The panel recommended approval of the device contingent upon several conditions including: long-term follow-up of current patients, the conducting of studies tracking patients yet to be treated and a requirement that the company will have to make adjustments to the product's suggested labeling with emphasis on the uncertainty of "long-term effectiveness and risk." It is now up to the FDA to determine when Adiana will be made available to the public.
Hologic, Inc, the manufacturer of Adiana, is marketing Adiana as a novel, two-step approach to permanent contraception that is a minimally-invasive, non-incisional sterilization alternative. Through a catheter positioned inside the opening of a woman’s fallopian tube, bi-polar radiofrequency removes a thin layer of cells. Next, the catheter delivers an implantable, soft “matrix,” (smaller than a grain of rice). Healthy tissue will grow on and around the matrix to create a complete a permanent blockage. The whole procedure takes about 15 minutes to complete.
Tony Kingsley, President of Hologic GYN Surgical Products, explains in a press release, “Today represents a tremendous milestone in enabling us to realize our goal in making Adiana a viable and better alternative for women looking for permanent contraception. We will work closely with the FDA to address any remaining issues and expedite final approval. We are confidently on course to provide women with an important new treatment option.”
- All About Tubal Ligation
- Essure Hysteroscopic Sterilization
(the only currently FDA-approved non-incisional sterilization method. The Adiana procedure would be similar to the Essure procedure).
