DALLAS NEWS: Silicone suits crawl along

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Silicone suits crawl along

Thousands await money years after implant maker pledged $2.35 billion

09:15 PM CDT on Saturday, May 28, 2005

By SHERRY JACOBSON / The Dallas Morning News

It's been 25 years since Dintino got silicone breast implants

and more than a decade since she sued the manufacturer, Dow Corning

Corp., believing the devices made her sick.

RICHARD MICHAEL PRUITT/DMN

Dintino says the silicone breast implants she wore from 1980

to 1994 have caused neurological problems. But she and tens of

thousands of other women haven't received a penny despite the

promise of a $2.35 billion settlement by the implant maker in the

mid-1990s. The company began compensating breast implant wearers

last June after emerging from Chapter 11 bankruptcy. But most of the

women are still waiting.

" Personally, I think they're just waiting for everybody to die, "

said the 51-year-old Burleson woman, who is seeking $40,000

compensation for neurological ailments she attributes to the

silicone implants she wore from 1980 to 1994.

Women have filed more than 70,000 claims against Dow Corning,

although fewer than 24,000 have been paid – most of them for $5,000

or less. Women seeking as much as $300,000 for debilitating diseases

are the most likely to be waiting.

Medical research has questioned the link between silicone implants

and serious health complications. But officials involved with the

settlements deny that the company is trying to avoid paying claims.

" I have no intention of delaying or keeping these claimants from

getting paid, " said s, a Dallas judge and attorney who

serves on the finance committee that oversees Dow Corning's

settlement office, which is funded by Dow Corning Trust.

He said some of the claims are very complicated, especially when

they involve significant illness and disability. So far, 17,484 of

these types of claims have been filed; 3,286 have been paid.

" It could always be faster, " Mr. s conceded of the payout

pace. " But we'd be taking money away from the claimants in order to

speed it up. " He explained that it would require additional staffing

and resources – all of which would come out of the settlement fund.

Even as the implant payments are trickling out, implant

manufacturers are stepping up efforts to market a new generation of

silicone devices to American women. Last month, an advisory

committee to the U.S. Food and Drug Administration recommended that

Mentor Corp., a California company, be allowed to sell silicone

breast implants to the general public again. The panel, however, did

not endorse a similar request from another California company,

Inamed Corp.

Reassessing the risk

After a 13-year ban on the devices for all but breast-cancer

patients, the federal government is reconsidering the rupture risk

of silicone implants, a key issue in allowing them to be widely used

again. This time, the manufacturers acknowledge that silicone breast

implants are " temporary devices " that could rupture over time and

expose women to the gel inside.

Opponents of the devices say that admission alone should be enough

to keep them off the market.

" This is a really, really ugly issue as far as women's health is

concerned, " said Sybil Goldrich, who runs a national clearing house

for breast implant information (www.commandtrust.org) and attended

the FDA hearings. " Breast implants that don't work are bad. Women

are being duped. "

But the FDA advisors are proposing various safety measures that

would allow the devices to be brought back, including creation of a

voluntary registry of implant wearers who could be followed for 10

years. The FDA is expected to rule on the devices by July.

" This is good news for Mentor and great news for doctors and

patients, " said H. Levine, Mentor's president and chief

executive officer. " The panel deserves a lot of credit for

thoroughly examining the scientific data before reaching the same

conclusion we have reached – that Mentor's silicone gel-filled

breast implants are a safe and effective option for women. "

In affidavits released last week, however, two former Mentor

employees alleged that the company has concealed high rupture rates

for its implants. Mr. Levine quickly discounted their claims, saying

the FDA also dismissed them in the past.

The debate over silicone implants comes at a time when saline breast

implants have never been more popular. According to the American

Society of Plastic Surgeons, nearly 256,000 women underwent breast

enhancement surgery last year, 40 percent more than received them

five years earlier. Fewer medical problems have been associated with

the saline implants.

Many plastic surgeons say the demand for silicone implants is

growing. Silicone gel creates a more natural appearance than the

heavier saline-filled implants.

Rod Rohrich, a Dallas plastic surgeon, says his practice includes

women on both sides of the issue. Some want new silicone implants

while others had problems with earlier versions and sought

compensation from the manufacturers.

Dr. Rohrich, the chairman of plastic surgery at the University of

Texas Southwestern Medical Center at Dallas, said he has resolved

any safety concerns in his mind.

" The whole thing was really unfortunate because it was shown that

hardly any of the complications had scientific merit, " Dr. Rohrich

said. " It's time to move on. "

Variety of ailments

The massive breast implant settlement was triggered by widespread

complaints of unexplained illnesses from implant users in the late

1980s and early 1990s. The women asserted that the devices had

ruptured and leaked silicone gel into their bodies, causing

autoimmune and connective tissue diseases, such as rheumatoid

arthritis, along with severe lethargy, depression and a variety of

infections.

" Women are still coming to my office wanting their silicone implants

out, " Dr. Melmed, a Dallas plastic surgeon, said

recently. " I'm seeing the same terrible symptoms over and over

again. Something is really wrong. "

But over the years, medical researchers have found no decisive link

between the illnesses the women complained of and silicone implants.

A comprehensive report by the National Institute of Medicine in 1999

concluded that there was no evidence that implants caused major

diseases in women, although other health problems could result when

the devices ruptured.

Some critics said the studies were flawed because they tended to

focus narrowly on specific diseases rather than look for a broader

spectrum of symptoms that were being reported. Regardless, Dow

Corning and the other implant makers had agreed to the massive

payoff by the time the scientists weighed in.

" We certainly believed the science came out on our side, " said Doug

Schoettinger, Dow Corning's associate general counsel. " But we put

that behind us and moved on. "

The company did not move as fast as other implant manufacturers,

some of which have completed their payment plans while other

companies are nearly done.

Eliason, a settlement claims administrator for a half dozen

implant makers, said the payments women received varied by company.

For example, Inamed split $32 million among 45,000 women, paying a

modest $725 per person. Mentor, meanwhile, paid out $26.5 million in

claims of $377 and $1,500 apiece, while Bioplasty Inc. divided up

$4.5 million at $481 or $1,925 per claim.

She is overseeing implant claims paid by Baxter, Bristol-Meyer and

3M, although the companies have not disclosed how much money they

are distributing.

" Gigi " Lawrence, whose implants were removed in 1998, said

there is much anger among women who already received their

settlements.

" This is a sordid, terrible, corrupt mess because nobody is being

paid what they deserve, " insisted the 58-year-old Grapevine women,

who called her Inamed payment " a pittance " for the variety of

chronic illnesses she has suffered.

Dow Corning began paying from $2,000 to $300,000 per claim this

year. By March 31, its trust fund had settled 23,795 claims totaling

$208 million, or about 10 percent of the total settlement amount.

The company, which was the largest breast implant manufacturer, got

a slower start because it remained in Chapter 11 bankruptcy for

nearly a decade, protected from the 19,000 breast implant lawsuits

that had been filed by 1995 alone.

Mr. Schoettinger said it took until last June for the company's

settlement plan to satisfy the federal court and all the parties

involved in the bankruptcy, including the women who had filed the

thousands of lawsuits.

" It's not the case that Dow Corning was happy in Chapter 11 and was

prolonging the case, " he said. " We acted in good faith. "

Burden of proof

Regardless, the long wait has rendered moot thousands of claims

against the implant manufacturer, said several advocacy groups for

the women. In some of those thwarted cases, hospitals and doctors

inadvertently have destroyed women's medical records. Also, doctors

have died before they could provide the kind of detailed medical

information that a settlement claim requires.

CHERYL DIAZ MEYER/DMN

" We'd be taking money away from the claimants in order to speed it

up, " said Dallas Judge s, who is helping oversee the

implant settlement. About 9,000 such claims have been rejected

because women simply could not prove that they have – or once had –

Dow Corning implants, said Mr. s, who also handles all the

appeals filed by rejected claimants.

" I'm very sympathetic to these claims, " said the former state

district judge for Dallas County. " Most of these people got their

implants years ago and their doctors have died or they don't have

their records. They're not in a situation where they'll ever be able

to prove manufacturing criteria. "

Some women are being sent back to their doctors for specific proof

that their implants ruptured before they were removed. The

word " rupture " must be included in the doctor's notes and lab

reports, Mr. s noted.

Other women must track down the implants that were removed from

their bodies more than a decade ago. And women who claim severe

disabilities, which bring payments up to $300,000, are getting the

toughest reviews.

For example, they must find doctors who will verify that a woman is

both 100 percent disabled and unable to take care of herself in

order to be paid, said Dianna Pendleton-Dominguez, a Houston

attorney who serves on a court-appointed claimant's advisory

committee.

" Women have to incur a lot of time and expense to get an evaluation

to meet both criteria, " she said. " It's those kinds of things that

are driving women crazy. "

Some women also struggle through the claim's process after dumping

their lawyers.

" Having it drag on this long has created unnecessary and

inappropriate friction between lawyers and clients, " said Memphis

attorney Bill Colvin, who is handling more than 60 Dow Corning

claims. " Doctors told some women that all their other patients had

received their checks, so they better get a new lawyer. "

Women who fired their lawyers have to understand the rules of

evidence required in filing a claim, he said. " If there are

deficiencies in their cases, they're not going to know how to fix

them. "

E-mail sjacobson@...

DECADES LATER, THE JURY'S STILL OUT

1962 – The first silicone breast implants are installed

experimentally in a Houston woman. Doctors pressure the

manufacturer, Dow Corning Corp., to market them for breast

enlargement.

1960s and '70s – Women around the U.S. clamor for silicone implants

to enlarge their breasts in eight sizes from mini to " large extra

fill. "

1984 – A San Francisco jury awards $1.2 million to a woman who

suffered an autoimmune disease that she believed was caused by a

ruptured breast implant.

1988 – Two studies suggest serious health risks related to silicone

implants. About 1 million American women are estimated to have such

implants, 80 percent of them for cosmetic enlargement and 20 percent

for breast reconstruction after cancer.

Late 1980s to early '90s – Many U.S. lawsuits are filed against

implant manufacturers alleging a variety of health problems suffered

by women who received silicone implants.

March 1992 – Dow Corning announces that it will stop making breast

implants, and it starts a $10 million research fund for the study of

implant safety.

March 1992 – FDA restricts silicone implants to breast cancer

victims, who are enrolled in controlled clinical trials that track

any ill effects.

May 1992 – Dow Corning files for federal bankruptcy protection.

June 1992 – The largest study to date of women with breast implants

finds no connection to breast cancer. The FDA's Dr. Kessler

continues restricted use due to " inadequate " safety information.

June 1994 – The FDA opens an inquiry into the safety of saline

breast implants as critics call for more safety data related to

implant leakage.

Sept. 1994 – Dow Corning and other implant manufacturers agree to

pay a $4.2 billion settlement for injuries allegedly caused by

silicone breast implants.

1995 – A Harvard nurses' study finds that those with silicone

implants have no increased risk of developing connective tissue

diseases such as rheumatoid arthritis. Critics say the study didn't

detect ill-defined symptoms suffered by some women with implants.

1997 – An FDA study concludes that implants do not cause breast

cancer and finds only " borderline " evidence linking the devices to

any other disease, including connective tissue disease.

1998 – A Dow Corning settlement agrees to pay out $12,000 to

$300,000 each for 179,000 women who blame silicone implants for

illnesses. Other women without health problems get $2,000 each.

May 1999 – Evaluation of data from 35 silicone implant studies

suggests a failure (leakage) rate of 30 percent in the first five

years, 50 percent at 10 years and 70 percent at 15 years.

June 1999 – A National Institute of Medicine study finds no evidence

that silicone implants cause major illnesses in women.

May 2000 – The FDA allows saline-filled breast implants made by two

California companies to stay on the market but warns that breast

implants are temporary and need to be surgically replaced over time.

The decision is the first-ever government approval of breast

implants.

April 2001 – A National Cancer Institute study suggests that women

with implants do not face increased risk for most cancers. A slight

increase in brain and lung cancer, however, is detected.

June 2004 – Dow Corning emerges from bankruptcy protection and jump-

starts its $2.35 billion silicone implant settlement effort, now

involving 145,000 implant users.

April 2004 – An FDA advisory panel recommends approval of Mentor

Corp.'s plans to market silicone-gel implants but rejects Inamed's

similar application. Strict rules for use of the devices are urged,

however. The FDA is expected to rule on the requests this summer.

SOURCES: Dallas Morning News research; U.S. Food and Drug

Administration

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