Sterilization: New method options, failure rate info

Tubal sterilization continues to top the list when it comes to contraceptive choices for American women. Although other methods such as birth control pills are gaining ground, 17.8% of women ages 15 to 44 choose sterilization as their form of family planning.1 Providers need to be aware of new sterilization methods, as well as updated information on failure rates and the risks for ectopic pregnancy, as they counsel patients on this form of contraception, says Amy Pollack, MD, MPH, president of AVSC International in New York City. Pollack recently provided a sterilization update at the joint annual meeting of the Washing-ton, DC-based Association of Reproductive Health Professionals and the New York City-based Planned Parenthood Federation of America.

First year in U.S. for Filshie clips

Education has been the focus in the first-year after the Filshie clip system was introduced in the United States, says Stuart K.J. Smyth, chief executive officer of Williston, VT-based Avalon Medical Corp. Avalon is the American distributor of the system, which was developed by Femcare Ltd. in Nottingham, England. The Filshie clip received U.S. Food and Drug Administration clearance in September 1996. (See Contraceptive Technology Update, November 1996, pp. 129-131, for more information on the Filshie system.)

The company has completed several provider training sessions at major universities around the country and exhibited at national professional societies, Smyth says. Its initial training video is to be followed by at least two more films in 1998.

How are physicians responding to the new method? "I think the clip represents the introduction of a tubal occlusion method that is more in line with the technologies available to us in a modern age," Pollack says. "It’s an improvement over the other methods, mostly because it is newer. And the developers have had the opportunity to use newer materials, to think through and problem solve about application issues, and they’ve done a very good job doing that."

Andrew Kaunitz, MD, professor and assistant chair of obstetrics and gynecology at the Univer-sity of Florida Health Sciences Center in Jackson-ville, says before the introduction of Filshie clips, physicians at his facility were using Falope rings, based on the long-term failure rates for such methods as the Hulka clip and bipolar coagulation issued through the first report from the U.S. Collaborative Review of Sterilization (CREST).2 (See CTU, August 1996, pp. 93-94 and 99-100, for a review of the CREST findings.)

Kaunitz and Pollack agree that although the Filshie clip has a good track record, there needs to be more long-term, large-scale information available on its use. "We don’t have 10-year data on it, but we do know, because it’s been used in over two million women, that it can be used properly and safely," Pollack notes. Kaunitz says, "Time [and more data] will tell how well the Filshie clip stacks up against the ring and other tubal sterilization techniques." While he splits current use between the clip and the ring, Kaunitz continues to use the Falope method frequently "as this remains, in my opinion, cost-effective and well-studied."

Don’t forget to include the CREST findings on long-term failure rates and the risks for ectopic pregnancies when counseling your patients, Pollack says. (Even though failure rates for sterilization are low, CREST data show that when a pregnancy does occur, there is about a one in three chance it will be ectopic. These risks persist for up to 10 years after sterilization.3 See CTU, June 1997, pp. 67-69 for further review.)

Clinicians need to take away two critical points from the CREST reports, Pollack says:

• Failure rates are higher in younger women, as are the regret rates and failures overall. Be sure to counsel women, especially under age 30 but including women between 30 and 34, about the possible risks of failure and the need to consider other long-term effective methods if that is a major concern for them, Pollack says.

• Since the failure rate is higher in younger women, the risk for ectopic pregnancy is elevated as well. All women must be counseled about the need to see a provider immediately if they have pregnancy symptoms following a sterilization, Pollack asserts. This is key for those women younger than 30, since they are nearly twice as likely as older women to experience an ectopic pregnancy if they choose sterilization.

"For those women between ages 30, 34, and 34-plus, the risk of failure is about the same as we’ve been quoting, so there is no dramatic change in the counseling," Pollack says. "But now we know more about the ectopic rates, and they also need to be counseled about the risk."

Regret is possible for any woman choosing sterilization, says Gary Stewart, MD, MPH, a Boston-based family planning consultant and a co-author of Contraceptive Technology. It is imperative that the basic informed consent process be followed for those who do select sterilization, he says. "All contraceptive methods need to be discussed, and if a woman wishes a non-permanent method, it should be accommodated. Particularly young women and those newly-divorced should be carefully counseled before they undergo a sterilization procedure. Regret really does happen, and it is often in those women who are young and not married at the time of sterilization, as shown in the first CREST study."

References

1. Abma JC, Chandra A, Mosher WD, et al. Fertility, family planning, and women’s health: new data from the National Survey of Family Growth. National Center for Health Statistics. Vital Health Stat 1997; 23(19).

2. 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.

3. Peterson HB, Xia Z, Hughes JM, et al. The risk of ectopic pregnancy after tubal sterilization. U.S. Collaborative Review of Sterilization Working Group. N Engl J Med 1997; 336:762-767.