Medical Device Daily

Women now have a new choice in contraceptives: a single-rod implant called Implanon by Organon (Roseland, New Jersey), approved by the FDA last week.

Organon said it is the first and only single-rod implantable contraceptive that is effective for up to three years. Implanon was first approved for use outside the U.S. and has been used and marketed – with about 2.5 million implants thus far – in 30 countries since 1998.

“Implanon, based on the clinical trial data and our review of postmarketing data from other countries outside the U.S., is a highly effective contraceptive that importantly does not depend on patient compliance,” said Scott Monroe, MD, acting director, Division of Reproductive and Urologic Products, Center for Drug Evaluation and Research at the FDA, in a teleconference for media early last week.

Implanon continually releases a “low, steady dose” of a progestin, called etonogestrel, for a period of up to three years via Organon's technology, the company said.

An Organon spokeswoman told Medical Device Daily that the company expects it to be “another option” for women, in addition to existing contraceptive options ranging from sterilization to a weekly birth control patch worn externally on the skin.

“This allows the ability to have another option in your life, and it's not self-administered,” she said. “The doctor does it, so your confidence is that it's working and efficacious, and that there's no compliance issue there. You don't have to remember something every day. This is a benefit for some women.”

It is, Monroe said, “the only long-term implantable product available in the U.S.” Some years ago, a contraceptive for women called Norplant was on the market, which required an implant of six rods and was effective for up to five years.

However, the company that made Norplant ultimately stopped marketing it after one of its suppliers stopped providing an essential component and the replacement from another company was not acceptable, Monroe said (Medical Device Daily, July 30, 2002). Also in contrast to Norplant, there is a great deal of postmarketing data on Implanon.

Implanon is about the size of a matchstick and is made of a “soft medical polymer,” Organon said, inserted into the upper inner portion of the arm. Monroe noted that it does require a minor surgical procedure that can be accomplished in a physician's office with a local anesthetic both to implant the device and to remove it.

“Labeling for Implanon clearly describes the procedure for insertion and removal,” Monroe told listeners during the teleconference. “The labeling stresses what we think are some of the most important aspects of effective use of the product.”

For example, it includes a bolded warning that advises the healthcare provider to “palpate the skin over the insertion site” to ensure that the implant has been properly inserted.

“This is obviously critical for the product to be effective,” Monroe said. “If it can't be palpated, the woman is advised to not depend on Implanon for prevention until it can be localized by another method – ultrasonography or another procedure.”

And because it is implantable, it is also a “discreet” method of birth control.

The Organon spokeswoman also said that should a woman decide during the three-year implantation period that she would like to become pregnant, the implanted device is simply removed.

“They can have it taken out, and their fertility will quickly return back to what it was before taking it,” she said. “So, it . . . does not interfere with your current fertility status. It doesn't make you more or less fertile; it just brings you back to whatever you were before [the implantation].”

Women must be counseled on the product profile to ensure that it does, in fact, fit their lifestyle. The product will contain an information brochure for patients, Monroe said, as well as a consent form that patients must sign, indicating that they have been informed of the product's benefits and risks.

Offering a case of lessons learned from the Norplant experience, Monroe said that a card indicating which arm the implant was inserted will be placed with the patient's medical records, in the event she forgets and goes to another physician for removal.

That card will also contain the manufacturing lot number, so that in the event of a recall, the patient can be notified if she has one of the affected device and have it removed.

However, Monroe said that the “principal clinical trials” evaluated the safety and effectiveness of the product in 942 reproductive-age healthy female subjects. Safety and efficacy data were collected during more than “24,000 28-day treatment cycles.”

In the principal clinical trials, there were “only six pregnancies that occurred either just before removal or within two weeks of removal” of the device.

“Two of these pregnancies occurred during one year of use, two occurred during year two of use, two occurred during year three of use, indicating there's no loss of effectiveness over this three-year period,” he said.

Monroe said: “We feel postmarketing data is consistent with the clinical trial database, which supports our decision that Implanon will be a safe and effective product for those women who find it in line with what they would want in a [contraceptive].”