Contraceptive Technology Reports: Sterilization in the Office: The Concept Now is a Reality

Author: Susan A. Ballagh, MD, FACOG, Assistant Professor of Obstetrics and Gynecology, CONRAD/Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk.

Peer Reviewer: David J. Levine, MD, Director, Women’s Diagnostic Center, St. Luke’s Hospital, Chesterfield, MO.

Introduction

Editor’s note: This article discusses a use of quinacrine that has not been approved by the Food and Drug Administration.

Despite an increasing number of birth control methods, surgical sterilization is the most common form of birth control for women 15-44 years of age in the United States. Eleven million women rely on sterilization for contraception, and an estimated 500,000 men are sterilized annually in the United States.1 Sterilization is used much more commonly in the United States than in Europe, in part because U.S. medical insurance has covered all or part of the sterilization procedure but has not covered reversible contraception until recently. The 1965 National Fertility Study showed approximately equal numbers of men and women receiving sterilization procedures.2 Today, more than twice as many women as men are sterilized annually.2 The convenience of an office procedure has been afforded only to men, until the recent approval of the first office procedure for female sterilization.

The zenith of tubal sterilization for women was in 1977 when more than 700,000 women underwent the procedure. The peak coincided with exaggerated concern about the safety of long-term oral contraceptive use during the 1970s.3 Today about half of the 600,000 tubal sterilizations performed annually are done at cesarean section or immediately postpartum.3 The vast majority of the remaining procedures are interval tubal sterilizations performed with a laparoscope under general anesthesia in an outpatient setting. More women depend on sterilization as their contraceptive method as they get older: 5% of 20- to 24-year-olds compared to nearly half of 40- to 44-year-olds count on female sterilization.3 Women of color choose sterilization more often: 25% of African-American, 21% of Latin-American, and 16% of Caucasian women use tubal ligation as their birth control method.3

Reversible methods with efficacy equivalent to sterilization, such as intrauterine contraception, are rarely chosen in the United States. Fear generated by the flawed Dalkon Shield, manufactured in the 1970s by AH Robins in Richmond, VA, has generalized to all intrauterine devices. Large initial investment cost coupled with spotty insurance reimbursement has impeded acceptance of these devices.4 Contraceptive implants provide similar pregnancy prevention, but are no longer marketed in the United States. Injections have similar efficacy when used properly, but the discontinuation rate is high because women must physically come to an appointment to continue the method. Women and many physicians are unaware that these reversible methods are just as effective as sterilization. While somewhat less convenient, the reversible methods clearly are preferred in situations in which women are likely to regret their sterilization decision, which include women younger than 30 years of age, women sterilized within one year of the birth of their last child, and women who are unmarried at the time of the sterilization.5

History of Transcervical Sterilization

Sterilization by minilaparotomy has been practiced since the early 1900s. Techniques for sterilization also were done by colpotomy. With the advent of fiberoptic technology, endoscopic methods to apply cautery, clips, or bands to the tubes for occlusion in an outpatient setting were developed. Both the vaginal and abdominal routes were employed to provide tubal blockage, but some form of anesthesia was required, and infections were problematic. A means to perform female sterilization in the office proved elusive. Several transcervical approaches to sterilization were explored in the 1970s — chemical agents and physical barriers — but none has reached general use until now.

Chemical Methods of Transcervical Tubal Blockage

The most studied transcervical sclerosing agent is quinacrine, a drug first used more than 70 years ago to prevent and cure malaria. An intrauterine device (IUD) inserter was modified to introduce quinacrine pellets into the uterine fundus to chemically block the fallopian tubes and prevent pregnancy. The Food and Drug Administration (FDA) has not approved this procedure. Two rodent carcinogenicity studies have been requested and are in progress. The pellets are estimated to cost less than $20 and would provide an inexpensive approach to tubal sterilization.

Safety. Quinacrine has a long history of human use. More than 3 million American soldiers took quinacrine orally while serving in the South Pacific to prevent malaria with no serious long-term side effects.6 No evidence of carcinogenesis was noted among nearly 1,500 women sterilized by Jaime Zipper, MD, in Chile. He followed these women over 13,000 person-years and observed 25 cancer cases, which is equivalent to the expected rate of 22.7 In a Vietnamese trial of nearly 32,000 women, no deaths were reported. Only one woman required hysterectomy for infection/hemorrhage that followed the third pellet insertion. Two women were dilated to relieve hematometra due to cervical stenosis.8 Accidental perforation of the uterus depositing quinacrine intraperitoneally resulted in marked abdominal pain, but it did not cause bowel obstruction or require surgery.9 Overall, quinacrine pellets have been placed into the uterus in more than 100,000 women, with no deaths attributed to the procedure.10

Mechanism of Action. Hysterectomy evaluation one month following quinacrine insertion demonstrated that nine of 17 available tubes had obliteration of the lumen or absence of the epithelium. The other eight tubes showed mild inflammation. No intrauterine adhesions were detected. The one case of intraperitoneal adhesion between the fundus and the omentum was assessed as unrelated to the pellets by the investigator.11

Efficacy. The efficacy of the pellets was improved by Indian investigators who coupled the insertion of 242 mg of quinacrine (seven pellets) with a 50-mg intrauterine dose of diclofenac and an injection of 150 mg of depo-medroxy-progesterone acetate. A repeat insertion of quinacrine and diclofenac was performed one month later. One hundred and thirty-four women were followed for a minimum of one year and a mean of 3.5 years.12 No pregnancies were reported. Zipper, by contrast, reported 3.1 failures per 100 women at one year with three pellet insertions.13 The deposition of the pellets high in the fundus results in superior pregnancy prevention as reported by Biaragi and co-workers.14 For all ages, an interim analysis of the five-year experience in Vietnamese women showed an overall success rate with two insertions of 87%. Only 6.8% of the women older than age 35 conceived while relying on the pellets during the five-year follow-up.10

Family Health International in Research Triangle Park, NC, is studying the use of macrolide antibiotics such as erythromycin for nonsurgical female sterilization. Tetracycline is another antibiotic that has been studied. Other chemical methods previously attempted for tubal blockade include papavarine, phenol-mucilage, and methylcyano-acrylate.15 The latter is a tissue adhesive that hardens through polymerization when hydrated. An initial occlusive plug is formed that degrades over several weeks and releases a sclerosing molecule as a by-product. The product was introduced with an intrauterine balloon device to force a measured dose of product into the tubes. Following two instillations, less than or equal to 90% bilateral tubal occlusion was noted, so the method was abandoned. An iodine-releasing polymer is being investigated as a possible alternative. Another compound that has been tested in rabbits is ethylene vinyl alcohol copolymer.16

Physical Methods of Transcervical Tubal Blockage

The concept of providing sterilization through the cervix has captivated researchers since fiberoptic technology allowed visualization of the tubal ostia. A great deal of research in the 1970s resulted in several devices designed to be placed into the tube. Others attempted sterilization by destroying tubes with heat, laser,17 cautery, or cryosurgery with variable success.15

Steptoe18 reported on a silicon rod inserted into the oviduct in 14 women. Other hysteroscopically applied plugs included the P block plug19 that swelled with hydration to occlude the tube, the Hamou tubal plug — a plastic thread anchored in the interstitial portion of the tube.15 The drawbacks of the plug systems included the tendency for the plug to migrate or fracture20 and limited success in placing the devices.

Ovabloc. Another method injected liquid silicone hysteroscopically into the tubal ostia. Once hydrated, the material cured quickly forming a cast of the fallopian tube.21 Reed reported that 1,400 (78%) of 1,800 procedures were considered to be successful. Uterine perforation occurred five times, and 11 patients had spontaneous separation or expulsion of the plugs at 3-24 months.22 Of the 438 women sterilized at his center, 309 (71%) had proper plugs form bilaterally by follow-up X-ray. Ninety-one women were sterilized a second time, and 45 (50%) had bilateral X-ray occlusion after the second attempt. Three of the initial 309 women became pregnant during 8,600 months of follow-up,22 equivalent to 0.4 pregnancies per 100 woman-years of use. The pregnancies were intrauterine and occurred between five and 22 months after placement. In another report, six pregnancies were noted in 275 women, for a pregnancy rate of 2.3 per 100 woman-years.23 Designed to be reversible, no pregnancies were reported followed removal or spontaneous expulsion. Any hope for the product was dashed when Dow Corning Corp. discontinued production of medical-grade Silastic in the late 1980s.

New FDA-Approved Device: Essure

A new approach to transcervical sterilization blocks the tube by encouraging local tissue in growth with polyester (PET) fibers. To anchor the polyester in place, an attached outer super-coiled spring is released that molds to the shape of the interstitial (uterine) portion of the tube. The FDA approved this device called Essure in November 2002 for tubal sterilization. It is made of an alloy outer coil, a stainless steel inner coil, and the PET fiber core. The expandable coils provide stability, while the polyester encourages tissue in growth resulting in occlusion. The plug induced in the tube is made of the woman’s own tissue reaction. (See Figure 1.) The device costs about $950. It is designed for interval sterilization and is not to be used at cesarean section or immediately postpartum.

Procedure. The Essure device is designed for office-based application with a special inserter that comes prepackaged with the system. Hysteroscopy using normal saline is best performed during the follicular phase closely following menses. This reduces the chance of inadvertent luteal pregnancy and provides the best environment for device placement. Thickened endometrium seen in the luteal phase may obscure the tubal ostia. The device is designed to pass through a hysteroscope operating channel with a minimum inner diameter of 5 French. Olympus, Stortz, and Wolfe manufacture scopes with inflow and outflow capability of approximately less than or equal to 5.5 mm outer diameter that have been used for this purpose. A 30-degree device improves the lateral view of the tubal ostia. Insertion of these two devices may require more than one operation. It requires a physician trained to insert Essure.

Nonsteroidal premedication is strongly recommended not only for patient comfort, but to reduce the chance of tubal spasm. A paracervical block, other local anesthesia, or oral or injected narcotic may be used as adjuncts. In the Pivotal Trial (described further in this article), 41% of women used intravenous sedation, and 7% did not use any anesthesia except the required paracervical block. In our office and several others, no IV sedation was available. Some women do better watching the procedure on a monitor to distract them from pain and reduce their trepidation. Dim lighting and music via headphones is soothing for others. All the women in our clinic could correctly identify the side being occluded during the procedure.

Once prepped for diagnostic office hysteroscopy, the scope often can be advanced into the cavity with minimal cervical dilation under direct guidance. It is recommended to visualize both ostia and then guide the first micro-insert into the least accessible ostium. An assistant opens the device, preloaded into its inserter, using sterile technique and assists in introducing the apparatus into the operating channel. The device is passed into the tube under direct visualization of the ostium up to a black marker. The outer delivery catheter is then withdrawn, while taking care to maintain the position of the coil itself. Minor adjustments of the position of the coil still can be made in most cases until the device is released. Pressing a button on the handle of the inserter releases the coil and allows it to expand. The guidewire is gently twisted off the device and then removed. The catheter system is similar to that used for cardiovascular stent placement.

Essure is operated with one hand so that the surgeon can stabilize the hysteroscope with the other. A 6-10 mm portion of the coil should be visible in the uterine cavity after the device is placed. The guidewire and outer delivery catheter are removed from the operating channel, and the second device is loaded into the hysteroscope. Then the other ostium is located, and the placement procedure is repeated on the contralateral side to complete the sterilization.

Mechanism of Action. To demonstrate the occlusive tissue reaction, 49 women had the device placed several weeks to several months prior to hysterectomy.24 At the subsequent hysterectomy, the fallopian tube and uterus were removed in one block. Pathology showed a fibrotic and inflammatory response localized to the region of the tube containing the device. The tissue reaction was confined to the mucosa and muscularis layers. The tubal serosa appeared normal. Fallopian tube architecture began to normalize just 5 mm from the end of the device. Occlusion appeared complete.25

Pivotal Trial. The clinical trial for device registration was conducted in Australia, Europe, and the United States.26 Six hundred and fifty women met initial inclusion and exclusion criteria for the study and provided informed consent. Women were not considered if they had unexplained pelvic pain, fibroids, or other known uterine or tubal abnormalities. Ninety-two later voluntarily withdrew from the study, 24 failed screening primarily due to an abnormal pap smear or irregular menses, and five became pregnant. Eleven women older than 33 years of age had been consented but did not get the procedure because enrollment closed for their age group.

A total of 518 women underwent hysteroscopy, and 507 (98%) of them had visible tubal ostia. Of these women, 446 had successful bilateral device placement during the first procedure. Eighteen additional women had successful completion of the procedure at a second attempt. Two women were found to have a unicornuate uterus, and 10 had unilateral placement only. Overall, 466 women (92%) had proper device placement. Four women had a perforation, and in three women, the device lay in an unsatisfactory location. No complication required major surgery. The only hospitalization that followed the procedure was due to a reaction to pain medication. By protocol, women were to use another form of birth control until a hysterosalpingogram confirmed tubal blockage at three months. During that time, 14 women (3.0%) experienced an expulsion of one or both devices. Procedures with more than 16 mm of coil extending into the uterine cavity had a higher rate of expulsion. Nine of these women had Essure reinserted successfully. In the Pivotal Trial, 92% of women returned to work in one day; most resumed normal activities the same day as the procedure.

Efficacy. 453 women (89% of the initial intention to treat population) relied on Essure for contraception for one year after documentation at three months (428) or later (25) that the device prevented dye spillage into the abdominal cavity. No pregnancies were noted during the first year of follow-up. At two years, the effectiveness rate quoted by the company is 99.8%.27 This rate is at least as good for the first two years as other interval sterilization methods. Five-year data will be required to properly compare results to data on other sterilization methods from the U.S. Collaborative Review of Sterilization (CREST).28 In a manner similar to vasectomy, the required hysterosalpingogram at three months provides a functional test of tubal occlusion that verifies the success of the procedure. Compared to other tubal sterilization techniques, the hysterosalpingogram at three months and the necessity of using an alternative contraceptive until the hysterosalpingogram results are completed add to the cost and complexity of the Essure technique. Compared to vasectomy procedures for men, the functional test to determine the success of the Essure procedure is more complex and more expensive.

There were four luteal phase pregnancies noted during the trial, despite negative urine pregnancy tests on the day of the procedure. These pregnancies were terminated surgically (2), medically (1), and spontaneously without device disruption.

Comfort. The protocol limited the time for hysteroscopy to 30 minutes. The average operating time was 13 minutes, with a median of 10 minutes. The total procedure time was 36 minutes, with a median time of 32 minutes. Most surgeons reduced their time of procedure significantly after the first five procedures. Additional decrease in operating time was noted with more experience but was not statistically significant. Eighty-four percent of women received some nonsteroidal medication before the procedure. Fifty-two percent received local anesthesia, while 41% received intravenous sedation or narcotic analgesia. Only 0.2% of subjects had general anesthesia, and 7% chose to forego analgesia altogether. Three-quarters of the women reported the average pain of the procedure to be mild or none. Only 1% said that the average pain was severe. More than 95% of women at the end of the first week and more than 99% of women at the end of one year said that they felt good, very good, or excellent. More than 95% would recommend it to a friend.

Adverse Events. Of the 518 women with hysteroscopy, three had a vasovagal reaction, three had vomiting after the procedure, two had hypervolemia, two had a portion of the device detach due to improper surgical technique, and one had excessive vaginal bleeding. Four perforations were noted: In two, women had a proximally occluded tube, and in two, the ostia were poorly identified. There were six minor complications. In the week following the procedure, 94% of women had bleeding or spotting that lasted less than four days for most women. More than 70% of employed women missed less than one additional day of work following the procedure. Virtually all women (> 95%) were back to work within three days. No major change in menstrual function was detected. Some increased spotting, infrequently requiring sanitary protection, was reported by trial participants, especially just prior to or just preceding the menses. This spotting lessened with time. During the first year of contraceptive use, other side effects possibly related to the product included back pain (9%), abdominal pain (3.8%), and dyspareunia (3.6%). All other events were noted in fewer than 3% of women. Only 448 of 518 women (86.5%) had successful device placement for sterilization at the time of the first procedure. This is a major disadvantage of transcervical sterilization via the Essure technique.

Warnings.29 Unlike tubal interruption procedures where tubal segments may be reconnected with significant success, tissue in growth in the interstitial portion of the tube has not been shown to be surgically reversible. Given the high rates of regret following tubal sterilization in published studies, it would be wise to inform women considering having the Essure procedure done that reversal is more expensive and less successful than reversal of current tubal sterilization techniques.

Procedures to reverse this type of sterilization will require tubal reimplantation into the uterus with a much lower success rate and a risk of uterine rupture during a subsequent pregnancy. While tubal ligation always should be performed with the intention that it be permanent, this procedure is ill advised for women with a high probability of regretting their decision in the future. The inserts can conduct energy to surrounding tissue, so energy application should be avoided near the inserts during procedures that use radio frequency energy such as endometrial ablation or surgical cautery.

The Essure device can provide permanent sterilization in the physician’s office. Some physicians may feel more comfortable performing the procedure initially with IV sedation readily available, but a number of centers perform the Essure procedure in the office. It is highly effective without incision or general anesthesia. Women recover quickly. Similar to vasectomy, the procedure should not be used for contraception until a functional test, in this case the hysterosalpingogram (recommended at three months), demonstrates successful blockage of the tubes.

Adiana Procedure. Another device in development would use a two-step process. A catheter passed through a hysteroscope into the intramural portion of the fallopian tube would deliver low-level bipolar energy to remove surface epithelium. Following cautery, a permanent porous implant would be placed at the site of the lesion to encourage tissue in growth similar to the Essure process described above. It has been tested in early (Phase I) clinical trials and appears to be safe with little discomfort associated with it.10

Intratubal Ligation Device. A catheter in development would be inserted into the tube using hysteroscopic guidance or possibly blind placement. A balloon coated with adhesive would inflate to 4-5 mm and make contact with the mucosa. Once firmly attached, the balloon would deflate and retract, which allows a band to be placed around the folded knuckle of tube. The band would provide immediate occlusion, but it likely would lead to necrosis and scar formation providing permanent blockage. The device is being tested in animal tissue and excised human oviducts.

Reversible Tubal Occlusion Device. The device to be introduced through the hysteroscope would be made of a nickel-titanium to cause minimal tissue injury. The device would have a unique structure that would allow mechanical or electrical reversible closure of the fallopian tube.

Summary

After several decades of development, a new transcervical sterilization office procedure is available to women in the United States. Essure micro-inserts provide office sterilization that is safe, effective, and well tolerated without incisions or general anesthesia. Sclerosing agents and other devices are discussed briefly and suggest that additional options may become available within the next decade to give women other office-based choices for female sterilization.

References

1. Haws JM, Morgan GT, Pollack AE, et al. Clinical aspects of vasectomies performed in the United States in 1995. Urology 1998; 52:685-691.

2. Chandra A. Surgical sterilization in the United States: Prevalence and characteristics, 1965-95. Vital Health Stat 1998; 23:1-33.

3. Westoff C, Davis A. Tubal sterilization: Focus on the U.S. experience. Fertil Steril 2000; 73:913.

4. Speroff L, Darney P. A Clinical Guide for Contraception; Baltimore: Lippincott, Williams & Wilkins Publishers; 2001.

5. Hillis SD, Marchbanks PA, Tylor LR, et al. Poststerilization regret: Findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999; 93:889.

6. Lippes J. Quinacrine sterilization: The imperative need for American clinical trials. Fertil Steril 2002; 77:1,106-1,109.

7. Sokal DC, Debancens A, Guzman-Serani R, et al. Cancer risk among women sterilized with transcervical quinacrine in Chile: An update through 1996. Fertil Steril 2000; 74:169-171.

8. Hieu DT, Tan TT, Tan DN, et al. 31,781 cases of non-surgical female sterilization with quinacrine pellets in Vietnam. Lancet 1993; 342:213-217.

9. El-Kady AA, Nagib HS, Kessel E. Efficacy and safety of repeated transcervical quinacrine pellet insertions for female sterilization. Fertil Steril 1993; 59:301-304.

10. Clinical Update on Transcervical Sterilization. ARHP Clinical Proceedings. May 2002, p. 11.

11. Laufe LE, Sokal DC, Cole LP, et al. Phase I Prehysterectomy Studies of the Transcervical Administration of Quinacrine Pellets. Contraception 1996; 54:181-186.

12. Sarin AR. Quinacrine sterilization: experience among women at highest risk for surgery. Adv Contracept 1999; 15:175-178.

13. Zipper JA, Stachetti E, Medel M. Human fertility control by transvaginal application of quinacrine on the fallopian tube. Fertil Steril 1976; 21:581-589.

14. Biaragi NR, Mullick BC, Kessel E, Mumford SD. Comparison of the efficacy of intrauterine diclofenac and ibuprofen pellets as adjuvants to quinacrine nonsurgical female sterilization. Adv Contracept 1995; 11:303-308.

15. Transcervical sterilization methods. Progress in Reproductive Health Research 1995; 36:4-5. Web: http://www.who.int/reproductive-health/hrp/progress/36/news36_1.en.html

16. Abdala N, Levitin A, Dawson A, et al., Use of ethylene vinyl alcohol copolymer for tubal sterilization by selective catheterization in rabbits. J Vasc Interv Radiol 2001; 12:979-84.

17. Kukreja LM. In vitro occlusion of human fallopian tubes with Nd:YAG laser. Natl Med J India 1998; 11:122-124.

18. Steptoe PC. Advances in laparoscopic sterilization techniques. S Afr Med J 1975; 49:2,019-2,021.

19. Brundin J, Sandstedt B. Long-term toxicity of a hydrogelic occlusive device in the isthmus of the human oviduct. A light microscopic study. Acta Pathol Microbiol Immunol Scand [A] 1985; 93:121-126.

20. Houck RM, Cooper JM, Rigberg HS. Hysteroscopic tubal occlusion with formed-in-place silicone plugs: A clinical review. Obstet Gynecol 1983; 62:587-591.

21. Erb RA, Reed TP: Hysteroscopic ovaductal blocking with formed-in-place silicone rubber plugs: I. Method and apparatus. J Reprod Med 1979; 23:65.

22. Reed TP III. Ovabloc. Five Years of Experience. J Reprod Med 1984; 29:601-602.

23. Reed TP, Erb R. Hysteroscopic tubal occlusion with silicone rubber. Obstet Gynecol 1983; 61:388-392.

24. Valle RF, Carignan CS, Wright TC, et al. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril 2001; 76:974.

25. Clinical Update on Transcervical Sterilization. ARHP Clinical Proceedings. May 2002, p. 9.

26. Clinical Update on Transcervical Sterilization. ARHP Clinical Proceedings. May 2002, p. 10.

27. Reference from www.essure.com. Accessed December 2002.

28. Pati S, Cullins V. Female sterilization. Evidence. Obstet Gynecol Clin North Am 2000; 27:859-899.

29. Package insert. Essure, Conceptus, 1021 Howard Ave., San Carlos, CA 94070.


CME Objectives/Questions

After reading this issue, the CME participant will be able to:

  • list the contraceptive method used by more couples in the United States than any other;
  • identify the method(s) of contraception with efficacy equivalent to tubal ligation;
  • identify women most likely to regret their decision to have permanent sterilization;
  • identify the key advantages of transcervical sterilization;
  • list the drawbacks of the Essure transcervical sterilization method.

Effective with this issue, Contraceptive Technology Reports is changing its testing procedure. You will no longer need to return a Scantron answer sheet to earn credit for the activity. Please review the text, answer the following questions, check your answers against the key on the following page, and then review the materials again regarding any questions answered incorrectly. To receive credit for this activity, you must return the enclosed CME evaluation in the enclosed envelope.

This testing procedure has proven to be an effective learning tool for adults. If you have any questions about the new testing method, please contact Customer Service at (800) 688-2421.

1. What method birth control used by more women in the United States than any other?

A. oral contraceptives

B. male sterilization

C. female sterilization

D. male or female condoms

E. injectable or implantable hormonal methods


2. The method(s) of contraception with efficacy equivalent to tubal ligation include(s):

A. intrauterine contraceptives, Lunelle monthly injections, and vasectomy.

B. intrauterine contraceptives and vasectomy.

C. Lunelle monthly injections and transdermal contraception.

D. transdermal contraception or the vaginal ring.


3. Women most likely to regret their decision to have permanent sterilization:

A. are younger than 30 years of age, have been pregnant within the past year, and unmarried.

B. are younger than 30 years of age and unmarried.

C. have been pregnant within the past year and have two or fewer children.

D. have two or fewer children and are unmarried.


4. The key advantage(s) of transcervical sterilization include:

A. use of local anesthesia, no incision, and office procedure.

B. use of local anesthesia, and office procedure.

C. no incision and easily reversible.

D. easily reversible and office procedure.


5. The drawback(s) of the Essure transcervical sterilization method include:

A. little time required off from work, difficulty removing the micro-inserts once placed, and slow reversal of the contraceptive effect.

B. little time required off from work and slow reversal of the contraceptive effect.

C. Difficulty removing the micro-inserts once placed and ability to conduct cautery or radio frequency energy.

D. Ability to conduct cautery or radio frequency energy (only).