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Meir Rinde

 

You Down With the IUD?

Thirty years ago, IUD became a dirty word. Five years ago, a new intrauterine device was approved by the FDA. And now, finally, a promising contraceptive method has begun its long-awaited resurgence.

 

By Meir Rinde

September 22, 2005

   

After Liz Santiago gave birth to her twin sons, she didn’t want any more children. She’d had a miscarriage before — also of twins — and didn’t want to risk another multiple pregnancy.

At the same time, she wasn’t ready to get her tubes tied, and her doctors would likely have discouraged surgery at her age. Santiago decided birth control pills were her best option, but they didn’t work out that well, either. “After a year, I was starting to forget my birth control, or taking it late,” said Santiago, a 32-year-old patient care assistant at Hartford Hospital. “So my doctor decided that it was better off to place an IUD. Being with my partner for so long, that was one of the best birth control.”

An IUD? An intrauterine device as the best method? Like many people, Santiago heard objections from friends and relatives for whom the term IUD set off alarm bells. “My mother-in-law was one of those that didn’t want me to have the IUD in there,” she said.

But working in a hospital, Santiago ran into salespeople for the Mirena, a newly available brand of IUD, and what she heard from them and her doctor convinced her to put aside the concerns she’d heard.

“I said, well, I’m going to give it a try,” Santiago recalled. “I’m forgetting the birth control pills, and I don’t want no more kids. The chance for twins is high, so I don’t want any more.”

Her doctor inserted one of the tiny T-shaped devices in her uterus almost five years ago, and Santiago says she came to love it. She had constant menstrual spotting for the first few months, but now she doesn’t even get a period, other than a few days of spotting once or twice a year. “It’s not a problem,” she said. “As long as I go for my Pap smear every year, I’m fine.”

Clinicians stress that IUDs aren’t for everyone, as they don’t provide protection from HIV and other sexually transmitted diseases. But 30 years after the horrors of the Dalkon Shield and the resulting lawsuits destroyed the market for the devices in the United States, safer versions are staging a comeback.

 

Five years ago the FDA approved the Mirena, which had been used in Europe for a decade and is now one of two IUDs available in the U.S. The attendant advertising push by its marketer, Berlex Laboratories, is helping introduce a new generation of women to intrauterine contraception.

Other factors are also in play. Many women who are potential IUD users are too young to know about injuries caused by the Dalkon Shield. In addition, their doctors have observed other models working for years without major problems, despite the bad rap they inherited.

IUDs were once blamed for causing pelvic inflammatory disease, or PID, which can lead to infertility. But since the early 1990s, research data has shown the devices do not cause the disease. By aggressively marketing the Mirena, Berlex has let doctors know it believes the device is really safe safe enough to trump concerns over the safety issues that drove most other IUDs off the market.

Among U.S. women who use contraception, 2 percent or about 770,000 had IUDs in 2002, according to the Alan Guttmacher Institute. It’s a small number compared to the rate of use worldwide, which one survey pegged at 11.9 percent among married women (or 5.1 percent if you exclude China). But the U.S. figure represents a big jump from 1995, when a study found that only 1 percent of women using contraception had IUDs.

Women have other viable contraceptive options, of course. When used “perfectly,” birth control pills and shots are more than 99 percent effective at preventing pregnancy. But IUDs are also more than 99 percent effective, and that’s whether they’re used perfectly or not. Once put in place, the Mirena works for five years with almost no effort by the woman using it. The other approved IUD, the Paragard Copper-T, is effective for at least 10 years.

“You don’t have to insert anything when you have sex, you don’t have to avoid sex, you don’t have to take a pill, you don’t have to go to the drugstore once a month,” said Moriah Ritson, director of medical and clinician services for Planned Parenthood in Connecticut.

In the United States, about half of the nation’s 6 million annual pregnancies are unintended, and half the unwanted pregnancies are terminated in abortion. IUD advocates say wider use of the devices could provide a huge benefit to women and their families, making it easier for them to control the course of their lives.

For several years the advocates have been encouraging doctors and nurses to suggest IUDs to their patients, and clinicians say in the last two or three years they’ve finally begun to see a resurgence.

“The numbers are starting to climb,” said Hartford gynecologist Dr. Alan Fine. “Slowly, people are hearing about it, and realizing this is not a dangerous, offensive device. There’s a little more acceptance with time. Unfortunately, here in the United States, it’s very slow. It’s a shame, because the IUD is an underutilized form of birth control.”

 

While IUDs never disappeared completely, by the mid-1980s they were so scarce and so unpopular among health providers that many women never learned they were an option.

That lack of awareness continues. When the Paragard Copper-T came up in a women’s discussion forum on Craigslist recently, one person wrote, “What exactly is an IUD? [I’m] not familiar...” After someone explained what the device was, another person responded, “People still use those!?!? Wow.”

Even when people are familiar with the idea of intrauterine devices, many have outdated notions that they are risky, or may even attribute mythical dangers to them.

One Hartford-area woman, a 39-year-old college-educated mother of two, said that although she has used birth control since the 1980s, she couldn’t remember IUDs ever being mentioned in her doctor’s office. “They just automatically prescribed birth control pills when I was younger,” she said. “I don’t think I know anybody who uses the IUD. It caused cancer, didn’t it?”

As Liz Santiago demonstrated, worries tend to fade once women are educated about the devices, and they diminish even further among actual IUD users. In a statistic advocates like to cite, a 1996 study found that only 16 percent of the women surveyed had a favorable attitude toward IUDs, but among users, 99 percent said they were “somewhat satisfied” or “very satisfied” with their device.

Sally, a 43-year-old New Haven woman with two children, said it took 14 years to change her mind. When she was a college freshman in 1979, her roommate, who had heard Dalkon Shield stories from her gynecologist father, made Sally and other friends swear never to use IUDs.

But after her second child was born, Sally had a pregnancy scare while using a diaphragm, and two nurse-midwives persuaded her the Dalkon Shield had just been a bad product. They said IUDs especially suited women who, like her, were in monogamous relationships and didn’t want more children. “That fit my situation, and I have used an IUD for the past 11 years,” she said.

 

Historically IUDs were reserved for women who were at least in their 30s, in part because of fertility concerns relating to the insertion process. The current IUDs are inserted using a tube that resembles a long plastic straw; after the cervix has been dilated and the uterus measured, the doctor or nurse folds down the IUD’s T-arms, pulls it into the tube, inserts the tube to the appropriate measurement and pushes out the device, whose arms unfold and come to rest against the top of the uterus.

If a woman has chlamydia or gonorrhea, a device that pushes past the cervix can carry the disease into the uterus, causing upper genital tract infections, which in turn can cause fallopian tube scarring, ectopic pregnancy, infertility and chronic pain.

Despite countervailing research findings, some medical professionals also remain concerned that the IUD’s two plastic strings could act as a conduit for infection. The string ends remain in the cervix to aid in removal and to allow women to check on the IUD. Infertility is of particular concern to younger women, who are more likely to want to get pregnant in the future.But infertility is a worst-case scenario, and studies show that, statistically, IUDs are not associated with a greater incidence of pelvic inflammatory disease. Health care providers say screening and testing of patients allows them to avoid such problems.

That means not giving IUDs to women who are at high risk for contracting sexually transmitted diseases. At Hartford Hospital, Planned Parenthood and other providers, it also means testing patients in advance to make sure they don’t have chlamydia or gonorrhea. “I had a patient who had chlamydia twice in her pregnancy, and she wanted the IUD, but someone like that is very high risk,” said Lucinda Canty, a nurse midwife at Hartford Hospital. “If they have a current, active infection, we wouldn’t do it.”

For those who do meet the profile, youth is becoming less of a disqualifier. Alan Fine said last week he received a fax from Paragard saying the Copper-T is now approved by the FDA for a women as young as 16 years old, as long as they have at most one sexual partner, who is also monogamous. Hartford Hospital treats many poor women who have multiple children while still in their teens, and is already applying the expanded patient profile for IUDs.

“We used to gear IUDs toward older women, someone who was like 38 with three children, and now we’re looking at younger women, some as young as 18,” Canty said. “You know, I have an 18-year-old patient with three children, and she tried Depo [quarterly Depo-Provera hormone shots], she tried the pills, and she’s been on the IUD for about six months now. She’s doing good with it. She’s just been counseled about STDs. That’s our biggest worry.”

“It really is a simple procedure,” said Dr. Chris Morosky, a second-year resident at Hartford Hospital, “and more and more we’ll probably start putting it in nulliparous women [women who have never had a baby].”

The Mirena is also being given to women for reasons other than contraception. IUDs appear to cause changes in the chemistry of the uterus by their mere presence, inhibiting sperm and preventing fertilization, but the Mirena also releases small amounts of levonorgestrel, a progestin commonly used in birth control pills. The hormone causes lighter periods, and at least one-fifth of Mirena users stop menstruating altogether, which many patients find desirable. That effect further expands the device’s patient profile to include women who suffer from heavy bleeding and cramping.

As a result, Mirenas are even given out for health reasons at providers like Hartford’s St. Francis Hospital, which does not normally provide contraception because of its Catholic affiliation.

Intrauterine devices can even be used as emergency contraception if inserted within five days of unprotected intercourse. They’re highly effective even more effective than Plan B, the dose of hormones approved by the FDA as emergency contraception. However, IUDs aren’t often used that way, as getting one requires enough time to make an appointment with a doctor or nurse, and usually a test for sexually transmitted diseases as well.

 

The Dalkon Shield was a relatively large IUD, a bug-like disc with wavy arms that extended from its sides. Soon after its introduction in 1971 there were reports of increased incidents of pelvic inflammatory disease among patients. Several women who used the device died after suffering septic abortions, which are miscarriages caused by infections.

Manufacturer AH Robins sold more than 2 million Dalkon Shields but was finally forced to take them off the market in 1976. The company was destroyed by a massive wave of litigation, its corporate officers characterized as irresponsible monsters.

The legal onslaught also affected the Copper-7, an apparently safe IUD shaped like a number 7. Its manufacturer, Searle, eventually withdrew the product from the U.S. market, though it did not lose FDA approval and was still used in Canada and Europe. The withdrawal removed from the market two sizes of Copper-7, including a smaller one useful for women who had never been pregnant.

Critics of the Dalkon Shield blamed its strings, which were made of multiple filaments (as opposed to monofilaments on other IUDs) that provided a pathway for disease into the uterus. But while the Shield was clearly a poorly designed IUD, some observers also noted that the device itself may not have been completely at fault for its accompanying problems.

For example, studies did not find a corresponding increase in PID among British women who used the device. Some observers noted its appearance in the U.S. coincided with the sexual revolution and an increase in multiple sexual partners. Methods for testing for disease were not as advanced as they are now. Infections reportedly dropped once better screening of patients was introduced.

Some women may have blamed the Shield for leading to infertility that actually had other causes. And, observers note, while the infections and scarring were devastating, those affected were few in number compared to the millions who used the device.

All of which, while not exculpating the Dalkon Shield, may prompt women to consider using better-designed and administered IUDs, especially if other methods haven’t worked for them. For those who can’t bear condoms and won’t risk the diaphragm, who gain weight with pills or lose hair with Depo, for those who aren’t ready to go under the knife, at least there’s another viable option.

 

The current IUDs aren’t perfect, but their drawbacks are relatively mild. With the Mirena and Copper-T, in the first 20 days after insertion there’s a slightly elevated risk of infection, which subsequently diminishes. The Copper-T may initially cause cramping and heavier bleeding. Insertion is accompanied by cramping; some find the process painful. IUDs can fall out or become embedded in the uterus.

The upfront cost is high at least $250 for the device, plus provider fees though in the long term they’re cheaper than condoms or pills, and are usually covered by insurance.

As with every method, IUDs don’t work every time. Chris Morosky, the second-year medical resident, said he has already seen two IUD pregnancies, which raises the problem of whether to remove the IUD and possibly cause a miscarriage. On the Internet, users anecdotally report suffering ectopic pregnancies and other problems, though the problems also occur in women who do not use IUDs.

There’s also a small debate about whether IUDs work by causing abortions. Experts on the devices say they don’t; rather, they they prevent sperm from reaching the egg, or prevent fertilization. However, if an egg is fertilized the IUD will prevent implantation, as in its emergency use.

For many women who never knew there was a reason to fear IUDs, all the side effects and issues are proving acceptable, and even attractive.

“Once the consumers really get the idea that it’s a very good option, that’ll push things along,” said Jack Greene, assistant director of women’s health at Hartford Hospital. “Certainly the Mirena sort of started the steamroller going it’s a new device, it had great success in Europe. They did a real good marketing job. And other devices will sort of go along for the ride.”

 

Copyright 2005, 2007, New Mass Media.