Hysteroscopic Female Sterilization with Microinsert (Essure)

Jay M. Berman, MD, FACOG
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Subject: Hysteroscopic Female Sterilization with Microinsert (Essure)

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Introduction

Female sterilization is one of the most common methods of birth control used in the United States, accounting for approximately 22% of users. Until recently, female sterilization was a hospital or surgery center procedure, either performed postpartum at the time of delivery or shortly after or as an interval procedure performed more than 6 weeks after a delivery. 
In November 2002, the U.S. Food and Drug Administration approved the sale of the first hysteroscopic sterilization method available in the United States. This device is called the Essure microinsert. The device is constructed from Nitinol (nickel titanium), stainless steel, platinum, and PET (polyethylene terephthalate) fibers. The wound-down insert is 4 cm long and 0.8 mm in diameter. When released from the delivery system, the outer coil expands to 1.5 to 2.0 mm in diameter to anchor the microinsert in the fallopian tube. 
The approval of this device has been heralded as the start of a new age in female sterilization. The Essure procedure is safe, simple, and effective and can be performed in the hospital, ambulatory surgery center, or office setting. Patients can frequently choose their location and type of anesthetic. Local, local and sedation, and general anesthesia are all options for anesthesia during Essure microinsert placement. The vast majority of patients will return to normal activities in 0 to 2 days. 
Recently, the manufacturer of the Essure microinsert released a third-generation device with a simplified delivery and deployment system. The new device is identified by its purple handle and has an even faster time of insertion. Average operating time for an experienced user is about 4 minutes. Several other devices are undergoing trials, but as of this writing, none have been approved for use in the United States. 
The majority of patients who desire permanent sterilization are between 30 and 45 years. This age group also has a large group of women with menorrhagia. It is tempting to offer simultaneous endometrial ablation for these women. However, the package labeling is clear that simultaneous endometrial ablation with the balloon device is not indicated. Anecdotally, this author has collected more than 70 cases of simultaneous hysteroscopic sterilization and endometrial ablation with freely circulating hot water (HTA, Boston Scientific) with no significant complications. The key issue for the package labeling is the ability to obtain a satisfactory hysterosalpingogram (HSG) at 3 months. In addition, payment from insurance carriers for procedures done on the same day is usually less than satisfactory. 
Prior to scheduling a hysteroscopic sterilization procedure with Essure microinserts, all patients need contraceptive counseling, especially because 49% of pregnancies in the United States are unintended (U.S. Centers for Disease Control data). Visualization of the endometrial cavity is facilitated by timing procedures in the early luteal phase. Treatment with oral contraceptives or medroxyprogesterone (Depo-Provera) also improves visualization. This has the added benefit of providing the needed contraception until the HSG is completed at 3 months. 
One of the most significant benefits of this technique is its high efficacy of 99.74% at 5 years. It provides this high efficacy with no incision and without general anesthesia in an outpatient setting. It is safe for patients who are poor candidates for laparoscopic surgery or hormonal contraceptives. It also requires less time lost from work and family. 
Prior to the date of the procedure, informed consent should be obtained from the patient. Also in some states, a separate state-mandated form must be signed >30 and <180 days before the procedure. The need for contraception until the confirmatory HSG at 3 months should be reviewed and emphasized. 

Equipment

  • Urine pregnancy test.

  • Premedication with a nonsteroidal anti-inflammatory drug (NSAID) of the provider’s choice (suppositories, oral medicine, or intramuscular injection).

  • Atropine (0.5 to 1.0 mg) can be given intravenously, subcutaneously, or intramuscularly. Initial single doses in adults vary from around 0.5 to 1 mg for bradycardia associated with vagal reaction.

  • Standard gynecological equipment tray including tenaculum and dilators.

  • Stirrups.

  • Weighted speculum, Graves speculum, or Graves speculum with open side.

  • Single-tooth tenaculum (two).

  • Gimpelson tenaculum for patulous cervix or endoloop for patulous cervix.

  • Sterile gauze, 2 × 2 inches or 4 × 4 inches.

  • Betadine.

  • Operating hysteroscope sheath with 5-French or larger channel.

  • 30-degree hysteroscope lens (12-degree or 0-degree will not work with lateral tubes).

  • Tubing and drapes for hysteroscope system being used.

  • Normal saline, 1- or 3-L bags warmed to reduce tubal spasm.

  • Sterile gloves.

  • Local anesthetic for paracervical block (bupivacaine or lidocaine).

  • Control-top syringe and 22-g spinal needle.

  • Essure systems, two minimum. Additional units should be available in case of malfunction or inadvertent contamination.

  • Patient ID card supplied with Essure package.

Indications

  • Patient who desires to end fertility permanently (must be older than 21 in most states)

  • Younger than 45 years of age, although this is a personal choice of patient and physician

  • Inability to tolerate general anesthesia

  • Medical conditions that make pregnancy and/or general anesthetics dangerous

  • Previous abdominal surgeries that increase the risk of complications

  • Willing to use another form of birth control for 3 months and undergo an HSG to confirm placement and tubal occlusion

Contraindications

  • Unsure about desire to end fertility

  • Patients in whom only one microinsert can be placed

  • Patients with previous tubal ligation

  • Patients with unicornuate uterus

  • Known or suspected pregnancy

  • Pregnancy less than 6 weeks prior to placement

  • Active or recent pelvic infection

  • Known allergy to contrast media

  • Known allergy to nickel confirmed by skin test

  • Inability to follow-up or refusal to have confirmatory HSG

  • Immunosuppressive therapy with systemic corticosteroids, chemotherapy, or other agents such as tumor necrosis factor (TNF) blockers (relative contraindication, as the therapy is expected to negatively affect tissue response)

The Procedure

Step 1

On the day of the procedure, patients are instructed to refrain from food and drink from midnight until the time of surgery. If taking any other medications, they should take them as usual with a sip of water, except for anticoagulants. Depending on the venue and anesthetic, patients should be given an oral NSAID or a parenteral NSAID 30 to 45 minutes prior to the procedure. Patients are placed in the dorsal lithotomy position or stirrups, and the vagina is prepped with povidone-iodine solution (if not allergic). An electric examination table is helpful but not required in the office setting. 
  • PEARL: Anticoagulated patients should be managed with the patient’s primary provider, depending on the anticoagulant and the underlying medical disorder.

  • PEARL: Routine catheterization of the bladder is not required but may be necessary if there has been a long wait or the patient has received excessive intravenous fluids.

Step 2

A weighted or bivalve speculum is inserted, and the cervix is visualized. The anterior lip of the cervix is grasped with a single-tooth tenaculum, and the paracervical block is placed (see Paracervical Block Anesthesia). If no resistance to injection is met, the needle may be intraperitoneal, and the block will not be effective. If very strong resistance is felt, the needle is too deep in the cervix, again resulting in decreased effectiveness. 
  • PITFALL: The key to successful local anesthetic is placing it properly and waiting for it to work prior to stimulating the surgical site. Begin assembling the other equipment only after placing the anesthetic. It takes about 3 minutes to assemble the hysteroscope and prepare for the next portion of the procedure, just about the time needed for local anesthetic to be effective.

Step 3

The hysteroscope used for this procedure should have 30-degree lenses and a 5-French operating channel. The 30-degree lenses facilitate placement of microinserts in laterally located tubes. The outside diameter of the sheath is approximately 5.5 mm (16.5 French). Normal saline solution is the distending medium of choice because of its safety and low cost. A 1-L bag should be adequate in most circumstances. Three-liter bags are just as cost–effective, and if the cervix is patulous, more fluid may be needed. Once the anesthetic has taken effect, the hysteroscope is inserted into the cervical os, and the fluid is started. Most of the women undergoing this procedure do not require dilatation. It is important to visualize the endocervical canal and endometrial cavity while advancing the hysteroscope to decrease the chance of perforation. 
  • PITFALL: Cold solution increases pain and tubal spasm. This can be greatly reduced by heating the solution to body temperature. Care must be taken not to make the solution hot enough to cause a burn.

  • PITFALL: The uterine sound is not necessary and indeed increases the risk of perforation. It is not possible to continue this procedure if perforation is diagnosed.

Step 4

As the hysteroscope is advanced, the endocervical canal and endometrial cavity should be thoroughly examined. Both tubal ostia should be identified and note taken of any abnormalities, including polyps, fibroids, and the thickness of the endometrium, because these abnormalities can interfere with proper placement of the microinserts. It may be possible to remove polyps and then complete the procedure. Fibroids will not generally be amenable to treatment on the spot but may require separate procedures. Any areas where hyperplasia or cancer is suspected should be biopsied, and the Essure should be delayed until a diagnosis is made. After the endometrial cavity is visualized and both tubal ostia seen, the micro-insert package can be opened. Insert the DryFlow introducer into the 5-French working channel. 
  • PITFALL: It is important not to open the Essure microinsert package until the endometrial cavity is visualized and both tubal ostia confirmed. If both tubal ostia cannot be seen or the endometrium is too thick, then the procedure should be cancelled and possibly rescheduled.

  • PITFALL: Note which device is being used. The following steps are for the new ESS305 system with the purple handle, not for the previous version with the white handle.

  • PEARL: The valve in the introducer prevents fluid from splashing back. The fluid no longer needs to be turned off during catheter insertion.

Step 5

Insert the Essure catheter carefully into the introducer. 
  • PITFALL: Note that the tip of the Essure is curved. Do not attempt to straighten the tip, because the curve is important for guiding it into the tubal ostia. The dominant hand should manipulate the catheter and the nondominant hand should hold the hysteroscope.

Step 6

Move the hysteroscope close to the tubal ostia. Advance the delivery catheter into the tube until the black positioning marker is at the ostium. Catheter guidance may require rotating the hysteroscope for a better view of the ostium. The catheter should be manipulated close to the introducer to avoid bending it. It is helpful to have an assistant hold the handle while the operator advances the catheter. 
  • PEARL: Consider starting with the right tubal ostia. This makes it easier to keep track of which side was done first and to find the opposite side.

  • PITFALL: If the catheter flexes while advancing, moving the hysteroscope closer to the ostium will make the catheter act stiffer.

  • PEARL: To place the catheter in lateral tubes, it is necessary to turn 30 degrees away from the ostium; that is, turn the lightpost toward the ostium, not away from it. This is counterintuitive to most hysteroscopists, but it is necessary for successful placement.

Step 7

At this point, it is extremely important that the operator hold the hysteroscope and handle in the same (usually nondominant) hand. The dominant hand should then carry out the maneuvers to deploy the microinsert. Most of the difficulties seen in teaching this procedure come from not adhering to this rule. 

Step 8

Once the operator is happy with the position, the thumb wheel is rolled back. The black positioning marker moves toward the operator until the thumb wheel reaches a hard stop. 

Step 9

At this point, the gold band and green release catheter should be visible with the gold band just outside the ostium. 

Step 10

Depress the button on the purple handle to initiate deployment. The microinsert will not yet deploy, allowing final positioning. 
Step 10
Step 10

Step 11

Roll the thumb wheel back again to a hard stop; this expands and detaches the microinsert. The thumb wheel should be rolled backward at about one click per second; this allows full control of the procedure. This detaches the release catheter from the insert. This procedure for the ESS305 is greatly simplified from the previous version. 
Step 11
Step 11

Step 12

There should be two to four coils visible at the ostium marking optimal placement. Up to 15 coils can be visible for acceptable placement. If more than 15 coils are visible, the microinsert should be removed with a hysteroscopic grasper and another one inserted. Document the placement and the number of proximal coils in the cavity. Withdraw the catheter, and repeat with second catheter for contralateral ostium. When completed, remove all of the instruments, note condition of tenaculum site, and perform a sponge count. Office patients can lie down or sit in a lounge chair for approximately 20 minutes until ready for discharge. Surgery center or hospital patients should be discharged as per their normal protocols. 
Step 12
Step 12

Complications

  • Transient cramping

  • Pain

  • Nausea and vomiting

  • Bleeding or spotting

  • Tubal perforation

  • Expulsion or migration of microinsert

  • Uterine perforation

A perforation is diagnosed in several ways. Most commonly, there is loss of visualization, and increasing flow or pressure does not improve the situation. Rarely, the peritoneal cavity or ovaries are visualized. If either of these is noted, the procedure should be terminated immediately and the patient observed closely. It would be rare to require surgery for these situations because no energy source has been applied to the peritoneal cavity. A repeat procedure can be scheduled in month. 

Pediatric Considerations

In general, the Essure microinsert is not applicable to the pediatric population. There are a small number of individuals who might benefit from this procedure because of developmental abnormalities that carry a risk of pregnancy. The need for sterilization in this group should only be after careful consultation with parents and pediatric specialists. 

Postprocedure Instructions

Prior to discharge, review with the patient the need for additional contraception until the HSG is performed and confirms bilateral placement and occlusion. After the procedure, patients can resume normal activities as soon as they wish, and intercourse can resume as soon as the spotting stops, usually 7 to 10 days. Patients should be seen for a postoperative visit in 1 to 2 weeks. At that time, a referral slip or appointment should be made for the HSG, and the instructions should be repeated. Because most primary providers do not perform HSG, the provider should make arrangements with a radiology group to provide this service. The HSG for Essure confirmation has different requirements than those done for infertility. A complete description is available at http://www.essuremd.com. It is in the best interests of the provider to make this document available to the radiologist who will be providing this service. 
Inform the patient that the Essure microinserts have been tested and found to be safe to use in magnetic resonance imaging/magnetic resonance angiography (MRI/MRA) units. 

Coding Information and Supply Sources

ICD-9 Codes

Hysterosalpingogram Testing (Use Both in This Order)

Suppliers

The procedure kit, consisting of two introducers and two devices, is available only from Conceptus, Mountain View, CA. Web site: http://www.conceptus.com
Office hysteroscopy equipment is available from Olympus, Karl Storz, Richard Wolf, ACMI, or any number of small manufacturers. 

Bibliography

Chandra A. Surgical sterilization in the United States: prevalence and characteristics, 1965–95. Vital Health Stat .  1998;23(20).
Chern B, Siow A. Initial Asian experience in hysteroscopic sterilization using the Essure permanent birth control device. BJOG .  2005;112:1322–1327. [View Abstract]
Connor V. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fert Steril.  2006;85:1791–1793. [View Abstract]
Cooper J, Carignan C, Cher D, et al. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol .  2003;102:59–67. [View Abstract]
Essure. Prescribing and procedural information. http://www.Essuremd.com. Accessed October 2007.
Kerin J, Carignan C, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure PBC clinical study. Aust NZ J Obstet Gynaecol .  2001;41:364–370. [View Abstract]
Kerin J, Cooper J, Price T, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicenter phase II study. Hum Reprod .  2003;18:1223–1230. [View Abstract]
Kerin J, Munday D, Ritossa M, et al. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc.  2004;11:388–1193. [View Abstract]
Thiel J, Suchet I, Lortie K. Confirmation of Essure micro-insert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound. Fertil Steril .  2005;84:504–508. [View Abstract]
Valle R, Carignan C, Wright T, et al. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril.  2001;76:974–980. [View Abstract]
2008 MAG Mutual Healthcare Solutions, Inc.’s Physicians’ Fee and Coding Guide. Duluth, Georgia. MAG Mutual Healthcare Solutions, Inc. 2007.
 
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