Pro & Con

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 FDA 2011

Date: Sun, 18 Oct 1998 07:40:42 -0700

St. Lawrence woman describes her 30-year struggle to survive
A medically sanctioned pre-emptive strike against cancer turns into decades of painful surgeries and baffling illnesses.

By Francine M. Scoboria

Kathleen V.F. Nye was only 22 when doctors told her she had pre-cancerous tissue in both breasts. They suggested a double mastectomy, followed by silicone gel breast implants.
I passed out in the elevator after I had the biopsy," recalled Nye, now 52 and living in St. Lawrence. I woke up in the emergency room, hysterical. I cried, but then I accepted it. I had children to think about."

At 22, she was a Navy wife with two young sons, living on a military base in Portsmouth, Va., while her first husband was serving in Vietnam. Nye said doctors told her she was lucky - that breast implants manufactured by Dow Corning Corp. of Midland, Mich., would last into her 80s. Someday, she was told, she would be the sexiest lady in her nursing home.

Now - a survivor of more than 20 surgeries and several diseases - she is one of 400,000 U.S. women suing Dow Corning for health problems they say were caused by silicone breast implants. About 170,000 of the litigants, including Nye, have developed diseases they say were caused by the implants.

Dr. Robert F. Garry, a professor of microbiology and immunology at Tulane University Medical School, New Orleans, said studies show 50 percent of silicone gel implants rupture within 10 years and that 95 percent rupture within 20 years. He said studies concluding that silicone gel implants do not cause diseases have been financed by manufacturers of breast implants.

Nye, the wife of Robert A., is represented by attorney Scott B. Cooper of Harrisburg.
Cooper said lawyers in his office represent 200 women suing Dow Corning, which produced silicone implants between 1962 and 1992.

Nye said her original implants were replaced several times by updated versions that also caused problems, including wounds that would not heal. She said she has been diagnosed with osteoarthritis and fibromyalgia, a disease defined by chronic pain in muscles and tissue surrounding joints. She said doctors have told her she also has symptoms of lupus, a disease of the immune system, although tests have been inconclusive.
Cooper said many women suing Dow Corning have problems involving their immune systems. Nye and other plaintiffs have also had what are called foreign-matter tumors removed from various parts of their bodies, Cooper said.

Nye, who spends many hours on the Internet communicating with women she calls her silicone sisters, believes the foreign matter is silicone, although doctors have not confirmed her suspicion. A debate exists among medical and legal experts about whether silicone breast implants have been proven to cause health problems.

Dr. Raymond L. Smith, chairman of plastic surgery at Reading Hospital, said medical studies have not proven that silicone breast implants cause diseases.
There is a lack of evidence that shows a connection between silicone gel implants and connective tissue diseases," Smith said.

However, implants carry a low risk of complications, such as leaking or rupturing, Smith said. Plastic surgeons have the responsibility to tell women the possible complications, he said.
Today most breast implants are silicone containers filled with saline, he said. While these carry a low risk of leaking, the saline is not dangerous in most cases, he said.

This is a new disease that does not fit into any pre-existing category," Tulane's Garry said.
It is similar to lupus, but not quite lupus," he added. Defining a new disease takes a long time, especially in such a charged medical and legal environment where every side has a vested interest." Garry added that saline implants can trap bacteria. If a leak occurs, the bacteria can cause toxic shock, which is fatal in some cases, he said. Both types of breast implants can interfere with breast cancer screening, he said.

In a cruel twist of fate, Nye developed breast cancer in 1986 in the small amount of breast tissue she still had, located under her arms. After surgery and six months of chemotherapy, she reached out again toward life. When you have cancer, you think about death and things that you didn't do," Nye said. I dropped out of school to get married and have children. I always wanted to go back to college."

Nye enrolled part time at Reading Area Community College and earned an associate degree in travel and tourism. She worked part time as a travel agent for several years.
These days she serves as a volunteer at the Berks Unit of the American Cancer Society and as a member of the RACC alumni council.

Once the biggest producer of silicone breast implants, Dow Corning filed for bankruptcy in 1995 after a rush of lawsuits. U.S. Bankruptcy Judge Arthur Spector, Bay City, Mich., tentatively approved a $3.2 billion settlement in July. Once the settlement is approved by Dow Corning's creditors and a majority of the plaintiffs, some of the money will be split among the women, Cooper said.

Kevin M. Wiggins, a spokesman for Dow Corning, said the company has agreed to the settlement to end the lawsuits and give the company an opportunity to emerge from bankruptcy. We have made no admission of guilt," Wiggins said. We absolutely believe that scientific studies have conclusively shown there is no link between silicone breast implants and diseases."

Dow Corning no longer produces breast implants, Wiggins said. The company manufactures many products used in construction, automobiles and aerospace, he said. A sizable portion of the money will go to parties other than the plaintiffs, including creditors, doctors and lawyers, Cooper said. While some reports indicate the women may receive as much as $250,000, most will receive much less, Cooper said.

I have no idea how much money Kathleen would get," Cooper said. I don't think the case will be settled until the spring." Cooper explained that the women will receive different amounts of money depending on how their symptoms match up with specific diseases.

Nye said she is suing Dow Corning for something more important than money.
It would make me feel much better if Dow Corning would admit that they produced a product that caused illnesses," she said. There is not enough money to buy me back 30 years of my life."