It was anticipated for decades and arrived with great fanfare in 1990. But now Norplant--the first new birth control method offered to American women since oral contraceptives were introduced 25 years ago--is the target of an expanding pool of lawsuits alleging serious health problems.
About 100 Southern California women have joined a class-action lawsuit charging that the implanted hormone contraceptive--with a failure rate of only 0.04% when properly used--has caused them severe side effects and complications they were not warned about.
The women are among several hundred others nationwide who have filed more than a dozen lawsuits in recent months against Wyeth-Ayerst Laboratories, the Philadelphia-based U.S. distributor of Norplant.
The lawsuits--which charge such adverse side effects as depression and heavy bleeding as well as excessive scarring and pain from removal of the device--are a disappointing development for family planning experts who had heralded Norplant's arrival. Since the lawsuits began, the number of women who have asked that the device be removed has risen dramatically while requests for Norplant have fallen, family planning clinics nationwide report.
"I'm sure the women who have joined in these lawsuits have good reason to do so, but I feel like it will have a chilling effect on other companies which might want to get into contraceptives research," said Lisa Kaeser, a public policy analyst with the Alan Guttmacher Institute, a nonprofit research and policy organization in New York.
But unlike the thousands of lawsuits over silicone breast implants, which led to that product's demise, many health experts predict that Norplant will survive the scrutiny over its safety and efficacy.
"Most women who have Norplant are happy with the method, and most who have had them removed have had no problem with removals. It's unfortunate that some women have had problems, but I think they are in the minority," said Sandra Waldman, a spokeswoman for the nonprofit Population Council, which developed Norplant after 20 years of testing.
"It's a very well-researched method," she said. "We conducted numerous studies in many countries with thousands of women participating in the trials. And hundreds of scientific articles have been written about Norplant. So we stand by the safety of the method."
Government health officials also appear unworried by the lawsuits thus far.
"Essentially, the Food and Drug Administration is not seeing any (problems) that were not reported in clinical trials and are not above the rates found in clinical trials," FDA spokeswoman Susan Cruzan said.
The government did approve revised product labeling submitted by Wyeth in July to alert consumers to possible side effects that were not seen before marketing of the device, including rare instances of stroke, phlebitis and birth defects.
But, Cruzan said: "That doesn't necessarily mean there is a cause-and-effect relationship" between those ailments and Norplant.
Plaintiffs paint a much different picture of the risks. Norplant consists of six matchstick-size silicone rods that are implanted in the upper left arm, just under the skin. The synthetic hormone progestin, an ingredient in many birth control pills, is slowly released from the rods to prevent pregnancy. The implant can be left in place for up to five years.
Two major complaints--severe side effects and removal problems--have emerged in the lawsuits filed in Minneapolis, Miami, Chicago, Dallas and other cities, plaintiffs' attorneys say. Dozens of potential side effects are listed in the product labeling by Wyeth, but some of those have been more severe than anticipated in some women, according to the lawsuits. A second common grievance focuses on the difficulty of removing the rods, which some women charge is much more painful, time-consuming and costly than Wyeth suggests in its product information brochure.
"The (product labeling) gives considerable warnings, but you can only go so far in how warnings are communicated to recipients," said Arthur Sherman of Sherman, Dan & Portugal, a Beverly Hills firm representing the California women. "Most women didn't realize the severity of the menstrual changes and length of the changes. The severity is really difficult for these women to handle."
Although removal of the implant is described in informational brochures as a simple, 20-minute procedure that requires only local anesthesia and no stitches, Sherman says some women have conveyed horrendous experiences that require several surgeries and general anesthesia, leaving them with residual scarring and pain.
Among the women who have filed suit is Cindy, a Los Angeles flight attendant who is in her 20s and asked not to be identified. She received Norplant three months ago and said she began having severe headaches and anxiety about a month later. She was also dismayed at her irregular menstrual cycle.