More than a year after the U.S. Food and Drug Administration restricted the use of silicone breast implants in the United States, potentially thousands of foreign women are expected to sue for damages over illnesses allegedly caused by the implants.
U.S. attorneys representing women in Britain, Ireland, Australia, Canada, New Zealand, Holland, Germany, Switzerland and Israel filed a class-action suit May 17 for damages in the U.S. District Court in Michigan, the home state of manufacturer Dow Corning Corp., which is one of the defendants. The case was transferred to U.S. District Court Judge Sam Pointer of Birmingham, Ala., who is hearing pretrial actions in all suits against Dow Corning over the implants.
Although the debate over silicone breast implants has prompted a spate of lawsuits in the U.S., the class action is an unprecedented step by such a large group of women outside the United States who claim to have suffered everything from hardening of the tissue and chronic fatigue to autoimmune disorders, rheumatoid arthritis and scleroderma as a result of leakage. The defendants, all of which are U.S.-based, are companies involved in the making, selling or distributing of silicone breast implants and their component parts to women outside the United States.
New York attorney Sybil Shainwald, one of the main attorneys in the claction, says the goal is to alert women in foreign countries of their rights and to have the devices removed from the foreign market.
“It was an important step to take to protect women in other countries,” Shainwald says. “Any woman who has implants and feels she has been damaged is covered by this class action.”
The FDA issued a moratorium on the sale of implants in January 1992 after questions were raised about the possible dangers of the devices. In April that year the FDA announced it would allow the implants for surgical reconstruction following mastectomies for breast cancer but not for cosmetic breast enlargements.
Today, those who want the devices for reconstruction after breast cancer or to correct deformities can receive them through enrolling in clinical studies. A limited number of women who want the implants solely to make their breasts larger will be able to receive them by participating in tightly controlled long-term safety studies sponsored by the implant manufacturers and approved by the FDA.
The guidelines do not apply to women outside the United States. Although many foreign women have filed individual claims against U.S. manufacturers, the class action is an alternative way for them to receive compensation for their alleged illnesses.
Fewer than 100 foreign women officially have signed on to the complaint, but the number is expected to swell to about 6,000 if the case is accepted, says Michigan attorney Tom Bleakley, the other main attorney for the plaintiffs.
One Australian woman participating in the class-action lawsuit had implants put in for cosmetic reasons in 1977 and said she began to experience pain, hardness of the breasts and the sensation of coldness and lumps. When the implants were removed in 1984, it was discovered the left one had ruptured and silicone had migrated through her body, the complaint says.
The woman had another set put in that same year but had the left implant removed in June 1991 after suffering problems again, including breast deformity. Once more the implant had ruptured and leaked silicone through her body, which required tissue to be removed from her left breast, according to the complaint.
Another woman who is joining the action is Jean Perrin, who coordinates the Breast Implant Support Group in Britain for women who have questions about the devices.
She says she received her implants for cosmetic reasons in the early 1970s but began suffering arthritic symptoms 10 years ago. Because there was little debate about the devices at that time, Perrin did not connect her symptoms with the implants until last year when one ruptured. Both have been removed and replaced with saline implants.
The complaint alleges that some of the defendants sold implants abroad that were known to be defective and unsuitable for use in the United States, and as early as 1975 concealed data that showed the potential harmful effects of the implants, Bleakley says.
Attorneys are calling for an order forcing the defendants to create an international medical monitoring program to notify foreign women of the potential defects of silicone implants, to finance surgical removal and to research the long-term effects.
Christy Meter, a spokeswoman for Dow Corning Corp., which stopped worldwide sales of the implants in March 1992, says the company cannot discuss the specifics of the charges but will be filing its argument in middle to late summer.
She says Dow Corning anticipates that it will oppose the “certification” or approval of the class action on the grounds that so many women with varying medical backgrounds, physicians and implant manufacturers cannot be lumped together legitimately in a class action.
An estimated 1 million to 2 million women have implants in the U.S., 80 percent for cosmetic reasons. It is not known how many have been sold worldwide.
In the last few years, American juries have awarded multimillion dollar payouts in implant litigation. On June 4, Mentor Corp. announced that it had received preliminary approval of its proposed class settlement of $24 million for women claiming injury from the implants.
Although still facing thousands of lawsuits, Dow Corning Corp. recently scored a victory in the courts. On June 10, a Denver jury found that silicone implants were not the cause of illness suffered by Tammy Turner McCartney, 30, who sued Dow Corning Corp. and her plastic surgeon.
“We presented to the jury a growing base of scientific evidence based on controlled studies on women who have implants,” Gary Anderson, Dow Corning executive vice president, said after the verdict. “The research is consistently showing no cause-and-effect link between silicone gel breast implants and immune-system disease.”
However, a main factor in the verdict was widely considered to be the court’s allowing Dow Corning to introduce into evidence Turner McCartney’s personal life, that she was an exotic dancer, gave a child up for adoption and had an abortion.
