Sterilization: Is your practice up to date?
With the growing popularity of a new approach to sterilization in the form of the Essure device (Conceptus, San Carlos, CA), family planning providers need to update their counseling information in presenting the option to women considering permanent contraception.
Three presentations at the recent annual meeting of the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG) focused on use of the device in current practice.1-3 Understanding how Essure fits into the contraceptive picture is important for providers and patients, says Amy Pollack, MD, MPH, president of EngenderHealth in New York City.
According to Pollack, the Essure device represents a "completely new paradigm" since it is the first new sterilization method of its kind.
"It is the first time since 1970 that we are introducing a completely different method," says Pollack, who presented at the ACOG meeting. "We have introduced methods of occlusion, from Hulka, bipolar, unipolar, the ring, and then the Filshie clip; we are now looking at something completely different, so we have to step back and reevaluate."
Know the population
Eleven million U.S. women ages 15-44 years of age now rely on tubal sterilization for contraception.4 Of the estimated 750,000 tubal sterilization procedures performed each year in the United States, half are performed postpartum and half as ambulatory interval procedures.4 The average age of sterilization in the United States is about 30, says Pollack.1
Women now are having their first child later in life: the mean age of women bearing their first child in the United States now is about age 27, and about 20% of women are having their first child at the age of 35 or older, says Pollack.1
Much data have been collected on various forms of sterilization through the United States Collaborative Review of Sterilization (CREST), which analyzed the experiences of 11,232 women ages 18-44 who had tubal sterilizations between 1978 and 1987.5 CREST data show that while most women express no regret after tubal sterilization, women 30 years of age and younger at the time of sterilization have an increased probability of expressing regret.6 In another analysis of CREST data, women who were sterilized at a young age had a high chance of later requesting information about reversal, regardless of their number of living children.7
A recent analysis of Quebec women shows that sterilization reversal and pregnancy after sterilization are not rare.8 Relatively high rates of reversal among the youngest age groups suggest a need for better counseling about alternative contraceptive strategies, researchers conclude.8
Providers need to understand that the Essure method is "completely irreversible," states Pollack. Unlike tubal interruption procedures where tubal segments may be reconnected with a measure of success, tissue in growth in the interstitial portion of the tube has not been shown to be surgically reversible.9 Research indicates that use of mechanical devices such as the Hulka clip and the Filshie clip offer minimal degree of tubal destruction, increasing the chance for reversibility.10
The design of the Essure device may make it difficult for women to undergo in vitro fertilization (IVF) if they should wish to reverse the sterilization process, says Pollack. With more women considering Essure as an option, providers should keep this fact in mind when discussing the method, she adds.
While providers should continue to counsel women that sterilization should be considered a permanent procedure, they should look at the ages of their patient population, understand that the risk of regret and the desire for reversal is real, and decide whether the addition of Essure is appropriate to their practice, says Pollack.
Who is a candidate?
Women who are not candidates for tubal sterilizations, such as obese women or women with severe medical disease, are eligible for using the Essure device for permanent contraception, says John Nichols, MD, reproductive endocrinologist and director of the Piedmont Reproductive Endocrinology Group in Greer, SC. Women who have large fibroids or polyps in the uterus may not be good candidates because a hysteroscopy is needed to visualize the tubes, he points out.
Since there is no incision required, the procedure is less invasive that tubal sterilization, and general anesthesia is not needed, says Nichols, who presented at the ACOG conference as part of the Washington, DC-based Association of Reproductive Health Professionals’ set of special family planning presentations. Women have less discomfort and are able to return to work within one to two days, he notes.
Efficacy with the Essure device is good, Nichols notes. As of 2001, women had accumulated more than 4,800 and 5,200 months wearing the device in the phase II and pivotal trials, respectively; no pregnancies have been reported in either group.11
Nichols, who served as an investigator in the clinical trial of the device, sees the procedure as one that can be scheduled in the office, much as a vasectomy is handled for men. Training for Essure placement includes a one-day didactic training session, training on an Essure simulator, three to five proctored cases, and five cases assisted by Conceptus product specialists.11 (See the resource listing below for information on Essure and transcervical sterilization.)
"It’s quick, it’s simple, and patients do very well," states Nichols.
1. Pollack AE. An overview of female sterilization: The relativity of opportunity and risk. Presented at the 52nd annual meeting of the American College of Obstetricians and Gynecologists. Philadelphia; May 2004.
2. Nichols J. New developments in contraception: Permanent options for women. Presented at the 52nd annual meeting of the American College of Obstetricians and Gynecologists. Philadelphia; May 2004.
3. Valle RF. Permanent transcervical tubal sterilization. Presented at the 52nd annual meeting of the American College of Obstetricians and Gynecologists. Philadelphia; May 2004.
4. Westhoff C, Davis A. Tubal sterilization: Focus on the U.S. experience. Fertil Steril 2000; 73:913-922.
5. Peterson HB, Xia Z, Hughes JM, et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996; 174:1,161-1,168; discussion 1,168-1,170.
6. Hillis SD, Marchbanks PA, Tylor LR, et al. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999; 93:889-895.
7. Schmidt JE, Hillis SD, Marchbanks PA, et al. Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Fertil Steril 2000; 74:892-898.
8. Trussell J, Guilbert E, Hedley A. Sterilization failure, sterilization reversal, and pregnancy after sterilization reversal in Quebec. Obstet Gynecol 2003; 101:677-684.
9. Ballagh SA. Sterilization in the office: The concept is now a reality. Contraceptive Technology Reports 2003; 5.
10. Penfield AJ. The Filshie clip for female sterilization: A review of world experience. Am J Obstet Gynecol 2000; 182:485-489.
11. Association of Reproductive Health Professionals. Clinical update on transcervical sterilization. Clinical Proceedings; May 2002:10.
- For more information on Essure, contact Conceptus, 1021 Howard Ave., San Carlos, CA 94070. Telephone: (877) 377-8732 or (650) 628-4700. Fax: (650) 610-8363. Web: www.conceptus.com.
- Learn more about Essure by reviewing the Washington, DC-based Association of Reproductive Health’s Clinical Proceedings publication, part of its continuing medical education program, "New Developments in Contraception: Permanent Options for Women." Go to www.arhp.org and click on "Health Care Providers," "CME/CEU," "Monographs," and "Clinical Update on Transcervical Sterilization."