Silicone suits crawl along

[Guest guest]

Note: forwarded message attached.

Subj: DALLAS NEWS: Silicone suits crawl along

Date: 5/29/2005 9:48:11 AM Eastern Standard Time

From: ilena03@...

Bravo to all who contributed with the truth!

http://www.dallasnews.com/cgi-bin/bi/gold_print.cgi

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

Online at: http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/052905dnmetimplants.f2e6720e.html