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CNN article dated July 18th, 2006
SOURCE: CNN.COM
Choosing a method of birth control is a decision women can now make once a day, week or month. Starting later this summer, add "once every three years" to the list.
That's how long the latest birth control option should last. Called Implanon, it's a slender implantable rod that releases a pregnancy-preventing hormone into the body. It's meant for women seeking a long-term solution to birth control.
Implanon sales will begin in August or later, after doctors receive mandatory company training on how to implant it, according to manufacturer Organon USA Inc. The company announced Tuesday that federal regulators had approved it.
Once implanted, the matchstick-size rod should provide longer protection than any other hormonal contraceptives now sold here. The list includes the pill, patch, shot and vaginal ring.
It also will be the only implant currently available on the U.S. market and the first since Norplant. Wyeth Pharmaceuticals stopped selling Norplant in 2000.
Unlike Norplant and its six tiny rods, Implanon includes a single rod, just 1.5 inches long. Once injected under the skin of the upper arm, Implanon provides 99 percent contraceptive protection for up to three years.
Norplant worked for up to seven years, or four years more than Implanon. It also spawned lawsuits by women injured while having its six rods removed or disturbed by side effects. Another implant, a two-rod product called Jadelle, received Food and Drug Administration approval in 1996 but has never been sold in this country.
Implanon has been sold in more than 30 countries since 1998. More than 2.5 million women have used it, according to Organon.
That track record, along with the implant's single-rod design and the training doctors must receive before they can prescribe it to women, shouldn't lead to a repeat of the Norplant experience, said Dr. Scott Monroe, acting director of FDA's Division of Reproductive and Urologic Products.
The rod is inserted by a doctor in a quick surgical procedure that requires only a local anesthetic. It must be removed after three years, although it can be taken out at any time before then, according to the company, a unit of Netherlands-based Akzo Nobel NV.
Implanon releases a low, steady dose of progestin to prevent pregnancy. It may not work as well in women more than 30 percent heavier than their ideal weight, Monroe said.
The implant also can cause irregular bleeding and spotting. For some women, it can eliminate monthly periods altogether.
Progestin is a synthetic hormone that's similar to the progesterone made in the ovaries. The hormone can thicken the mucus in a women's cervix, preventing the union of sperm and egg. It also can prevent ovulation, or the release of an egg from the ovaries.
Implanon and all other hormonal contraceptives are associated with an increased risk of several serious side effects like blood clots. Smoking can further increase those risks.
That list includes a shot, called Depo-Provera, that provides three months of protection against pregnancy. Organon also makes a vaginal contraceptive ring, the NuvaRing, that must be replaced monthly.
Organon did not release the price of Implanon. Spokeswoman Frances DeSena said it would be competitive with other hormonal contraceptives.
Its availability will benefit women who want to skip the daily, weekly or monthly ritual associated with other birth control methods, said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.
CNN article dated July 18th, 2006
SOURCE: CNN.COM
Choosing a method of birth control is a decision women can now make once a day, week or month. Starting later this summer, add "once every three years" to the list.
That's how long the latest birth control option should last. Called Implanon, it's a slender implantable rod that releases a pregnancy-preventing hormone into the body. It's meant for women seeking a long-term solution to birth control.
Implanon sales will begin in August or later, after doctors receive mandatory company training on how to implant it, according to manufacturer Organon USA Inc. The company announced Tuesday that federal regulators had approved it.
Once implanted, the matchstick-size rod should provide longer protection than any other hormonal contraceptives now sold here. The list includes the pill, patch, shot and vaginal ring.
It also will be the only implant currently available on the U.S. market and the first since Norplant. Wyeth Pharmaceuticals stopped selling Norplant in 2000.
Unlike Norplant and its six tiny rods, Implanon includes a single rod, just 1.5 inches long. Once injected under the skin of the upper arm, Implanon provides 99 percent contraceptive protection for up to three years.
Norplant worked for up to seven years, or four years more than Implanon. It also spawned lawsuits by women injured while having its six rods removed or disturbed by side effects. Another implant, a two-rod product called Jadelle, received Food and Drug Administration approval in 1996 but has never been sold in this country.
Implanon has been sold in more than 30 countries since 1998. More than 2.5 million women have used it, according to Organon.
That track record, along with the implant's single-rod design and the training doctors must receive before they can prescribe it to women, shouldn't lead to a repeat of the Norplant experience, said Dr. Scott Monroe, acting director of FDA's Division of Reproductive and Urologic Products.
The rod is inserted by a doctor in a quick surgical procedure that requires only a local anesthetic. It must be removed after three years, although it can be taken out at any time before then, according to the company, a unit of Netherlands-based Akzo Nobel NV.
Implanon releases a low, steady dose of progestin to prevent pregnancy. It may not work as well in women more than 30 percent heavier than their ideal weight, Monroe said.
The implant also can cause irregular bleeding and spotting. For some women, it can eliminate monthly periods altogether.
Progestin is a synthetic hormone that's similar to the progesterone made in the ovaries. The hormone can thicken the mucus in a women's cervix, preventing the union of sperm and egg. It also can prevent ovulation, or the release of an egg from the ovaries.
Implanon and all other hormonal contraceptives are associated with an increased risk of several serious side effects like blood clots. Smoking can further increase those risks.
That list includes a shot, called Depo-Provera, that provides three months of protection against pregnancy. Organon also makes a vaginal contraceptive ring, the NuvaRing, that must be replaced monthly.
Organon did not release the price of Implanon. Spokeswoman Frances DeSena said it would be competitive with other hormonal contraceptives.
Its availability will benefit women who want to skip the daily, weekly or monthly ritual associated with other birth control methods, said Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America.
