While suspect Norplants were found safe, implant won’t be reintroduced
Rewind to August and September 2000: Two manufacturer’s advisories caution that certain lots of Norplant implants may be ineffective and alert clinicians to provide backup contraception for women using the suspect kits. Shipments of the product are suspended while effectiveness testing is conducted.
Fast-forward to July 2002: An announcement informs providers that the suspect lots have been found effective, and there is no need to use backup contraception. However, due to what the manufacturer, Wyeth Pharmaceuticals of Madison, NJa, terms "limitations in product component supplies," the Norplant System will not be reintroduced in the United States. (See "Check Norplant stock, company says: Recent batches might be ineffective," Contraceptive Technology Update, October 2000, p. 117, and "Are Norplant’s days numbered in the U.S.? Test results could decide its fate," November 2000, p. 129.)
Before you cross implants off the contraceptive options list, however, know this: Organon of West Orange, NJ, plans to submit its New Drug Application to the Food and Drug Administration (FDA) for its single-rod implant Implanon in the fourth quarter of 2002, and Wyeth is planning to make its two-rod levonorgestrel implant available in the United States.
Overcoming the barriers
Properly introduced, the implant technology still has great potential, says Allan Rosenfield, MD, dean of the Mailman School of Public Health and DeLamar professor of public health and obstetrics/gynecology at Columbia University in New York City. However, reintroduction of contraceptive implants in the United States will be a difficult task due to the Norplant experience, he notes.
"It certainly has not been easy getting [intrauterine devices] the kind of acceptance and use they deserve, with the Dalkon Shield experience still present so many years later," comments Rosenfield, who led a national committee that examined the U.S. experience with Norplant.
He says the key to successful implant reintroduction will be a careful marketing strategy, first implemented in family planning clinics in both medical school settings and in Planned Parenthood and other public programs, then with private clinicians through the normal channels of continuing education and marketing visits.
"I would focus on the available data on the single- and two-rod implants, the ease of insertion and removal, and the fact that these are new innovations, based on, but different from, the older six-rod Norplant system," suggests Rosenfield. "I would make absolutely certain that clinicians are well trained both to insert properly and to remove the devices."
Thorough training will be crucial, agrees Paul Blumenthal, MD, associate professor of obstetrics and gynecology at Johns Hopkins University in Baltimore. Manufacturers will need to create "new identities" for these products when marketing them, he says.
"In essence, it will be necessary to distance’ the new products from the old one, while at the same time capitalizing on some of the positive features of Norplant: safety, acceptability/satisfaction and effectiveness," states Blumenthal.
Organon, which has launched Implanon in many European countries as well as in Australia and Indonesia, is developing programs to educate and train U.S. clinicians, states Nancy Alexander, PhD, director of contraception. (See "Contraceptive implants: Single-rod Implanon headed to United States," CTU, June 2002, p. 61.)
"We view this as an important and necessary effort so that those health care providers who will be offering the method are competent and proficient in both insertion and removal," reports Alexander. "We also are developing materials for potential patients so that they understand the advantages and drawbacks of this contraceptive choice."
Check insertion device
One of the real benefits of Implanon to the clinician and patient lies in its ease of insertion, says Edio Zampaglione, MD, Organon’s associate director of contraception. No incision is necessary, and the average time for insertion is just over one minute, he reports. The key? Look to the disposable applicator, an insertion device with a beveled needle on one end in which the Implanon implant is preloaded. This eliminates any contact with the implant prior to insertion, thus minimizing the chance of contamination, says Zampaglione.
The needle is inserted at an approximate 20-degree angle in the upper inner arm between the biceps and triceps. Once the skin is penetrated, the clinician tents up the skin and gently advances the insertion device until the needle end is completely inserted. The opposite end of the device is turned about 90 degrees. The needle is gently withdrawn, resulting in the Implanon rod being left in the tunnel that was created by the needle, explains Zampaglione. After insertion, the clinician palpates Implanon to confirm correct placement, and the puncture site is covered with a butterfly bandage.
"The major differences between Implanon insertion and its predecessor are there is only one rod to insert, it comes preloaded in a disposable applicator device, and that no incision is necessary for insertion," he explains.
The timeline for the U.S. introduction of the two-rod contraceptive implant has not been established, says Wyeth spokeswoman Natalie de Vane. The method was originally developed by the New York City-based research organization, the Population Council.
"At this time, we are currently working on plans to make the two-rod levonorgestrel implants available," she says. "This process involves several commercial and regulatory actions."
FDA approval for the two-rod implant was issued in 1996; however, it has not yet reached the U.S. commercial market. Marketed elsewhere as Jadelle, the method is approved for five years in Finland and other European countries, and it is approved for three years in Indonesia and Thailand. The FDA initially approved the two-rod implant for three years’ use; in July 2001, the agency sent an approvable letter for extension of use to five years, according to the Population Council.
Norplant support on tap
What is Wyeth doing to support providers and women with Norplant implants? Wyeth issued provider letters on July 26, 2002, and stated that backup contraception is no longer needed for patients who were using Norplant kits from lots distributed beginning Oct. 20, 1999, with expiration dates in 2004. However, women who are using condoms for protection against sexually transmitted diseases should continue to use them.
In its communication, Wyeth included an information sheet that could be sent to women using the affected product to inform them that backup contraception was no longer necessary to prevent pregnancy. Wyeth will pay for backup, barrier, or other nonhormonal methods of contraception until Dec. 31, 2002.
In addition, health care providers and patients can call the toll-free Norplant System Information Line, (800) 364-9809, which operates weekdays during business hours, says de Vane.
Since Norplant will no longer be available, women will need to consider other contraceptive options as they approach the five-year expiration dates of their implants, according to information included in the July 26, 2002, letter. If patients would prefer to have the Norplant capsules removed, Wyeth will pay for removal procedures until Dec. 31, 2002, the letter states.
Remember that recently published research conducted in seven countries indicates that Norplant is safe and highly effective for seven years for women whose weight is less than 154 pounds, two years longer than the five-year period approved in the U.S. product labeling,1 says Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance.
Reference
1. Sivin I, Mishell DR, Diaz S, et al. Prolonged effectiveness of Norplant capsule implants: A seven-year study. Contraception 2000; 61:187-194.
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