The company that supplied the once-popular but perpetually troubled Norplant contraceptive device has quietly decided to withdraw the product from the U.S. market.
Wyeth Pharmaceuticals had temporarily suspended U.S. distribution of the implantable contraceptive two years ago after health experts raised concerns that the device might be less effective than believed at preventing pregnancy. At the time, Wyeth advised women who used Norplant to use a supplementary form of non-hormonal contraceptive.
When subsequent studies found that those concerns were unfounded, the Food and Drug Administration in late July issued an advisory saying that backup contraception was not needed. Ironically, Wyeth also announced in late July that it was permanently withdrawing Norplant from the market, citing business reasons.
“We think it’s a shame Norplant won’t be available to women in the United States any more,” said Melissa May, a spokeswoman for the Population Council, a nonprofit organization that developed Norplant. “We think it’s a real loss.”
When Norplant was introduced in 1990, the implantable contraceptive was heralded as a significant option for American women, the first new method of birth control in 20 years. It features six matchstick-size silicone rods that release the hormone levonorgestrel. It is more than 99% effective.
But the device was swept up in controversy from the start.
Some women complained about side effects such as menstrual irregularities, headaches and nausea. Others said they were scarred when doctors botched the insertion or removal of the rods. And hundreds of lawsuits alleging problems with Norplant were filed on behalf of women who claimed they had not been adequately informed of the contraceptive’s risks.
Some family planning specialists worry that Norplant’s unceremonious end could spell trouble for a second generation of implantable hormonal contraceptives expected to hit the U.S. market sometime next year.
Norplant, which is sold in nearly 60 countries, was used by more than 1 million Americans at its peak. Wyeth says that 113,000 U.S. women still use the product.
“Women are still calling us all the time about it,” said Dr. Felicia Stewart, a reproductive health expert at UC San Francisco. “There certainly are women who really liked it.”
Although contraceptive choices have expanded in the last two years--with a vaginal ring, hormonal patch and monthly hormonal shot now available--there are still few choices for long-lasting, reversible contraception, Stewart said.
“The only other methods that come close to this are surgical sterilization and IUDs,” she said. “And there are consequences and risks to both of those.”
The FDA has advised women using Norplant to see their doctors and consider other contraceptive options. Women who still have Norplant can have it removed; Wyeth will pay the cost of the removal if the procedure is completed by the end of 2002.
Wyeth has established a Norplant System Information Line at (800) 364-9809.
Some experts hope that women may soon have the option of using a new generation of implants, including a two-rod version of Norplant, approved by the FDA in 1996 but not yet marketed in this country. That product, Jadelle, is used in dozens of countries.
Natalie de Vane, a Wyeth spokeswoman, said the company is considering whether to introduce Jadelle in the United States.
Organon International, a Netherlands-based pharmaceutical firm, expects to seek U.S. approval to market its implant, Implanon, later this year, said spokeswoman Frances DeSena. Implanon is a single rod that contains desogestrel, a hormone different from that used in Norplant that could have fewer side effects.
Implanon will also come with a special instrument to ease insertion and is designed to last three years, perhaps appealing to women who seek reversible contraception between pregnancies.
Whether those products reach U.S. women may, in part, rely on their disassociation from Norplant, experts say. “We need to create an identity for each of these new products that is different from Norplant,” says Dr. Paul Blumenthal, a medical advisor to Planned Parenthood and researcher at Johns Hopkins University. “It’s highly likely they will be a lot easier to insert and remove than the six-rod system. And, according to the data, they will be equally effective.”