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Implant is the latest in birth control

A new sterilization procedure for women requires no surgery. It's also irreversible.

November 11, 2002|Shari Roan | Times Staff Writer

For couples who want permanent birth control, the sterilization decision can be a difficult one. Vasectomy for him? Tubal ligation for her? Now, the choice may be easier.

A device approved last week by the Food and Drug Administration creates a permanent obstruction in a woman's Fallopian tubes, preventing pregnancy. The device, called Essure, requires no surgery and significantly less recovery time than the traditional sterilization method for women. And it may be just what a lot of men are looking for too. Even though vasectomy is easier on a man than tubal ligation is on a woman, many more women are sterilized.

For La Tia Mayer and her husband, Essure was the perfect compromise. Although the St. Louis couple had decided not to have a child together, the newlyweds couldn't agree on how to accomplish birth control.

"My husband compared a vasectomy to being neutered," Mayer said. "I had a problem with the idea of surgery. I just have a fear of being knocked out and in pain."

The stalemate was resolved, when Mayer discovered -- and participated in -- a study of the new nonsurgical sterilization device. It should be widely available in most urban areas by early next year.

"It was really easy. It was painless. It was just what I was looking for," Mayer said.

With the relative simplicity of Essure, some health experts predict more women will undergo sterilization and that vasectomy rates may drop. About 700,000 U.S. women undergo tubal ligation each year. About 400,000 men have vasectomies.

"The argument has always been that it's easier for the man [to undergo sterilization] than it is for the woman," said Dr. Jay M. Cooper, medical director of Women's Health Research in Phoenix and the principal investigator in one of the Essure studies. "Essure is leveling the playing field. Men who would have chosen vasectomy might now want their spouses to consider Essure instead."

Essure, however, is considered irreversible. While tubal ligation and vasectomy are also permanent, reversals are sometimes possible.

"The problem with the Essure is that it is only for women who are absolutely certain they don't want to have children again," said Dr. Arnold Belker, a clinical professor of urology at the University of Louisville School of Medicine. "Despite its simplicity, I'm not sure how many women will opt for a method of sterilization that is not reversible."

Essure is a small, flexible implant that is inserted, using a catheter and telescope, through the cervix and into each Fallopian tube. Scar tissue forms over the device, creating a permanent obstruction and preventing fertilization. The procedure takes no more than 90 minutes, Cooper said, and most women return to work within a day.

In comparison, tubal ligation requires an abdominal incision, general anesthetic, hours in a surgery center or hospital and about a week of recovery time.

Vasectomy involves one or two small cuts in the skin, the use of local anesthetic and a day or two of recovery time. Vasectomy is as effective as tubal ligation but is cheaper and less risky.

For La Tia Mayer, not having to miss much work was the most attractive aspect of Essure. "At 10:30 a.m., I was walking out the office door," she said.

The ease and effectiveness of Essure, however, will depend somewhat on the doctor's skills. Under FDA guidelines, doctors must be trained to insert Essure. The training will be coordinated by the manufacturer, Conceptus Inc. of San Carlos, Calif.

In one clinical trial, doctors failed in 14% of cases to place the implants in both tubes. The FDA is requiring Conceptus to study the placement failure rate with doctors newly trained in the procedure and to identify the causes of failures.

In addition, women should have an X-ray after three months to confirm proper placement of the device and should use other birth control until then. Essure is not recommended for women who have tubal scarring or an abnormality of the uterus.

So far, there are no pregnancies among almost 500 women using Essure. Pregnancies occur in well under 1% of all tubal ligations and vasectomies, and Essure is not expected to be perfect, either.

"Tubal ligation has been here for 30 years. You can't compare it to Essure because the follow-up on Essure is just beginning," said Dr. Rafael Valle, an obstetrician-gynecologist at Northwestern Memorial Hospital in Chicago who has studied the implant. "It will take five to 10 years of follow-up to understand any side effects to this method."

Essure is expected to cost slightly less than tubal ligation, which ranges from $1,000 to $2,500. Many insurers pay for sterilization and are expected to cover Essure, according to Conceptus officials.

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