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Guideline Summary
Guideline Title
Benefits and risks of sterilization.
Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Benefits and risks of sterilization. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003 Sep. 12 p. (ACOG practice bulletin; no. 46).  [104 references]
Guideline Status

This is the current release of the guideline.

The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of the guideline in 2008.

Jump ToGuideline ClassificationRelated Content

Scope

Disease/Condition(s)

Unintended pregnancy

Guideline Category
Assessment of Therapeutic Effectiveness
Counseling
Evaluation
Prevention
Clinical Specialty
Family Practice
Internal Medicine
Obstetrics and Gynecology
Surgery
Urology
Intended Users
Physicians
Guideline Objective(s)
  • To aid practitioners in making decisions about appropriate obstetric and gynecologic care
  • To review the evidence for the safety and effectiveness of sterilization in comparison with other forms of contraception
  • To review the evidence of the likelihood that a woman will regret having had a sterilization procedure
Target Population

Women and men of reproductive capability

Interventions and Practices Considered
  1. Timing of tubal sterilization procedure (postpartum, post-abortion, or other)
  2. Patient and partner presterilization counseling
  3. Surgical/occlusive methods of tubal sterilization
    • Laparoscopy
    • Minilaparotomy
    • Transcervical approaches (e.g., Essure device)
    • Transvaginal approaches (e.g., fimbriectomy or Pomeroy methods)
    • Electrocoagulation
    • Mechanical occlusion (e.g., Falope ring, Hulka-Clemens clip, Filshie clip)
    • Ligation
    • Chemical sclerosing agents (not currently approved in the United States)
  4. Vasectomy
Major Outcomes Considered
  • Minor and major complications of sterilizations procedures, including mortality
  • Failure rate
  • Ovarian cancer incidence
  • Rate of subsequent hysterectomy
  • Rate of subsequent regret

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The MEDLINE database, the Cochrane Library, and the American College of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and January 2003. The search was restricted to articles published in the English language. Priority was given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles.

2008 Reaffirmation

For reaffirmation of a current Practice Bulletin, MEDLINE and Cochrane are searched for new literature. At the discretion of the review committee, additional databases may be searched for particular topics as warranted. In addition, committee members identify relevant literature for review.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force:

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence obtained from well-designed controlled trials without randomization.

II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.

II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician–gynecologists were used. See also the "Rating Scheme for the Strength of Recommendations" field regarding Grade C recommendations

2008 Reaffirmation

Each American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin is reviewed every 18-24 months by a member of the Practice Bulletins Committee. The reviewer presents the practice bulletin and any new literature at a full committee hearing. The committee then reaches a consensus on whether to reaffirm or withdraw the practice bulletin.

Rating Scheme for the Strength of the Recommendations

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

Level A — Recommendations are based on good and consistent scientific evidence.

Level B — Recommendations are based on limited or inconsistent scientific evidence.

Level C — Recommendations are based primarily on consensus and expert opinion.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.

Recommendations

Major Recommendations

The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of the "Major Recommendations" field

The following recommendations are based on good and consistent scientific evidence (Level A):

  • Tubal sterilization may be recommended as a safe and effective method for women who desire permanent contraception. Women should be counseled that tubal ligation is not intended to be reversible; therefore, those who do not want permanent contraception should be counseled to consider other methods of contraception.
  • Patients should be advised that neither tubal sterilization nor vasectomy provides any protection against sexually transmitted diseases, including human immunodeficiency virus (HIV) infection.
  • Patients should be advised that the morbidity and mortality of tubal ligation, although low, is higher than that of vasectomy, and the efficacy rates of the 2 procedures are similar.
  • Patients should be counseled that tubal sterilization is more effective than short-term, user-dependent reversible methods.
  • Patients should be counseled that failure rates of tubal sterilization are comparable with those of intrauterine devices (IUDs).

The following recommendations are based primarily on consensus and expert opinion (Level C):

  • If a patient has a positive pregnancy test result after a tubal ligation, ectopic pregnancy should be ruled out.
  • Indications for hysterectomy in women with previous tubal sterilization should be the same as for women who have not had tubal sterilization.

Definitions:

Grades of Evidence

I: Evidence obtained from at least one properly designed randomized controlled trial.

II-1: Evidence obtained from well-designed controlled trials without randomization.

II-2: Evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group.

II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Levels of Recommendations

Level A — Recommendations are based on good and consistent scientific evidence.

Level B — Recommendations are based on limited or inconsistent scientific evidence.

Level C — Recommendations are based primarily on consensus and expert opinion.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Safe and effective use of sterilization procedures for women and men

Potential Harms

Women

  • Dilation and curettage concurrent with all interval sterilizations as a routine practice is not recommended on the basis of effectiveness, cost, and morbidity.
  • Death from tubal sterilization is a rare event, and overall complication rates are low. (See the original guideline document for a detailed discussion of complication rates and risk factors.)
  • The disadvantages of laparoscopy include the risk of bowel, bladder, or major vessel injury after insertion of the needle or trocar. The use of general anesthesia also increases risk.
  • One major disadvantage to the transvaginal approach is the need for adequate vaginal surgical training to minimize potential complications, such as cellulitis, pelvic abscess, hemorrhage, proctotomy, or cystotomy.
  • Unipolar electrocoagulation is associated with thermal bowel injury.
  • Mechanical devices are most likely to be effective when used to occlude a normal fallopian tube; tubal adhesions or thickened or dilated fallopian tubes increase the risk of misapplication and subsequent failure. Spontaneous clip migration or expulsion is rare.
  • For all methods of sterilization except postpartum partial salpingectomy, women younger than 30 years were more likely to experience ectopic pregnancy than women older than 30 years
  • Post-sterilization regret

Men

  • Minor complications of vasectomy include infection at the site of incision, bleeding and hematoma formation, granuloma formation, and epididymitis. Vasectomy-related major morbidity and mortality are extremely rare in the United States.
  • "Postvasectomy pain syndrome," or chronic testicular pain, has been described in the literature and is poorly understood.

Contraindications

Contraindications

Contraindications to the transvaginal approach include suspicion of major pelvic adhesions, enlarged uterus, and inability to place the patient in the lithotomy position.

Qualifying Statements

Qualifying Statements

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.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Foreign Language Translations
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Benefits and risks of sterilization. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003 Sep. 12 p. (ACOG practice bulletin; no. 46).  [104 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2003 Sep (reaffirmed 2008)
Guideline Developer(s)
American College of Obstetricians and Gynecologists - Medical Specialty Society
Source(s) of Funding

American College of Obstetricians and Gynecologists (ACOG)

Guideline Committee

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Gynecology

Composition of Group That Authored the Guideline

Not stated

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of the guideline in 2008.

Guideline Availability

Electronic copies: None available

Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

The following is available:

Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on August 3, 2007. The information was verified by the guideline developer on September 10, 2007. The information was reaffirmed by the guideline developer in 2008 and updated by ECRI Institute on February 9, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

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