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The American College of

Obstetricians and Gynecologists


WOMEN’S HEALTH CARE PHYSICIANS

P RACTICE BULLET IN
clinical management guidelines for obstetrician – gynecologists

Number 133, February 2013 (Replaces Practice Bulletin Number 46, September 2003. Reaffirmed 2015)

Benefits and Risks of Sterilization


Female and male sterilization are both safe and effective methods of permanent contraception used by more than
220 million couples worldwide (1). Approximately 600,000 tubal occlusions and 200,000 vasectomies are performed
in the United States annually (2–4). For women seeking permanent contraception, sterilization obviates the need for
user-dependent contraception throughout their reproductive years and provides an excellent alternative for those
with medical contraindications to reversible methods. The purpose of this document is to review the evidence for the
safety and effectiveness of female sterilization in comparison with male sterilization and other forms of contraception.

Background are affected by individual patient preference, medical


assessment of acute risk, access to services, and insur-
Prevalence of Sterilization Compared ance coverage. The timing of the procedure influences
With Other Contraceptive Methods both the surgical approach and the method of tubal occlu-
sion. In the United States, more than one half of all tubal
According to data from the 2006–2010 National Survey
occlusions are performed in the early postpartum period,
of Family Growth, 38.4 million women aged 15–44 years
with sterilization procedures performed after 8–9% of all
used contraception. Sterilization remained the most com-
hospital deliveries (6).
mon method, used by 47.3% of married couples (tubal
occlusion, 30.2%; vasectomy, 17.1%) (5). In compari- Postpartum. Postpartum sterilization is performed at the
son, 18.6% of married couples used oral contraceptives, time of cesarean delivery or after a vaginal delivery
15.3% used male condoms, 7.1% used intrauterine devices and should not extend the patient’s hospital stay. Mini-
(IUDs), and 3.9% used injectable contraceptives (5). laparotomy after vaginal delivery is generally performed
Rates of female sterilization increased dramatically in the before the onset of significant uterine involution through
1970s, peaking at 702,000 procedures in 1977; remained a small infraumbilical incision. It typically is performed
stable in the 1980s and early 1990s; and decreased slightly with regional or general anesthesia, but may be performed
to 643,000 procedures in 2006 (6). using local anesthesia with sedation. In most cases, epi-
dural anesthesia placed during labor can be left in place
Female Sterilization for the procedure (7).
Postpartum sterilization requires counseling and
Timing informed consent before labor and delivery (8). Ideally,
Female sterilization can be performed at any time before consent should be obtained during prenatal care, when
or after pregnancy. The choice and timing of sterilization the patient can make a considered decision, review the

Committee on Practice Bulletins—Gynecology. This Practice Bulletin was developed by the Committee on Practice Bulletins—Gynecology with the
assistance of Alison Edelman, MD and Elizabeth Micks, MD. The information is designed to aid practitioners in making decisions about appropriate obstet-
ric and gynecologic care. These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be
warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.
risks and benefits of the procedure, and consider alterna- Sterilization Approaches and Techniques
tive contraceptive methods. Various obstacles, including Hysteroscopy. Hysteroscopic tubal occlusion for ster-
young age and concern for patient regret, the consent ilization has high efficacy and low procedure-related
process, lack of available operating rooms and anesthe- risk, cost, and resource requirement. Hysteroscopic tech-
sia, and receiving care in a religiously affiliated hos- niques are not indicated for sterilization after delivery
pital, prevent as many as 50% of women who request or abortion. Hysteroscopic techniques avoid entry into
postpartum sterilization during their prenatal care from the peritoneal cavity and may decrease the risk of injury
undergoing the procedure before discharge after deliv- to abdominal organs. Unlike laparoscopic or minilapa-
ery. Risk of repeat, unintended pregnancy within 1 year rotomy techniques, hysteroscopic sterilization is com-
of delivery, which has been reported to be as high as monly performed as an office procedure, which involves
46.7% for women who requested but did not receive the use of a paracervical block with or without oral seda-
postpartum sterilization, emphasizes the importance of tion or intravenous sedation. Hysteroscopic occlusion
facilitating this requested procedure (9). In order to be
techniques, followed by a confirmatory hysterosalpingog-
an effective advocate for postpartum sterilization, the
raphy (HSG), have at least equal if not superior efficacy to
obstetrician–gynecologist needs to be proactive about
tubal occlusion done by laparoscopy or minilaparotomy.
identifying and overcoming barriers to accomplishing a
Two hysteroscopic methods are currently approved
postpartum procedure (10).
for use by the U.S. Food and Drug Administration.
Health care providers also must be familiar with
Essure, approved in 2002, involves the insertion of a
any laws and regulations that may constrain sterilization,
4-cm long implant with a stainless steel inner coil and
such as limitations on the patient’s age, and time and
nickel titanium outer coil into each fallopian tube by a
procedural requirements for the consent process. Some
disposable delivery catheter; tubal occlusion occurs by
patients have insurance coverage restricted to pregnancy
an inflammatory reaction and tissue growth in response
and the immediate postpartum period; such women
to polyethylene terephthalate fibers. Essure is generally
may have limited access to contraceptive options after
performed with normal saline as the distention medium
delivery. The health care provider should inform the
and is approved for use in women who are at least
patient that insurance coverage for sterilization is vari-
6 weeks postpartum. A second method, Adiana, which
able so that she can discuss this issue with her insurer. In
involved a combination of radiofrequency energy and
cases of intrapartum or postpartum maternal or neonatal
implant placement, is no longer manufactured because
complications, the patient and the health care provider
of financial reasons and is not available for use. There
should consider postponing sterilization to a later date
were no safety or efficacy concerns with Adiana.
(11).
Hysteroscopic procedures require the use of an
Postabortion. Postabortion sterilization can be per- alternative method of contraception for at least 3 months
formed immediately after an uncomplicated spontaneous after the procedure and until a confirmatory HSG
or induced abortion with no increased risk compared indicates successful tubal occlusion. Many of the preg-
with an interval procedure (12). After a first-trimester nancies that occurred after hysteroscopic sterilization
abortion or a second-trimester abortion, tubal occlusion have been attributed to inadequate occlusion, which
by either laparoscopy or minilaparotomy is acceptable. emphasizes the importance of adherence to follow-up
With either approach, a single anesthetic may be used HSG protocols. Depending on the patient population,
for the abortion and the tubal occlusion. As with post- postoperative HSG adherence rates range from as low
partum sterilization, it is important to consider state as 13% up to 71.1%. Patient reminders and a follow-up
regulations. Some states have enacted statutes that limit tracking system have been shown to improve adherence
a woman’s ability to consent for sterilization when seek- (13, 14). When considering a hysteroscopic approach to
ing an abortion. sterilization, it is recommended that patients and their
Interval. Tubal occlusion can be performed as an interval health care providers discuss the need for HSG follow-
procedure separate from pregnancy. A urine pregnancy up and consider whether insurance will provide coverage
test should be done before the procedure; however, this for the imaging procedure. The opportunity to have an
does not rule out a luteal phase pregnancy. Although office procedure with minimal anesthesia and recovery
not a requirement, performing the procedure during the time motivates some patients to elect hysteroscopic ster-
patient’s follicular phase or using an effective method ilization over the more traditional laparoscopic approach
of contraception before the procedure reduces the like- (15).
lihood of a concurrent pregnancy and may facilitate In early clinical trials for Essure, the successful
visualization of tubal ostia for hysteroscopic procedures. bilateral placement rate was approximately 90%. In

2 Practice Bulletin No. 133


subsequent studies of procedures performed with the and a cutting device. These techniques may be more
third-generation delivery catheter, the successful bilat- technically difficult and more likely to cause bleeding
eral placement rate was 96.9% (16). No pregnancies than mechanical tubal occlusion techniques. Advantages
have been reported among the 643 women in clinical of salpingectomy include high-contraceptive efficacy
trials with tubal occlusion confirmed by HSG after bilat- and prevention of future tubal disease, although there is
eral Essure insert placement. Of the women in clinical some concern that salpingectomy may adversely affect
trials with successful placement, 3.5% had tubal patency ovarian function.
confirmed by HSG at 3 months and 0% were patent at Minilaparotomy. In the United States, minilaparotomy
6 months (17, 18). Health care providers should be generally is reserved for postpartum procedures and
aware that there is a specific HSG protocol outlined by rarely considered for patients at high risk of complications
the manufacturer of Essure that optimizes the accuracy associated with laparoscopic procedures. Minilaparotomy
of this follow-up testing. is performed using a 2–3-cm incision placed in rela-
Laparoscopy. The laparoscopic approach is used for tion to the uterine fundus (generally infraumbilically for
interval and postabortal tubal occlusion procedures and postpartum sterilization and suprapubically for interval
is performed as an outpatient procedure. Laparoscopy procedures). Obese patients and those failing laparoscopic
provides an opportunity to inspect the abdominal and procedures may require a larger incision. In contrast with
pelvic organs, requires small incisions, is immediately laparoscopy, minilaparotomy requires only basic surgical
effective, and enables a rapid return to full activity. instruments and is appropriate for low-resource settings
The disadvantage of laparoscopy is the risk of bowel, where specialized surgical equipment is not available.
bladder, or major vessel injury. The procedure can be In randomized trials, there was no difference in major
performed in appropriately selected patients with local morbidity between women who underwent tubal occlu-
anesthetic and intravenous sedation. However, the pro- sion procedures performed by laparoscopy compared with
cedure is typically performed under general anesthesia minilaparotomy (23). When sterilization is performed
in an operating room setting. Use of general anesthesia concurrent with cesarean delivery, any higher associated
slightly increases risk of complications, but increases the morbidity rate compared with sterilization after vaginal
acceptability of the procedure to patients and health care delivery has been attributed to the indications for which
providers. Tubal occlusion can be achieved using elec- the cesarean delivery was performed (24).
trocoagulation, mechanical devices, or tubal excision. The commonly used techniques for tubal ligation
Electrocoagulation. Bipolar electrocoagulation for and excision at the time of minilaparotomy and cesarean
tubal occlusion is used exclusively with laparoscopic delivery include the Pomeroy, modified Pomeroy, and
approaches. At least 3 cm of the isthmic portion of the the Parkland methods. The Uchida and Irving methods
fallopian tube must be completely coagulated (19). Mon- rarely are used in the United States (25). To ensure
opolar electrocoagulation has been associated with ther- complete transection of the tubal lumen, care should be
mal injury to the bowel and is rarely used. taken to excise a sufficient section of the fallopian tube,
Mechanical Devices. Mechanical devices commonly particularly in cases of a previous failed tubal ligation or
used in the United States include the silicone rubber preexisting tubal disease. When an excision method is
band, the spring-loaded clip, and the titanium clip lined used, tubal segments should be submitted to pathology
with silicone rubber. Special applicators are necessary to confirm complete transection.
for each of these mechanical occlusion devices. The
silicone band can be applied only to a fallopian tube Male Sterilization
that is sufficiently mobile to allow it to be drawn into Vasectomy performed as an outpatient procedure with
the applicator. All of these devices are most likely to be local anesthesia has been popular in the United States
effective when used to occlude a normal fallopian tube; since 1965. Based on data from the National Survey
tubal adhesions, thickened tubes, or dilated fallopian of Family Growth, 6.2% of reproductive-aged women
tubes may increase the risk of misapplication and sub- reported relying on vasectomy as a birth control method
sequent failure. Spontaneous clip migration or expulsion (5). Compared with abdominal approaches to female
is rare (20–22). sterilization, vasectomy is safer, more effective, and less
Tubal Excision. Complete or partial salpingectomy may expensive (26). Vasectomy is not immediately effective;
be preferable in the setting of abnormal fallopian tubes an alternative form of contraception must be used until
(such as hydrosalpinx), in which tubal occlusion devices a semen analysis confirms azoospermia. Most men are
may be less effective. Tubal division can be accom- azoospermic at 3 months after vasectomy, and 98–99%
plished using either monopolar energy or bipolar energy are azoospermic at 6 months after vasectomy (27).

Practice Bul­le­tin No. 133 3


Clinical Considerations and laparotomy reported no intraoperative or postoperative
deaths (30).
Recommendations Major complications from laparoscopic tubal liga-
tion are uncommon, vary by study definition, and occur
Who are good candidates for female steriliza- in 0.1–3.5% of laparoscopic procedures (20, 21, 29, 30).
tion? Using a standard definition of intraoperative and post-
Women who have completed their childbearing are can- operative events, overall complication rates for laparo-
didates for sterilization. Preoperative counseling should scopic tubal occlusion are estimated to be 0.9–1.6 per
be comprehensive and include a discussion of surgical 100 procedures; unintended conversion to laparotomy
technique, efficacy, safety, potential complications, and is estimated as 0.9 per 100 cases (29). This complica-
the alternatives to female sterilization. These alterna- tion rate did not vary significantly according to the
tives should include long-acting reversible methods and method of occlusion used. Intraoperative complications
vasectomy. include unplanned major surgery needed because of
Women should have ample opportunity to make a a problem related to the tubal surgery, transfusion, or
considered decision about sterilization, and they should a life-threatening event. Postoperative complications
be informed that factors, such as young age, unstable include unintended major surgery, transfusion, febrile
relationship, and low parity might increase the risk of morbidity, a life-threatening event, or rehospitalization.
regret. Women should understand the permanence of the Use of general anesthesia, previous abdominal or pelvic
procedure and that in the event of regret, reversal pro- surgery, obesity, and diabetes were independent predic-
cedures are likely to be prohibitively expensive and not tors of complication (29).
covered by insurance. Women should be counseled about
the risk of failure, risk of regret, and alternatives (includ- How effective is traditional sterilization com-
ing LARC and vasectomy). In a well-informed woman, pared with reversible contraceptive methods?
age and parity should not be a barrier to sterilization. Laparoscopic tubal occlusion is far more effective
Choice of sterilization type should involve consideration than short-term, user-dependent, reversible contracep-
of the patient’s medical health, her tolerance of office tive methods, such as oral contraceptive pills, injec-
procedures, her ability to adhere to follow-up testing, the tions, and barrier methods. Data from the 2002 National
safety of abdominal surgery and general anesthesia, and Survey of Family Growth indicate that within 1 year of
any health insurance limitations. There are no medical starting any reversible method, 12.4% of typical users
conditions that are strictly incompatible with sterilization, experience a contraceptive failure (31). Based on recent
but the safety of a sterilization surgery must be assessed in analysis by method, contraceptive failure occurs in the
the context of the patient’s medical conditions. The U.S. first year of typical use for 9% of women using oral con-
Medical Eligibility Criteria for Contraceptive Use, from traception, patch, or ring; 18% of women relying on the
the Centers for Disease Control and Prevention, provides male condom; 3% of women using injectable methods;
guidance for many of these circumstances (http://www. and 24% using fertility awareness-based methods (32).
cdc.gov/mmwr/pdf/rr/rr5904.pdf). Failure rates of sterilization are comparable with
those of long-acting reversible contraception methods,
How safe is laparoscopic sterilization? such as IUDs and the etonogestrel implant. The annual
Tubal occlusion via laparoscopy is a safe and effective failure rates for the IUD are 0.8% for the copper T380A
method of permanent contraception. Overall complica- and 0.2% for the levonorgestrel-releasing intrauterine
tion rates are low, and procedure-related death is a rare system. The etonogestrel implant has a 0.05% reported
event. Mortality rates in the United States have been failure rate, the lowest of any contraceptive method (32).
estimated at one to two deaths per 100,000 procedures The U.S. Collaborative Review of Sterilization
(26), with most deaths attributed to hypoventilation and (CREST), a large, prospective, multicenter observa-
cardiopulmonary arrest during administration of gen- tional study of 10,685 women conducted in 1996 by the
eral anesthesia. Results from a U.S. study from 1977 to Centers for Disease Control and Prevention, concluded
1981 indicate that 11 of 29 sterilization-related deaths that although sterilization via laparoscopy or minilapa-
occurred in women with underlying medical conditions rotomy is a highly effective method of contraception,
(28). A more recent study found no mortality among the risk of failure is substantially higher than previ-
9,475 women who underwent interval laparoscopic tubal ously reported (33). Analysis of CREST data found a
ligation (29). A large Swiss study of 27,653 women 5-year cumulative failure rate of 13 per 1,000 for aggre-
undergoing tubal occlusion by laparoscopy or mini- gated sterilization methods (including laparoscopy and

4 Practice Bulletin No. 133


laparotomy) (33), compared with a 5-year cumulative site (1–3%), implant migration, and deep implant inser-
failure rate of 14 per 1,000 procedures for the copper tion that leads to difficult removal (<1%) (42). Both of
T380A IUD (34). The 5-year cumulative pregnancy rate these devices are placed in the outpatient setting with no
for the levonorgestrel-releasing IUD ranged from 5–11 systemic anesthetic, and if placed at the appropriate time
per 1,000 procedures (35–37). The risk of pregnancy should be immediately effective.
persists for years after the sterilization procedure and Although pregnancy after a sterilization procedure
varies by occlusion technique and age of the woman is uncommon, there is substantial risk that any postster-
(Table 1). ilization pregnancy will be ectopic. Analysis of CREST
data found that one third of poststerilization pregnancies
How does the safety of female sterilization (47 out of 143 pregnancies) were ectopic (43). Pregnan-
compare with intrauterine devices and the cies that occur in the setting of hormonal contraceptive
contraceptive implant? or IUD use are also more likely to be ectopic; 20% of
all IUD failures result in an ectopic pregnancy (33, 37).
There are few medical contraindications to the use of There have been several case reports of ectopic preg-
either IUDs or the contraceptive implant (38). Long- nancies that occurred in patients with the contraceptive
acting methods of contraception, including IUDs and the
implant (44, 45). However, overall, patients who have
contraceptive implant, are at least as effective as tubal
undergone sterilization procedures have a lower ectopic
occlusion and are associated with lower morbidity and
risk than noncontraceptive users.
mortality. Among women using IUDs for contracep-
tion, approximately 1% will experience pelvic infection How does hysteroscopic sterilization compare
within the first 20 days (39). Overall, complications
with traditional sterilization methods?
with IUDs are uncommon and mainly include expul-
sion, method failure, and perforation. The expulsion There are no randomized studies that compare hystero-
rate is between 2% and 10% during the first year (40). scopic sterilization to other methods of interval steriliza-
Perforation occurs in 1 per 1,000 insertions or less (41). tion. Data from clinical trials indicate that Essure is a
Complications associated with contraceptive implant highly effective method of sterilization, but long-term
use are rare, but include bruising and pain at the implant data are lacking. Out of the 50,000 women who had

Table 1. Pregnancy Rates by Sterilization Method ^

5-year 10-year Ectopic


(per 1,000 (per 1,000 (per 1,000
Method procedures) procedures) procedures)
Postpartum partial 6.3 7.5 1.5
salpingectomy
Bipolar coagulation* 16.5 24.8 17.1
Silicone band methods 10.0 17.7 7.3
Spring clip 31.7 36.5 8.5
Hysteroscopy (Essure) †
1.64 — —
Vasectomy 11.3 No association
*Secondary analysis of 5-year failure rates with bipolar coagulation performed in different decades found that failure
was significantly lower in later periods, reflecting improved technique with the method: 19.5 per 1,000 procedures for
1978–1982 versus 6.3 per 1,000 procedures for 1985–1987 (Peterson 1999).

U.S. Food and Drug Administration recommended projections based on Bayesian statistical analysis (Baskinski 2010).
Data from Basinski CM. A review of clinical data for currently approved hysteroscopic sterilization procedures. Rev
Obstet Gynecol 2010;3:101–10; Jamieson DJ, Costello C, Trussell J, Hillis SD, Marchbanks PA, Peterson HB. The risk
of pregnancy after vasectomy. US Collaborative Review of Sterilization Working Group [published erratum appears in
Obstet Gynecol 2004;104:200]. Obstet Gynecol 2004;103:848–50; Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR,
Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am
J Obstet Gynecol 1996;174:1161–8; discussion 1168–70; Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J.
The risk of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group. N Engl
J Med 1997;336:762–7; and Peterson HB, Xia Z, Wilcox LS, Tylor LR, Trussell J. Pregnancy after tubal sterilization with
bipolar electrocoagulation. U.S. Collaborative Review of Sterilization Working Group. Obstet Gynecol 1999;94:163–7.

Practice Bul­le­tin No. 133 5


undergone Essure procedures between 1997 and 2005, Can patients with nickel sensitivity use
64 unintended pregnancies were reported to the manu- Essure?
facturer. Most failures were attributed to patients not
adhering to the use of an alternative contraceptive until An Essure insert releases a very small amount of nickel
tubal occlusion had been confirmed by HSG (46). each day, less than one thousandth the amount in the aver-
Complications of hysteroscopic sterilization include age daily food intake. The reported incidence of adverse
tubal perforation, improper coil placement, and expul- events suspected to be related to nickel hypersensitivity
sion of the occlusion devices. In the clinical trials of in patients with Essure microinserts is extremely small
Essure, tubal perforations occurred in 1–3% of women, (0.01%). The incidence of confirmed nickel reactions is
intraperitoneal placement in 0.5–3%, and other improper even smaller. This very low incidence of clinical reac-
placements in 0.5% of the cases. Coil expulsion occurred tions is consistent with data from other nickel-containing
in 0.4–2.2% of subjects (17, 18, 47, 48). In a retrospec- implantable devices and is reassuring (54). In 2011, the
tive analysis of 4,306 office-based Essure placements, nickel sensitivity contraindication was removed from
98.5% of patients had successful coil placement and the Essure procedure instructions. Patients with nickel
the overall complication rate was 2.7%, with vasovagal sensitivity are candidates for Essure and do not require
syncope being the most common. No patients had seri- preprocedure confirmatory skin testing. However, they
ous complications that required more than 2 hours of should be counseled that microinserts do contain minute
observation in the outpatient unit (47). amounts of nickel, which are likely to be of no clinical
One major benefit of hysteroscopic sterilization is significance (55).
that it can be performed as an office procedure using
paracervical block and does not require entry into the Which method of tubal occlusion is most
peritoneal cavity (49). For this reason, major morbidity effective for postpartum sterilization?
associated with general anesthesia and abdominal sur-
gery can be avoided. This is particularly appealing for Data from the CREST study indicate that postpartum
patients with significant coexisting medical disorders, partial salpingectomy is associated with lower failure
obesity, or intra-abdominal adhesive disease. Several rates than interval tubal occlusions done by laparoscopy
studies have suggested lower cost to hysteroscopic ster- (33). This lower failure rate may be because a segment
ilization when compared with laparoscopic sterilization. of tube is removed rather than mechanically occluded
However, if both are performed in the operating room or cauterized, or because a pathologist is able to con-
and HSG costs are included, the cost difference is sig- firm complete tubal cross sections. A recent systematic
nificantly reduced (50). review of studies of the titanium clip lined with sili-
Patients and health care providers should be pre- cone rubber and partial salpingectomy by the modified
pared for the possibility that bilateral coil placement may Pomeroy technique concluded that the titanium clip may
not be possible in every patient. Visualization of tubal have decreased efficacy when used in the immediate
ostia and successful device placement may be optimized postpartum period (56). A randomized control trial that
in the setting of a thin endometrium (follicular phase compared the titanium clip with partial salpingectomy
versus preparation with hormonal agents). A history for postpartum sterilization concluded that the titanium
of sexually transmitted infection has been associated clip is significantly less effective (57).
with decreased success rates of device placement, likely
related to a history of pelvic inflammatory disease (51). Does the technique used for female steriliza-
If health care providers chose to perform hysteroscopic tion affect the risk of ectopic pregnancy?
sterilization in the operating room, it is advisable to have
a contingency plan for establishing contraception in the The risk of ectopic pregnancy varies substantially with
event that device placement is not possible. the method and timing of tubal occlusion. Based on
Concomitant hysteroscopic sterilization and endo- CREST study data, the 10-year cumulative probability of
metrial ablation has been described in the literature (52); ectopic pregnancy after tubal occlusion by any method
however, device labeling explicitly precludes this prac- was 7.3 per 1,000 procedures (43) (Table 1). Ectopic
tice. The formation of intrauterine adhesions subsequent pregnancy was not reported in the clinical trials with
to ablation may limit the ability of HSG to assess tubal hysteroscopic tubal sterilization, but has been described
patency (53). For patients desiring both procedures, a in a case report after tubal occlusion was confirmed by
two-stage procedure should be planned with endometrial HSG (58).
ablation performed after documentation of tubal occlu- For all methods except postpartum partial salpingec-
sion by HSG. tomy, the probability of ectopic pregnancy was greater

6 Practice Bulletin No. 133


for women sterilized before age 30 years than for women Does tubal occlusion cause menstrual
sterilized at age 30 years or older. Postpartum partial sal- abnormalities?
pingectomy was the only method reported by the CREST
Prospective studies that account for confounding factors,
study that did not have a higher 10-year cumulative
such as presterilization use of hormonal contraceptives,
probability of ectopic pregnancy in younger women (43).
have found that tubal occlusion had little or no effect on
For all methods of tubal occlusion, the risk of ectopic
menstrual patterns (74–81). An analysis of CREST data
pregnancy did not diminish with the length of time since
found that women who underwent sterilization were no
the procedure.
more likely than controls to report persistent changes in
their menstrual cycle length or intermenstrual bleeding
How do the safety and efficacy of tubal
(82). However, they were more likely to have beneficial
occlusion compare with vasectomy? changes in their menstrual cycle, including decreases in
Vasectomy is safer than tubal occlusion. It is a less the amount of bleeding, in the number of days of bleed-
invasive surgical procedure, is performed using local ing, and in menstrual pain. The method of tubal occlusion
anesthesia, and is protective against ectopic pregnancy. did not have a significant effect on the findings. There
Although specific data are lacking on major morbidity are conflicting data describing the effect of hysteroscopic
and mortality related to vasectomy, serious complica- sterilization on menstrual patterns (83, 84).
tions are thought to be rare (59– 61).
Vasectomy has a failure rate of 0.15% in the first Are women who undergo tubal occlusion
year, which is lower than the rate reported for most meth- more likely to have a hysterectomy?
ods of female sterilization (31, 60). Neither female nor In an analysis of CREST data, women who had tubal
male sexual function appears to be affected after tubal occlusion were found to be four to five times more likely
occlusion or vasectomy (62, 63). to undergo hysterectomy over a 14-year follow-up period
Vasectomy failure is not associated with an increased than those whose partners underwent vasectomy (85).
risk of ectopic pregnancy. When controlling for preg- Increased risk was independent of patient age and the
nancy rates, tubal occlusion has a higher rate of ectopic method of tubal occlusion used, but was associated with
pregnancy than vasectomy. The incidence of ectopic a presterilization history of menstrual disorders or other
pregnancy is 0.32 per 1,000 women-years in women who benign gynecologic disorders, including endometriosis
had tubal occlusion and 0.005 per 1,000 women-years and uterine leiomyomas. There is no known biologic
in women whose partners had vasectomy (64). By com- mechanism to support a causal relationship between
parison, the estimated absolute incidence of ectopic preg- tubal occlusion and subsequent hysterectomy.
nancy in women using no contraception is 2.6 per 1,000
women-years (64). Does tubal occlusion have noncontraceptive
Vasectomy-related major morbidity and mortal- benefits?
ity are extremely rare in the United States (59). Minor Multiple observational trials have confirmed that laparo-
complications of vasectomy, such as infection at the site scopic tubal occlusion reduces the incidence of ovarian
of incision, bleeding, hematoma formation, granuloma cancer (relative risk, 0.29–0.69) (86–89). This protective
formation, and epididymitis, are reported to occur at rates effect persists after adjusting for age, use of oral con-
of 0.4–10% (65, 66). In comparison with the incisional traceptives, and parity (86). Tubal occlusion maintains
technique, the no-scalpel vasectomy technique has a its protective effect in women at high risk of ovarian
lower incidence of hematoma formation, infection, and cancer due to BRCA1 and BRCA2 mutations (90). Recent
pain and has a shorter operative time (59, 65, 67, 68). evidence suggests that ovarian cancer may originate
Multiple large epidemiologic studies have con- from the fimbrae of the fallopian tube, which leads
cluded there is no causal relationship between vasectomy some health care providers to remove the entire tube for
and both atherosclerosis disease and immunologic dis- sterilization (91–93). Although tubal occlusion does not
ease (60, 62, 69, 70). In addition, there are robust data protect against sexually transmitted infections (includ-
suggesting no association between vasectomy and tes- ing human immunodeficiency virus [HIV]), it has been
ticular cancer or prostate cancer (63, 71–73). The nerves shown to reduce the spread of organisms from the lower
involved in male erectile function and ejaculation are genital tract to the peritoneal cavity and, thus, protect
not affected by vasectomy, and there is no increased risk against pelvic inflammatory disease (94). This protection
of impotence. Chronic testicular pain after vasectomy is incomplete, however, as suggested by rare case reports
may rarely result from obstructive epididymitis or sperm of pelvic inflammatory disease and tubo-ovarian abscess
granuloma. in women who have undergone sterilization (95–97).

Practice Bul­le­tin No. 133 7


What is the risk that a patient will regret
having had sterilization, and how can the Box 1. Components of Presterilization Counseling ^
risk be reduced? • Permanent nature of the procedure, not intended to
be reversible
Most women who choose sterilization do not regret their
• Alternative methods available, particularly long-acting
decision; however, information and counseling about
reversible contraception and vasectomy
this method of contraception should be provided with
the intent to minimize regret among individual women • Details of the procedure, including risks and benefits
(98–101). Although there are certain key indicators for of anesthesia
future regret—such as young age (less than age 30) at • The possibility of failure, including ectopic pregnancy,
the time of sterilization—many indicators of regret are with sterilization and other methods
part of individual social circumstances, which should be • The need to use condoms for protection against
explored with the patient before a decision is made. sexually transmitted infections, including HIV
Prospective analysis of CREST study data found • The need to use an alternative form of contraception
that the cumulative probability of regret over 14 years after hysteroscopic sterilization until hysterosalpingo-
of follow-up was 12.7% (98). However, the probability gram confirms tubal occlusion
was 20.3% for women aged 30 years or younger at the • Completion of informed consent process
time of sterilization, compared with 5.9% for women
• Local regulations regarding interval from time of
older than 30 years at the time of sterilization. A meta-
consent to procedure
analysis of studies of poststerilization regret concluded
that women who underwent sterilization at age 30 years • Effect of sterilization on future health insurance
or younger were twice as likely to express regret as coverage (eg, noncontraceptive uses of hormonal
contraceptives, reversal, or infertility services)
women older than 30 years at the time of sterilization
(101). Women aged 30 years or younger at the time of Data from Pollack AE, Soderstrom RM. Female tubal sterilization.
their procedure were 3.5–18 times more likely to request In: Corson SL, Derman RJ, Tyrer LB, editors. Fertility control. 2nd ed.
London (ON): Goldin Publishers; 1994. p. 293–317.
information about sterilization-reversal and approxi-
mately eight times more likely to undergo reversal or
evaluation for in vitro fertilization. In the CREST study,
the 14-year cumulative probability of requesting reversal However, patients should not be denied sterilization
information was as high as 40.4% in women who under- because of presence of such risk factors, especially
went sterilization between ages 18 years and 24 years— young age. Both the patient and her partner, when appro-
almost four times higher than for women older than 30 priate, should be counseled (see Box 1). The choice to
years at the time of the procedure (98). Similarly, men undergo sterilization is an individual and personal
who underwent vasectomy at young ages were more decision. It is critical that health care providers refrain
likely to have the procedure reversed than those who from inserting their own biases or judgments about the
underwent vasectomy at older ages (38). appropriateness of a patient’s decision to proceed with
Analysis of CREST data also showed a relation- sterilization. Full consideration should be given to all
ship between regret and the timing of the procedure. reversible contraceptive options, particularly the long-
The cumulative probability of regret diminished steadily acting reversible methods. Patients must be informed
with increased interval between delivery and steriliza- that IUDs and the implant are at least as effective as
tion (98). Postabortion sterilization was not associated sterilization.
with increased regret when compared with interval ster-
ilization (98, 102–104).
Other risk factors for increased regret include having Summary of
received less information about the procedure, having Recommendations and
had less access to information or support for use of an
alternative contraceptive method, and having made the Conclusions
decision under pressure from a spouse or because of med- The following recommendations and conclusions
ical indications (105–107). The number of living children are based on good and consistent scientific evi-
is not associated with a request for reversal information.
dence (Level A):
It is important to attempt to reduce the likelihood
of poststerilization regret with thorough and effective Tubal occlusion by laparoscopy is a safe and effec-
counseling that takes into account known risk factors. tive method of permanent contraception.

8 Practice Bulletin No. 133


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83. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibil- 96. Reedy MB, Galan HL, Patterson KM. Acute pelvic
ity, success and patient satisfaction associated with inflammatory disease after tubal sterilization. A report
outpatient hysteroscopic sterilisation. BJOG. 2007 Jun; of three cases. J Reprod Med 1994;39:752–4. (Level III)
114(6):676–83. (Level II-2) [PubMed] [Full Text] ^ [PubMed] ^

12 Practice Bulletin No. 133


97. Cibula D, Widschwendter M, Majek O, Dusek L. Tubal
ligation and the risk of ovarian cancer: review and The MEDLINE database, the Cochrane Library, and the
meta-analysis. Hum Reprod Update 2011;17:55–67. American College of Obstetricians and Gynecologists’
(Meta-analysis) [PubMed] [Full Text] ^ own internal resources and documents were used to con­
98. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. duct a lit­er­a­ture search to lo­cate rel­e­vant ar­ti­cles pub­lished
Poststerilization regret: findings from the United States be­tween January 1990–October 2012. The search was
re­strict­ed to ar­ ti­
cles pub­ lished in the English lan­ guage.
Collaborative Review of Sterilization. Obstet Gynecol
Pri­or­i­ty was given to articles re­port­ing results of orig­i­nal
1999;93:889–95. (Level II-3) [PubMed] [Obstetrics &
re­search, although re­view ar­ti­cles and com­men­tar­ies also
Gynecology] ^
were consulted. Ab­stracts of re­search pre­sent­ed at sym­po­
99. Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson sia and sci­en­tif­ic con­fer­enc­es were not con­sid­ered adequate
HB. Requesting information about and obtaining rever- for in­clu­sion in this doc­u­ment. Guide­lines pub­lished by
sal after tubal sterilization: findings from the U.S. or­ga­ni­za­tions or in­sti­tu­tions such as the Na­tion­al In­sti­tutes
Collaborative Review of Sterilization. Fertil Steril 2000; of Health and the Amer­i­can Col­lege of Ob­ste­tri­cians and
74:892–8. (Level II-3) [PubMed] [Full Text] ^ Gy­ne­col­o­gists were re­viewed, and ad­di­tion­al studies were
100. Jamieson DJ, Kaufman SC, Costello C, Hillis SD, located by re­view­ing bib­liographies of identified articles.
Marchbanks PA, Peterson HB. A comparison of women’s When re­li­able research was not available, expert opinions
regret after vasectomy versus tubal sterilization. US from ob­ste­tri­cian–gynecologists were used.
Collaborative Review of Sterilization Working Group. Studies were reviewed and evaluated for qual­i­ty ac­cord­ing
Obstet Gynecol 2002;99:1073–9. (Level II-3) [PubMed] to the method outlined by the U.S. Pre­ven­tive Services
[Obstetrics & Gynecology] ^ Task Force:
101. Curtis KM, Mohllajee AP, Peterson HB. Regret following I Evidence obtained from at least one prop­ er­
ly
female sterilization at a young age: a systematic review. de­signed randomized controlled trial.
Contraception 2006;73:205–10. (Level III) [PubMed] II-1 Evidence obtained from well-designed con­ trolled
[Full Text] ^ tri­als without randomization.
II-2 Evidence obtained from well-designed co­ hort or
102. Cheng MC, Cheong J, Ratnam SS, Belsey MA, Edstrom
case–control analytic studies, pref­er­a­bly from more
KE, Pinol A, et al. Psychosocial sequelae of abortion
than one center or research group.
and sterilization: a controlled study of 200 women ran-
II-3 Evidence obtained from multiple time series with or
domly allocated to either a concurrent or interval abor-
with­out the intervention. Dra­mat­ic re­sults in un­con­
tion and sterilization. Asia Oceania J Obstet Gynaecol
trolled ex­per­i­ments also could be regarded as this
1986;12:193–200. (Level I) [PubMed] ^
type of ev­i­dence.
103. Wilcox LS, Chu SY, Peterson HB. Characteristics of III Opinions of respected authorities, based on clin­i­cal
women who considered or obtained tubal reanastomosis: ex­pe­ri­ence, descriptive stud­ies, or re­ports of ex­pert
results from a prospective study of tubal sterilization. committees.
Obstet Gynecol 1990;75:661–5. (Level II-3) [PubMed] Based on the highest level of evidence found in the data,
[Obstetrics & Gynecology] ^ recommendations are provided and grad­ed ac­cord­ing to the
104. Wilcox LS, Chu SY, Eaker ED, Zeger SL, Peterson HB. following categories:
Risk factors for regret after tubal sterilization: 5 Level A—Recommendations are based on good and con­
years of follow-up in a prospective study. Fertil Steril sis­tent sci­en­tif­ic evidence.
1991;55:927–33. (Level II-3) [PubMed] ^
Level B—Recommendations are based on limited or in­con­
105. Hardy E, Bahamondes L, Osis MJ, Costa RG, Faundes A. sis­tent scientific evidence.
Risk factors for tubal sterilization regret, detectable
Level C—Recommendations are based primarily on con­
before surgery. Contraception 1996;54:159–62. (Level I)
sen­sus and expert opinion.
[PubMed] [Full Text] ^
106. Boring CC, Rochat RW, Becerra J. Sterilization regret
among Puerto Rican women. Fertil Steril 1988;49: Copyright February 2013 by the American College of Ob­ste­t-
973–81. (Level II-3) [PubMed] ^ ri­cians and Gynecologists. All rights reserved. No part of this
107. Neuhaus W, Bolte A. Prognostic factors for preoperative publication may be reproduced, stored in a re­triev­al sys­tem,
consultation of women desiring sterilization: findings of posted on the Internet, or transmitted, in any form or by any
a retrospective analysis. J Psychosom Obstet Gynaecol means, elec­tron­ic, me­chan­i­cal, photocopying, recording, or
1995;16:45–50. (Level III) [PubMed] ^ oth­er­wise, without prior written permission from the publisher.
Requests for authorization to make photocopies should be
directed to Copyright Clearance Center, 222 Rosewood Drive,
Danvers, MA 01923, (978) 750-8400.
ISSN 1099-3630
The American College of Obstetricians and Gynecologists
409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920
Benefits and risks of sterilization. Practice Bulletin No. 133. Ameri-
can College of Obstetricians and Gynecologists. Obstet Gynecol 2013;
121:392–404.

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