The first paragraph of a story about intrauterine devices yesterday's editions incorrectly stated because of an editing error that the devices "prevent contraception." IUDs are contraceptive devices.
Manufacturers of intrauterine devices to prevent contraception will be required starting Nov. 7 to provide each prospective IUD user with a brochure saying in plain language what the benefits and risks are.
Thus a woman will have a chance - before the device in inserted - to make an informed judgment on whether the IUD is the appropriate birth-control method for her, the Food and Drug Administration says. Currently, an estimated 3 million American women are fitted with IUDs.
The text of the brochure is being published in today's Federal Register under final FDA regulations that also establish, for the first time, uniform prescribing instructions for all types of IUDs. The regulations have been under consideration since July, 1975.
One section of the brochure lists conditions in which a user should call her doctor, including severe or prolonged bleeding disappearance of the "tail" or thrtad that comes through the cervix, exposure to venereal disease, and pelvic pain and cramps that could signal an infection.
Infections - some fatal - accompanied pregnancy and miscarriage in hundreds of the 2.2 million American women who were fitted with an IUD called the dalkon Shield after the A. H. Robins Co. marketed and heavily promoted it to physicians starting in 1970. The device has not been sold for three years. As of January, 1976, more than 500 women had sued the Richmond, Va., manufacturer, charging negligence.
The brochure, in a "special warning about pregnancy with an IUD in place," advises women to see their physicians "right away" if they miss a menstrual period, have a scanty flow" during a period or suspect they might be pregnant.
"Serious complication of stpsis (severe infection), septic abortion (infected miscarriage) and death have occurred when a pregnancy continues with an IUD in place," the brochure says. "Most of the occurrences of these serious complications have been reported in the middle third of pregnancy.
"If your doctor confirms that you are pregnant, he should remove the IUD is the tail is visible. Removal of an IUD in pregnancy decreases the likelihood of serious complications.
"If removal of your IUD proves to be difficult, you and your doctor should discuss at that time that question of continuing the pregnancyin view of the serious complications that may occur. In reaching a decision as to whether or not to have an abortion, it should be remembered that the risks associated with terminating a pregnancy increase with the length of time you are pregnant."
The brochure, which will be available in clinics and doctors' offices, will list, for each model, test results on the rate of unplanned pregnancies and on the rate of adverse reactions requiring medical removal of the IUD or on the rate of discontinuance for medical reasons.
FDA Commissioner Donald Kennedy said the brochure and the new physician labeling are parts of a continuing agency effort to inform women fully about the IUD and the pill.
The FDA began in 1970 to require a terse. 150-word leaflet in each user package of oral contraceptives. Last December, the agency proposed rules - still pending - to update the leaflet and to require doctors and pharmacists to give a more detailed brochure to users each time a birth-control pill prescription is written or refilled.