Jan 9 U.S. regulators on Wednesday approved a
new low-dose hormone intrauterine device designed to prevent
pregnancy, the first new device of its type in 12 years,
according to Bayer AG.
The T-shaped polyethylene device is designed to prevent
pregnancy for 3 years, during which time it releases a
diminishing dosage of progestin, according to Bayer documents.
The proportion of women using long-acting reversible
contraceptive methods such as an intrauterine device (IUD)
climbed to 7.7 percent in 2009 up from 2.0 percent in 2002,
according a 2012 study by the Guttmacher Institute, a
reproductive health and rights organization based in New York.
The highest level of use was among women aged 25-39 and
those who already had at least one child.
The IUD, called Skyla, is aimed at younger women who have
not had children. During a trial of 1,432 women aged 18 to 35
years, the rate of pregnancy over a three-year period was 0.9
per 100 women, and 77 percent of women wishing to become
pregnant did so within 12 months of its removal, Bayer documents
"Over half of all pregnancies in the U.S. are unintended and
there's just a need out there to have effective birth control,"
said Pamela Cyrus, Bayer's head of medical affairs said in an
Bayer makes one of the two other IUDs available on the U.S.
market, Mirena. It is designed for use for women who have
already had children.
Bayer will launch Skyla in the United States starting next
month. It is still seeking other regulatory approvals outside
the United States. Its side effects include bleeding pattern
alterations, vulvovaginitis, abdominal/pelvic pain,
acne/seborrhea, ovarian cyst and headache.