Adiana Permanent Contraception

Adiana [mostly] Permanent Contraception has recently been approved by the FDA. In case you're considering tubal sterilization as your method of birth control, here's a very good animation of the Adiana process.



And if you're considering permanent contraception, don't forget about Essure, another type of [mostly] permanent birth control. Here's the Essure animation (with bonus sperm, I might add).

Essure Permanent Birth Control

Photo via

Of course, there is another choice for couples who don't want to take any chances [with female sterilization]--right, gents? But twice as many married women as married men in the U.S. get sterilized. "I would've gotten a vasectomy, if that's what she wanted," says Theresa Jackson's husband Mike. "But then we talked about Essure," he says. "And I'm a sissy."

More on Essure and Adiana (also, here).

FDA Recommends Adiana Approval

In a a vote of 10 to 3 the FDA's Ob/Gyn specialty panel recommended that the pre market application for Adiana(R) Permanent Contraception for female sterilization is Approvable.

Adiana

Photo via Ob.Gyn. News

If you recall, Adiana is a new female birth control method in the Sterilization group, a novel, two-step approach to permanent contraception. Here's how it works:

First, a catheter is positioned immediately inside the opening of the patient's fallopian tube using a hysteroscope, eliminating the need for any incisions. The catheter applies a very low-level of bi-polar radiofrequency (RF) energy to remove just a thin layer of cells that line a 1cm section of the inside of the fallopian tube. The catheter then delivers an implantable, soft polymer, called a "matrix," which remains within the prepared section of the tube. The matrix is smaller than a grain of rice. The procedure is then repeated on the other fallopian tube. Healthy tissue will grow into the matrix, creating a complete blockage of each tube. A confirmatory dye test called a hysterosalpingogram (HSG) is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked and that the woman can begin relying on Adiana for permanent contraception.

Adiana Sterilization System

Adiana

Adiana, a new transcervical sterilization system, is performing well in phase III studies:

Adiana in situ

Photos via Ob.Gyn. News

The Adiana transcervical sterilization system appears to be easy to use, safe, and effective, according to phase III data, Alan Johns, M.D., reported at the annual meeting of the AAGL.

The Adiana Complete system is available only for experimental use, but U.S. Food and Drug Administration submission is anticipated in mid-2006, said Dr. Johns, one of the clinical investigators in the trial.

The FDA approved Essure, currently the only nonincisional approach to female sterilization, in November 2002. The Adiana system "is the next step in the evolution of hysteroscopic devices," Dr. Johns said in an interview. It may be better than the Essure simply because it doesn't require as much manipulation and the whole device is altogether shorter and easier to put in and cannulate, he said. "More importantly, in contrast to the Essure system, after the Adiana matrix has been deployed, nothing remains in the endometrial cavity."

This may be important in women who later choose to undergo in vitro fertilization or endometrial ablation, because these options can be limited by the presence of a portion of a device in the endometrial cavity, he said.

The Adiana system also differs from Essure in that it uses radio frequency energy before placement of the polymer matrix in the fallopian tubes. This process is designed to stimulate vascularized tissue ingrowth into the matrix material, said Dr. Johns of Fort Worth, Tex. He accepted payment to enroll and treat patients in the trial but said he has no financial interest in Adiana Inc.

As of Sept. 30, 2005, the Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women (EASE) study had enrolled 770 women at 16 sites. Almost half (47%) were aged 28‚–33 years. A total of 655 patients were taken for hysteroscopy, and 10 were excluded for hysteroscopic findings. The remaining 115 patients either withdrew from the study or were excluded from the study protocol.

Treatment was attempted in 645 patients and bilateral placement was achieved in 614 (95%).

This placement rate is comparable with that attained by Essure in its clinical trials, he said. Lateral location of the ostia is the most common reason for failure of placement of hysteroscopic sterilization devices.

The average procedure time from insertion to removal of the hysteroscope was 12 minutes. Local and oral anesthesia was used in 35% of patients, local anesthesia plus intravenous sedation in 48%, and local plus intravenous analgesia in 17%. Nine patients were lost to follow-up or are awaiting 3-month hysterosalpingogram (HSG).

Failure of tubal occlusion occurred in 26 (4.29%) women, and there were two pregnancies. One occurred after proper placement of the device and HSG confirmation of occlusion. The second occurred when a physician misinterpreted the HSG and retreated the patient but placed the device in the occluded tube instead of the patent tube. There were no device-related significant adverse events. One procedure-related incident of hyponatremia was reported. All other events were minor and included spotting, cramping, and headache.

Here is a good review, from 2003, of transcervical birth control methods in the U.S. pipeline.

Update: The Essure site.