The FDA is currently reviewing the Adiana permanent contraception system using hysteroscopy.
The Adiana permanent contraception system using hysteroscopy has received "CE marking" approval in Europe and its premarket approval application is currently under review by the Food and Drug Administration, according to Hologic, Inc. (Bedford, MA). The system is designed to provide a minimally-invasive, non-incisional alternative to traditional female sterilization surgery. Using hysteroscopy, and usually under local anesthesia, the Adiana procedure can be performed in a physician's office. This approach will generally permit patients to return to work or resume daily activities within a day. In contrast, recuperation from a bilateral tubal ligation is usually done in a hospital OR under general anesthesia and requires one or two abdominal incisions, necessitating 4 to 5 days of recuperation.
The pivotal clinical trial to show the safety and effectiveness of the system was done in the United States, Australia, and Mexico. Some 645 women aged 21 to 45 had treatment attempted with the Adiana system. Placement success was very high, as were patient tolerance, comfort, and satisfaction, according to the company. A pregnancy prevention efficacy of 89% after 12 months of reliance on the device was demonstrated, which successfully met the trial's primary endpoint.
For more information, visit the Web site at http://www.hologic.com/.