The company that will launch an intrauterine contraceptive device early next year is expected to urge physicians to seek the informed consent of the consumer as a condition for use of the prescription product.

GynoMed Pharmaceutical Co., a small, privately owned firm founded three years ago in Somerville, N.J., thus plans to follow the same path as Alza Corp., which makes an IUD system called the Progestasert in Palo Alto, Calif.

The GynoMed IUD, called the T 380A, has been distributed in other countries since the early 1980s, and was approved by the Food and Drug Administration in 1984. It was developed by The Population Council, which is an international nonprofit organization dedicated to family planning.

Peter F. Carpenter, an Alza executive vice president, said Alza has given GynoMed permission to adopt, with certain changes, the seven-page informed-consent format Alza asks physicians to give to women.

By signing the Alza leaflet, a prospective user acknowledges that she has read it "in its entirety and discussed its contents with my doctor or nurse-practitioner," who "has answered all my questions and has advised me of the risks and benefits associated with ... the Progestasert system, with other forms of contraception, and with no form of contraception."

The woman also is saying she understands she "may experience serious medical problems {that} could lead to surgery, sterility, permanent hormonal imbalance, or death."

Carpenter said public reaction to Alza's and GynoMed's moves could influence other manufacturers.

But GynoMed's intention to seek informed consent drew differing reactions from the Pharmaceutical Manufacturers Association (PMA), and two nonprofit groups, the National Women's Health Network and Public Citizen Health Research Group (HRG).

"I don't see any industrywide implications, because it {informed consent for the two IUDs} is limited to specific circumstances," said a PMA spokesman.

HRG director Sidney M. Wolfe noted that written informed consent is required for surgery although the number of deaths and injuries incurred during surgery is comparable to those caused by drugs and medical devices, which are prescribed without such consent.

"There are two primary ways to prevent these deaths and injuries and the product-liability lawsuits that inevitably follow," Wolfe said. The first is to make medical devices and drugs "as safe as possible," and "the second is to fully inform patients about the risks as well as the benefits so that they can make an informed choice to use or not to use."

Network executive director Victoria Leonard said: "Obtaining informed consent to educate and let the consumer know all the risks and benefits of the product is terrific. However, if it's used to escape liability later, the network is certainly wary.

"On the basis of unhappy experiences with IUDs inducing pelvic inflammatory disease and sterility, we certainly hope that the T 380A will be used only with women who have completed their child-bearing, are over 30, and have only one long-term sex partner. We also think it's incumbent on family-planning professionals to recommend an IUD only for a woman who has finished having children, or who matches the above criteria."

To enhance effectiveness in preventing conception, the T 380A contains copper, while the Progestasert continually releases tiny quantities of a naturally occurring contraceptive hormone into the uterine cavity. Copper-bearing IUDs are on a multiyear replacement cycle, while the Progestasert must be replaced annually.

Alza acquired a sudden monopoly of the U.S. IUD market on Jan. 31, 1986, when G.D. Searle & Co., citing the costs of defending against product-liability lawsuits, announced its decision to halt sales of its copper-bearing IUDs, the CU-7 and the TATUM-T.

Last week, GynoMed Chairman Roderick L. Mackenzie began sending announcements to all practicing obstetrician-gynecologists that a copper-bearing IUD would again be available. He is a former president of Ortho Pharmaceutical Corp., which has made all kinds of contraceptives, including the Lippes Loop IUD until September 1985.

Doctors prescribed about 300,000 to 400,000 of the Searle devices in 1985; about 100,000 Progestaserts a year have been subscribed since Searle abandoned the market. Alza introduced its informed-consent program about six months after Searle's action.