Arguments Against the Safety of Silicone Breast Implants
In 1962 The Dow Corning Center for Aid to Medical Research, headed by Silas Braley, worked with Dr. Thomas Cronin, a professor at Baylor University and his resident, Dr. Frank Gerow to develop the first silicone breast implant. For years injected silicone was used with drastic effects. The silicone traveled through the body freely. It caused death in many women when silicone entered their lungs or heart. The silicone sack developed by Dr. Cronin and Dr. Gerow held the silicone inside
the sack so it would not enter the body, or so they summarized, thus making it safe for implantation into the human body. Later independent studies showed that the silicone leaked through the silicone shell. The term used by the manufacturer was gel bleed.
The Food and Drug Administration (FDA) issued a statement in 1992 saying because of possible links between the implants and physical manifestation by patients who received the implants, the FDA was removing the silicone breast implant from the market. The silicone breast implant could not be used, except for controlled studies. The FDA said further studies were needed to provide the proof of the safety of silicone breast implants.
According to an editorial published in the New York Times:
During the last 30 years at least one million American women have undergone breast implant surgery. The figure is inexact, but then so is everything that's known, or suspected, about the procedure. In fact, the most important information was how little information there is. Which means that not one of these women made a truly informed decision. (1992, p. A18)
As to the 800-telepone number provided by Dow to halt the fears of implant safety Dow Corning Wright was warned by the FDA in a letter, about giving false information to patients over the telephone by Dow workers. This letter complained that company employees were making these following false statements over the telephone:
* "Scientific data and research show that breast implants are 100% safe."
* "After 30 years of study conducted with patients there have never been health problems with implants or silicone".
* "Breast implants are safe," (Hilts, 1991, p. A12).
Some Physicians also came forward and said that the implants are not safe. Dr Sidney Wolfe, a critic of implants...said "Women simply will not use these implants when told what the risks are, and those who do, it will be because the plastic surgeons will try to tell women there is no problem" (Hilts, 1992 p. A1).
Even the Food and Drug Administration has now updated their web page to include new information in the following way. While many women believe breast implants cause debilitating systemic illnesses, such as autoimmune disease, this is not proven at this time. However, most women with breast implants will experience some local complications such as rupture, pain, capsular contracture (a tightening of the scar tissue or capsule the body forms around the breast implant), disfigurement, and serious infection. These may lead to nonsurgical medical treatments and repeat surgeries.
Breast implants are not lifetime devices and cannot be expected to last forever. Some implants deflate or rupture in the first few months after being implanted and some deflate after several years; others are intact 10 or more years after the surgery Silicone Gel-Filled Breast Implants - When silicone gel-filled implants rupture, some women may notice decreased breast size, nodules (hard knots), uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in sensation. Other women may unknowingly experience a rupture without any symptoms (i.e., "silent rupture").