FDA approves Hologic sterilization treatment

July 7, 2009 by MassDevice staff

The Food & Drug Administration gave the nod to the Bedford women's health products maker's Adiana permanent contraception procedure.

The Food & Drug Administration gave the nod to Hologic Inc.'s Adiana sterilization treatment, which uses a minimally invasive natural orifice surgical technique to provide permanent contraception.

The Bedford women's health products maker said the the federal safety monitor gave pre-market approval for procedure, which involves threading an endoscope through the vagina, cervix and uterus into the fallopian tubes, where radiofrequency energy is applied to small sections of the tube.

Tony Kingsley, SVP of gynecological surgical products, told MassDevice the catheter delivers about 3 watts of energy for roughly 60 seconds in order to create a tiny, shallow lesion in the fallopian tube. A small, silicon matrix plug with a solid core is then inserted at the site to block ova from contact with sperm.

"That lesion stimulates a healing response from the body," Kingsley said. "The reaction of the tissue of the fallopian tube is to grow into and through the pores of the matrix and thereby occlude the tube. It's a clever and elegant technique. This is a less-than-12-minute procedure that can be done in the doctor's office."

The technique is fully effective after three months, as new tissue enfolds the implanted plugs. Patients continue to use birth control during that three-month period, until an X-ray confirms that the plugs are in place and working properly.

It's an alternative to tubal ligation, in which surgeons tie off the fallopian tubes; about 700,000 women have tubal ligations each year, according to Kingsley. In clinical trials, Adiana's efficacy rate was 98.4 percent after three years, he added (about 2 percent of tubal ligations fail).

"That's exciting data. No sterilization method is perfect," Kingsley said, adding that the cost of procedure itself will vary according to patients' insurance coverage ("In an office setting, it's conceivable the patient might have only the co-pay," he told us).

Kingsley said the treatment should be available within a few weeks, once Hologic has a chance to run participating doctors through what he called "a pretty rigorous training requirement."

The technique won CE Mark approval in the European Union earlier this year and has been available since about February there, he added.