Silicone Breast Implant Victims to See Settlement Dollars

June 1, 2004

by Rachel Weisshaar, NOW Communications Intern

In a victory for women, a U.S. district court judge last week set today as the deadline for Dow Corning to begin processing claims from thousands of women who suffered complications from the silicone breast implants the company manufactured until the early 1990s. The money will come from a $2.35 billion fund created in one of the largest class-action settlements in U.S. history.

After more than ten years of legal wrangling, Dow Corning is expected to send out the first checks by June 15; claimants in the massive class-action will be eligible to receive anywhere from $2,000 to $250,000, depending on their injuries. The company, facing 19,000 implant lawsuits, filed for Chapter 11 bankruptcy in 1995; the settlement plan was confirmed in 1999, but has been delayed by appeals.

The settlement follows the Food and Drug Administration's (FDA) decision in January 2004 to deny implant manufacturer Inamed's application to market silicone-gel breast implants for general use. The FDA advisory committee recommended (9 votes to 6) approving Inamed's application, but the FDA sided with scientists who argued that there was insufficient long-term health data to deem the product "safe and effective" for general use. The FDA had banned silicone-gel breast implants in 1992, and currently only approves their use in limited cases, such as for breast reconstruction after a mastectomy.

Earlier this year, women's health advocates praised the FDA's rejection of Inamed's application.

"The FDA's decision is a victory for all those who believe that reliable scientific research is the best foundation for these decisions," said National Organization for Women (NOW) President Kim Gandy.

Advocates argue that no existing research, either by implant manufacturers or independent scientists, has shown silicone implants to be safe over the long term. In May 2000, however, the FDA approved less-pernicious saline breast implants, despite concerns that many members of the advisory panel expressed regarding high incidences of pain, additional surgery, and other complications. The panel expressed additional objections in 2002, but the saline implants were nevertheless re-approved by the FDA.

Numerous health risks are associated with silicone-gel breast implants, which have been marketed in the U.S. since 1963. Some of these dangers apply to both saline and silicone implants, including the risks of surgery (infection and negative reaction to anesthesia), capsular contracture (the contraction of the scar tissue around the implant, which can cause painful hardening of or distortion of the shape of the breast), rupturing of the implant, interference with the accuracy of mammograms, and difficulty breast feeding. Women with silicone breast implants often develop serious autoimmune disorders such as lupus and scleroderma. Fibromyalgia, a painful connective tissue disorder, is also common in women with silicone breast implants. Most women think that their implants are permanent, but both silicone and saline implants frequently rupture, leak, and cause other complications. Many women have to undergo several painful, costly, and debilitating corrective surgeries to address these problems.

Although no direct links have been proven between silicone breast implants and rheumatoid arthritis, brain tumors, lung cancer, other respiratory diseases and suicide, a study conducted by the National Cancer Institute has found that women with breast implants are significantly more likely to die from these causes than are other plastic surgery patients. Another study at the National Cancer Institute has found that women with implants experience an overall 21% increased risk of cancer compared with women of the same age in the general population. Even Inamed admits that silicone is not bio-compatible with human tissue. When silicone leaks out of implants, it can migrate to other parts of the body, including the lymphatic system, lungs, liver, spleen, and brain.

Scientists have been aware of most of these health risks since the 1970s, but women's health advocates note that the FDA has historically bowed to pressure from outside and inside the organization to keep breast implants on the market. A 1992 Congressional report entitled "The FDA's Regulation of Silicone Breast Implants" found that FDA officials often ignored the concerns of their own scientists and advisors regarding the safety of breast implants. In addition, the FDA did not support efforts to disseminate safety information to the public.

NOW and other women's health advocacy organizations have spoken out against FDA approval of silicone implants. NOW organized a symposium on the safety and effectiveness of silicone gel-filled breast implants in July 2003, which concluded that silicone implants are associated with a high prevalence of "local complications" such as fibromyalgia, chronic inflammation, and frequent reoperation, but that little reliable long-term research has been done on the implants.

"The women who will be receiving monetary compensation for years of diseases, chronic pain and corrective surgeries were not adequately notified of the dangers associated with breast implants. We hope the publicity surrounding this settlement will help inform women about the serious risks involved with breast implant surgery," said Gandy.

More information on the Dow Corning settlement is available at www.dcsettlement.com.