It is the largest single product-liability settlement in U.S. history-$4.25 billion to be paid by the manufacturers of silicone breast implants to the thousands of women who say the implants have ruined their health and shortened their lives.
It is too large a number to enter on a pocket calculator: $4,250,000,000.
And angry women say it is nowhere near enough to pay for the damage done by the half-pound bags of silicone gel that have been stitched into the breasts of about a million U.S. women over the last 30 years.
The problem, critics of the settlement say, is that so many women have had the implants, so many of them-some believe all of them-will become sick from leaking silicone, and their illnesses are so debilitating. The settlement, these critics say, won’t begin to cover the need.
“What it means is that most people will get next to nothing,” said Lynda Roth, of Broomfield, Colo. Roth organized a breast-implant information organization out of her home after suffering health problems from her own implant.
The settlement “is really a joke,” Roth said; $20 billion to $30 billion might take care of the claims, she believes.
As it stands, U.S. manufacturers of breast implants have agreed to put together a pool of $4.25 billion. Half the money would be distributed to women who already have health problems, based on age and their medical symptoms. Payments would range from $105,000 to $1.4 million.
The rest would be distributed to women who become sick over the next 30 years and to those who want their implants removed or need ruptured implants replaced. Part of the money would be available to women simply because they have implants.
If an unexpectedly large number of women sign up, the manufacturers may agree to put up more money. Or they may drop out of the agreement. The same is true if the number of women opting in is unexpectedly low, leaving the manufacturers to face thousands of individual lawsuits and settlements.
Those numbers are speculative now. June 17 is the first deadline for women to opt out, but lawyers say only women who know absolutely that they want no part of the settlement should opt out then; there will be other opportunities to make that decision when the settlement numbers become more solid.
Already, more than 10,000 individual lawsuits have been filed by women who believe their breast implants have poisoned them. Another 10,000 cases are on hold while the global settlement is worked out in a federal court in Birmingham, Ala.
The settlement is open to any woman who has had implants, whether or not she is involved in a lawsuit, whether or not she now has health problems.
“I think 50,000 would be a very low number of women who will participate,” Roth said.
Marie Walsh, a Californian who runs the national Breast Implant Information Foundation, is predicting “we’ll get 200,000 women coming out of the woodwork” before the legal wrangling is over.
Before the proposed settlement was reached, Walsh said, her national hot line received 25,000 calls in four years. Since the information came out, she has been getting 20 to 30 calls a day and has had to call in two volunteers to help answer requests for information.
“We can’t keep up,” she said.
Roth has just bought four new filing cabinets to deal with the rush of business for her Coalition of Silicone Survivors.
“I’m adding 200 new people a month,” she said.
She has spoken to concerned groups in Tennessee, Hawaii, California and Minnesota in the last few months.
It’s just beginning, Roth says: “The majority of women with implants got them in the last six to eight years. National estimates say that’s when most women begin to have problems. Most of the problems haven’t begun yet.”
Researcher Britta Austermeyer Shoaib agrees. Eight years ago, Shoaib, then a medical student, went to work for neurologist Bernard Patten at the Baylor University College of Medicine in Houston. Patten had about 20 patients with a puzzling collection of symptoms affecting their nervous systems; all had silicone breast implants. Patten assigned Shoaib to study the connection.
As word of the research spread, their patient load boomed.
“Women and doctors read about it,” Shoaib said. “Doctors kept referring women to us because they didn’t know what to do about it.”
Their patient list has grown to 2,000, making theirs the largest neurological implant research project in the country. They are booked until 1995 with patient appointments.
“You can compare this with AIDS, politically,” Shoaib said. “The first guy who reported what he was seeing in his patients in San Francisco, they told him that he was crazy. They didn’t want to believe he had patients with different symptoms and signs than the diseases known to us.
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“This is the same with implant diseases. A lot of doctors look at the patient and say, `You have too many complaints that don’t fit any of the known diseases.’ Doctors like to put diseases into drawers. You have disease A, we put you in this drawer and treat you with the standard treatment for disease A. That’s what we learn in medical school.”
Physically, too, silicone poisoning is “compatible with AIDS” in some ways, Shoaib said.
“Because the immune system is very busy fighting with the silicone, it neglects other corners of the body, the viruses and bacteria. It can’t protect itself against everyday symptoms. We believe over the long run every patient carries the potential for getting sick.”
The result: patients with 20 to 30 symptoms-skin rashes, diarrhea, cold hands and feet, stomach problems, bladder and respiratory tract infections.
Roth had memory loss, a low white blood-cell count, a flushed “mask” across her face and sores on her skin that yielded tiny brown crystals.
“We were the guinea pigs, and now we are the research,” she said.
Ruth Kear, of Boulder, Colo., a longtime runner who got an implant after a mastectomy, suddenly noticed pain in her knees. When she went to an orthopedic surgeon, “he patted me on the head and said, `You’re getting older.’ Then I read and find out one of the most common symptoms is joint pain.”
When Kear consulted a law firm specializing in implant cases, a nurse working with the firm read off a three-page list of most common symptoms. There it all was: joint pain, fatigue, numbness.
“I was amazed how many things I responded `yes’ to that I thought were related to other things,” Kear said. “I’ve had a granuloma, a little cyst on my eyelid that I had removed year ago. I thought nothing more of it, had no idea it could be related. The real crazy thing is they really don’t know because there are so many generic diseases that this is emulating.”
Walsh, who got implants in 1968, developed muscle aches and pains, chronic fatigue and depression and irregular menstrual periods. She was told she needed a hobby. When she woke one morning with her nightgown plastered to her chest and found silicone gel oozing from her nipple, she had the implants removed.
That was three years ago. Today, “I’m up for two hours and have to lie down for 30 minutes-that’s my day,” said Walsh, 48.
In the last decade, Walsh said, her hospital and medical bills have added up to $2 million. One medication costs $9 a day. Because she is on disability, Medicare pays part of the cost.
“My prognosis is not good,” she says bluntly. “The disease is now attacking my heart.”
Roth said: “For some of our women, $2 million would not be near enough. We have had women who have died (there have been about 40 deaths). How do you repay that? Right now the cost (of treatment) is being paid by insurance companies and the federal government. The manufacturers will take a slap on the wrist and walk away. Now, I ask you, is that fair?”
This is not a blanket condemnation of opting into the settlement, she said: “Some people have no choice-their company’s gone bankrupt, they don’t know who the manufacturer is, they have things in their background or confidentiality is their biggest issue. For women like that, a class action might be OK, but for the majority of women it’s another Dalkon Shield debacle.”
The Dalkon Shield, a contraceptive device, caused infection, infertility and sometimes even death.
Denver lawyer Steve Werner shares the worry: “We are uncertain but very concerned there is a possibility that there will be ratcheting down of the disease compensation schedule such that the amount of compensation per woman just isn’t adequate.”
Werner, whose firm is the state liaison passing on information on the settlement to Colorado residents, said he has no set advice for his clients. Each case is filled with individual issues and complexities. The thing to do now, he said, is for each woman to preserve as many options as possible.
That may mean opting into the settlement for the time being while the wrangling over numbers continues.
The question that chills Kear, who has uneasily replaced her leaking silicone implant with a saline implant, is what good the money can do when “we don’t know what to do for treatment if we get the money. I don’t know, once you get lupus, if there is a way to go back and fix it. We’re talking about generating money for the medical care that you get until you die.”
For Walsh, who intends to pursue an individual case and encourages other women to do the same, “it’s not the dollars at all-it’s exposing this information. I lost a career; I’m virtually bed-ridden. My life is completely changed. I would like the manufacturers to say, `I’m sorry.’ They are still not admitting any guilt in this conspiracy. Where are the criminal charges?”
In addition to her case against the maker of her implants, Walsh said, she intends to file a class-action suit against the Food and Drug Administration.
“No one is doing anything of the things that need to be done,” she said. “It’s so frustrating. Everyone wants to pretend this never happened.”
MORE FACTS FOR VICTIMS
Here’s where to get more information about the $4.25 billion product-liability settlement that manufacturers of silicone breast implants have agreed to pay:
– Office of Liaison Counsel: 24-hour recording of information about the settlement: 1-800-960-6784.
– Breast Implant Settlement Information Line: 24-hour recording of information set up by counsel for plaintiffs: 1-800-887-6828.
– Breast Implant Information Foundation, national clearinghouse for information: 714-448-9928.
– U.S. Food and Drug Administration: 24-hour recording on FDA stand on breast implants: 301-443-3170.
– Dr. Britta Ostermeyer Shoaib, implant research project, Baylor University: 6550 Fannin, Suite 1801, Houston, Texas 77030.
– Immunosciences Laboratory, 8730 Wilshire Blvd., Suite 305, Beverly Hills, Calif. 90211; 1-800-950-4686.
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