Inaccurate data may sway choices when it comes to intrauterine devices

Push is on to dispel the myths surrounding IUDs

You are discussing contraceptive options with a patient. When you come to intrauterine devices (IUDs), she dismisses the method and says that it can lead to an ectopic pregnancy. Where did she get such misinformation?

Look to the Internet. According to the results of a recent survey of consumer and provider web site, many sites carry inaccurate or outdated information: Half of the sites surveyed depict the IUD as increasing the risk of pelvic inflammatory disease (PID) (not just in the first few weeks), two-thirds say the device heightens ectopic pregnancy risk, and one-fourth of the sites portray use of the method as an infertility risk. 1

Efforts are needed to improve the quality of information available to women about their contraception options, says Kirsten Moore, MPA, president of the Washington, DC-based health advocacy organization Reproductive Health Technologies Project (RHTP) and co-author of the article that discussed the survey results. This effort particularly is needed when it comes to intrauterine devices, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville.

"IUDs continue to America’s best-kept contraceptive secret," he observes. "Too few women recognize that the copper and levonorgestrel devices are completely reversible, with efficacy comparable to that of surgical sterilization."

Look for ParaGard push

Get set to see more information on one IUD option, the Copper T 380A IUD, marketed until late 2003 as the ParaGard Intrauterine Copper Contraceptive by Ortho McNeil Pharmaceutical of Raritan, NJ. The device’s longtime U.S. manufacturer, FEI, has now secured the U.S. marketing rights from the New York City-based research organization, the Population Council, and plans an extensive patient and provider campaign to advance education of the IUD.

The Copper T 380A, approved for contraceptive use up to 10 years by the Food and Drug Administration (FDA), is the most widely available IUD in the world. FEI has manufactured and supplied more than 65 million Copper T 380A contraceptives for women around the globe.

"FEI’s ownership and management view the ParaGard intrauterine contraceptive as a dramatically underutilized method, given the broad range of benefits it offers and its advantages relative to women’s other birth control alternatives," says Fred Studier, FEI’s president and chief executive officer. "FEI is in the process of investing heavily to educate consumers, health care providers, and payers about the product and its benefits, and to remove barriers to more widespread use of the product."

The Copper T 380A was codeveloped by the Population Council and FEI in the 1970s; the company, which operates offices in El Segundo, CA, North Tonawanda, NY, and New York City, has been the exclusive U.S. manufacturer of the device since 1984. The Population Council announced the sale of the device’s New Drug Application to FEI for an undisclosed sum in November 2003.

"We are confident that FEI will work to increase awareness of this contraceptive in the medical community and among women who have never before considered using the Copper T 380A to manage their fertility," says Sandra Arnold, vice president of corporate affairs for the Population Council.

FEI plans new approach

FEI has worked closely with Ortho to ensure a smooth transition, says Studier. The company assumed full responsibility for marketing and distributing ParaGard as of Jan. 1.

"As of January 2004, the price of ParaGard will remain unchanged from the current Ortho-McNeil pricing," states Studier. "FEI will introduce a direct-to-consumer credit card payment program and pricing for this new program." 

The product will continue to be branded as ParaGard, says Studier. The company is investing heavily in sales and marketing, including building a ParaGard-dedicated institutional sales force and developing continuing medical education curriculum to train and educate a range of new providers, he states.

Mirena makes inroads

American providers currently have two options when it comes to intrauterine contraception: the ParaGard T 380A, and the Mirena levonorgestrel intrauterine system (IUS) marketed by Berlex Laboratories of Montville, NJ. (Editor’s note: Take a look at a comparison chart of the two devices. Visit CTU’s web site, www.contraceptiveupdate.com, and click on "Toolbox" for the fact sheet. Your user name is your subscriber number from your mailing label. Your password is ctu [lowercase] plus your subscriber number [no spaces].)

The Mirena received FDA approval in December 2000. 

While the Mirena is approved for use up to five years of contraception, its noncontraceptive benefits are encouraging some women to consider IUD use, says Kaunitz.

Recently published research indicates that the levonorgestrel IUS reduces menstrual bleeding associated with uterine fibroids.2 Use of the IUS use was associated with significant reduction in menstrual blood loss and an improvement in hematologic parameters during a 12-month study among women with small leiomyomatous uteri.2

The Mirena and the ParaGard represent cost-effective methods of contraception. When used for five years, a new analysis shows that the three least costly methods are the levonorgestrel-releasing IUS, the Copper T 380A IUD, and the three-month injectable (depot medroxyprogesterone acetate, DMPA, Depo-Provera, Pharmacia Corp., Peapack, NJ), with total five-year costs per person of $1,646, $1,678, and $2,195, respectively. The five most effective methods, based on success rates, are tubal ligation (99.7%), the IUS (98.9%), the IUD (98.5%), DMPA (98.3%), and oral contraceptives (96.2%).3

Number of insertions up

More providers are reporting interest in intrauterine contraception, according to results from the 2003 CTU Contraception Survey. The number of providers reporting no insertions dropped to 39.5%, down from 2002’s 45% level. A little more than 15% of survey participants said they had inserted 11-15 devices, which is up from the 9.9% reported in 2002. Device removals rose slightly from 2002 numbers; 59% of survey respondents reported they had removed one to five devices in 2003, compared to 54% in 2002.

Since performing its Internet survey, RHTP has been in contact with web sites and offered them updated information to ensure that correct material is posted about intrauterine contraception, says Moore. A fact sheet, which provides key points about the method, has been distributed. (Editor’s note: Use the fact sheet to educate your patients; visit CTU’s web site, www.contraceptiveupdate.com, and click on "Toolbox" for the fact sheet.)

In talking with women about the myths and misinformation about the IUD, remind them that the Internet can be a source of confusing and inconsistent health information. Provide them with trusted sources of Internet information.

The survey should remind providers that a discerning eye and search for consistency are requisite elements in surfing the web, says Michael Rosenberg, MD, MPH, clinical professor of obstetrics and gynecology and adjunct professor of epidemiology at the University of North Carolina at Chapel Hill and president of Health Decisions, a private research firm specializing in reproductive health.

"Of greatest concern is that a disturbingly high proportion of information presented is incorrect — in this survey, one-quarter of sites oriented to consumers, those who most need it and are least qualified to plow through a complex and demanding medical literature," notes Rosenberg. "Material can be attractively presented and well written, but caveat emptor: Euphonious phrases may fall far from fact."

(Editor’s note: Have your patients obtained inaccurate information from the Internet about contraceptives or sexually transmitted diseases? If so, please share that information with your peers. Go to www.contraceptiveupdate.com. Click on "forum." See message titled "Inaccurate information on the Internet.")

References

1. Weiss E, Moore K. An assessment of the quality of information available on the Internet about the IUD and the potential impact on contraceptive choices. Contraception 2003; 68:359-364.

2. Grigorieva V, Chen-Mok M, Tarasova M, et al. Use of a levonorgestrel-releasing intrauterine system to treat bleeding related to uterine leiomyomas. Fertil Steril 2003; 79:1,194-1,198.

3. Chiou CF, Trussell J, Reyes E, et al. Economic analysis of contraceptives for women. Contraception 2003; 68:3-10. 

Resources

For ParaGard direct ordering information, contact:

FEI, 4006 Beltline Road, Suite 100, Addison, TX 75001. Telephone: (800) 322-4966. Fax: (800) 299-8332. E-mail: info@fei-womenshealth.com. Web: www.fei-womenshealth.com.