|
Item from the NYTimes, w/o permission:
WASHINGTON -- The Food and Drug Administration Monday approved a
birth control device called the cervical cap, a barrier
contraceptive that is already available in Europe.
The cap, which fits over the base of a cervix, prevents pregnancy by
blocking sperm from entering the uterus. After initial fitting by a
doctor, the latex device can be inserted and removed by the user
much the same way a diaphragm is.
The device, which looks like a large rubber thimble, is made of
pliable rubber-like material and has a firm, pliant rim. The cap,
which is less than half the size of a diaphragm, comes in several
sizes for a firm fit and is used in conjunction with spermicidal
jelly.
The agency approved the device after years of lobbying by women's
health groups and others who say it is a safe alternative form of
contraception for women that gives users more choices in birth
control devices. An advisory panel to the agency urged approval of
the device last February, saying it appeared to be safe and
effective.
A recent study sponsored by the National Institutes of Health showed
that the cervical cap was about 85 percent effective in preventing
pregnancy, which is comparable to the diaphragm. This means that of
100 sexually active women using the device for a year, about 15
become pregnant. This failure rate includes pregnancies that result
from errors in using the device.
"We are very pleased," said Victoria Leonard, executive director of
the National Women's Health Network, which has lobbied for approval
of the cap. "We think barrier methods are terrific because they give
more control to the user and offer lower risks than the birth
control pill and other methods. And many feminist health providers
like the cap because it can be worn longer than the diaphragm and is
less intrusive."
The agency said women could wear the device for 48 hours, compared
with a maximum of 24 hours for a diaphragm, and that some women find
it more comfortable. But many women's health groups who have been
fitting the device for years say it can remain in place for 72 hours
or longer with no ill effects.
The federal agency said the device, formally called the Prentif
Cavity-Rim Cervical Cap by its British manufacturer, Lamberts
(Dalston) Ltd., was approved on the condition that tests would be
conducted after it was put on the market to see if it was linked to
abnormal Pap smears.
The Pap smear, an examination of cells scraped from the cervix,
detects cellular changes that can, but do not necessarily, precede
cancer. These abnormalities can also result from infection,
inflammation or other conditions and in most cases are easily
treatable.
In recent clinical trials, about 4 percent of cap wearers
experienced conversions of their Pap smears from normal to abnormal
after a three-month period, as against 1.7 percent of diaphragm
wearers. But beyond six months of use, the conversion rates were
similar and relatively low. Scientists say they are not sure whether
the abnormalities detected in a fraction of the women indicated any
increased risk of cancer or whether they indicated benign or
treatable conditions of less concern.
Under terms of the approval, the federal agency said that the caps
should be prescribed only for women with normal Pap smears and that
these women would be required to take another test three months
after starting to use the device. If the results of this subsequent
test are abnormal, the agency said, use of the device should be
discontinued as a precaution.
Julie Carlston of the Environ Corp., a Washington-based scientific
consulting firm that has represented Lamberts in the approval
process, said the devices should be more widely available within
several months after the selection of U.S. distributors and
completion of marketing plans.
While the devices awaited formal approval, about 50,000 American
women were fitted with cervical caps under "investigational device
exemptions" given by the food and drug agency to birth control
clinics, health groups and others experienced with the devices.
Versions of the cervical cap have been used since pre-Victorian
times and were previously popular in the United States. But use of
the device dropped after the turn of the century with the increasing
popularity of the diaphragm, which required less physician attention
and fitting, and continued to decline with the rise of other
contraceptive methods, such as the birth control pill.
The caps were not in wide use in 1977 when Congress ordered the FDA
to toughen regulation of birth control and other devices. Because
of this low popularity, the caps missed getting an exemption from
the toughened new standards and required re-approval before they
could be prescribed. Diaphragms and condoms, which because of past
experience continued to be considered safe and effective, were
exempted.
Failure rates for both the diaphragm and cervical cap are believed
to be close to 15 percent per year. When the methods are used
correctly, failure rates are less than 5 percent.
In comparison, condoms have a failure rate in practice of 10 percent
to 25 percent in various studies, although with careful users the
failure rate is less than 5 percent. Users of birth control pills
experience failure rates of 1 percent to 3 percent.
Some scientists say the cervical cap, like the diaphragm, might
provide partial protection against the spread of the AIDS virus from
an infected partner when it is used together with spermicides
containing the chemical nonoxynol-9. The chemical has been shown in
laboratory studies to kill the virus. But experts warn that condoms
should also be used to provide greater, though still not foolproof,
protection against AIDS and other sexually transmitted diseases.
|