Dowing Corning

Dow Corning and the Silicone Breast Implant Controversy

Corning, the giant glass company lacked the chemical expertise to develop silicone polymers or to manufacture them efficiently so they turned to Dow Chemicals for help. The two companies formed a partnership in 1943. This joint venture would be a separate company, owned by Corning and Dow, called appropriately, Dow Corning.

Safety issues concerning the use of silicone in medical devices have primarily focused on the possible link between breast implants (both saline-filled and gel-filled) and certain illnesses, including breast cancer and connective tissue disorders (also referred to as autoimmune diseases such as lupus, scleroderma, and rheumatoid arthritis). Silicone materials have been tested extensively in laboratory studies, as well as clinical studies (those that study human health).

Dow Corning while trying to set their presence in the silicone venture has had a few ups and downs. What Dow Corning has done with the manufacturing of medical devices has made them a true leader in the business world.

Dow Corning and the Silicone Breast Implant Controversy

Why all the hub-bosh over the size of women's breasts? This is not a new fetish. Dating back to the 1940's, Japanese prostitutes injected their breasts with substances such as paraffin, sponges and non-medical grade silicone to enlarge them. They believed that American servicemen favored women with large breasts. In 1960, the first silicone breast implants were developed by two plastic surgeons from Texas: Frank Gerow and Thomas Cronin. In 1962, silicone breast implants were developed into a commercial product by Dow Corning. In this same year, Timmie Jean Lindsey became the first woman to receive the silicone breast implants.

Fifteen years later, in 1976, the Food and Drug Administration enacted the Medical Devices Amendment to the Federal Food, Drug, and Cosmetic Act. FDA now had the authority to review and approve the safety and effectiveness data of new medical devices.

Between 1977 and 1991, 137 individual lawsuits were filed against Dow Corning. Richard Mithoff, a Houston attorney, would win the first lawsuit for a Cleveland woman who claimed that her ruptured implants and subsequent operations had caused pain and suffering. She received a $170,000 settlement from Dow Corning. Lawsuits continue to be filed and won. Maria Stern's systemic autoimmune disease was found by a jury to be caused by her silicone breast implants and was awarded $211,000 in compensatory damages and $1.5 million in punitive damages. Brenda Toole, who showed only preliminary symptoms of systemic autoimmune problems, nevertheless, had silicone in her lymphatic system and thus an increased risk of developing an autoimmune disease was awarded 5.4 million.

The Stern vs. Dow Corning, San Francisco case won on many internal Dow Corning documents that had been discovered in a Dow storage area by attorney Dan Bolton. Bolton introduced the silicone-induced problems for the first time in court; with "experts" that theorized the silicone-immune system connection. After a month long trial, the jury awarded Maria Stern $7.3 million. Attorney Dan Bolton, now representing Mariann Hopkins, was able to prove mixed connective-tissue disease is linked to her ruptured silicone breast implants. He won the suit with the help of internal memos and studies from the Stern lawsuit. In addition to new studies he recently obtained from Dow, Mr. Bolton turned over several of the internal documents to the FDA, whom had never seen the documents before. In February 1992, Attorney Stan Chesley, hoping to compensate women at a faster rate than filing individual lawsuits, filed a class action lawsuit in Cincinnati. In March 1992, Dow Corning left the silicone breast implant business and set up a fund for further research into the safety of breast implants.

The Mayo Clinic epidemiological study was published in the New England Journal of Medicine, in June 1994, and found no increased risk of connective-tissue disease or other disorders that were studied in women with silicone implants. However, lawsuits continued to be filed, and in May 1995, Dow Corning filed for Chapter 11 bankruptcy. The bankruptcy essentially halted all litigation.

Research by the American College of Rheumatology issued a statement in 1995, stating that the evidence was compelling that implants did not cause systemic disease. This was backed up by The Harvard Nurses Epidemiologic Study published in the New England Journal of Medicine, which found no increased risk of connective-tissue disease or certain signs and symptoms of connective-tissue disease in women with silicone implants. In January 1997, The American Academy of Neurology reviewed existing silicone implant studies and reported that existing research showed no link between silicone breast implants and neurological disorders. Then in March 1997, a Michigan judge ruled that the Dow Chemical Company was not liable for the medical problems of hundreds of women in the state. Thus far, some state appellate courts have upheld Dow Chemical's liability and others have not. In September of 1997, The Journal of the National Cancer Institute published a review of scores of medical studies concluding that breast implants do not cause breast cancer. The researchers described the evidence for linking implants to any other disease as borderline. In December 1998, after two years and $800,000, a panel of four independent experts, appointed by Judge Sam C. Pointer (overseer of implant lawsuits in the Federal courts) concluded that scientific evidence so far had failed to show silicone breast implants cause disease. Silicone-gel-filled implants remained off the market as of spring 1999, in the U.S. pending manufacturer safety studies. They are available only to women who have had or will have breast surgery for a medical condition or have other complications from existing implants, and only if they agree to be part of a scientific study.

The American Society of Plastic Surgeons reported over 237,000 women had breast augmentation in 2002. Overall demand for breast augmentation has grown 593% since 1992. A report in 2002 published in Plastic and Reconstructive Surgery showed more than 90 percent of women were satisfied with the way their breast augmentation and resulting body image was in two years post implant. (US NEWS Oct 15,2003)

Inamed (similar company to Dow Corning) completed a 5-year follow-up of data from 686 breast augmentation patients and 140 reconstructive patients. In the 5-year post implant data, results were astounding; breast augmentation patients were 95 percent satisfied with their results. Reconstructive