November 07, 1994 12:00 PM

IN 1991, AFTER HER SECOND CHILD was born, 21-year-old single mother Patricia O’Neill was desperate to find a foolproof form of birth control. “I was on the pill with both pregnancies,” she says. “All I had to do was look at a bed, and I’d get pregnant.”

That’s when the former Chicago emergency medical technician turned to Norplant, then being hailed as hassle-free contraception. As more than 1 million other American women have done, O’Neill underwent a 15-minute procedure under local anesthetic, during which a doctor inserted six matchstick-size capsules into her upper arm. The capsules, designed to prevent pregnancy for five years by continually releasing a hormone into the bloodstream, have a 99 percent effectiveness rate, rivaling that of the pill. “It sounded like a wonder drug that would solve my problems,” says O’Neill. “The doctors said I might have heavy menstrual bleeding, but I thought it was the answer.”

Within weeks, however, O’Neill was having serious doubts about Norplant. She began experiencing such severe stomach pain that she made frequent trips to the emergency room. O’Neill was then diagnosed with blood clots, a rarely encountered side effect of Norplant that, although it is mentioned in product literature, she says she had not been warned about. After nine months of health problems, O’Neill insisted that her doctor remove the capsules. Though information given to patients who receive Norplant says this procedure usually lasts about 20 minutes, it took a painful hour and a half. “I could feel them pulling and twisting,” she says. “At least six times I had to tell the doctors I needed more anesthetic.” (Shortly after going off Norplant, O’Neill became pregnant again and gave birth to a daughter. Now in school, she relies on welfare.)

O’Neill’s Norplant ordeal is hardly unique. In fact she is just one of the almost 2,000 women nationwide who have joined the class-action lawsuit filed by Chicago attorney Jewel Klein against Wyeth-Ayerst Laboratories, the U.S. distributor of Norplant. Another is Charity Bullard of Chicago. “I tried Norplant because I didn’t want more kids,” says Bullard, 24, a single mother of two living on public assistance. After a few months, when she complained to her doctor about morning sickness and severe abdominal pain, Bullard learned that she had an ovarian cyst and an ectopic pregnancy—in which a fertilized egg develops outside the uterus, a life-threatening condition if left untreated. Both are disclosed side effects of Norplant. “When I found out I was pregnant, I couldn’t believe it,” she says. Soon after having surgery to remove the ectopic pregnancy and the cyst, Bullard had the Norplant capsules removed just six months after they were inserted. “It took 2 1/2 hours because the original doctor had inserted them so far under my skin they couldn’t get to it,” she recalls, wincing at the memory. “I should never have used it.”

More than a dozen class-action suits have been filed against Norplant. Says attorney Klein: “Like the recent scandal involving silicone breast implants, this is another example of a large corporation’s failure to warn about possible negative consequences of a product inserted inside a woman’s body.” Klein also charges that the company failed to ensure that doctors were properly trained before undertaking the insertion or removal of the implants.

Citing legal constraints, Wyeth-Ayerst refuses to comment on individual cases. The company says it has trained more than 28,000 health-care providers on how to properly administer Norplant since it was introduced in the U.S. in 1991, though the company concedes that sales are not restricted to those trained in the procedure. “We believe the litigation is inappropriate because Norplant removal is an individual procedure affected by a number of variables, which include…circumstances unique to a given patient,” says Dr. Marc Deitch, Wyeth-Ayerst’s medical director.

But Mark Robinson Jr., a California product-liability lawyer, says the company could have limited distribution of the product only to doctors trained in its use. Moreover, he says, the company left itself open to a legal challenge by not requiring women to sign a consent form confirming that they understand the risks involved, similar to those currently designed for users of some IUDs and breast implants.

Last summer, Wyeth-Ayerst received permission from the federal government to update Norplant’s labeling for both doctors and patients. The new literature says that there have been “post-marketing reports” of users suffering strokes, blood clots and even having children born with birth defects. But the company notes that these problems are experienced by fewer than 1 percent of all users. The new warning also states that removal may cause arm pain, numbing or scarring.

Medical experts say the current controversy should not obscure Norplant’s value to the many women who want a long-term, reliable contraceptive choice. “It’s not for everyone,” says Susan Tew of the Alan Guttmacher Institute, a reproductive-health-research group in New York City. “But for the vast majority of those who choose it, Norplant is very effective protection against pregnancy.”



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