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Argument Supporting the Safety of Silicone Breast Implants

Disagreement over the safety of implants has been simmering since the 1960s.and it was not until 1988 that the FDA demanded safety data from the manufacturers. There were numerous complaints to the FDA about ruptured and leaking implants. Complaints of vague joint pain and fatigue were also reported.

The silicone breast implant was on the market before a law was changed stating that a manufacturer had to prove the safety of a medical device. Since silicone breast implants were available before this change it was "grandfathered" in by the FDA as a medical device. Without proof of their safety, the implants were then sold and implanted in patients. Unconcerned by the lack of safety data, plastic surgeons relied on the manufacturer unwarranted assurances that the implants were safe.

This was a breakthrough that many women were looking for. A safe and natural feeling breast to replace a breast lost to cancer or birth defect. Many women used it to correct hypomastia (small breast).

There were further studies. July 22-24,1998 there was a meeting of the Committee on the Safety of Silicone Breast Implants by the Institute of Medicine, National Academy of Sciences in Washington, DC. The committee was given the task to review the substantial scientific and clinical data on breast implant safety that had been gathered since the Food and Drug Administration (FDA) placed restrictions on the use of silicone gel-filled breast implants in 1992.

Dow Corning Wright Company, a manufacturer of breast implants, has denied that silicone breast implants cause cancer or any other health problems. To counter act these reports Dow provided an 800-telephone number for people with questions or concerns about SBI. (Hilts, 1991, p. A12) By calling and asking questions the women could be reassured of the safety of breast implants.

The manufacturers are not the only ones who believe that silicone breast implants are safe. The New England Journal of Medicine published the results of a study about breast augmentation and the risk factor, which may cause cancer. In summary, its study did not find an increased risk of cancer among women who received breast implants (NEJM, 1992, p 1649).

Two plastic surgeons societies had issued a statement about the safety of Silicone breast implants. After reviewing the information, The American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) believe that current data substantiates scientifically that women with breast implants are at no large risk for the development of connective-tissue disease (CTD), even in the case of implant rupture And no increased risk for breast cancer or other cancers. The results of more than 20 important epidemiologic studies of CTD and breast implants have become available since 1992.
(ASPS, ASAPS 1998)

In a study of the correlation of silicone breast implants and breast cancer in 1997, Brinton and Brown reviewed many studies relating to the carcinogenicity of silicone breast implants and concluded that these studies found no association of breast implants with breast carcinoma (National Academy Press 2000)

Arguments Against the Safety of Silicone Breast Implants
Part II

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").
(FDA 2001)

Analysis of the Controversy
Part III

For many women two little words, time bomb, take on a new meaning. There are hundreds of thousands of women living with the fear of having had time bombs, literally, implanted in their chest. The fear is all too real for these women who, with information supplied mostly in part by their physicians, have undergone augmentation with silicone breast implants.

With new facts that are coming to light, refuting past studies on the safety of Silicone breast implants, women need to research their decision about getting breast implants. When making their decision women should ask themselves the following questions:

* For psychological reasons the replacement of a breast lost to cancer is best for some women. But does it outweigh the psychological turmoil that most women who are implanted feel?

* Has Dow been unethical in the past by with holding the results of safety testing on silicone breast implants?

* Are the Plastic Surgeons implanting women, knowing that the implants have to be replaced and a second surgery, while painful for the women, will increase their income?

* Who funded the different studies that found breast implants safe? Were they biased?

These are just a few questions women must research before seeing a plastic surgeon. With today's technology there are many breast implant sites on the Internet. Pro and Con sites are available to the public. The FDA and many Plastic Surgeons have sites that offer information.
In the end it is a personal decision to be made by the women, but given all the facts, it should be an informed decision.

References

American Society of Plastic Surgeons, American Society for Aesthetic Plastic Surgery, Joint Position Statement -Silicone Breast Implants: Scientific Update July 17, 1998 available online at:
http://www.plasticsurgery.org/mediactr/jps-798.htm

Hilts Philip J. (1991) December 31, final ed.) Breast implant maker is accused of misleading telephone callers. New York Times, p. A12

Hilts Philip J. (1992) January 7, F.D.A. Seeks halt in breast implants made of silicone.
(Cover Story) New York Times, p A1

National Academy Press (2000) Safety of Silicone Breast Implants
Available online at http://www.nap.edu/openbook/0309065321/html/234.html

New England Journal of Medicine, (1992) Breast Augmentation: A risk factor for breast cancer?
Vol. 326 Issue 25, p1649

U.S. Food and Drug Administration, (2001)
Available online at http://www.fda.gov/cdrh/breastimplants/birisk.html