Sterilization update: Two options now approved as transcervical procedures
Sterilization update: Two options now approved as transcervical procedures
Adiana a choice for minimally invasive, nonincision sterilization
Women who want a permanent form of birth control now have a new option. The Food and Drug Administration (FDA) has approved the Adiana permanent contraception system, manufactured by Hologic of Bedford, MA.
"While tubal ligation is the most common form of permanent contraception used throughout the world, hysteroscopic procedures such as those employing the Adiana permanent contraception system enable women to choose lifetime protection from pregnancy without the risks of general anesthesia and the longer recovery periods associated with traditional sterilization procedures," says Ted Anderson, MD, PhD, associate professor of obstetrics and gynecology at Vanderbilt University in Nashville, TN, and clinical investigator of the pivotal clinical trial for the Adiana system. "The Adiana procedure is a safe and simple alternative that not only provides patients with peace of mind in preventing pregnancy, but also leaves nothing in the uterus that might limit women's options for future gynecologic tests and procedures."
To perform an Adiana procedure, a catheter is positioned immediately inside the opening of the patient's fallopian tube using a hysteroscope. The catheter applies a low level of bipolar radiofrequency energy to remove a thin layer of cells inside the fallopian tube, then delivers a soft polymer matrix to the site that remains within the prepared section of the tube. The procedure is then repeated on the other fallopian tube. A hysterosalpingogram is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked blocked by the tissue ingrowth and matrix, and that the woman can begin relying on the method for permanent contraception.
The procedure is most appropriate for women who are sure about their decision to use a highly effective permanent contraceptive method, don't want to undergo an abdominal/surgical procedure, are concerned about safety, need to get back to normal activities or work quickly, and recognize the appeal of having an office-based procedure, says Amy Pollack, MD, MPH, senior lecturer in the Mailman School of Public Health at the New York City-based Columbia University. Pollack is former chief medical officer for Adiana and current consultant for Hologic. (See patient exclusion criteria, left .)
The method joins Essure (Conceptus; Mountain View, CA) as a sterilization option. The Essure procedure involves the use of a soft micro-insert that is placed into the fallopian tubes through the cervix using a hysteroscope. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the tubes over a three-month time period. A hysterosalpingogram (HSG) must be performed after 12 weeks to determine tubal occlusion.
Both options in transcervical sterilization have moved female sterilization from a minimally invasive laparoscopic technique, which requires entry into the abdominal cavity, to a less invasive hysteroscopic procedure, states a 2009 review of the Adiana and Essure procedures.1 With their decreased potential for complications, and ease of performance with minimal anesthesia, the two methods now allow physicians to move such procedures from the operating room to the office.
Review the research
To demonstrate the safety and effectiveness of Adiana, researchers recruited 770 women with known parity to participate in a prospective, multicenter study. Overall, bilateral placement success was achieved in 611 of 645 women (95%). Bilateral occlusion was confirmed in 570 of 645 (88.4%). The one-year pregnancy prevention rate as derived with life-table methods was 98.9%.2
Investigators contacted 625 women in the clinical study after one year and reported the following side effects that might be related to the Adiana procedure: cramping unrelated to menstrual periods (6%), painful menstruation (5%), vaginal bleeding (4%), pelvic pain (3%), back pain (3%), vaginal spotting (1%), painful sexual intercourse (1%), headache (1%), unusually heavy or long-lasting nausea (1%), and menstrual periods (1%).3
Adiana and Essure, in terms of their safety profile, are almost exactly alike, notes Pollack. Their safety profiles, as presented to the FDA during the regulatory process and the approval process, were comparable in terms of patient satisfaction, ease of use, and complication rates, Pollack says. Whereas Essure reported efficacy approaching 100% in its pivotal trial, and Adiana reported just more than a 1% difference, this small gap closes when providing sterilization for women in the United States, whose fertility is beginning to decline at the average age of sterilization, says Pollack.
To help physicians get up to speed with the Adiana procedure, Hologic offers a three-part training program, explains Tony Kingsley, senior vice president of gynecological surgical products. The first section is a didactic, which can be delivered online, through a physician speaker, or through a company sales representative. The second section is a hands-on training with an inanimate model to allow the physician to become comfortable with the equipment used to perform the procedure. The final section includes the completion of three proctored procedures to ensure the physician is capable of safely and effectively performing the procedure.
Physician and patient information materials on the method are available at Adiana's dedicated web site, www.adiana.com. The company is scheduled to present information at the Nov. 15-19, 2009, meeting of the Global Congress of Minimally Invasive Gynecology in Orlando, FL, sponsored by the American Association of Gynecologic Laparoscopists.
As office-based procedures, Essure and Adiana represent cost-effective options to tubal sterilization.1
"The outpatient office-based nature of transcervical female sterilization with Essure gives this method a very favorable cost profile as compared with other methods," states the 2009 review of the transcervical methods. "Taking into consideration the cost related to the initial purchase and upkeep of the required equipment, it appears that Adiana will be similarly or slightly less economically efficient than Essure."
Most insurance plans will cover the Adiana procedure; however, women should check with their insurance providers for confirmation. Participating insurance companies list the procedure as hysteroscopic sterilization, CPT 58565. According to Adiana's patient information, some plans will cover only part of the cost of the procedure; in addition, the amount of the copay might vary depending on where the procedure is performed, such as in a physician's office or at an outpatient clinic.
It always is good news when a safe and effective contraceptive option becomes available to women, Pollack says. "Adiana is a safe, effective transcervical method," she reports. "Now that there are two different transcervical methods available to women in the U.S., we should see a faster-paced transition from laparoscopic surgical methods to those more easily provided in the office and using local anesthesia."
References
- Palmer SN, Greenberg JA. Transcervical sterilization: A comparison of Essure™ permanent birth control system and Adiana™ permanent contraception system. Rev Obstet Gynecol 2009; 2:84-92.
- Vancaillie TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices. Obstet Gynecol 2008; 112:1,270-1,277.
- Hologic. Adiana Permanent Contraception Patient Information Booklet. Accessed at www.adiana.com/pdf/info/adiana-patient-information-booklet.pdf.
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