Silicone breast implants: serious problems are virtually guaranteed

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SILICONE BREAST IMPLANTS: SERIOUS PROBLEMS ARE VIRTUALLY GUARANTEED

"When we started out, our intent was to cover all plastic surgery, but the response was so overwhelming that we had to confine ourselves to breast implants," said Kathleen Anneken referring to the Command Trust Network, a mutual-aid grassroots organization and information clearinghouse she co-founded early this year. The Command Trust quickly discovered that "for thousands of people, simple and successful plastic surgical solutions are being promised but not delivered by the medical community and by medical device manufacturers."

Silicone breast implants became the organization's focus because they generated the highest number of complaints from people who contacted Command Trust. Silicone-containing prostheses are implanted in the breasts of about 130,000 women each year and, to date, over two million American women have had breast implant surgery. About 25 percent are cancer patients who have had the operation to reconstruct the breast following mastectomy. The rest have the operation for cosmetic purposes to enlarge, or augment, the breasts.

Silicone has been implanted in the breast for more than 25 years. In the early days, it was injected directly into the breast. As time went on, a soft pliable prosthesis, intended to mimic normal contours of the breast, was developed. The implants can consist of a silicone gel or saline solution encased in a silicone envelope. In one version the implant is polyurethane-coated. "They keep changing the formula and the styles about every five years," said Ms. Anneken. "They keep improving them, but, unfortunately, some of the improvements have been disasters. From 1978 to 1984, the implants were even more dangerous because a more liquid silicone gel was used that migrated elsewhere in the body." The saline implants tend to rupture more, but Ms. Anneken said their most frequently reported problems come from women with silicone gel implants for breast augmentation. "The effects of the presence of silicone throughout the body have not been studied extensively enough to determine the degree of risk," said Ms. Anneken, who is a registered nurse. Today, surgeons use a more cohesive gel that can still migrate but, theoretically, to a lesser degree.

The most common complication is capsular contracture, a hard web of tissue that can form around any devices implanted in the body. At its most extreme, capsular contraction can give a hard baseball look to the breast and make it resistant to compression. A version of this complication occurs in 30 percent of the women with breast implants, said Pierre Blais, Ph.D., an associate chemist at the Laboratory for Experimental Surgery, Laval University, Quebec City. The laboratory, the only one of its kind in North America, is staffed by pathologists, surgeons, and chemists, who conduct analyses of medical devices. Another common complication, determined by the ongoing analysis of silicone implants, is the formation of gritty crystals between the breast tissue and the prosthesis in 30 percent of the women with breast implants. "Over time," said Dr. Blais, "the crystals can be seen on mammography and mistaken for cancer because cancer is associated with a similar type of calcification." Women with this condition are often subjected to frequent biopsies to rule out cancer.

No statistics are available to show how many women are informed prior to surgery of the complication rate and the need for repeat surgery once the prosthesis must be replaced. "Re-operation is the rule," said Dr. Blais. "Depending upon the type of prosthesis, most patients can expect to go back for surgery every five to seven years for the rest of their lives." As with other implanted medical devices, such as cardiac valves, these products do not last a lifetime. "Breast prosthesis technology is inherently short-lived and unstable," said Dr. Blais. Of all the women who contacted Command Trust, Ms. Anneken reports that she has yet to find one who was informed by her surgeon of the need for a series of operations following breast augmentation surgery.

"One of the most shocking facts concerning the implantation of silicone gel breast implants is that there has never been a properly done prospective study with excellent followup on any aspect of their use or complications," said Sidney M. Wolfe, M.D., of the Public Citizen Health Research Group (HRG), testifying before the FDA advisory committee on general and plastic surgery devices. The HRG obtained internal Dow Corning and FDA documents showing that silicone gel caused highly malignant cancers in over 23 percent of laboratory animals. (Dow Corning is the main producer of silicone gel.)

While this finding does not prove silcone causes cancer in humans, the HRG found considerable reason to suspect that it could. The Washington, D.C. based consumer group also discovered that Dow Corning had failed to alert the FDA promptly of its animal findings. When the agency finally became aware of these and other preliminary results suggesting a cancer-causing effect, it failed to take the appropriate steps to warn women of the health risks posed by implants. Dow Corning and the plastic surgeons who have spoken out on the subject contend that the animal findings are not relevant to humans.

Immunological problems and systemic disease are other serious, and potentially life-threatening, consequences of silicone implantation. Physicians have begun to document cases of connective tissue diseases, particularly scleroderma, diagnosed years after breast implant surgery. Scleroderma is a fairly rare arthritic disease affecting the blood vessels and connecting tissue. Its chief characteristic is a hardening of the skin of the face and hands.

In order to find out how many women have developed systemic rheumatic symptoms after breast implant surgery, Varga, M.D., and colleagues at the University of Pennsylvania School of Medicine and the V.A. Medical Center in Philadelphia, conducted a critical review of all cases reported in the English-language medical journals (ls of Internal Medicine, 1 September 1989). They found only 12 documented cases of scleroderma, most also had respiratory symptoms.

The small number of reported cases was explained by L. Teich, M.D., a research associate for HRG and a specialist in internal medicine. "The association between silicone [injections and implants] and a whole variety of connective tissue diseases, in particular scleroderma, has only recently been recognized. Remember, the woman has the implants put in by a plastic surgeon who sees her for an average followup of about a year or a year and a half," said Dr. Teich. "It takes time for these illnesses to develop and when they do, the plastic surgeon may not even see the patient again because she goes to an internist. Someone has to make the connection between her symptoms and the implant. Many times, the primary care physician is not aware that the woman has had an implant, and the plastic surgeon would not know scleroderma if it hit him over the head. . .besides, he is in the business of denying the connection."

Several physician groups have recently begun to take a concerted look for cases of silicone-related connective tissue disease. This has been done in what is known as higher-frequency areas of the country. As with other operations, breast implant surgery's incidence shows regional variations. Southern California, southern Florida, Texas, New York, and Quebec City, are higher-frequency areas. One group of rheumatologists in southern California and another in southern Florida found clusters of cases of scleroderma, 50 and 20 respectively, due to silicone injections or implants.

Why has it taken so long for all these silicone-related problems to come to light? Part of the answer lies in the lack of a mandatory reporting system for adverse reactions to surgery and medical devices. Furthermore, manufacturers of medical devices did not have to prove safety and efficacy until a 1976 law stipulated that all new devices go through an approval process similar to that required for drugs. The silicone implant--in all of its incarnations--was "grandfathered" when the 1976 law went into effect.

Now, thanks to the HRG, the FDA will require the submission of animal and other study results as part of the pre-market approval process for silicone implants. But, the wheels of bureaucracy grind slowly, and the process is not likely to begin for another year and a half. In the meantime, the devices will continue to be implanted without any requirement of the manufacturers or the plastic surgeons to warn women of the health risks posed by silicone.

WHAT YOU CAN DO:

--If you have had silicone implanted, seek regular medical attention. Dr. Wolfe advises all women with silicone implants to be carefully followed by their primary care physician--at least once a year--to check for the possible development of complications. --If you are about to have a silicone implant removed and would like to make a contribution to medical science, consider undergoing an experimental blood test. Microbiologist Heggers, Ph.D., at the Shriners' Burn Institute in Galveston, Texas, has funding to develop the ELISA (Enzyme Linked Immune System Antibodies) test to determine silicone sensitivity. The test is a step toward developing a treatment. Dr. Heggers is testing people at no charge before and after silicone implant removal. If you are interested, have your physician contact Dr. Heggers. Similar instructions apply to contacting pathologist Shanklin, M.D., at the University of Tennessee College of Medicine, Memphis, who will review tissue from people with silicone implants. --If you are considering any type of plastic surgery, check to see if your prospective surgeon is board certified in plastic and reconstructive surgery. While this is no guarantee of excellent results, it assures that the surgeon is a specialist who completed residency in this field and passed the boards. All board-certified physicians in the U.S. are listed in the Directory of Medical Specialists which is usually available at most libraries. --If you are considering silicone breast implant surgery and want to speak with a woman in your area who has been through it, contact the Command Trust Network. Augmentation Division: P.O. Box 17082, Covington, Kentucky 41017. Reconstruction Division: 297 S. Beverly Dr., Suite 295, Beverly Hills, California 90212. You will be put in touch with women in your area for a support group or to learn their experience with the operation you are considering. There are also support groups for women who feel they were injured by their surgery. Get trade secrets for amazing burgers. Watch "Cooking with Tyler Florence" on AOL Food.