Hysteroscopic Sterilization

I. Introduction

Around 153 million women around the world have chosen to be sterilized for contraceptive purposes, of these 138 million are in the developing countries. 1 Approximately fifty percent of all female sterilization is performed during the puerperal period or a cesarean section, and the other fifty percent is called “interval sterilization” when there has been no pregnancy for the previous six weeks. The most common surgical procedure today for sterilization is via minilaparotomy. However, the technique of fallopian tube ligation is still being done today largely by a procedure developed at the beginning of the 20 th century. The advent of fiber optic technology led to the introduction of the laparoscope in the 1960’s followed quickly by techniques of electrocoagulation and application of clip/rings to the fallopian tubes to block them. There had been improvements in the design of devices for blocking the tubes, but gains in safety and efficacy were small. Efforts to reach the fallopian tube through the vagina rather then abdominally increased in the 1970’s, but there was a high rate of failure in completing the operation and significant complications. The possibility of reaching the tubes transcervically was recognized in the late 19 th century, but the efforts to perform female sterilization by this method had mixed success.

II. Historical Review of Hysteroscopic Sterilization

In 1869, Pantaleoni published his article entitled “On endoscopic examination of the cavity of the womb” in the medical press. He did this when a woman presented for investigation of abnormal vaginal bleeding. This was the first described hysteroscopic examination of the uterine cavity in recorded history. Then 1878, Kocks attempted to blindly occlude the uterotubal junction by transcervical insertion of electrodes. 2 Similar attempts to improve this rudimentary technique by using guide wire fluoroscopy did not produce significant clinical success. The use of a hysteroscope for direct visualization of the tubal ostia for the purpose of sterilization was initially suggested by Mickulicz-Radecki and Freund in 1927. 3 Schroeder in 1934 performed intramural sterilization of the tubes by electrocoagulation. Although the idea of utilizing hysteroscopy for tubal occlusion goes back to 1920’s, and was explored in clinical trials in the 1950’s, particularly by Japanese investigators, it did not produce acceptable results. Modern hysteroscopy was introduced in the early 1970’s as a method of visualizing the uterine cavity and uterotubal junction. It was not until this period that well designed clinical trials were initiated utilizing electrodes delivered directly under hysteroscopic guidance. These studies were done at several centers; in West Germany by Lindeman, in Japan by Sugimoto, in Mexico by Quinones, and in the United States by Neuwirth. This was a time of growing interest in this new technology which spurred the development of reliable hysteroscopic instrumentation and safe distention medium.

Various methods were evaluated including inert plugs, chemicals, caustic and sclerosing agents; however they often proved difficult, inefficient, and dangerous. 4 Failures were high and serious complications were reported in clinical trials. 2, 5-8 A quarter of a century later, owing to improved technology, new intratubal devices have been designed that achieve sterilization in an ambulatory setting employing a tubal occlusive transcervical method.

After decades of searching for an acceptable hysteroscopic method of permanent birth control, without the need for incisional surgery or general anesthesia, a safe and acceptable form of female sterilization came onto the horizon. The STOP (selective tubal occlusion procedure) device (Conceptus, Inc., Mountain View, CA) was developed and was studied in a clinical trial in pre-hysterectomy patients who wore the device for 1-12 weeks prior to hysterectomy. At hysterectomy hysterosalpingography (HSG) was performed to determine tubal occlusion. 9 Subsequently, the tubes containing the STOP device were processed, sectioned, and evaluated to determine the histological response. Histology showed an acute inflammatory and fibrotic response in the short term that over time, became a chronic inflammatory response with extensive fibrosis, occluding the fallopian tube at the uterotubal junction. This supported the usefulness of the STOP device for pregnancy prevention.

III. Background Study of the Essure ® Permanent Contraceptive Micro-insert

The Essure (previously known as the STOP device) micro-insert underwent several design changes during its evolution. In 1995, there were animal studies with the initial product called the Alpha design which was a static design with curled ends. The second product was Beta 1 and 2 which changed from a curve design to a linear static design. The Beta 2 version was introduced with a delivery catheter. Next a Beta 3 design was developed with an increased quantity of PET (p olyethylene terephthalate) fibers to induce the tissue response. The Gamma, or Essure, design is the model sold commercially today. It is a dynamic coil design with increased length and increased quantity of PET fiber. These various evolutions in the design of the product were progressively more successful in allowing the anchoring of the device in the tubal ostia, and promotion of tissue in-growth, thus occluding the interstitial portion of the tube for permanent contraception.

In 1998 a Phase II FDA IDE clinical trial utilizing the micro-insert for sterilization patients commenced. In the year 2000 a Pivotal Trial to evaluate safety and efficacy of the micro-insert had begun. Both studies are still on-going and data continues to be collected. 2001 saw the commercial sale of the Essure micro-insert in Australia, Singapore and Canada. FDA approval of the micro-insert and commercial sales in Europe and the United States began in 2002.

The Phase II study was designed as a prospective, multi-center, single arm non-randomized international study of women seeking permanent contraception. The objectives of the study were to evaluate:

• Women’s tolerance of, and recovery from, the micro-insert placement procedure;
• The safety of the micro-insert placement procedure;
• Women’s tolerance of the implanted micro-inserts
• The long-term safety and stability of the implanted micro-inserts; and
• The effectiveness of the micro-inserts in preventing pregnancy

The Pivotal study was of similar design and used findings from the U.S. Collaborative Review of Sterilization (CREST ) study 10-11 as a qualitative benchmark. The primary endpoints for the study included:

• Prevention of pregnancy
• Safety of device placement procedure, and;
• Safety of device wearing

Secondary endpoints for the study included:

• Participant satisfaction with device placement procedure;
• Participant satisfaction with device wearing;
• Bilateral device placement rate, and;
• Development of a profile for an appropriate candidate for the Essure procedure

The study population of the two studies combined consisted of 664 women in whom bilateral device placement was achieved after one or more attempts (200 in the Phase II study and 464 in the Pivotal trial). All study participants were between 21 and 45 years of age and were seeking permanent contraception prior to enrollment in the study.

Additionally, all women had at least one live birth, had regular cyclical menses and were able and willing to use alternative contraception for the first three months following Essure micro-insert placement.

An Essure device placement procedure was attempted on each fallopian tube. In the Pivotal trial, a pelvic x-ray was performed within 24 hours following device placement to capture a baseline evaluation of device location. Participants were instructed to use either a barrier contraceptive method or oral contraceptives for the first three months following the device placement procedure.

A hysterosalpingogram (HSG) was performed three months post-procedure to evaluate device location and fallopian tube occlusion. If both fallopian tubes were occluded and both devices were in satisfactory location, then the participant was instructed to discontinue use of alternative contraception and rely on the Essure micro-inserts for prevention of pregnancy. Women were evaluated to assess any adverse symptoms or events and post-procedure satisfaction at 1,1½, 2, 3, 4, and 5-year intervals. A Bayesian perspective was adopted to combine efficacy information across trials, and statistically age-adjusted for comparison to the CREST study results.

The most recent data from these ongoing studies was presented at the 2005 Annual Meeting of the American Association of Gynecologic Laparoscopists. 12 Bilateral micro-insert placement and confirmation of tubal occlusion was achieved in 643 women. The mean duration of follow-up was 52.9 months for the Phase II study and 42.5 months for the Pivotal study. Persistent pain or bleeding has not been reported by any of the study participants. Recurrent pain (reported at more than one follow-up visit) pain and bleeding were rarely reported. Sixteen hysterectomies have been reported, none of which was determined to be due to the Essure procedure.

To-date no failures have occurred with up to five years (n=75) and 29,357 women-months of follow-up. The table below provides efficacy rates for the combined trials.

Age-adjusted Posterior cumulative Bayesan efficacy rates (posterior means) for the Essure procedure: Phase II and Pivotal trials combined*

1 year

2 years

3 years

4 years

5 years

99.95%

99.90%

99.84%

99.80%

99.74%**

* Age adjustments are for comparison to the CREST study as a reference population

**Represents 75 Phase II patients who have completed 5-year follow-up. No patients in the Pivotal study have reached the 5-year follow-up visit at this time.

Among women in the Phase II study, 99% rated their tolerance of wearing the Essure micro-insert as “Good” to “Excellent”. Within the Pivotal study group 99% rated their comfort for wearing the Essure micro-insert as “Good” to “Excellent” and 97% rated their satisfaction as “Somewhat” to Very Satisfied”.

These data indicate that hysteroscopic interval tubal sterilization with micro-inserts is well tolerated, results in high patient satisfaction and effective permanent contraception.

Since the introduction of the Essure procedure, extensive physician training has been conducted both in proficiency in hysteroscopy, as well as performance of the procedure. Qualified physicians have been provided with information and skills necessary to select appropriate patients, perform competent procedures and manage technical issues or adverse events related to the placement of the micro-insert. The training requirements include knowledge of hysteroscopy, successful completion of a physician training course at a site approved by Conceptus, Inc., a successful completion of simulated performance of the procedure, and completion of (typically) five cases under a designated preceptor to assure competency. To-date thousands of physicians worldwide have been trained and are performing the Essure procedure routinely in their practices. In the United States, residency programs are increasingly having residents learn this skill along with other routine gynecological procedures. At present there have been tens of thousands successful bilateral placements of Essure micro-inserts worldwide.

IV. Effectiveness of Sterilization: Hysteroscopic versus Laparoscopic/ Minilaparotomy

Laparoscopy gained wide spread acceptance in the United States in the early 1970’s. By 1973 more sterilization operations were performed for women than for men due to the dramatic decrease in cost, hospital time and pain after the introduction of laparoscopy and minilaparotomy methods. The use of laparoscopy for tubal occlusion increased from only 0.6% of sterilizations in 1970 to more then 35% in 1975. 13 Laparoscopic and minilaparotomy sterilizations were not only convenient but also highly effective methods of preventing pregnancy and replaced the older, complex procedures. Hospitalization is not required, most patients return home within a few hours, and the majority of women return to full activity within a few days. The discomfort is minimal, the incision scars barely visible and sexual activity need not be restricted. In addition, the surgeon has the opportunity to inspect pelvic and abdominal organs for abnormalities. However the disadvantages of laparoscopic sterilization include: the cost, the expensive and fragile equipment, special training requirements, risk of inadvertent bowel and vessel injury, and the need for general anesthesia (in most instances). It is now apparent that the long term failure rates for all methods of laparoscopic sterilization are higher than previous estimates. Overall 1.85% of sterilized American women experience a failure within 10 years. 11-12 As much as one third of these failures are ectopic pregnancies. In 2002, in the United States female sterilization was used by 10.3 million women and was second only to oral contraceptive users of 11.6 million women. 14 Although female sterilization by laparoscopy/minilaparotomy is effective it is associated with significant risks of major complications. As published by Jamieson et al., tubal sterilization performed via laparoscopy is associated with a 1.6% major complication rate, and Layde et al, reported 5.7% major complication rate when tubal sterilization is performed via laparotomy. 15-16 Additionally, performing laparoscopy for sterilization under local anesthesia increased the risk of complications five-fold as reported by Destefano et al. 17 The vast majority of the major complications through laparoscopy/ minilaparotomy are created by the incision, blind insertion of laparoscopic instruments and the use of general anesthesia. It was only a question of time until improvements in female sterilization came about as it affects such a huge proportion of women.

In a direct comparison to the CREST study data at five years, the Essure procedure presents a favorable risk profile over the majority of tubal sterilization methods, as evidenced in the table below.

Comparison of cumulative risk of pregnancy in the CREST study vs. Essure sterilization*

The Essure Procedure does not require cutting or penetrating the abdomen. It can be performed without general anesthesia in an outpatient/office setting. This major advantage of the hysteroscopic technique of sterilization has firmly placed the Essure procedure as a contender for first choice for female permanent contraception. A disadvantage of the procedure is the need for alternate contraception three months after the procedure, as is not effective immediately. A perceived disadvantage is the required HSG at three months post-procedure. However, no method of contraception is 100% effective, the HSG provides the patient and the physician assurance that the method is working. In addition, if there is an issue, it can be identified at the time of HSG and appropriate action can be taken.

V. Indications and Contraindications of the Essure Procedure

The Essure procedure is indicated for women who desire permanent birth control by bilateral occlusion of the fallopian tubes.

The Essure procedure should not be performed in the following patients:

• A person who is uncertain about permanent sterilization
• When bilateral tubal micro-insert placement cannot be performed due to uncertainty of the status of the contralateral tube; ie. where either partial or total salpingectomy has been performed in the past or where pathological conditions of the tube may exist
• When both tubes have already had tubal occlusion performed by another method
• Known allergy to contrast media
• Known hypersensitivity to nickel confirmed by skin test

The Essure procedure should be delayed in the following patients

• When question of pregnancy or suspected pregnancy may be present
• When a birth or pregnancy termination has occurred less than six weeks prior
• In the presence of active or recent pelvic or lower genital tract infection 

VI. The Essure System: Description of Product

The Essure permanent birth control system consists of the Essure micro-insert, a disposable delivery system, and a disposable split introducer. A standard hysteroscope with a 5 French working channel, a continuous flow, and a 12-30 degree angled lens is used in concert with the system. The 5mm hysteroscopes made by Karl Storz Endoscopy and Richard Wolf Medical Instruments both accommodate the Essure system.

The Micro-insert

This consists of a stainless steal inner coil, a nitinol super elastic outer coil, and PET fibers. PET fibers are used in other medical application such as prosthetic arterial graphs, percutaneous catheters, aneurysm coils and other long term implants. The PET fiber is wound in and around the inner coil. The micro-insert is 4cm long and 0.8mm in diameter in its wound down configuration. When released the outer coil expands to 1.5-2.0mm. This anchors the micro-insert inside the tube.

The Disposable Delivery System

This consists of an ergonomic handle which contains a delivery wire, release catheter, and delivery catheter. The ergonomic handle controls the delivery and release. A thumb wheel on the handle allows the operator to retract both the delivery catheter and release catheter. The delivery wire is detached from the micro-insert on deployment by rotating the system in a counter-clockwise direction.

Split Introducer

This helps protect the micro-insert as it passes through the sealing cap of the hysteroscopic working channel.

Mechanism of Action

The Essure micro-insert remains anchored in the fallopian tube resulting in permanent contraception because it is small enough in diameter to be placed across, and long enough to span, the uterotubal junction. This specific portion of anatomy was chosen for placement of the micro-insert to prevent the expulsion of the device during menstrual uterine contractions and it is the narrowest portion of the tube. Yet, the device is long enough in its proximal portion to allow coils to trail inside the uterine cavity (specifically 3-8 coils). This trailing portion in the uterine cavity aids in anchoring. The expanded outer coils within the uterus are almost twice the diameter of the expanded coils within the tube. This greater outer diameter of the expanded coils initially anchors the micro-insert preventing the migration of the device into the peritoneal cavity.

Stages of Micro-insert Deployment

The PET fibers then begin to elicit the fibrotic response. The long term nature of the tissue response is not known. The majority of the clinical data at the end of 5 years of use suggest permanence of fibrotic response.

Histological response to PET fibers

VII. Procedure Description and Pre/Post-procedure Protocol

Pre-procedure Protocol 18:

Standard pre-procedure consent for sterilization must be obtained as required by local laws. The physician should be trained in hysteroscopy and the Essure procedure and should have been proctored for at least five cases or as required by the hospital credentialing committee. Similarly the operating room nurses and staff should be familiar with the instrumentation. The anesthesiologist should be supportive of the patient during the procedure under local anesthesia and/or with any IV sedation, as required. Before the procedure reconfirmation of consent must be performed by the circulating nurse, especially emphasizing the fact that the Essure procedure is an irreversible, permanent contraception technique. It is preferable to perform the procedure in the early proliferative phase to avoid placement during an undiagnosed luteal phase pregnancy. Additionally, this enhances the visualization of the fallopian tube ostia. Micro-insert placement should not be performed during menses.

A pregnancy test should be conducted 24 hours prior to the micro-insert placement. The patient must be informed that there is a 12%-14% chance that a bilateral placement would be unsuccessful during the first attempt due to pre-existing pathology, anatomic abnormalities, or procedure related difficulties like poor visualization of the tube. 19 However, bilateral placement may be completed during the second attempt.

Pre-op Medications

Injection Toradol 30mg IM or IV should be given half an hour prior to the procedure to prevent tubal spasm. An anxiolytic agent may be given half an hour before as preferred by the anesthesiologist

The Procedure

The patient is placed in the lithotomy position and is draped per standard protocol, and an under buttocks drape with a pouch for fluid collection is recommended. Ski boot style stirrups are recommended. If the fallopian tubes are laterally situated the patient’s legs may need to be widened to allow hysteroscopic access. Next the speculum is introduced into the vagina to expose the cervix. The cervix is prepped with betadine then a local anesthetic is given as a paracervical block. A bi-valve open-sided speculum is recommended so that it can be readily removed once the hysteroscope is in place. It is important to inform the patient before administering the local anesthetic injection to reduce pain and discomfort. Soothing words may help to minimize the discomfort. The circulating nurse is an important adjunct to this process. The paracervical block takes about 3-4 minutes. This time may be utilized to connect the camera, light source, sealing cap, fluid in flow and out flow to the hysteroscope. The hysteroscope may be balanced and focused, and in-flow may be checked. Then tenaculum is placed on the anterior lip of the cervix. The hysteroscope is introduced without dilation of the cervix through the external os, here the patient may be invited to view the procedure on the monitor while the anatomy is being described. The irrigation is turned on using normal saline through a fluid management system which may be in use in the hospital setting or the fluid may be introduced by gravity. If excessive force is required to enter the cervix it is better to terminate the procedure then run the risk of uterine perforation. Other measures pre-operatively may be utilized in the future to achieve cervical dilation of a stenotic cervix (ie. laminaria, misoprostol, or vaginal suppository).

It is important to maintain visual and verbal contact with the patient during the potentially uncomfortable segment. If cervical dilation is required, dilate only sufficiently to insert a 5mm hysteroscope. After the hysteroscope negotiates the cervix remove the speculum. Uterine cavity distention is achieved with 0.9% saline infusion. It is strongly recommended to pre-warm the infusion fluid to prevent tubal spasm. Adequate uterine distention must be achieved and maintained throughout the procedure to allow the identification and access of the tubal ostia. Fluid intake and out-flow must be accounted for per standard protocol. If the fluid deficit exceeds 1500cc the procedure must be terminated to avoid hypervolemia.

Both tubal ostia must be identified and assessed hysteroscopically prior to proceeding with Essure micro-insert placement. No attempt should be made to place a micro-insert in one tubal ostium unless there is a reasonable expectation that the opposite tubal ostium is accessible and patent. If there is a doubt about successful bilateral placement then the procedure should be terminated. Either tubal or uterine anomalies may make it impossible to place the Essure micro-insert. It is recommended that the system remain within the sterile packaging until both ostia are visualized. It is important to assess the actual system for any damage. Next, insert the split introducer with the opening face up through the sealing cap of the working channel of the hysteroscope. Insert the Essure delivery catheter through the introducer after removing the stylet of the split introducer. Now the Essure delivery catheter is advanced half way down the hysteroscope working channel when the split introducer is removed. The hysteroscope is rotated as required to access the ostium using the light cable attachment while the camera head is kept steady. Angling the lens 12-30 degrees will aid in aligning the hysteroscope with the tubal ostia. Now the catheter is advanced into the fallopian tube until the black positioning marker can be visualized as having reached the ostium.

This visual marker indicates that the micro-insert is spanning the intramural and proximal isthmic segments of the fallopian tube with the outercoil spanning the uterotubal junction. This positioning is for the placement of the micro-insert. Occasionally, it is necessary to exert gentle forward pressure to advance the catheter into the tube to overcome tubal resistance. Resistance to advancement is usually apparent if 1) the black positioning marker on the outside surface of the catheter does not advance forward to the tubal ostia and/or 2) the delivery catheter bends or flexes excessively preventing the application of forward pressure on the catheter. When such resistance is observed further attempts for advancement must be terminated to avoid uterine or tubal perforation. A follow-up HSG may be undertaken to determine tubal patency. If tubal or uterine perforation occurs or is suspected, immediately discontinue the Essure procedure. If tubal obstruction is encountered or if the delivery catheter cannot be advanced to the black positioning marker then the case should be terminated.

After confirming proper positioning of the black marker the micro-insert can be deployed. To do so, stabilize the handle of the Essure micro-insert against the hysteroscope or the camera to prevent inadvertent forward movement of the micro-insert during the retraction of the delivery catheter. Care must be taken at all times to not to bend the delivery catheter outside of the hysteroscope which may result in the unwanted movement of the distal tip of the catheter. Now the thumb wheel on the ergonomic handle is rotated toward the physician to withdraw the delivery catheter. The thumb wheel rotation should be performed at the rate of one click per second until the wheel stops. The black positioning marker will move away from the tubal ostium towards the hysteroscope and will disappear in the hysteroscope operating channel. Withdrawal of the delivery catheter exposes the wound down Essure micro-insert attached to the orange release catheter. Approximately one centimeter of the micro-insert wound down coils should appear trailing into the uterus when the delivery catheter is withdrawn.

Placement: Spanning the uterotubal junction

A small notch identifies this aspect of the micro-insert – the notch appears where there is a slight increase in the diameter of the coils. The visualization outside the notch just outside the ostium, as well as, the visualization of the distal tip of the orange release catheter will confirm proper positioning. Forward and backward movements of the entire system may be gently performed to achieve perfect placement. After retracting the delivery catheter and confirming the proper positioning the deployment button on the ergonomic handle is depressed to enable the thumb wheel to be further rotated. Now rotate the thumb wheel backwards towards the physician to withdraw the orange release catheter while continuing to stabilize the handle. When the thumb wheel cannot be rotated any further then the withdrawal of the orange release catheter is complete. This enables the outer coil of the Essure micro-insert to expand which is easily visible to the operator. Allow ten seconds for the outer coil expansion while aligning the hysteroscope and the delivery system to minimize the bending of the catheter. The entire delivery system should be carefully straightened out prior to the next step which is the counter clockwise rotation of the ergonomic handle. This rotation allows the delivery wire to become visibly disengaged from the Essure micro-insert. Ten such rotations are usually required to allow disengagement. While continuing the rotation to remove the delivery wire, the delivery system may be gently drawn from the micro-insert by pulling the handle backwards. If there is difficulty in separation of the micro-insert from the delivery wire then the hysteroscope tip may be used to accomplish this step as a last resort. In a majority of instances counter-clockwise rotation and application of gentle backward tension on the handle is able to achieve successful detachment of the delivery wire from the micro-insert. To verify the separation, obtain a panoramic view by sliding the hysteroscope backwards over the delivery wire. For trouble shooting Essure system retraction appropriate training with a clinical specialist is recommended. It is encouraging that the learning curve is very short for these procedures. If none of these techniques are successful the deployed micro-insert can be pulled out of the fallopian tube by continuous backward movement of the delivery system and removing the hysteroscope and the Essure system out of the patient as a unit. If the micro-insert is partly broken, the patient must be instructed not to rely on this for contraception and if the broken micro-insert is causing an adverse event an attempt must be made to remove it.

The ideal number of expanded outer coils trailing within the uterine cavity is 3-8 coils. If the number of outer coils is less than eighteen the micro-insert should be left in place and evaluated with an HSG three months post device placement. Removal may be attempted if eighteen or more coils are trailing into the uterine cavity. The physician must refer to company sponsored instructions on how to attempt removal of micro-insert. There is a likelihood of fallopian tube perforation or other patient injury if such instructions are not adhered to. If the micro-insert is inadvertently deployed into the uterine cavity it should be removed from the uterus and another attempt should be made at tubal placement. Repeat the Essure micro-insert placement procedure in the contralateral fallopian tube. Do not place more than one micro-insert in a single fallopian tube.

Recording the Number of Coils

It is important to record the number of coils from the micro-insert trailing into the uterine cavity, as well as noting any issues with identifying the tubal ostia, or concerns regarding potential perforation. These issues can be reviewed at the three-month post-procedure HSG. Additional information in the patient records should include any concern at the time of micro-insert placement of possible perforation, certain loss of resistance, or no visible trailing length after device placement. Also, the visible trailing length at the conclusion of device placement of less than three and greater then eight should be noted – as three to eight coils trailing into the uterine cavity is considered ideal placement.

Post-Procedure protocol

A patient identification card is supplied with each Essure system. This must be given to the patient and she must be advised to carry it with her at all times and show it to all healthcare providers involved in her present and future care.

Patient must be instructed to use an alternative form of contraception, except an intra-uterine device (IUD) for the first three months following the procedure. It is important to ensure that the patient is supplied with or already has contraception for this time frame. This contraception must be the most effective means for which she is a candidate (ie: oral contraception or injection Depo-provera 150mg).

The patient should be scheduled for the HSG three months after the Essure micro-insert placement procedure. The HSG is performed to evaluate micro-insert location, and fallopian tube occlusion. Only if the micro-insert location is satisfactory and there is evidence of bilateral occlusion of the tubes may the physician instruct the patient to discontinue the use of alternative contraception and rely entirely on Essure micro-inserts.

HSG Protocol

The following steps should be followed for performing and evaluating the HSG. One objective of HSG is to evaluate the relationship of the proximal end of the inner coil of the micro-insert to the uterine cornu thus verifying that the micro-insert spans the uterotubal junction. In order to achieve this, the following guidelines must be adhered to:

1) Uterine cavity silhouette must be seen with good cornual filling

2) The fluoroscopy beam should be as close to anterior-posterior projection as possible to the uterus

3) Good cervical seal must be maintained for achieving uterine distention

4) Downward traction on the cervical tenaculum may be required to obtain a mid position of the uterus for ideal images of the uterine cavity. The speculum can be removed prior to fluoroscopy to assure best possible visualization of the uterine anatomy.

5) A minimum of six still radiographs should be taken to assess micro-insert location and tubal occlusion.

The following are images of the Essure micro-insert during hysterosalpingogram with descriptions.

Radiographic view and photographic views showing proximal and distal ends of inner and outer coils.

Radiographic views show poor cervical seal and non-opacification of the uterine cornu.

Radiography showing non-distension of the cornua with the dye.

Radiography showing cornual distention of the uterine cavity has been achieved with adequate distention of the dye.

Magnification of bilateral cornua. Highlights the position of the micro-insert in reference to the uterine cornua. a. Right cornua b. Left cornua.

Radiography showing expulsion of micro-insert a. Complete expulsion of the left micro-insert b. expulsion of the left micro-insert into the uterus.

Radiography showing distal ends of inner coils within the tubes a. Proximal end is trailing into the uterine cavity b. On patient left side, proximal end of inner coil in <30mm from contrast at cornua.

Radiography showing micro-insert in peritoneal cavity a. Shows micro-insert in the peritoneal cavity b. distal placement of the micro-insert.

Radiography showing contrast in the proximal tube on the right side;

Radiography showing tubal occlusion at the cornua.

Contrast is seen beyond the proximal tube with spillage into the peritoneal cavity.

If the HSG does not demonstrate tubal occlusion or in other words shows tubal patency beyond the micro-insert, the patient must continue the use of alternative contraception for three additional months and repeat the HSG at six months post-procedure. If tubal occlusion is not established at six months, the patient must be advised not to rely on the Essure micro-inserts for contraception.

In a recent clinical study utilizing an improved coil catheter delivery system (which is now standard), correct device placement was confirmed in 100/102 (98%) of patients. 20 Between the two patients with failed attempts the delivery system could not be advanced to the ostia. Subsequent HSGs identified one of these patients had fibrosis with thickening of the isthmic tubal segment, and the other, tubal stenosis. The average procedure time, defined as the time from scope insertion to removal was 8.1 minutes. Of the 100 women with successful bilateral placement 94 underwent a post-procedure HSG. All but one of these women demonstrated bilateral tubal occlusion.

Satisfaction Rating of the Device

At one-week follow-up, satisfaction was rated as “very satisfied” by 94 of 100 (94%) women, and “reasonably satisfied” by the remaining six.

VIII. Possible Complications/ Risks/ Adverse Events

Unsuccessful Attempts

A variety of technical and or procedural issues may arise when performing the Essure procedure, a trouble shooting guide provided by Conceptus, Inc. has categorized these into the following major steps: 1) introducing the hysteroscope, 2) achieving uterine distention, 3) achieving ostial visualization, 4) advancing the micro-insert into the fallopian tube, 5) deploying the micro-insert. In the advent of unilateral or bilateral micro-insert placement failure the patient should be informed that she has not achieved permanent contraception, and should be counseled about the opportunity to undergo a second attempt. If the second procedure fails the patient is unlikely to have success at subsequent attempts. If the patient chooses laparoscopic sterilization both fallopian tubes should be clipped or coagulated in the ampullary portion of the fallopian tube and not at a portion of the tube containing a micro-insert.

Possible Adverse Events and Complications

In the coil catheter study, the patient who did not demonstrate bilateral occlusion at HSG had experienced a tubal perforation. Other possible adverse events are vaso-vagal response, device expulsion or migration, device proximal band detachment, broken device tip. None of these has clinical sequelae.

Possible Minor Side Effects

• Post-procedure pain: In the coil catheter study post-procedure pain was reported by 68 of 98 (69%) respondents. Thirty women (31%) experienced some pain during the first week; 16 reported it as mild, 10 as moderate, and four as severe. In recent publication there was a comparison between Essure versus laparoscopic sterilization which concluded pain was less following the Essure procedure versus laparoscopic sterilization (31% vs. 63% respectively, P=0.008). 21 Data of Radha Syed and Sultana Khimani presented at the 2005 American College of Obstetrics and Gynecology annual clinical meeting, comparing laparoscopic sterilization and Essure, where the primary end point was post-procedure pain, concluded that patient report of pain was higher in the laparoscopic group than the Essure group. The mean pain score being 5.7 on the analog pain score in the laparoscopic group versus 1.3 in the Essure group. Additionally patients requiring pain medications post-procedure was 75% in laparoscopic group versus 5% in Essure group. 22
• Post-procedural bleeding: At one-week follow-up during the coil catheter study, light vaginal bleeding or spotting was experienced by 56 of the 98 (57%) women for up to one week following the procedure.
• Nausea/ Vomiting: In the same study post-procedure recovery was reported as uneventful by 99 (97%) of the women, and 3 (3%) experienced some nausea and vomiting on the day of the procedure.
• Over absorption of infusion fluid: This is a rare occurrence which is manifested when routine protocol for hysteroscopic procedures is not followed. Intake and output of infusion fluid must be appropriately accounted for and procedure completion is ideally performed within twenty minutes to reduce this risk. If this complication is recognized by patient complaining of shortness of breath or noted by anesthesiologist appropriate action must be taken by administering intravenous diuretics and terminating the procedure.
• Undiagnosed pregnancy at time of device placement: A pregnancy test prior to the Essure procedure or scheduling this procedure in the first half of the menstrual cycle will obviate this complication. On rare occasions if the procedure is performed in the second half of the cycle women can be unknowingly pregnant at the time of the procedure. The effects of micro-inserts on a developing fetus are unknown.
• Pregnancy and ectopic pregnancy: No method of birth control is one hundred percent effective. Essure has been shown in clinical studies to be 99.74% effective at five years. Ectopic pregnancies have not been reported so far in any clinical study, but the clinical possibility exists and therefore the patient must be instructed that if she suspects that she may be pregnant or has delayed menses she must report it to her physician immediately for further investigation.
• Changes in menstrual cycle: In clinical studies there were temporary changes in the menses either heavier or more prolonged or inter-menstrual spotting. However, none of these changes were reported as permanent.
• Pelvic/Back/Abdominal Pain: There were rare episodes of pelvic, back, and abdominal pain following the Essure procedure, but very few women reported persistent pain.
• Anesthesia risk: The risk of general anesthesia or local anesthesia when used during the Essure procedure are similar to that of any procedure and treatment should be customized to particular situations.
• Infection: Infection is rare and may include fever, vaginal discharge or odor. Severe pelvic pain may dictate investigation and intravenous antibiotics.
• Risk of hysterosalpingogram (HSG): Those patients who have known allergies to intravenous contrast dye should avoid the Essure procedure as this is an integral part of the follow-up required by the FDA. Also, there is mild risk of pelvic infection with the use of HSG.
• Risk of future medical procedures: If the patient requires dilatation and curettage, endometrial biopsy it is possible that the portion of the micro-insert that is trailing within the uterine cavity maybe be snagged during these procedures. If a tubal procedure is required, especially electrocautery, the proximal segment of the fallopian tube must be avoided. An invitro fertilization (IVF) procedure may face interference with the trailing portions of the outer coils and therefore impair successful implantation of the fertilized eggs. Only one publication has thus far reported successful IVF resulting in the live birth of healthy twins post-Essure. 23
• MRI and micro-inserts: Micro-inserts have been found to be safe at the standard MRI field strength. No substantial temperature increases were observed, presenting no heat-related risk to tissue. And, the micro-insert did not pose an impediment to diagnostic accuracy. An exception may be if the area of interest to be imaged is in exactly the same position as the insert. 24

IX. Future Strategies

Hysteroscopic sterilization has revolutionized women’s health care delivery. This technique is an office based procedure which can be performed in any standard examination room because it’s non-incisional and non-invasive. In most instances intravenous sedation is not required, and is relatively comfortable for the patient. In this respect, the Essure procedure exemplifies the benefits of hysteroscopic sterilization. There are other companies examining transcervical sterilization techniques which have yet to be FDA approved. Amongst them is the Adiana procedure, manufactured in Australia. 4 The Adiana procedure, like the Essure procedure involves hysteroscopic placement of devices that rely on both mechanical occlusion and stimulation of tissue in-growth to effect tubal occlusion.

The Adiana sterilization method is a combination of controlled thermal damage of the endosalpinx and insertion of a biocompatible matrix within the tubal lumen hysteroscopically. The thermal injury to the endosalpinx is aimed at removing the epithelium. Healing brings fibroblast into direct contact with the matrix which soon becomes colonized with the fibroblast. Then tissue in-growth effects occlusion of the lumen, and simultaneously anchors the matrix in place. The procedure is performed under hysteroscopic control and on an average takes fifteen minutes. It is performed under local anesthesia, with occasional intravenous sedation. The histology of the tube demonstrates the incorporation of tissue in-growth into the matrix at twelve weeks post-procedure.

The device is currently being investigated in an FDA study in the United States, and in Australia, and Mexico. 25 It can delivered to more than ninety percent of the tubes, has a high success rate of pregnancy prevention (over 99% in studies to date), and has a high patient satisfaction rate. 376 women have had the procedure performed, with 353 bilateral placements. 273 women have had a three-month HSG demonstrating tubal occlusion. There have been a total of 2445 women months of device wearing and one pregnancy which occurred in a woman who had both devices placed in the same tube. The Adiana study is expected to be completed in 2006. The Essure procedure is the only FDA approved hysteroscopic sterilization technique currently in the United States.

X.Conclusion

Hysteroscopic sterilization is a technique whose time has come. In this era of minimally invasive female surgery hysteroscopic procedures offer not only a premium experience but also are devoid of serious complications of laparoscopy. The Essure device’s effectiveness as a permanent form of contraception has been established to be equal or superior to the existing standard sterilization technique of laparoscopic tubal ligation. This non-incisional method of permanent contraception is associated with rapid recovery, high patient satisfaction, and effective permanent contraception. Following placement there have been no serious side effects, nor the need for hospitalization. No pregnancies have occurred in a five year follow-up in those with proper bilateral placement of the micro-inserts.

The advantage of the hysteroscopic approach is that it offers a less invasive and taxing procedure that will appeal to all requesting interval tubal sterilization. Patient satisfaction approaches 96% and a great majority of women tolerated this procedure with either intravenous sedation or no sedation at all. 19 Most women are able to walk from the procedure room to the recovery room and can be discharged in forty-five minutes of the procedure. The most powerful predictor of return to normal activity is the total amount of pain experienced. With the Essure procedure the return to normal activity has been reported to be within 24 hours.

As more physicians are trained in this technique and the patient population educated as to the advantages and availability of hysteroscopic sterilization, the request for this modality is bound to exponentially increase. Healthcare expenses are constantly being evaluated in both developed and developing nations. Hysteroscopic sterilization has been shown to be more cost-effective than laparoscopic sterilization. 26 The cost of the Essure device is currently prohibitive for use in developing nations, but is likely to come down in the future so that there may be a world-wide application of this minimally invasive form of female sterilization. This technology most importantly offers a choice to the patient, and a safer alternative to transabdominal sterilization.

References:

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