14 DAY TRIAL // Hormones come with unwanted secondary effects, while the knife dreads anyone. The new contraceptive method destined to women involves none of these and lasts just 15 minutes. The procedure has the role of impeding women getting pregnant and implies the use of radio waves for making a lesion at the level of the fallopian tube, connecting the ovary to the uterus.
First, the radio signals are employed for inducing a lesion inside the fallopian tube.
Through a catheter inside the tube is introduced a soft material having a size smaller than a rice grain. Healthy tissue grows around the material and create a blockage which is permanent. After the intervention, the patients can turn back to their daily tasks in just one day. The team which developed the procedure stated that the technique presents very little risks and can be made by any gynecologist.
Another method, currently in use, is the tubal ligation. In US, about 70.000 women appeal to this method, which is irreversible, and it is performed in a hospital operating room.
The new method was checked in a trial which involved 570 women. 15 months later, only 11 cases of pregnancy were registered. 5 of the pregnancy cases occurred in women told to use also an alternative birth control, while the other 6 cases used exclusively Adiana as a birth control method. Overall, this means the method is secure in a proportion of 98,9%.
The Adiana device was developed by Hologic Inc. of Bedford, Mass. The company markets the product as a low-risk procedure that can be performed in the doctor's office.
FDA's Obstetrics and Gynecology Devices Panel has recommended the Adiana with a vote 10-3. Still, the producing company has to make long-term follow-up of current patients and to investigate long-term effectiveness and risk.