Filshie clip system gains U.S. acceptance
As American women continue to rely on sterilization as the leading method of birth control, U.S. physicians are adding another mechanical clip option to their techniques for tubal occlusion.
More than 35,000 U.S. women have been sterilized using the Filshie clip system in the two years since it received federal Food and Drug Administration (FDA) approval, says Stuart Smyth, chief executive officer of Avalon Medical Corp. of Williston, VT, distributor of the system. [Contraceptive Technology Update covered the clip’s introduction in November 1996 (p. 129) and reported on efficacy data presented to a FDA review panel in May 1996 (p. 58).]
10-year data to come
Look for 10-year effectiveness data to be published this spring, says Smyth. (CTU will offer an analysis of the data when the information is released.) Family planners are indeed interested in such information, for in the 1996 landmark U.S. Collaborative Review of Steril ization (CREST) study (which did not include the Filshie clip), the probability of failure for laparoscopic spring clip applications was recorded at 36.5 pregnancies per 1,000 procedures, the highest among six sterilization methods.1 (See CTU, August 1996, pp. 93 and 99, for more on the CREST study findings.)
Avalon Medical Corp. has quoted two-year failure rates at 2.7 per 1000 on the integral failure; seven to nine per 1000 on the postpartum, says Smyth. Although he declined to reveal final rates from the 10-year data, he says the results "are not surprising."
Canadian providers and patients have been well satisfied with the Filshie clip system since it was introduced 15 years ago, reports Albert Yuzpe, MD, professor emeritus of OB/GYN at the University of Western Ontario in London and co-director of the Genesis Fertility Clinic in Vancouver, British Columbia. About 85% of interval female sterilizations in Canada now are performed using the clip system, says Yuzpe, who presented a paper on the method at the recent Emory University Quest for Excellence in Women’s Health conference in Atlanta.
The clip, which features a titanium construction with an inner silicone rubber lining, has only one moving part, which locks into place upon application, notes Yuzpe. The silicone rubber expands as the clamped tube shrinks, giving full occlusion. The applicator is specifically designed for single- or dual-incision laparos copy or mini-laparotomy.
A new provider training video will be released this year covering both single- and dual-incision methods, as well as local anesthesia conscious sedation, states Smyth. The company sponsors grand rounds teaching presentations and offers an extensive physician network so providers can get support and feedback on the method.
The clip system has found favor with U.S. managed care programs, with large preferred provider and health maintenance organizations purchasing from Avalon, Smyth reports.
Regret important factor
Between 1965 and 1988, the prevalence of surgical sterilization grew from 16 to 42% among U.S. married women ages 15 to 44, with the meth od the most popular form of birth control, states a new report on U.S. surgical sterilization from the National Survey of Family Growth, conducted by the National Center for Health Statistics in Hyattsville, MD, a division of the Atlanta-based Centers for Disease Control and Prevention.2 In 1995, the prevalence remained at 41%. Since 1982, tubal ligation has become more common than vasectomy, occurring at a rate of 1.5 to two times as often among currently married and ever-married women ages 15 to 44. Among married women in 1995, 24% noted a tubal ligation, compared with 15% of husbands who underwent a vasectomy. In earlier years, tubal ligation and vasectomy were equally common among these women and their partners.
It is important for family planners to point out failure rates for tubal sterilizations along with those of other long-acting contraceptive methods, such as the intrauterine device, when counseling on long-term birth control decisions, says Anita Nelson, MD, medical director of the Women’s Health Care Clinic at the Harbor-University of California in Los Angeles Medical Center in Torrance, CA. Remember that among younger women included in the CREST study, 10-year failure rates for clip systems were comparable to those for the IUD, she notes.
Address regret when counseling
Regret following sterilization is an important factor to consider when counseling on the method. A 1998 survey conducted by Wirthlin Worldwide, a McLean, VA-based market research firm, and funded by Ortho-McNeil Pharmaceutical of Raritan, NJ, finds that one of five U.S. women who have undergone surgical sterilization later regretted their decision.3 Ortho-McNeil manufactures the ParaGard T380A IUD.
About a third of the women who chose sterilization selected it due to its high level of effectiveness. Yet 53% of those women agreed that if an equally effective, nonsurgical option had been available, they would have chosen it.
Nearly 25% of women with an unreversed tubal ligation in 1995 expressed a desire for reversal of the operation, on the part of herself, her husband or partner, or both, states the National Center for Health Statistics report. Desire for tubal ligation reversal was more frequently reported by younger women, Hispanic women, and women with lower levels of education and income, the report notes.
Provide contraceptive choices, assess the patient’s understanding of the procedure, and facilitate the decision-making process so the patient has sufficient time to make a thoughtful, informed decision about sterilization, note the authors of Contraceptive Technology.4 While reversal techniques do exist, be sure to emphasize that sterilization should be considered a permanent form of contraception.
References
1. Peterson H, 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.
2. Public Health Service. Surgical Sterilization in the United States: Prevalence and Characteristics, 1965-95. 1996; 98:40.
3. Wirthlin Worldwide. Women report having second thoughts about surgical sterilization: New survey shows women should consider alternatives. Ortho-McNeil Pharmaceuticals survey. Raritan, NJ; Sept. 17, 1998.
4. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York: Ardent Media; 1998.
Resource
For more on the Filshie Clip system, contact:
• Avalon Medical Corp., 372 Hurricane Lane, Suite 201, Williston, VT 05495. Telephone: (888) 872-2547 or (802) 878-2900. Fax: (802) 878-3100.
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