Changes in store for sterilization method
The company responsible for developing the Essure non-incisional permanent birth control procedure is seeking approval from the Food and Drug Administration (FDA) to extend effectiveness data on the Essure product labeling.
The Essure method, approved by the FDA in November 2002, involves the use of a proprietary micro-insert device and catheter delivery system for minimally invasive transcervical tubal access. The supplemental FDA filing submitted by Conceptus of San Carlos, CA, supports an extension of Essure’s effectiveness to four and five years of follow-up. The procedure’s effectiveness is expected to be consistent with the 99.8% effectiveness rate currently claimed at three years of follow-up, according to the company.
The FDA is reviewing the amendment, says Ed Sinclair, Conceptus’ vice president of clinical research and regulatory affairs. Action on the request is expected soon, he states.
The Essure procedure relies on the placement of a soft micro-insert into the fallopian tube through the cervix using a minimally invasive transcervical tubal access catheter. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion in the fallopian tube. The procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. A woman is able to return home about 45 minutes after the procedure is completed. Women must use backup contraception for three months, when a hysterosalpingogram evaluation ensures that both of the micro-inserts are in the correct location and that both tubes are blocked.
According to John Kerin, MD, PhD, professor of reproductive medicine at Flinders University and director of reproductive medicine at Flinders Medical Centre, both based in Adelaide, Australia, the Essure method’s advantages include:
- No need for general anesthetic.
- No need for incisions.
- Rapid recovery and minimal inconvenience.
- Ability for the patient to observe the procedure with the clinician on a video screen.
- Much lower risk procedure than a laparoscopic procedure.
Kerin presented information on hysteroscopic sterilization’s long-term safety and efficacy at the Washington, DC-based American College of Obstetricians and Gynecologists’ (ACOG) May 2005 annual clinical meeting in San Francisco.1 He has served as an investigator in Essure’s clinical trials.2-4
Sterilization is a leading form of contraception; 11 million U.S. women ages 15-44 years of age rely on it for birth control.5 Of the estimated 750,000 tubal sterilization procedures performed each year in the United States, half are performed postpartum and half as ambulatory interval procedures.5 The Essure method is non-reversible; providers should factor that information into their counseling on sterilization options.
See reimbursement rules
Effective January 1, 2005, physicians performing the Essure procedure in a hospital, ambulatory surgical center, or an office setting may use CPT Code 58565. Physician RVU’s when performed in a facility have been set at 12.11 and when performed in an office at 57.77. With a Medicare 2005 conversion factor of $37.8975 per RVU, this results in a Medicare national average payment of $458.94 when performed in a hospital and $2,189.34 when performed in a physician’s office. Commercial carriers may defer to these payment levels when negotiating their own physician fee schedules for the procedure.
Have the new code values proven helpful to physicians? Yes, says Carla Monacelli, senior director of health affairs at Conceptus.
"Medicare has set a national average of $2,189.34, which commercial payers use as a benchmark," she says. "This removes some of the uncertainty that is common with an unlisted code."
More physicians are beginning to look at adding the procedure to their practices; Conceptus reports that it enrolled 168 physicians into its U.S. Essure preceptorship program during the first quarter of 2005, which brought the total number of U.S. physicians that perform the Essure procedure to 1,849. The company also supported two postgraduate courses at the 2005 ACOG meeting and educated some 160 physicians about use of the hysteroscopic approach in gynecology practices.
References
- Kerin JF. Hysteroscopic sterilization: long term safety & efficacy. Presented at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. San Francisco; May 2005.
- Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol 2001; 41:364-370.
- Kerin JF, Cooper JM, Price T, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod 2003; 18:1,223-1,230.
- Cooper JM, Carignan CS, Cher D, et al. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol2003; 102:59-67.
- Westhoff C, Davis A. Tubal sterilization: focus on the U.S. experience. Fertil Steril 2000; 73:913-922.
Resources
For more information on Essure, contact:
- Conceptus, 1021 Howard Ave., San Carlos, CA 94070. Telephone: (877) ESSURE1 [(877) 377-8731]. Web: www.essure.com or www.conceptus.com.
- The Washington, DC-based Association of Reproductive Health Professionals (ARHP) has focused on transcervical sterilization in three of its publications. Review its monograph, Clinical Update on Transcervical Sterilization; go to ARHP’s web site, www.arhp.org. Highlight "Healthcare Providers," "Online Publications," and "Clinical Proceedings," then click on the publication title. Also look at the patient education brochure, Questions and Answers About Transcervical Sterilization. From the home page, highlight "Patient Education," "Online Brochures," then the publication title. See the April 2003 edition of ARHP’s Health & Sexuality magazine, which focused on transcervical sterilization. From the home page, click on "Healthcare Providers," "Online Publications," "Health & Sexuality," then the publication title, Transcervical Sterilization: A Breakthrough in Expanding Options for Women.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content