Table 4.1 Permanent Contraception Use in Select Regions/Countries
vasectomy first gained popularity internationally. India introduced vasectomy as a means of population control in 1952, and massive vasectomy camps were established that often used coercive techniques.15 In the United States, vasectomy for family planning became more common in the 1960s after legal restrictions were removed on voluntary permanent contraception. Early vasectomy was performed through the inguinal canal and later moved to the scrotum. The no-scalpel vasectomy technique was developed in 1973 in China.16
women from 1978 to 1987 and followed them at periodic intervals until 1994.20 The CREST study compared bipolar coagulation, unipolar coagulation, silicone rubber band (Falope ring), spring clip (Hulka), interval partial salpingectomy via laparotomy, and postpartum partial salpingectomy. There were no deaths among 9,475 women who underwent laparoscopic permanent contraception in this study.19
1. Occlusion by bipolar electrocoagulation
2. Occlusion by mechanical means (titanium clips or silicone rubber rings)
3. Removal of a portion of the fallopian tube (partial salpingectomy)
4. Removal of the entire fallopian tube (salpingectomy)
focusing on procedures that ensured full fallopian tube desiccation by using electrocoagulation at three or more sites (3 cm total) indicated a comparable 5-year pregnancy rate of 3.2 pregnancies per 1,000 women.27 The use of an ammeter will assist the surgeon in confirming complete desiccation.
to the isthmic portion of the tube, 1 to 2 cm from the cornua of the uterus. Care must be taken to ensure the clip completely occludes the entire tube by visualizing the tip of the applicator through the mesosalpinx. The rubber lining of the clip expands on compression to keep the tube blocked. Only 4 mm of the tube is destroyed. Clips are left permanently in place. Failure rates 1 year after the procedure approximate 1 per 1,000 women. A 15-year follow-up study in Quebec reported a cumulative failure rate of 9 per 1,000 women, whereas the 10-year failure rate in the United Kingdom was 5.6 per 1,000 women.31,32 While the Filshie clip is also marketed for postpartum application at the time of cesarean delivery or via minilaparotomy after vaginal delivery, concerns have been raised over efficacy in this circumstance. The postpartum fallopian tubes are often hypertrophied and edematous, making correct clip application more difficult. One multicenter randomized controlled trial of 1,400 women compared the Filshie clip to partial salpingectomy.29 At 2 years, the cumulative probability of pregnancy was 0.017 with the clip (9 pregnancies) and 0.004 with partial salpingectomy (2 pregnancies) (p = 0.04).
hysteroscopic operations, expensive equipment. Simpler approaches could make permanent contraception available and acceptable to more women and avoid surgery. During the 1970s and 1980s, a number of investigators developed approaches for transcervical delivery of agents to occlude the fallopian tubes.40 While some involved the use of hysteroscopes to place occlusive devices, many techniques used sclerosing agents. Zipper developed the technique of quinacrine sterilization in which quinacrine pellets are placed to the fundus using a modified IUD inserter.41 The pellets caused epithelial damage resulting in occlusive collagen replacement to the intramural portion of the fallopian tube.42 Unfortunately, questions regarding potential toxicity of the approach emerged after the initiation of widespread human use in many developing nations.43,44 Since the human use occurred in the absence of regulatory approval in the United States or Europe, these allegations led to a loss of confidence in the approach and withdrawal of support by governments and funding agencies. Although subsequently completed epidemiologic studies support the safety of quinacrine sterilization,45,46 serious concerns regarding implementation of the program and a significantly higher (two to four times greater than surgical tubal ligation at 10 years) failure rate present significant obstacles to further research and development of the method.47,48 The FDA placed a planned U.S. phase three clinical trial program on hold in the United States in 2006, and the sponsor withdrew support effectively ending the program.
incisions or abdominal entry and the option to perform in the office setting under local anesthesia only.53 These features make the procedure potentially beneficial for individuals at high risk for complications with abdominal surgery or general anesthesia. Two disadvantages of the previously marketed methods were the lack of immediate effectiveness and the requirement for a delayed confirmation test. These multiple steps and delay expose patients to potential pregnancy.
into the uterine cavity should ideally be 3 to 8, however, between 0 and 17 is acceptable. Adequate uterine distention and a thin endometrium (follicular phase or preparation with hormonal agents) are essential to be able to visualize the tubal ostia. Over several months, the polyethylene terephthalate fibers stimulate an inflammatory response that results in replacement of the tubal lumen with a fibrotic scar. Unlike laparoscopic tubal occlusion and salpingectomy procedures, this method does not provide immediate contraception. Women must use a back-up method of contraception until a confirmation of tubal occlusion by a HSG or transvaginal ultrasound after 3 months. If occlusion is not present at 3 months, contraception is continued and HSG is repeated 3 months later (6 months postprocedure). Contraindications include less than 6 weeks from abortion or delivery, active or recent pelvic infection, uterine or tubal pathology blocking access to tubal ostia, suspected unicornuate uterus, and known allergy to contrast media preventing ability to undergo HSG.
Figure 4.4 Essure Procedure. UTJ, uterotubal junction; SUTJ, serosa of uterotubal junction. (Reprinted from Essure Permanent Birth Control product information, 2018 U.S. label, with permission from Bayer Healthcare, Whippany, NJ.)
stents. Similarly, although a randomized clinical trial was not required, Essure developers did complete open-label safety and efficacy studies for the device. Once available, the uptake of Essure after approval was rapid, and the manufacturer estimates that more than 750,000 units were sold worldwide.67,77,78,79 For example, in New York State, the use of Essure increased from 0.6% of all permanent contraception procedures in 2005 to 25.9% in 2013.80
room visit or prenatal labs, likely underestimating overall risk of pregnancy, there is less reason to support differential bias for this outcome.
adhesions. Most (97%) women who had successful hysteroscopic procedures returned for confirmatory testing, of whom 91% had tubal occlusion documented and could rely on Essure for contraception. In all, 902/1,085 (83.1%) of successfully performed hysteroscopic procedures with confirmatory testing were considered satisfactory, compared to 2,400/2,412 (99.5%) of laparoscopic procedures (OR 40.6, 95% CI 22.5-73.1). Women in the hysteroscopic group had six times greater odds of reoperation by 1 year postoperatively (2% vs. 0.3%, OR 6.2, 95% CI 2.8-14.0). Reoperations included removal of incorrectly placed devices, second-stage hysteroscopic procedures to achieve bilateral coil placement, and laparoscopic permanent contraception. The one-year pregnancy risk was similar, with three reported pregnancies after hysteroscopic permanent contraception and five after laparoscopic permanent contraception (OR 1.3, 95% CI 0.3-5.6). Possible limitations to external generalizability include the study population’s access to universal health care, which likely facilitates radiographic confirmation testing, and lack of information on race, ethnicity, and comorbidities. Furthermore, it is unclear if pregnancy rates after hysteroscopic procedures were only measured for successful procedures, and not by intention to treat.
hysteroscopic group had a higher risk of tubal disorder or surgery including salpingectomy (0.70% vs. 0.23%, adjusted HR 2.98, 95% CI 2.17-4.10). In contrast, women in the hysteroscopic group had a lower risk of uterine disorders (1.28% vs. 1.50%, adjusted HR 0.85, 95% CI 0.74-0.98), abnormal vaginal bleeding (0.23% vs. 0.33%, adjusted HR 0.71, 95% CI 0.52-0.96), and hysterectomy (0.43% vs. 0.81%, adjusted HR 0.54, 95% CI 0.44-0.66) compared to the laparoscopic group. At 3 years, pregnancy rates did not differ between the hysteroscopic group and the laparoscopic group (0.48% vs. 0.57%, adjusted HR 1.04, 95% CI 0.83-1.30). A composite outcome of sterilization failure (including salpingectomy, second sterilization procedure, and pregnancy) was significantly higher at 1 year in the hysteroscopic group compared to laparoscopic group (4.83% vs. 0.69%, adjusted HR 7.11, 95% CI 5.92-8.54). This difference persisted through 3 years (5.75% vs. 1.29%, adjusted HR 4.66, 95% CI 4.06-5.34). For medical complications, there was no difference between the two groups in autoimmune disease and thyroid disorders. Hysteroscopic procedures were associated with lower use of analgesics, antidepressants, benzodiazepines, outpatient visits, and sick days at 3 years compared to laparoscopic procedures. There was no real difference in the risk of suicide attempt or death in the two groups at 3 years. At 1 year,
risk of allergies was slightly higher in the subgroup of women with previous allergies in those that underwent hysteroscopic versus laparoscopic permanent contraception (43.2% vs. 40.0%, adjusted HR 1.10, 95% CI 1.03-1.17), but this small difference does not seem clinically important.
Table 4.2 Outcomes Evaluated After Hysteroscopic, Laparoscopic, and Open Permanent Contraception Procedures in Finland Between 2009 and 2014