Are Norplant’s days numbered in the U.S.? Test results could decide its fate

Use contraceptive backup for women with suspect implants

Look for the outcome of tests on suspect lots of Norplant implants to play a major role in the availability of the contraceptive method in the United States. Because the arsenal of contraceptives in the nation is already limited, compared with contraceptives available internationally, some family planning experts have expressed dismay at the possibility that Norplant might be removed from the market.

"Norplant is very popular in other parts of the world and widely used; it must be given more time to gain a market niche. I hope the company has the courage to continue supplying Norplant to American women," observes Sharon Schnare, RN, FNP, CNM, MSN, women’s health consultant and clinician with the Seattle King County Health Department in women’s and adolescent health care and the International District Community Health Center in Seattle. Some of Schnare’s patients are waiting for a shipment of Norplant for insertion.

Manufacturer Wyeth-Ayerst Laboratories in Philadelphia has been working with the Food and Drug Administration (FDA) to ensure that patients who may have the implants from the suspect lots are aware of the potential reduction in contraceptive protection.

Routine laboratory tests of the product’s shelf-life stability indicated lower-than-expected release rates of levonorgestrel in recently manufactured implants. The tests showed that implants from certain specified lots might not release enough levonorgestrel to deliver effective ongoing contraception. (Contraceptive Technology Update reported on Wyeth-Ayerst’s initial findings in its October 2000 issue, p. 117.) Some 22,000 kits were contained in the suspect lots, according to company estimates.

The investigation is expected to conclude in late October, reports company spokeswoman Audrey Ashby. Until that time, there are no additional Norplant system kits available for reinsertion, she says. "The resolution of this situation will have a significant impact on the decision of whether Wyeth will continue to market Norplant,’’ says Ashby.

Implant provides choice

Use of the implant lags behind other contraceptive methods in the United States. An analysis of a national survey indicates fewer than 2% of American women at risk of an unintended pregnancy rely on the implant for birth control.1

CTU readers also report low levels of Norplant use: More than 70% of those responding to the 2000 Contraception Survey said they had not performed any Norplant insertions in the last year, comparable to 1999 statistics. (See CTU, September 2000, for complete survey results.) The number of Norplant removals also remained consistent with 1999 figures; about 72% reported no removals, compared with 69.3% in 1999.

The number of women nationwide currently requesting Norplant implants is limited, agrees Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville and director of menopause and gynecology services at the Medicus Women’s Diagnostic Center in Jacksonville. However, providers are continuing to insert implants regularly at his institution, particularly in postpartum patients, he reports.

"If Norplant is removed from the U.S. market, the impact may not be great," says Kaunitz. "Nonetheless, Norplant is currently meeting the needs of certain women."

For many women, Norplant is the long-term solution when they want reliable, reversible contraception, says Susan Wysocki, RNC, NP, president and chief executive officer of the National Association of Nurse Practitioners in Women’s Health, based in Washington, DC. It would be unfortunate if Norplant were unavailable to women who want it, she notes.

Norplant was a very exciting product when first introduced, and the Population Council in New York City had worked long and hard on its development, reflects Allan Rosenfield, MD, dean of the Mailman School of Public Health, DeLamar Professor of Public Health, and professor of obstetrics/gynecology at Columbia University in New York City. The issue of removal, however, was never given the attention it needed, he notes. In 1994, complicated implant removals were the basis of the first lawsuit involving Norplant and the flood of media coverage and litigation that followed.2

After Norplant’s initial takeoff, when problems hit, the market for the method fell dramatically, states Rosenfield, who led a national committee on contraceptive research and development that examined the U.S. experience with Norplant. At this point, Norplant’s removal from the U.S. market would be unfortunate, but it probably would not have had a significant effect on contraceptive practice, he notes.

"There are a number of lessons to be learned, but it is most unfortunate that a major innovative and effective new approach to hormonal contraception may be lost to American women, despite the fact that it really is safe and equal to sterilization in effectiveness," Rosenfield asserts. "This latest blow probably will make it difficult for the company to continue its distribution."

Kaunitz says he looks forward to the availability of second-generation implants, including the single-rod Implanon, to become available in the United States. "Given the simplicity and insertion, the availability of easier-to-insert-and-remove systems like Implanon could perhaps increase patient and provider interest in contraceptive implants," he says. (See CTU, August 1999, p. 87, for information on Implanon, a 3-keto-desogestrel progestin product manufactured by Organon NV; Wyeth-Ayerst’s two-rod levonorgestrel implant; and the Population Council’s Nestorone subdermal contraceptive.)

Second advisory issued

Providers moved quickly to contact women with suspect implants after Wyeth-Ayerst distributed a second advisory Sept. 13. The letter recommended that all women who have suspect implants use an additional nonhormonal method of contraception until the company can determine the product’s effectiveness. The guidance is stronger than Wyeth-Ayerst’s initial letter issued Aug. 10, which advised backup contraception for those women with the suspect implants who would be considered at high risk if they became pregnant. When company officials realized the test results would be unavailable until late October, it issued the second letter as a precaution.

The FDA also issued an advisory "talk paper" on the subject that called for nonhormonal backup contraception for those with the suspect implants.3

All affiliates of New York City-based Planned Parenthood Federation of America were alerted of the second advisory letter the day it was issued, says organization spokeswoman Adina Wingate Quijada. "We’ve been following right along with the information that was directed from the first letter, and the second letter is just an amplification of the first letter," she notes.

How have affiliates dealt with the patient notification process? "The information we have received indicates that it has been absolutely consistent, smooth, and routine," she says.

Check your patient files for records of implant insertions beginning Oct. 20, 1999, to determine if any women received a kit from the specified lots of Norplant. If you are unable to ascertain the lot number, assume that any insertions performed on or after that date are from the suspect lots, Wyeth-Ayerst advises. If patients have implants that were inserted by another provider, contact them for the lot number and insertion date, the company instructs. Women who began using Norplant before Oct. 20, 1999, are not affected, and their Norplant implants remain effective, long-term contraceptives.

The company continues to recommend that there be no new insertions of Norplant implants from the following lots, which have expiration dates in January or February 2004:

• 3990729;

• 3990775;

• 3990776;

• 3993006;

• 3003127;

• 3003166;

• 3003355.

Facilities may return remaining implants from those lots to Wyeth-Ayerst. Providers may call the Norplant System Information Line at (800) 364-9809 for more on returning the product.

Patients with the suspect implants should be informed that they need to use a backup nonhormonal method of contraception until the company’s investigation is complete. Such types of backup contraception include condoms, spermicides, diaphragms, and intrauterine devices. Women who wish to receive financial assistance for backup contraception should call the Norplant System Information Line, which also is available to answer questions from health care providers, says Ashby.

Ashby says the company will pay up to $100 to women who request financial assistance for backup contraception. In addition, the company will reimburse women $700 if they wish to have the suspect Norplant removed, although Wyeth-Ayerst is not recommending removal yet, and the company says it has no reports of increased pregnancy rates among Norplant users.

References

1. Tanfer K, Wierzbicki S, Payn B. Why are U.S. women not using long-acting contraceptives? Fam Plann Perspect 2000; 32:176-183, 191.

2. Harrison PF, Rosenfield A, eds. Contraceptive Research, Introduction, and Use. Lessons from Norplant. Washington, DC: National Academy Press; 1998.

3. Food and Drug Administration. Talk Paper. Update of Advisory for Several Lots of Norplant Contraceptive Kits. Bethesda, MD: Sept. 13, 2000; T00-42.