FDA approves implant as birth-control device


In an article Tuesday about birth control, The Sun misstated the price Planned Parenthood of Maryland charges for oral contraceptives. The price, over a five-year period, is $540.

) The Sun regrets the errors.

The U.S. Food and Drug Administration approved yesterday the first new birth control method available to U.S. women in 30 years -- an implant that prevents pregnancies for five years once it is inserted under the skin of the upper arm.

The implant, called Norplant, consists of a fan-shaped arrangement of silicone rubber capsules -- about the size of small matchsticks -- that slowly release steroid hormones into the bloodstream. Norplant is inserted in a minor surgical procedure but can be removed any time a woman decides she wants to attempt to become pregnant.

Norplant, first developed in the late 1960s, has been eagerly awaited by family planning advocates who believe it may offer the most effective means of birth control yet available -- and prevent thousands of unwanted pregnancies and abortions each year.

"It's been long awaited, and we're sorry it didn't happen sooner," said Dr. Sheldon Segal, who developed Norplant for the non-profit Population Council. "It's a historical occasion for contraception because this is really the first new contraceptive measure to be introduced (in the United States) since the early days of the oral contraceptive" in the early 1960s.

"I think that Norplant represents an improvement in convenience, safety and effectiveness."

Norplant will be available in February, according to a spokeswoman for Wyeth-Ayerst Laboratories of Philadelphia, the company licensed to market the implant in the United States. Norplant is manufactured by a Finnish company.

The device has already been used by thousands of women in foreign countries.

In announcing Norplant's approval, an FDA spokesman said the implant is about 99 percent effective. Dr. Segal said studies were actually more glowing and show that one Norplant user out of every 1,000 would become pregnant during one year of use.

Norplant releases the hormone, levonorgestrel, which is also an active ingredient in some oral contraceptives.

Oral contraceptives are just as effective as Norplant -- but only when they are taken every day, Dr. Segal said.

The trouble some women have in taking "the pill" on schedule has produced a much higher failure rate -- about three pregnancies each year in every 100 women taking the oral contraceptives.

Faye Wattleton, president of Planned Parenthood Federation of America, said Norplant is best suited for women who want

long-term but reversible birth control; women who have the number of children they want but do not want to be sterilized; and for couples who want a method that does not involve "daily motivation" or interruption of sex.

Some advocates predicted that Norplant will also become an attractive alternative to sexually active teen-agers, one that might bring down the nation's skyrocketing teen pregnancy rate.

"We certainly look to it as an alternative for teens and hope this is another tool we can use to stop the epidemic," said Mary Ellen McNish, deputy director of Planned Parenthood of Maryland.

Cost will be the main issue determining its acceptance among teens and other groups, she said. Wyeth-Ayerst has not yet disclosed its price, saying only that it will be less expensive over a five-year period than oral contraceptives.

In Maryland, oral contraceptives cost approximately $1,200 over a five-year period, or $900 at Planned Parenthood clinics, according to a Planned Parenthood spokeswoman.

C. Wayne Bardin, director of medical research for the Population Council, said he had been told the price would be in the range of $200 to $300, not including the cost of implanting the device, the Associated Press reported.

Planned Parenthood will be ready to distribute Norplant by February, said Ms. McNish.

Norplant is being used in 14 countries -- Finland, Sweden, Indonesia, Thailand, Ecuador, Colombia, the Dominican Republic, Peru, China, Venezuela, Sri Lanka, Chile, Kenya and Czechoslovakia -- and is also being tested in about two dozen others.

An estimated half-million women have used Norplant.

Dr. Segal attributed the long wait for Norplant to the fact that research was funded entirely by private donations and that for-profit drug companies, which have been slow to develop contraceptives, chose not to become involved.

The organization pumped about $20 million into research and development -- compared with the $200 million to $300 million most drug companies spend before they take a new product to market, he said.

He said testing and distribution occurred in other countries first because the Population Council, an international organization with headquarters in New York, is devoted primarily to promoting family planning in developing nations.

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