St. Louis women among first to try new birth control procedure

ST. LOUIS -- Women in St. Louis will be among the first in the nation to try a new method of birth control approved by the government last week.

Dr. David Levine of St. Luke's Hospital in suburban Chesterfield, who led clinical trials for Essure, will perform his first two commercial procedures Friday. On Saturday, Levine will show 16 doctors how to do the procedure, which involves implanting a tiny device to scar fallopian tubes and takes as little as 30 minutes.

Essure is the first nonsurgical method of sterilizing women and could transform the way many women end their childbearing years. Today, sterilization is performed through an operation called tubal ligation, where doctors cut and tie the fallopian tubes to keep eggs released by the ovaries from reaching the uterus. It requires either conventional or minimally invasive surgery in which doctors work through small cuts in the abdomen. The procedure typically requires general anesthesia and can take up to a week for the patient to recover.

No cutting required

Essure, in contrast, requires no cutting, only a local anesthetic and is designed to block the fallopian tubes as effectively. Most patients return to their normal activities if not the day of the procedure, then the day after, said nurse Sharon Schwab, who helped Levine with the study.

"I think it's a revolution in permanent contraception for women," Levine said.

A drawback to Essure is the procedure is irreversible, unlike tubal ligation. It also has no long-term track record.

"I'd like to see a 10-year follow-up on 10,000 patients in carefully controlled studies," said Dr. Sherman Silber, director of the Infertility Center of St. Louis. "I don't think they've got enough cases to say it's safer."

The market for Essure -- which costs $980 according to the manufacturer -- could be huge. Each year, 700,000 American women undergo tubal ligation.

Levine said the procedure can be done in a gynecologist's office. Doctors use a catheter to thread Essure into each fallopian tube. The device looks like a tiny spring and measures about 4 centimeters long. Flexible nickel and titanium coils cling to the tubes' walls. The mesh inside the coils irritates the lining of the tubes and causes scar tissue to eventually form permanent plugs. While the scar tissue grows, women must use another type of birth control for three months.

Levine said women need to know about this alternative.

"Tons of patients have been sitting on the sidelines for years taking birth control pills because they didn't want to go to sleep and they didn't want to get cut," he said.

Tia Mayer, 33, of St. Louis was looking for permanent birth control when she heard about Essure clinical trials. The mother of two daughters had been taking birth control pills every day because she didn't want the pain associated with surgical tubal ligation. Her husband didn't want a vasectomy.

Mayer said she felt no pain during the procedure, which she watched on a television monitor as it took place. Afterwards, she resumed a normal day, going grocery shopping and cooking dinner that night, she said.

The device's manufacturer, California-based Conceptus Inc. is confident that health insurers will cover the device as they have for tubal ligations. Officials from Blue Cross and Blue Shield of Missouri said the insurance company covers tubal ligation and Essure procedures.

The Food and Drug Administration required Conceptus Inc. to continue monitoring the women involved in the studies for five years for long-term health effects.

The device currently is available in Australia, Europe, Singapore and Canada.

Levine said the FDA put Essure on fast-track because the data from the clinical trials was so credible. In studies of more than 600 women followed for about 18 months, no pregnancies have resulted in patients whose devices were implanted properly.