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10.ACOG - Benefits and Risks
10.ACOG - Benefits and Risks
P RACTICE BULLET IN
clinical management guidelines for obstetrician – gynecologists
Number 133, February 2013 (Replaces Practice Bulletin Number 46, September 2003. Reaffirmed 2015)
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
Compared with abdominal approaches to female 2. DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006
National Hospital Discharge Survey. Natl Health Stat
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less expensive.
3. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory sur-
Laparoscopic tubal occlusion is far more effective gery in the United States, 2006. Natl Health Stat Report
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injections, and barrier methods. vasectomies performed annually in the United States:
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Long-acting methods of contraception, including 2010;184:2068–72. (Level II-3) [PubMed] ^
IUDs and the contraceptive implant, are at least as
effective as tubal occlusion and are associated with 5. Jones J, Mosher W, Daniels K. Current contraceptive
use in the United States, 2006–2010, and changes in pat-
lower morbidity and mortality. terns of use since 1995. Natl Health Stat Rep 2012;(60):
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The following recommendations and conclusions 8. American College of Obstetricians and Gynecologists.
are based on limited or inconsistent scientific evi- Tubal ligation with cesarean delivery. ACOG Committee
dence (Level B): Opinion 205. Washington, DC: ACOG; 1998. (Level III)
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Hysteroscopic occlusion techniques, followed by a 9. Thurman AR, Janecek T. One-year follow-up of women
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The following recommendation is based primarily
13. Guiahi M, Goldman KN, McElhinney MM, Olson
on consensus and expert opinion (Level C): CG. Improving hysterosalpingogram confirmatory test
Women should be counseled about the risk of fail- follow-up after Essure hysteroscopic sterilization. Con-
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and vasectomy). In a well-informed woman, age
and parity should not be a barrier to sterilization. 14. Shavell VI, Abdallah ME, Diamond MP, Kmak DC,
Berman JM. Post-Essure hysterosalpingography compli-
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