Transcervical methods eyed for sterilization

Your next patient is a 35-year-old mother of three and has a body mass index of 36. She says she is interested in permanent birth control. What are her options?

Tubal sterilization is one of the leading contraceptive options for American women; 27% of all contracepting U.S. women in 2002 relied on the method.1 Of the 700,000 annual bilateral procedures, about half are performed postpartum and half as ambulatory interval procedures.2 When it comes to obese patients, though, anesthesia and surgery can be problematic, and special care must be taken to prevent complications.3

Hysteroscopic sterilization using the Essure nonincisional permanent birth control procedure (Conceptus; San Carlos, CA) represents a safe choice for such high-risk women, according to new information presented at the May 2006 annual meeting of the American College of Obstetricians and Gynecologists (ACOG).4 The method has a high margin of safety and bypasses the risk of potential intra-abdominal laparoscopic complications, says Mark Levie, MD, who presented the paper. Levie is director of obstetrics and gynecology at Montefiore Medical Center and an associate professor at the Albert Einstein College of Medicine, both in New York City.

To assess the procedural and post procedural outcome of women undergoing hysteroscopic sterilization who have high-risk medical and surgical conditions, a cohort of 75 women were identified within a group of 972 women who underwent the Essure method of hysteroscopic sterilization. The women were identified as having a significant surgical or medical condition that normally would place them in a high-risk group for a conventional laparoscopic sterilization procedure carried out under general anesthesia. All women in the cohort underwent the procedure without suffering an intra or post-procedural adverse event.4

"Essure is a good alternative for women who don't want a bilateral tubal ligation," says Levie. "The Essure procedure is minimally invasive, doesn't require a general anesthesia, allows for rapid patient recovery, and by avoiding general anesthesia and abdominal incisions, the risk to the patient is almost eliminated."

Is it permanent?

Women must consider any sterilization technique as permanent because reversal is not always successful and reversal procedures may not be available to all who want them, according to Contraceptive Technology.5 Informed consent documents that are presented to the patient prior to any sterilization procedure include language on the intended permanence of sterilization.5

However, regret following sterilization does occur; women who are ages 30 and younger at the time of sterilization are most likely to experience regret.6 Pregnancy with in vitro fertilization is possible in women who have previously undergone Essure hysteroscopic sterilization, suggests information presented at the ACOG session and the November 2005 annual meeting of the American Association of Gynecologic Laparoscopists.7,8

A small number of pregnancies have been achieved in Australian women who underwent in vitro fertilization following Essure procedures, says Barbara Levy, MD, assistant clinical professor of obstetrics and gynecology at the University of Washington School of Medicine in Seattle, who presented information at the ACOG session. Since tissue gradually encapsulates the coils of the Essure micro-insert that trail into the uterine cavity following hysteroscopic sterilization, the device is compartmentalized away from the uterine cavity, according to second-look hysteroscopies.9 Further research is needed to further prove that such reversals can be achieved successfully.

The Adiana method of transcervical sterilization (Adiana; Redwood City, CA) is under review by the Food and Drug Administration (FDA). Its procedure is performed in two steps; first, a catheter is delivered through a hysteroscope into the intramural portion of the fallopian tube. Using low-level bipolar radiofrequency energy, a superficial lesion is created to remove surface epithelium. The second step calls for placing a matrix (a porous, nonbiodegradable implant material) into the lesion. The matrix remains implanted within the fallopian tube, where surrounding tissue grows into it over a few weeks. The ingrowth results in permanent and total occlusion of the fallopian tube.10

Further away in the research pipeline is Ovion, a self-expanding, stent-like device that causes the fallopian tube tissue to grow shut. Developed by Ovion of Redwood City, CA, the device is being researched by American Medical Systems of Minneapolis, which acquired the California company in 2005.11

References

  1. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data 2004; 350:1-36.
  2. Westhoff C, Davis A. Tubal sterilization: Focus on the U.S. experience. Fertil Steril 2000; 73:913-922.
  3. Bongain A, Isnard V, Gillet JY. Obesity in obstetrics and gynaecology. Eur J Obstet Gynecol Reprod Biol 1998; 77:217-228.
  4. Kerin JF. Hysteroscopic sterilization: A safe choice for high-risk women. Obstet Gynecol 2006; 107:15S.
  5. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: 18th revised edition. New York City: Ardent Media; 2004.
  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. Kerin JF. Tissue encapsulation of the Essure device from the uterine cavity after hysteroscopic sterilization. Obstet Gynecol 2006; 107:3S.
  8. Kerin JF. Pregnancies in women who have undergone the Essure hysteroscopic sterilization procedure. Presented at the 34th Clinical Meeting of the American Association of Gynecologic Laparoscopists. Chicago; November 2005.
  9. Wendling P. In vitro fertilization successful following Essure sterilization. OB GYN News 2006; 41:13.
  10. Association of Reproductive Health Professionals. Transcervical methods in the U.S. pipeline. ARHP Clinical Proceedings; May 2002:14.
  11. Graebner L. Firms vie for nonsurgical permanent birth control edge. Silicon Valley/San Jose Business Journal. Sept. 5, 2005; accessed at: http://sanjose.bizjournals.com/sanjose/stories/2005/09/05/story7.html.