage, however, there is little clinical data regarding the safety of thermal endometrial
ablation in women with the Essure micro-inserts.
There are no data regarding cryo-ablation techniques or the use of laser for endometrial
ablation of the uterus with the Essure micro-inserts in place.
There are also no data regarding the use of endometrial ablation devices that operate at
microwave frequencies with the Essure micro-inserts in place. The use of microwave energy
near metallic implants has been shown to pose significant risk of serious injury to patients.
Use of microwave endometrial ablation devices near the Essure micro-inserts therefore
should be avoided.
Although not reported in the clinical trials of Essure, there is a theoretical increased
risk of ectopic pregnancy in patients with the Essure micro-inserts, should they become pregnant.
A very small percentage of women in the Essure clinical trials reported recurrent or
persistent pelvic pain, and only one woman requested device removal due to pain; however,
if device removal is required for any reason, it will likely require surgery, including
an abdominal incision and general anesthesia, and possible hysterectomy.
Patients may decide, in future years, to undergo in vitro fertilization (IVF) to become
pregnant. The effects of the Essure micro-inserts on the success of IVF are unknown.
If pregnancy is achieved, the risks of the Micro-insert to the patient, to the fetus
and to the continuation of a pregnancy are also unknown.
PRECAUTIONS:
Women should be counseled that:
No contraceptive is 100 percent effective. Ectopic and intrauterine pregnancy can occur in
contraceptive failure, even years after the procedure.
Data on Essure beyond two years are not yet available and may be different than current data.
Women who undergo sterilization at a relatively young age are at greater risk of
regretting their decision to undergo sterilization.
Any intrauterine procedure performed without hysteroscopic visualization following Essure
implantation could interrupt the ability of the Essure micro-inserts to prevent pregnancy.
Following such procedures, device retention and location should be verified by hysteroscopy,
x-ray, or ultrasound. In addition, the presence of the Essure micro-inserts could involve
risks associated with intrauterine procedures that, at this time, have not been identified.
Testing to ensure safety and compatibility with Magnetic Resonance Imaging (MRI) has been
conducted using a 1.5 tesla magnet. The Essure micro-inserts were found to be MR safe at
this field strength. Test results at 1.5 tesla indicate zero magnetic force and radio
frequency (RF) heating of 0.60 C in a phantom when a whole body specific absorption rate
(SAR) of 1.3 W/kg was applied. The presence of the micro-inserts produces an MR artifact,
which will obscure imaging of local tissue. The artifact is expected to be larger at
higher field strength.
ADVERSE EVENTS:
A total of 745 women underwent an Essure placement procedure in two separate clinical
investigations to evaluate the safety and effectiveness of the Essure System (227 in
the Phase II study and 518 women in the Pivotal trial). Some women underwent more than
one procedure if successful bilateral placement was not achieved in the initial procedure.
Placement of at least one Essure Micro-insert was achieved in 682 women (206 in the Phase
II study and 476 in the Pivotal trial). Adverse events, which prevented reliance on Essure
for contraception, were reported as follows: failure to place two micro-inserts in first
procedure (14 percent), initial tubal patency (3.5 percent), expulsion (2.2 percent), perforation
(1.5 percent), or other unsatisfactory device location (0.6 percent). All of the patients who experienced tubal
patency at the 3-month HSG were found to have bilateral occlusion at a repeat HSG performed
at approximately 6 months after Essure placement. In addition, all of the patients who
chose to undergo a second Essure placement procedure following a micro-insert expulsion,
achieved successful micro-insert placement and were subsequently able to rely on Essure
for contraception. The most frequent adverse events and side effects reported as a result
of the hysteroscopic procedure to place the Essure micro-inserts were as follows:
cramping (29.6 percent), pain (12.9 percent), nausea/vomiting (10.8 percent), dizziness/light headedness
(8.8 percent), and bleeding/spotting (6.8 percent). Hypervolemia occurred in less than one percent of
cases. During the first year of reliance on Essure for contraception (approximately 15
months after micro-insert placement), the following episodes were reported as at least
possibly related to the Essure micro-inserts: back pain (9.0 percent), abdominal pain (3.8 percent),
dyspaurenia (3.6 percent). All other events occurred in less than 3 percent of women.
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Tubal Ligation Procedures
