TransMed

Breast Implants:
An Uplift or a Downer?

by Sheila Kirk, M.D.

Several days ago a jury in Middlesex county, Massachusetts, ordered Baxter Healthcare Corporation and Baxter International, Inc. to pay one and a half million dollars to a woman who had silicone gel breast implants placed in 1977 and who now suffers from the symptoms of a disorder called atypical auto immune disease. She experienced rupture of implants and leakage into the breast tissue and subsequently to other parts of her body including the central nervous system.

The plaintiff's attorney argued that the company acted with callous disregard for the safety of American women who were receiving it's implants. Internal company documents introduced during the trial revealed that the silicone gel used in the implants had failed the only 90 day biocompatibility test which the company had conducted.

The attorney continued his argument saying "To proceed with production after learning that the gel failed its own test, was unconscionable. They essentially used American women as guinea pigs in a human experiment."

Another court hearing is scheduled near the end of the year wherein the judge will consider the possibility of doubling or tripling the damages award. This was the first breast implant products liability case in Massachusetts though not the first in the country. Elsewhere class actions and single plaintiff cases are in the courts at this time. Juries and judges are finding cause to blame the companies that manufacture and sell the implants and to award damages to the women who bring action because of very severe complaints.

In 1992, the number of women suffering illness and filing suits was so great, literally thousands, as to move the FDA to halt their use by direct appeal to surgeons and then subsequently to ban their use. The ban is still in effect and the companies that manufacture the implants have halted production. To clarify: discontinuing implant placement has to do with implants filled with silicone gel not with saline (salt solution.)

However, keep in mind that saline filled implants can also rupture and the contents will spread into the body tissues although saline is not a foreign or harmful substance in the human body. It is processed in the body quite efficiently. Yet the implant itself, no matter what is in it, can cause very severe reaction's.

Encapsulation, the breast's reaction to a foreign body can and usually does occur and is responsible for painful, hardened tissue in the breast and tissues around it. Tumors, called granulomas, can develop in the breast tissue next to the implant. These are hard growths that are benign but create alterations in breast appearance and induce discomfort or pain as well. When Dow Corning Corporation was studying the effects of breast implants, used dogs as recipients of the devices and observed them over a period of time.

The animals, only four in the study, did not fair well even though the company reported that the dogs remained in "normal health." One died during the experiment-one developed the granuloma mentioned.

There are several points to make about what seems to be a controversial yet devastating situation. Firstly, breast enhancement or augmentation is an important technique-an almost necessary surgical procedure in this society. Some genetic women and New Women feel the pressures of several societal views-whether one agrees with these views or not-- i.e. full breasted women are more attractive to men and to themselves.

Many women believe that femininity rises strongly in their body image to themselves and to others. This is important, and I do not find fault with this attitude. Even more so is the fact that women undergoing breast removal or a partial loss of a breast because of cancer, suffer strongly from not only the fear of the disease but the loss of their own self-esteem and the esteem of the circle in which they live. For the psychologic uplift given to individuals by the procedures done in breast reconstruction-the surgery must not be abandoned. Nor should the manufacture of the implants that are made for these purposes.

What is vastly important is that the companies that make these devices must produce implants that are safe, with minimum minor side effects and absolutely no major risks. The companies must originate products that will do no harm. They must study them completely to prove that this is so and they must show indisputable and honest results from those studies to reassure the very large population that will apply for this reconstructive and truly cosmetic surgery. The fault is really not with the surgeons who place them. They believed the manufacturer's literature as did patients. Surgeons are being sued as well in this very difficult situation. The real fault is with the companies who in reality knew that their products were faulty and that they were creating risk for the recipients.

Another very important concept to stress is that free silicone is a VERY dangerous substance in the human body. Many individuals who have had free silicone injections in different areas in the body can attest to the huge problems and eventual incapacities coming from the technique. When silicone gel in an implant is free, because of rupture of the device, the same situation exists.

The substance will be transported to various body tissues and eventually cause disability and disease. The major disorder encountered is a diverse array of symptoms that mimic auto immune disease and as investigators study the syndrome, they are becoming aware of the similarity to but not the actual connective tissue disorders that have been diagnosed.

Medical science cannot dispute that actual disease has occurred with freely dispersed silicone. What to call it and what complaints are really attributable to the disease is part of the discussions taking place in the study of the illness. Its most probable that many, many hundreds of women, both genetic and post-operative, will never have a complaint due to the silicone gel implants they have in place.

Some researchers state that the incidence of disease is in only about 5% of the total population who have implants. This incidence is probably an underestimation and probably not anywhere near the numbers that are currently complaining in the courts. One may never know what is real and not real in either the doctor's or the attorney's offices.

But it's like a number of other things-including alcohol and tobacco-Let the user beware!

    e-mail: SheilaKirk@aol.com
    Phone: (412) 781-1092 Fax: (412) 781-1096
    mailing address: Sheila Kirk, P.O. Box 38114, Blawnox, Pa 15238-8114

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