July 7, 2009 - The U.S. Food and Drug Administration (FDA) has approved Hologic Inc.'s premarket approval (PMA) application for the Adiana permanent contraception system.
The Adiana system is designed to provide women a minimally-invasive, non-incision alternative to traditional, surgical means of permanent contraception. In January 2009, Hologic received CE marking approval for the Adiana system and commenced marketing and sales of this product in certain European countries.
During the Adiana procedure, a slender, flexible instrument is passed through the body’s natural openings to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube. A tiny, soft insert, about the size of a grain of rice, is then placed in each fallopian tube in the location where the energy was applied. During the three months following the procedure, the patient continues to use
temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At three months, a special X-ray test (called a hysterosalpingogram or HSG) is performed
to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.
The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the comfort of the doctor’s office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels. There were approximately 70,000 female transcervical contraception procedures performed in the U.S. last year.1
For more information: www.hologic.com