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Tubal Ligation Procedures
DESCRIPTION
The goal of contraception (or birth control) is to prevent an unplanned pregnancy. The majority of methods of contraception enable sexually active couples to temporarily avoid pregnancy. Permanent birth control is accomplished through sterilization. Be sure you know and understand the different types of birth control available to you, the risks and benefits of each, and any side effects, so that you can make an informed choice.
MoonDragon's Contraception Methods Compared
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 Procedure Advantages
Effective: The Essure procedure is 99.80% 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 doctor 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% 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 i ts 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 physician 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% 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%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.5%), or other unsatisfactory device location (0.6%). 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%), pain (12.9%), nausea/vomiting (10.8%), dizziness/light headedness (8.8%), and bleeding/spotting (6.8%). 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%), abdominal pain (3.8%), dyspaurenia (3.6%). All other events occurred in less than 3% of women.
Quinacrine Pellet Sterilization (Q Method)
This method developed by Zipper et al, involves transcervical application of pellets of quinacrine and an anti-inflammatory ibuprofen in the proliferative phase 6th to 14th of the menstrual cycle using a copper T intrauterine device like inserter. The pellets are cylindrical in shape to accommodate the inner cylinder of the inserter. Seven pellets of 36 mg of quinacrine (252 mg) rapid dissolution time are inserted. The application technique is slightly different from that of an IUCD insertion, in that after the inserter has been introduced into the uterus after evaluation of uterine length, it is withdrawn from the uterus by 0.5 cm and then the plunger is advanced after fixation of the inserter sleeve to expel all the pellets into the uterus. The procedure is performed twice at monthly intervals. Inserter is preloaded with pellets and the entire package comes presterilized by radiation or ethylene oxide.
Adjuvant therapy: Medroxy-progesterone 150 mg IM given on the day of first insertion, or alternatively, Oral Contraceptives are prescribed from the first insertion cycle and continued for three cycles. Anti-prostaglandin such as 200mg Ibuprofen orally on the day of the first and second insertions.
Quinacrine acts by chelation of the DNA by formation of quinacrine-DNA complexes. This action is believed to result in fibrosis of the endothelial lining of the proximal areas of the fallopian tubes. Endometrium is spared as it has a high levels of zinc which prevents DNA-quinacrine complexes. Anti-prostaglandin adjuvants such as ibuprofen and diclofenac sodium probably act by preventing disposal of quinacrine from the local area by inflammatory reaction.
Medroxy-progesterone 150 mg IM or the Oral Contraceptives (OC's) acts by relaxing the tubal musculature, resulting in increase influx of quinacrine solution into the fallopian tubes. In addition it acts as a temporary contraception, till fallopian tubes are fibrosed.
The quinacrine pellet method requires technical skills similar to that for an IUCD insertion. In large trials conducted world over the procedures have been increasingly carried out by nurses and paramedical personnel quite efficiently. Thus the potential access for this method is very large and with a minimal levels of training large number of operators can be recruited.
EFFICACY OF THE Q-METHOD
The quinacrine pellet method originally considered to have a lifetime failure rate of 5-6 percent, shows remarkable improvement with the increase in number of insertions and additions of antiprostaglandins. Most ongoing studies have shown a failure rate from 1- 2 percent at the end of one year and the largest study in Vietnam have shown a failure rate of 2 percent and this is without additions of antiprostaglandins. Further studies with additions of antiprostaglandins such as ibuprofen, and diclofenac sodium along with Medroxy-progesterone 150mg IM have demonstrated failure rates between 1.4 percent to nil when followed up for a period of two years.
Surgical sterilization is highly effective and forms an effective benchmark of comparison. It has a low failure rate of less than 0.5 percent at the end of one year, however a 10 year follow up shows a failure rate of up to 2.5 percent.
The efficacy of newer protocols in the short term approaches that of surgical sterilization while on long term is still unknown. This marginal difference in efficacy is totally overshadowed by the excellent record on safety that quinacrine pellet method has over the surgical method.
Q-METHOD SAFETY
In over 30,000 cases of quinacrine pellet sterilizations in Vietnam, 10,000 cases in India and 5000 cases in other regions not a single death has been reported. Whereas for surgical sterilizations carrying a case fatality rate of 21 per 100,000 in India, we would have expected 10 deaths. Morbidity is another important aspect of safety. All major reports of the quinacrine pellet method are uniformly reassuring by their absence of any serious life threatening complications. In a large field trial at Vietnam there were common side effects such as lower abdominal pain, headache and mild fever which were easily treated with analgesics. Surgical sterilization carried an total major complication rate varying from 1.7 to 5.7 percent in various reviews.
Long term sequelae of both methods have been a concern, but present evidence suggests that both procedures are free of the problem. There has been a worry that quinacrine pellet method may induce carcinogenesis but recent studies have shown no increased risk either in the form of increased incidence of abnormal pap smears or in the increased risk of cancers in women who underwent quinacrine pellet method of female sterilization.
Reversibility: Since non-surgical method produces proximal tubal occlusion that does not extend beyond the muscularis layer the surgical approach for reversal involves reimplantation of the tube . This approach has a 50 percent intrauterine pregnancy rate. While reversal of surgical method of sterilization involves excision of the scar and re-anastomosis of the healthy ends and this has a intrauterine pregnancy rate of 80 percent. From all available data at this time it appears that the quinacrine pellet method of female sterilization is far safer than surgical sterilization.
ROLE IN REDUCTION OF MATERNAL MORTALITY AND MORBIDITY
The most potent argument for the Q method is that it is far easier to deliver in rural areas with high maternal mortality rates. It has always been difficult to deliver safe surgical sterilization in rural areas of India where it was required the most. It is in these areas where every sterilization can prevent two births. In these areas the maternal mortality is between 500 to 1000 per 100,000 live births. At a cost of less than Rs 1500, a maternal death can be prevented (a single sterilization by the Q method costs less than Rs 30) (8). It is estimated that to reach a complete coverage of sterilization in this country we will have to complete over 40 million sterilizations by the end of this decade. Only quinacrine pellet method can meet this demand and thus prevent over 80 million births and around 800,000 maternal deaths.
Maternal morbidity which is unfortunately unmeasured, is a factor that has to be accounted in weighing the role of quinacrine method in its role in reducing maternal morbidity.
NOTIFY YOUR MIDWIFE OR HEALTH CARE PROVIDER IF...
You are interested in more information about permanent female sterilization methods. Find out what options are available to you and the risks and benefits of each method.
If you have any adverse reactions to the sterilization devices, or medications involved with the procedure. If you show signs of infection, notify your health care provider immediately.
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