A new method of permanent birth control now available to Spokane-area women requires only a medical office appointment, rather than a hospital visit, and enables the patient to go back to work the next day.
The method, called Adiana permanent contraception, involves inserting tiny plugs, about the size of a grain of rice, into the fallopian tubes. Scar tissue then forms around the silicon plugs, permanently blocking the passage of eggs from the ovaries, and thus preventing pregnancy.
Dr. Scott Schade, a gynecologist with Spokane-based Rockwood Clinic PS, began offering the procedure to his patients this summer. He says he considers it to be better than other, similar methods of permanent birth control.
"With this procedure, there's no general anesthetic, no incision, and almost no recovery period," Schade says. In a clinical study of Adiana, there were no perforations of the fallopian tubes, so there is little risk to patients, he says.
That clinical study was done nationally over a three-year period, during which the Adiana procedure was performed on 645 women, ages 18 to 45. The Boston-based developer of the birth control method, Hologic Inc., says that in the study, Adiana was 98 percent effective in preventing pregnancy, and 99 percent of patients reported that they were either "very satisfied" or "satisfied" with the procedure.
The method was approved by the Federal Drug Administration in July 2009, and Schade says it became available to physicians last May.
Schade says many women who are finished with child bearing struggle with decisions about birth control, and Adiana offers them a convenient new option.
"It's going to be a big deal for women. I think they're going to be very surprised and happy that this is available," he says.
Schade typically does an initial consultation with a patient who's considering the method.
He says the patient needs to be certain that she doesn't want to become pregnant ever again.
"I don't look at this as reversible," he says.
If a patient elects to go forward with the procedure, Schade's office will schedule a 90-minute appointment. Hologic states that the procedure takes only 12 minutes, but Schade prefers to take a little longer, and offers anesthesia to increase the patient's comfort and safety.
With the type of sedation used, the patient remains awake, so the recovery period is shorter than with general anesthesia that puts a patient to sleep.
"You can do it with Novocain and pain pills, but the patient is still uncomfortable. I bring in an anesthesiologist. After 10 minutes, the patient is comfortable and not moving. With an anesthesiologist concentrating on the patient, I can concentrate on the procedure."
To do the procedure, the physician uses devices called dilators to open the cervix, then inserts a catheter through the vagina, cervix, and uterus to one of the two fallopian tubes.
A scope on the end of the catheter allows the physician to watch the catheter enter the fallopian tube. A small probe with electrodes on the end is inserted into the catheter. Radio-frequency electrical energy is then passed through the electrodes, creating a superficial burn on the inner tissue of the fallopian tube. That begins the process of producing scar tissue. The tiny silicone Adiana plug is left in the fallopian tube as the catheter is withdrawn, and the procedure is repeated in the other fallopian tube.
After a short recovery period, typically less than an hour, the patient can go home, and is able to resume normal activity the next day.
Results of the clinical study showed that about one-fourth of women experienced mild to moderate cramping afterward, and a small percentage experienced bleeding, back pain, or nausea for a short period of time.
Over the next three months, the patient must continue to use another method of birth control. During that time, scar tissue forms around the plugs, holding them in place and sealing the fallopian tubes.
At the end of the three-month period, the success of the procedure is tested by inserting a dye into the uterus that can be seen on an X-ray. The abdomen is X-rayed in several different positions to determine if there is any dye leakage into the fallopian tube. If no leakage is seen, the patient can discontinue other methods of birth control. If leakage is detected, the test is repeated three months later. Hologic's study showed a 95 percent success rate with placement of the Adiana plugs.
Jill Fix, a spokeswoman for Rockwood Clinic, says the procedure costs about $5,000. Because it is done in Schade's office, his patients are responsible for an office-visit co-pay. Any other amount they're responsible for depends on their insurance plan.
Schade says he is aware of at least one other Spokane-area physician who offers the Adiana method of birth control, but he believes he's the only one here doing the procedure with anesthesia. He says another form of fallopian tube blocking, called Essure, has been available since 2002.
"I was never that impressed with its safety or ease of insertion," Schade says of Essure. "It's a long, metal coil placed in the tube. You have to be careful to place it properly so it will not perforate the tube. The metal limits what you can do afterward. There can be no endometrial ablation."
That procedure, reported in the Journal of Business last October, stops heavy menstrual periods, and can be used in conjunction with the Adiana method.
Tubal ligation, or "getting your tubes tied," has been used for permanent sterilization for many years. It involves severing, sewing, or clamping the fallopian tubes, and can be done immediately after the birth of a baby during a Cesarean section. Otherwise, abdominal surgery involving a 2- to 3-centimeter incision is required. Pregnancies after a tubal ligation occur about 1.4 percent of the time, says Schade. Comparatively, Hologic says the rate of pregnancy after the Adiana procedure during the three-year study was 1.6 percent.
"There probably would be certain instances where you would do a tubal ligation at the time of a C-section," Schade says. "The failure rate is comparable, but there is an increase in the recovery time, the cost, and the risk involved."
In January of this year, Schade gave up his obstetrics practice to focus on office-based gynecology. He says he expects to perform the procedure more frequently as the Adiana procedure becomes more widely recognized.
"I can't imagine a woman who's done having children not wanting the procedure. She's going to pick this over an IUD, birth control pills, a tubal ligation, or having her husband get a vasectomy," Schade says.
He predicts that, in the future, "most women will choose this as a permanent form of contraception."