Essure, the brand name of the procedure and device from Conceptus Inc., recently received approval from the United States Food and Drug Administration (FDA) as the first alternative to tubal ligation -- the nation's most commonly performed sterilization procedure.
"I believe that the availability of Essure in our area will tremendously impact women looking for alternatives for permanent birth control," said James H. Miller, M.D., chief of obstetrics and gynecology at Swedish Medical Center/First Hill Campus and one of the first Seattle-area physicians certified in the procedure. "Prior to Essure, women wanting permanent contraception had to undergo an incisional tubal ligation, which requires general or regional anesthesia, an abdominal incision and a lengthy recovery period."
Currently, an estimated 700,000 American woman undergo tubal ligation each year, making it the most common form of contraception in the United States. Unlike tubal ligation, Essure requires no incisions and can be done with minimal sedation in less than 10 minutes and requires little recovery time.
Essure deploys a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal-access catheter. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tube to prevent fertilization. The procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. In fact, women typically return home about 45 minutes after the procedure is completed. About 12 weeks after the initial procedure, the physician uses a special X-ray to confirm placement of the inserts and complete tubal occlusion.
Mild discomfort and cramping are common during the first few days after the procedure. But in clinical trials, 92 percent of the women receiving the coil implants who were employed outside the home returned to work in one day or less after the day of the procedure and most patients were back to their regular physical activities within one or two days. By comparison, recuperation from tubal ligation can require up to two weeks.
The FDA approved the device based on data from two separate clinical trials involving more than 600 women who relied on the current Essure design for one to two years. Two years of follow-up data from the trials showed the procedure was 99-percent effective, with few, if any, side effects. Studies on long-term use are still under way.
Like all birth-control methods, Essure is not expected to be 100-percent effective and, although rare, pregnancies can occur. There is a three-month waiting period after the procedure until the tubes have become completely blocked -- during which women must use another form of birth control.
According to the United States Centers for Disease Control and Prevention, incisional tubal ligation continues to be the most prevalent form of birth control in the U.S., with 41 percent of women age 35 to 39 and 50 percent of women age 40 to 44 choosing this technique. Incisional tubal ligation remains the most popular form of birth control worldwide despite the fact that it is invasive and costly. About 93 percent of the incisional laparoscopic tubal-ligation procedures in the U.S. are performed in a hospital or surgery center under general anesthesia, typically requiring at least four to six days of recovery before returning to regular activities.
Patients can self-refer for sterilization procedures, which are usually covered by health insurance. However, not everyone is a candidate for Essure, including women with a history of fallopian-tube disease, pelvic infection, an unusually shaped uterus or allergies to nickel or the contrast used in the X-ray.
For additional details about the procedure, click here. For more information about the use of Essure at Swedish, call 1-800-SWEDISH (1-800-793-3473).
Swedish Medical Center is the largest, most comprehensive, not-for-profit health provider in the Pacific Northwest. Swedish is comprised of three hospital campuses (First Hill, Providence and Ballard), Swedish Home Care Services and Swedish Physicians -- a network of 11 primary-care clinics. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiac care, oncology, orthopedics, high-risk obstetrics, neurological care, sleep medicine, pediatrics, organ transplantation and clinical research. For more information, visit www.swedish.org
To read the transcript of a story KOMO Television (Channel 4; ABC) recently ran about Essure, click here.