July 18, 2006
New implantable contraceptive for women gets go-ahead
By Susan Heavey and Lisa Richwine
WASHINGTON (Reuters) - A new matchstick-sized contraceptive
that doctors insert in a woman's upper arm for as long as three
years won U.S. clearance on Tuesday, six years after an earlier
birth-control implant came off the market.
Once a doctor inserts the Implanon device under the skin, a
single rod releases a synthetic progesterone hormone each day
to block the release of an egg from the ovaries, maker Akzo
Nobel NV said.
Studies of 923 women suggested Implanon was 99 percent
effective at preventing pregnancy, Food and Drug Administration
officials said. Fertility returned quickly after the rod was
removed, sometimes within 30 days, said Dr. Scott Monroe, FDA's
acting director of reproductive and urologic products.
Eleven percent of women had Implanon removed because of
irregular menstrual bleeding. Some women may have no menstrual
period at all while using Implanon, Monroe said.
Implanon's approval follows Wyeth's withdrawal in 2000 of
the controversial Norplant contraceptive after tests found
thousands of implants may have been faulty.
Fewer problems should be reported with Implanon because it
involves implanting only one rod rather than Norplant's six,
and it is inserted less deep in the skin, Monroe said. Many
Norplant complaints involved insertion or removal of the rods.
FDA reviewers also were reassured by the experience with
Implanon in more than 30 countries, Monroe said. More than 2.5
million women worldwide have used Implanon, according to Akzo.
The company has promised to allow only doctors with
training in how to insert and remove Implanon to prescribe it.
"All of this we think will lead to less problems" than with
Norplant, Monroe said.
Amy Allina, policy director for the National Women's Health
Network, said "Implanon is an attempt to go back and do it
right this time."
Allina and representatives of other women's groups also
welcomed the device as another option for family planning but
stressed women need information upfront about the device,
"As long as women can change their mind, it's OK," said
National Organization of Women Vice President Olga Vives.
Training in how to insert Implanon will start later this
year and it should be more widely available in 2007, the
Women and doctors are advised to rub the skin to make sure
the implant is there after the insertion procedure.
Like other hormonal contraceptives, Implanon may increase
the risk of blood clots. Other hormone-based methods available
in the United States include birth control pills, a skin patch,
a ring inserted into the vagina and a shot given every three
Representatives of Organon, Akzo's human health unit, said
longer-term contraceptive methods are growing in popularity in
the United States, offering potential for Implanon.
"With an injectable, you still have to go back to the
health care professional every month or every three months,"
said a spokeswoman for the company, which has not yet set a
Rabo Securities, in a research note, said they expected
U.S. Implanon sales to peak at 100 million euros ($1.25
Akzo Nobel stock closed down 65 cents, or 1.3 percent, at
$50.56 on the Nasdaq.
($1= .7979 Euro)
(Additional reporting by Niclas Mika in Amsterdam)