It was all a frightening mystery to Kimberly Thompson: the throbbing migraines, the shortness of breath, the shocking 40-pound weight gain in just three months.
"It was the worst part of my life, wondering what is happening to your body," said the 25-year-old Chicago mother of two. "There were times I would cry and say, 'What's wrong? Is it me?' "
It was clear to Rhonda Rice that something was terribly wrong when she was hospitalized five times in a year.
"I was having anxiety attacks, irregular heartbeats, fainting spells," the 31-year-old Texas woman said. "Getting up out of a chair would exhaust me. I had severe hair loss. My face would break out in boils. I had a lot of problems."
Both women hope to prove their ailments had a common source: Norplant, a contraceptive touted as a major medical advance when introduced in the United States 4 1/2 years ago. Now it is the target of a flood of lawsuits that could jeopardize its future and, some say, perhaps even the future of birth control research.
Norplant, the first major new contraceptive since the birth control pill came on the market 30 years ago, was hailed as a safe, effective, no-fuss form of protection. Six matchstick-sized silicone-coated rods are implanted under the skin of the upper arm, releasing a synthetic hormone into the bloodstream that prevents pregnancy for up to five years.
Nearly 1 million U.S. women tried Norplant. Now, 50,000 users have retained lawyers to sue over it, according to Chris Parks, a Texas attorney representing 600 women. Most claim they weren't adequately warned of the scope and severity of side effects--including headaches, weight gain, persistent menstrual bleeding, hair growth or loss, ovarian cysts, anemia and depression--or removal problems.
"They were sold a dream and got a nightmare," Parks said. "If you tell women all the facts about Norplant they will not be interested. . . . The side effects don't go away, and that's what [the drug company] wants everyone to believe."
"Women who thought they made intelligent choices about birth control now hate themselves," said Jewel Klein, a Chicago attorney representing 4,100 women in a state class-action suit, including Thompson, whose implants were removed after three months. She says her health improved after that.
The manufacturer, Wyeth-Ayerst Laboratories, a division of American Home Products Corp., maintains Norplant is a good contraceptive--the Food and Drug Administration recently reaffirmed its support--and claims the litigation has been orchestrated by avaricious lawyers, some of whom were involved in the $4-billion breast implant settlement.
"We believe in Norplant and in its safety and its efficacy," said Audrey Ashby, a Wyeth-Ayerst spokeswoman. "We're going to defend the cases vigorously . . . and we hope the product will be vindicated in court."
Plaintiffs' attorneys contend that Norplant wasn't adequately tested (several tests were in Third World countries), that doctors weren't adequately trained and that women--many of them young and poor--weren't adequately counseled.
They also contend users weren't warned that silicone, which has been so controversial in breast implants, could cause serious health risks.
The company says Norplant has been tested for more than 20 years--including on more than 1,000 U.S. women--and been approved for distribution in 39 countries. It also says it provided extensive training for doctors.
The silicone, less than a gram, is commonly used in medical devices, such as pacemakers, Ashby said, adding that revised warning labels note the ingredient.
Ashby contends the timing of the litigation isn't coincidental. About 20 suits were filed through 1993 when 800,000 women had Norplant; that number skyrocketed to 309 in the last 1 1/2 years, and 59 seek class-action status.
"We feel Norplant was a new mark," she said, with the increase coming as breast implant cases wound down and publicity intensified. She cited one day when nearly identical lawsuits with the same typographical errors were filed in Minnesota, Texas and Kansas.
"It's greed," said Dr. Elizabeth Connell, professor of gynecology and obstetrics at Emory University's School of Medicine in Atlanta and a contraceptive expert for 30 years. "You have a bunch of attorneys who have deep pockets. As soon as they empty one, they look for the next one. That's what's happened here."
She said attorneys have employed the same tactics as in breast implant cases: recruiting women through media advertisements, then conducting seminars on what experts to use.
And although no one disputes that women are sick, the doctor said, studies don't support a cause-effect relationship with Norplant.
Connell also fears this controversy could discourage companies from developing contraceptives in what already is a shrinking U.S. industry.
"It's one of the worst things I've seen in all my years in medicine and one of the worst things that's ever happened to women," she said.
Parks, however, insists that this is no ploy by mercenary lawyers.
"It's impossible from a public relations campaign to blame 50,000 women, so you blame their lawyers," he said. "Lawyers aren't supposed to be popular."
While the legal battles have just begun, the publicity already has taken its toll: Daily sales have plummeted from 800 to 60, Ashby said.
Dr. Richard Ellenbogen, a Detroit-area obstetrician-gynecologist, said he has removed about three-fourths of about 75 implants he had inserted. "I don't know of any physicians putting them in anymore."
Though Ellenbogen hasn't seen significant problems, he said at least half of his Norplant patients suffered side effects. "I don't think it's a very good means of birth control."
Dr. Keith Brown, an osteopath in the Chicago suburb of Elmhurst who participated in a Wyeth-Ayerst training program, disagrees.
"It's as safe as any other form of birth control . . . when inserted properly and people are counseled properly," he said, noting he has received few complaints among his few hundred Norplant patients.
Gloriane Angellotti, 37, recently had her implants removed after nearly five years and had no problems. "I thought it was great. It worked and it was convenient. That's the bottom line."
But those who have sued say some doctors told them nothing and warnings didn't include some illnesses, while downplaying others. For example, potential side effects mention weight gain and prolonged bleeding but don't indicate that could mean 60 pounds or menstruation for 45 straight days.
Linda Salazar, a 21-year-old New Mexico mother of two, blames Norplant for gallstones, anemia, depression, a thyroid disorder and 16 consecutive months of menstrual bleeding that cost her a job.
Some women claim even more catastrophic illnesses, including strokes, paralysis and coma. Wyeth-Ayerst revised its adverse reactions in 1994, saying strokes and heart attacks have been reported in less than 1% of users, but the causal link to Norplant is unknown.
In mid-October, the company will begin including a voluntary patient acknowledgment form, asking Norplant users to sign a statement saying they understand the risks and benefits.
But even the Norplant removal has sparked complaints from women claiming they weren't told the rods could migrate or break up, making extraction painful and disfiguring.
Rice, the Texas woman, said when the doctor couldn't remove her implant, she had to be placed under anesthesia in the hospital.
Thompson already has resolved one issue in her mind. "As long as I live, I won't get anything put back in me."
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Some facts about Norplant and its use:
* The Product: Norplant consists of six silicone-coated rods containing the hormone levonorgestrel that are inserted in the upper arm and provide contraceptive protection for up to five years. It was approved in the United States in 1990; marketing began in 1991.
* Origins: The device was developed by the Population Council, an organization that focuses on global population problems. It is manufactured by Wyeth-Ayerst Laboratories of St. Davids, Pa.
* Users: Nearly 1 million American women, and more than 2.5 million women worldwide, according to the company.
* Complaints: Norplant users who have sued contend they were not adequately warned of the magnitude and severity of the side effects. Complaints include severe headaches, weight gain, vision loss, ovarian cysts, depression, prolonged menstrual bleeding, anemia, acne and insomnia. Some women also contend that problems with removal have resulted in disfiguring scars.
* Supporters: The Food and Drug Administration recently reaffirmed support of Norplant. The American Society for Reproductive Medicine and the World Health Organization also approve of it.
Source: Associated Press