Lena Ferrell needed a contraceptive, and her choices were dismal.
She was 29 and married. She had two children, and although she and her husband thought they might add to their family someday, this was not the time to become pregnant.
Condoms were out; she was allergic to latex. Birth control pills nauseated her. She had spent several hundred dollars to try Norplant, the surgically implanted contraceptive that releases hormones into the bloodstream. But Norplant made her sick. She couldn't wait to have it removed.
Back for another visit, Ferrell was sure that she and her doctor were going to have little to talk about. Then she picked up a pretty, copper-colored pamphlet in his Woodland Hills waiting room. It touted an "effective, convenient" contraceptive. It sounded perfect. But it also made Ferrell shiver.
It was an intrauterine device.
A year later, her concerns are gone. "I am so happy with the IUD," said the Canyon Country woman, who asked that her real name not be used. "I had qualms about it, but the doctor assured me that it has improved so much. I've even talked a couple of friends into getting it."
Almost 20 years after the notorious Dalkon Shield was pulled from the market because of side effects, IUDs are making a small, steady comeback among American women. Health professionals who stopped inserting IUDs in the mid-1980s--when the last of the old generation of devices were phased out by manufacturers--are stocking up again. A new group of doctors and nurse practitioners is learning how to use them.
These health professionals have come to believe that the Dalkon Shield was a dangerous exception, not representative of the IUD in general. The newest IUDs are safer and more effective, experts say, and doctors are more knowledgeable about how to prescribe them to minimize side effects, including risk of pelvic infection or damage to the uterus during insertion.
The manufacturer of the ParaGard copper T380A--now the predominant IUD in this country--said sales have increased steadily since it was introduced in 1988. GynoPharma Inc. attributes this rise largely to women telling women about their experiences, since it does not market to consumers.
"Word of mouth is a significant factor in expanding its use," said Roderick L. Mackenzie, chairman of the New Jersey-based company. "The safety data looks better all the time. The product is effective and women are satisfied. To be on the market five years in the United States and not be sued, well, you couldn't sell running shoes and not have that happen."
Although some consumer groups still urge caution, more American women appear to feel comfortable that the new generation of IUDs is unlike the Dalkon Shield, which was blamed for 18 deaths and thousands of complaints concerning infection, infertility, ectopic pregnancies and pain.
The ParaGard, for instance, is T-shaped and made of soft plastic, unlike the Dalkon Shield and other older designs, which were larger and harder.
The number of Americans with IUDs still represents a fraction of contraceptive users. An estimated 500,000 women--about 2.5% of those who use birth control--are thought to be using an IUD, mostly the ParaGard. Sales of that product rose 20% last year and are surpassing that rate this year, according to GynoPharma.
The introduction of the ParaGard ended a three-year period in the mid-1980s during which manufacturers of all IUDs, dogged by continuing safety questions, voluntarily withdrew from the market. During that time, no IUDs were available in the United States other than the Progestasert, a hormone-releasing device that must be replaced yearly.
A lot has happened in the 20 years since the Dalkon Shield disappeared, said Dr. Anita Nelson, medical director for women's health care at Harbor-UCLA Medical Center. Research on the new generation of IUDS shows:
* The device fails less than 1% of the time, the lowest among any reversible contraceptive.
* The IUD appears to work by interfering with sperm. Researchers previously suggested that the device prevented the implantation of a fertilized egg, a theory that led some religious groups to oppose IUDs as inducing abortion.
* Among monogamous women, who are unlikely to contract a sexually transmitted disease, the IUD does not increase the risk of pelvic infection, the devastating side effect associated with the Dalkon Shield.
"Although the Dalkon Shield was a pretty horrible story in the history of birth control, it is now clear that the problems were with that particular IUD," said Jade Singer, medical supervisor of the Westside Women's Health Center in Santa Monica. "Once women get this information about why risks were great before and what the differences are now, some are really interested in the IUD. They like the convenience and the efficacy.
"But," Singer added, "I have just as many women say, 'I'm scared.' "
Indeed, it requires a leap of faith for most women to reconsider the IUD, said Debra Bronstein, GynoPharma's vice president of marketing. And some consumer health groups, including the International Dalkon Shield Victims Education Assn., continue to warn against the device, saying there is not enough safety data.
The Dalkon Shield, which was on the market from 1971 to 1974, is the subject of one of the most well-known product liability cases in history. In 1980, the manufacturer, A. H. Robins Co., issued a warning that anyone still using the device should have it removed. In 1985 the company filed for bankruptcy in the face of 325,000 lawsuits, many of which still are pending. (An estimated 2.5 million Americans were using an IUD at its peak popularity in the mid-1970s.)
Although there were fewer problems associated with other IUDs--the Lippes Loop and the copper-bearing Cu-7 and TCu 200--their manufacturers also withdrew from the U.S. market, saying that it had become impossible to obtain liability insurance.
It was a nightmare that is hard to forget, Bronstein said.
"Women don't want the IUD because they remember that someone's mother or sister or friend had a bad experience with the Dalkon Shield," she said. "The publicity over the Dalkon Shield did a real disservice to women because it damned an entire category of contraceptives."
Worldwide, however, the IUD continues to be highly popular, with about 100 million users. The method is the leading contraceptive in China, Egypt, Norway, Finland and many other countries.
"What's happening in the United States is not at all typical of what's happening worldwide," said Nash Herndon, a spokesman for the nonprofit research and family planning group Family Health International. "Worldwide, the IUD is viewed as safe and effective. The problem here is a misperception that it is unsafe because of the Dalkon Shield."
One attraction of devices such as the ParaGard is that they can be left in place for up to eight years. The old IUDs had to be removed after three years. A ParaGard costs $167, with insertion fees ranging from another $160 to $400.
But Americans are generally distrustful of contraceptives, said Susan Tew of the nonprofit Alan Guttmacher Institute, which specializes in contraceptive research and education. Surveys show many women believe the risks of contraceptives outweigh the benefits, especially for pills and IUDs.
"All of the (family planning) organizations have been trying to point out the benefits are high and the risks are actually quite low. But it takes a lot of effort to keep correcting people," Tew said. "It takes a lot of work to get people to realize women who are in monogamous relationships are not at high risk for infection with the IUD."
Many doctors, too, were intimidated by the Dalkon Shield, said Dr. Daniel R. Mishell Jr., chairman of the department of obstetrics and gynecology at the USC School of Medicine and a longtime IUD researcher.
"Even physicians came to believe that all IUDs were dangerous," Mishell said. "It's a matter now of re-educating gynecologists in the post-Dalkon Shield era. Most doctors in practice now went through their training in the '70s and '80s. And it wasn't until 1992 that an article came out showing clearly that IUDs don't cause pelvic infection."
UCLA's Nelson travels the country teaching doctors and nurse practitioners how to insert an IUD, a relatively simple procedure. But in some areas, the device is still not available.
"Doctors fear patients with IUDs will (have complications and) sue them. But there have been no lawsuits with the new IUDs. So we have to get over that fear," she said.
According to many analyses, the major problem with the Dalkon Shield was a multifilament nylon tail string that tended to pull bacteria from the vagina into the uterus, causing pelvic inflammatory disease, or PID.
PID is an infection of the endometrium, Fallopian tubes or ovaries that is greatly feared because it can cause infertility. PID often is caused by sexually transmitted disease. It is curable with antibiotics.
Because the Dalkon Shield led to so many cases, women and even health professionals assumed that all IUDs increase the risk of PID. But several newer studies have debunked that theory, Mishell said.
"We know now that it was the (Dalkon Shield) itself that pushed bacteria into the uterus," he said.
Newer studies show the insertion of an IUD can sweep bacteria into the uterus and increase the risk of PID, but the risk is limited to a few months after insertion. Now, women receiving IUDs are examined for infections before and after insertion. If an infection is present, it can be treated promptly and should not cause PID, Mishell said.
In addition, a government-funded study is exploring whether antibiotics at the time of insertion limit the risk of PID. So far, the study shows this probably does not make much difference, said Terri Walsh, who is directing the study for the Los Angeles Regional Family Planning Council.
The low risk of PID seen today is largely the result of careful screening of IUD candidates, Walsh said. Under the product label, the IUD should only be used by women who have no evidence of infection and who are in a monogamous relationship with a partner who is also monogamous.
Selecting women at low risk for sexually transmitted disease is now considered so crucial that some researchers suggest that even the side effects from the Dalkon Shield might have been reduced had it been prescribed only to monogamous women.
More caution would have helped, but the Dalkon Shield was still linked to a higher rate of complications, said Dr. David Grimes, vice chairman of the department of obstetrics and gynecology at UC San Francisco. "My impression is that the Dalkon Shield itself was defective," he said. "It stands apart from all the other IUDs."
But even with a new product and stringent guidelines, there are doubters.
"IUDs are dangerous," said Constance Miller of the Seattle-based International Dalkon Shield Victims Education Assn. "They carry a risk of PID and tubal scarring. Although the overall incidence of infection is small, who is going to be the unlucky one?"
As someone who suffered ill effects from the Dalkon Shield, Miller said she is surprised that some women are opting for IUDs again. (Forty percent of new users have used IUDs before, studies show.) But, she noted, even during the uprising over the Dalkon Shield, a portion of women continued to defend the IUD; some even crossed into Canada to obtain one.
"I have spoken to some women who regret the demise of the IUDs," Miller said. "But to me, that demonstrates the full continuum of users and outcomes. For some women, it's perfect. For other women, it's hell."
Many health experts blame the memory of the Dalkon Shield for holding back IUD use, but Miller fears the memory is fading too soon.
"Too many younger women don't know about the legacy of the Dalkon Shield," she said. "Women still want a worry-free, carefree, easy-to-use type of contraceptive that doesn't cause the side effects of the pill. That's the attraction."
Julia Wildwood, a Seattle writer and former Dalkon Shield user, has another explanation for the return of the IUD:
"The baby boomers are getting older. They are looking for other birth control methods. And, really, what are our choices?"
Sixteen years ago, Pamela Langdon had a Cu-7. The device caused cramping and heavy menstrual bleeding, and she had it removed.
But years later, after having a child, the Temple City woman wanted a contraceptive that was long-lasting but not permanent.
Because the newer IUDs are smaller and more flexible, they are less likely to cause heavy bleeding and cramping. So, Langdon was ready to try IUDs again. She has used two Progestaserts and now has a ParaGard.
"Birth control pills gave me headaches," she said. "This IUD is excellent. It is so simple. And you don't have to worry about it."
In a 1989 survey by Ortho Pharmaceuticals, which makes birth-control pills, IUD users reported the highest satisfaction rate. Another benchmark--how many women use a contraceptive for at least one year--also put IUDs on top, with about a 90% retention rate compared to about 50% for pills.
Nevertheless, GynoPharma chairman Mackenzie said the privately held company will continue to keep a low profile, marketing the device to health professionals at medical meetings and in doctors' offices--in spite of the fact that their own surveys show 67% of women of reproductive age are still not aware that IUDs are available.
Reintroducing an intrauterine device in the shadow of the Dalkon Shield has required a contradictory mix of boldness and extreme caution, Mackenzie acknowledged.
"We weren't being cavalier when we introduced it," he said. "We started out with a very conservative approach, concentrating on education. We felt the product was extraordinarily safe and that if we bent over backward to present that view to physicians and women, then women wouldn't be damaged--and we wouldn't be sued."
IUDs such as the Dalkon Shield, above, have been in use in the United States since the early 1960s, except for a short period in the mid-1980s. Here is a look at the devices and their impact:
How they work: IUDs are inserted in the uterus and are now thought to work by causing a harmless inflammation of the tissue. This inflammation disrupts the action of sperm and possibly the egg. The device may also prevent the implantation of a fertilized egg, but that is not thought to be the primary action.
Technological changes: Most of the IUDs in use in the 1960s and '70s were larger and made of a harder plastic than those used now. The latest IUD, the ParaGard copper IUD, right, is made of a flexible plastic. It has copper tubes around the arms and copper wound around the stem. The addition of more copper to the new IUD has increased its effectiveness. The ParaGard also has a much different tail string than the earlier Dalkon Shield. The tail string on the Dalkon Shield is now thought to have been responsible for many cases of infection.
Effectiveness: Fewer than one in 100 women become pregnant during one year of IUD use. The device can be worn for up to eight years before being replaced.
Side effects: The most common ones associated with the ParaGard are increased menstrual flow, cramping and bleeding. The risk of pelvic infection is quite low.