The Adiana® permanent contraception system has been developed by Hologic Inc., a company which produces healthcare products for women and is located in Bedford, Massachusetts, in the United States. Hologic Inc. is promoting this new product as a minimally invasive, transcervical, method of female sterilisation which gives women who no longer wish to have children a non-surgical option for permanent contraception. Using the Adiana® procedure, a doctor or surgeon can block a woman’s fallopian tubes without actually making any cuts into her abdomen. Hologic Inc. says the Adiana® procedure can be carried out by trained doctors in their own clinics under local anaesthetic.
The new procedure takes approximately 15 minutes and doctors who have used it say patients may go home as soon as 30 minutes after it is completed. The patient is given a local anaesthetic. The doctor then uses inserts a hysteroscopy into the uterus so he can see what he is doing. (A hysteroscopy is an endoscopy inserted into the womb. An endoscopy is an optical instrument fitted with a fibre optic light source and attached to a video unit which displays the view inside the uterus.) Then, radio signals are directed at the fallopian tubes to create a lesion in each tube. A catheter (a very thin tube) is inserted via the cervix and used to deliver a very tiny piece of soft silicone (no bigger than a grain of rice) into each fallopian tube. After the procedure, healthy tissue grows on and around this piece of silicone and creates a complete and permanent blockage of each tube. This prevents eggs from a woman’s ovaries travelling down the fallopian tubes where they can be fertilised by her partner’s sperm. Women are advised to continue using contraception for 12 weeks after the procedure while waiting for the tissue to grow. In this way, Adiana® permanent contraception system renders a woman unable to get pregnant in the same way as a convention tubal ligation procedure does.
The Adiana® procedure is transcervical (carried out via the cervix) and therefore does not involve any incisions being made in the patient’s abdomen. The procedure is therefore performed under local anaesthetic and patients can usually return to their daily activities within one day. The advantages of this are obvious when compared with the conventional surgical procedure for having the fallopian tubes tied. Tubal ligation is performed under general anaesthetic and patients may need four or five days to recover.
Questions have been raised regarding Adiana®’s effectiveness. In total, 570 women have taken part in clinical trials. After having had the procedure and attending follow-up checks with doctors, 11 of these women reported pregnancies. Five of these women got pregnant in the period after the procedure in which the women had been advised to use other forms of birth control. The other six pregnant women conceived after they had been told it was safe to rely on Adiana® as their sole form of contraception. The United States’ Food and Drug Administration (FDA) has found that Adiana® is 98.9 % effective as a form of permanent contraception, but has instructed Hologic Inc. to change its product labeling to include mention of the uncertainty about Adiana®’s long-term effectiveness or possible risks to the health of the patient.
Availability In The UK
In January 2009, Hologic Inc. was awarded CE marking approval for its Adiana® Permanent Contraception System, which allows the company to market Adiana® in all European Union countries including the UK. The FDA in the United States is still reviewing the product for approval in the U.S. Hologic Inc. is in the process of registering Adiana® in Canada and Australia.
Learn more about non-surgical permanent birth control options in our birth control forum.