Beth
Administrator
| Joined: | Sat Apr 29th, 2006 |
| Location: | NoImplants, USA |
| Posts: | 14943 |
| Type of Implants?: | Saline Filled Silicone | | Explant Status: | Have been Explanted |
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http://www.freewebs.com/implants/implantresearch.htm
SILICONE INDUCED IMMUNE DYSFUNCTION SYNDROME
Andrew W. Campbell, M.D.
Medical Director
Center for Immune, Environmental and Toxic Disorders
Houston, TX
The use of silicone in medical devices has sparked controversy in the Food and Drug Administration, the medical and surgical community, the legal profession, the insurance industry and the manufacturers of silicone medical implants. Silicone is used in many medical prosthetic devices and the medical literature is replete with adverse reactions wherever it is implanted in the body. Today, in science and in medicine, the term Silicone Induced Immune Dysfunction Syndrome (S.I.I.D.S.) is most commonly used, a designation first used by the author in a study published in 1992. The author has examined several thousand patients with silicone implants, including Norplant, chin, TMJ, testicular, ocular and breast implants.
LIQUID SILICONE
Silicone was initially developed in the early 1940s for industrial use as an insulator and as a lubricant. In the late 1940s and in the 1950s Japanese women had liquid silicone injected directly into the breasts for augmentation purposes. This resulted in numerous complications, not only at the site of the injection but throughout the body, including tissue necrosis, granuloma formation (appropriately named siliconomas), carcinoma of the breast, chronic infection, sclerosis and blood clots to the lungs (pulmonary emboli). There were fatalities as a result of these complications. Japanese doctors reported in medical journals that the women receiving these liquid injections showed immune and autoimmune-like symptoms and diseases. In 1965 the FDA banned the injection of liquid silicone for breast augmentations, and its current commissioner, Dr. Kessler, further warned doctors in 1991 that silicone injections to erase wrinkles was illegal.
SILICONE BREAST IMPLANTS
In 1962 with the assistance of Dow Corning Corporation, Dr. Cronin at Baylor College of Medicine in Houston developed and used the first silicone gel implants. The following year, Dr. Gerow joined him and the silicone gel breast implant as a medical implantable device was launched by Dow Corning. It consisted of silicone gel contained in a silicone polymer envelope or bag. Up to 90% of the gel consisted of liquid silicone.
There were many early complications such as rupture, shifting of the position of the implant on the chest, and fibrous scar tissue formation around the implant called "capsule". As a result, several different designs and types of implants were developed. Dacron patches were added onto the posterior surface of the implant to aid in fastening to the pectoral muscle of the chest so that the implants would stay in place. Shortly thereafter, Dr. Henry Jenny, with the aid of the Heyer-Schulte Corporation, developed and marketed a new implant consisting of saline soluble implant consisting of an inner compartment of silicone gel surrounded by an outer compartment of saline. Lastly, commercial grade polyurethane foam was used to cover silicone implants with the hope that it would delay capsule formation as well as provide an improved anchoring device on the chest wall.
There are, therefore, four basic types of breast implants:
- Silicone gel contained in a silicone bag.
- Saline liquid contained in a silicone bag.
- Double-lumen implant consisting of an inner compartment of silicone gel in a silicone bag surrounded by an outer compartment of saline in a silicone bag; and
- Silicone gel in a silicone bag covered with polyurethane foam.
COMPLICATIONS OF SILICONE BREAST IMPLANTS
Capsule formation
One of the most common complications of silicone breast implants is capsule formation around the prosthesis resulting in the hardening of the breast. This causes discomfort, pain, disfigurement, and/or displacement of the implant on the chest. This condition may occur on one side or both, and may be more severe on one side. We have seen patients with one implant almost in the armpit while the other has migrated to the shoulder. Calcium may eventually accumulate in the capsule, making mammograms extremely difficult to interpret. The calcium deposits can mimic the appearance of cancer on X-ray film, thereby causing misinterpretations of cancerous lesions and delaying their diagnosis.
Plastic surgeons frequently perform what is known as a "closed capsulotomy". This is an office procedure whereby the breast is hand squeezed with enough pressure to break the fibrous capsule. The procedure is painful and can result in rupture of the implant itself. We have seen many patients in our Center who have had this procedure performed on one or both breasts several times.
Rupture of the Implants
Implant rupture may occur on one side or both and may be obvious to the patient or may not, depending on the amount of fibrous tissue capsule formation surrounding it. The rupture may occur spontaneously, after trauma to the chest wall or breast, or after closed compression capsulotomy. A ruptured implant should be removed at once to prevent further migration of silicone tissues. However, the rupture may go unnoticed by the patient, especially if there is capsule formation.
Silicone Leakage
Silicone gel "bleed" from the envelope and its spread throughout the tissues of the body is common and has been linked with several complications. Firstly, since the gel is composed partly of liquid silicone, its leakage may cause the problems described above associated with liquid silicone. Secondly, the effects of silicone can cause immune and autoimmune problems. Silicone particles have been found at distant sites from injection or implantations such as in the brain, liver, lungs, kidneys, adrenal glands, lymph nodes, pancreas and ovaries. Pockets of silicone may cause the formation of siliconomas, which have been found in the breast, neck, axillas, abdominal wall, thighs, and upper extremities.
Infections
Infections may occur after surgery with any implantable device but, fortunately, are rare. However, laboratory studies have shown that the polyurethane covered implant can harbor numerous microorganisms in the lattices of the foam. There have been reports in medical journals of both bacterial and fungal contamination associated with all four types of implants. These infections may play a role in the formation of the fibrous capsule. We have found that a majority of our patients have antibodies to several different fungi.
Cancer
Silicone gel breast implants can interfere with early tumor detection due to several factors. The implants may compress the breast tissue and render standard mammogram screening difficult at best. As mentioned above, calcification of the capsule may obscure or conceal a cancerous lesion. Studies have also suggested that the immune dysfunctions caused by silicone may have an adverse effect on the immune system’s ability to fight off and destroy cancer cells. We have seen rare, as well as more common types of cancers develop in our implant patients. A recent medical journal report compared breast cancer in women with and without silicone breast implants. The study showed that the cancer in women with silicone breast implants were of a more aggressive type and had invaded more lymph nodes than the cancer in the women without implants.
Foam Coated Implants
Polyurethane is known to break down into Toluene Diisocyanate (TDA), a chemical known to cause cancer. When the implants are surgically removed, it is not unusual to find the entire polyurethane foam coating gone, all of it dissolved into the tissues. This may very well increase the potential for the development of cancer.
CLINICAL SYMPTOMS AND SIGNS
Numerous patient case reports and controlled clinical trials have discussed some of the many disorders and clinical syndromes associated with silicone implants, some of which resemble systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's disease, polymyositis, mixed connective tissue disease, multiple sclerosis, and other neurological disorders. However, it is important to note that Silicone Induced Immune Dysfunction Syndrome is a multisystem disorder, which can affect any and all systems of the body.
The following is a list of the most common patient complaints compiled by us from over 4,000 patients with silicone prosthetic devices.
- breast pain or tenderness
- fatigue, usually made worse by exercise
- cognitive function problems, such as attention deficit disorder, calculation difficulties, memory disturbance, spatial disorientation, frequently saying the wrong word
- psychological problems such as depression, anxiety, personality changes, mood swings
- sleep disturbance and non-restorative sleep
- headaches of a greater intensity than before implantation
- changes in vision
- seizures
- loss of balance
- numbness and tingling
- lightheadedness
- paralysis
- joint and muscle aches and pains
- shortness of breath
- lymph node enlargement
- weight gain
- low grade fevers
- abnormal heart rhythm
- hair loss
- dry eyes and mouth
- frequent canker sores in the mouth
- low back pain
- skin changes and/or rashes
- severe muscular weakness
- intolerance of bright lights
- intolerance of alcohol
- decreased libido
- ringing in ears
- muscle tremors
- recurrent flu-like illnesses
- severe allergies
- irritable bowel syndrome
- night sweats
- uncomfortable urination
- chest pain
- cough
- Raynaud's phenomenon
- enlarged thyroid.
On physical examination, the common findings are:
- hair loss
- canker sores in the mouth
- breast pain and tenderness
- low back pain
- thickening of the skin, fingers, and hand
- optic neuritis
- enlarged thyroid
- upper back pain
- abdominal pain on palpation
- muscle pain
- photosensitive dermatitis: the skin is affected by exposure to the sun
- lymphadenopathy: enlarged lymph glands in the neck, under arm, and groin areas
- diffuse petechiae on torso: small red spots on the chest and abdomen
- positive Schirmer's test, indicating deficiency of tear formation
- reduced range of movement of extremities due to joint pain and stiffness
- Raynaud's phenomenon, with cold fingers or toes that can turn white and/or ulcerate
- malar or discoid rash: a rash over the cheeks of the face and upper back and chest
- migration of the implant, usually laterally, and superiorly, unilateral or bilateral
- capsule formation, unilateral or bilateral
- asymmetrical breasts from unilateral breast rupture, migration of implant, capsule formation, post-surgical complications such as hematoma or infection
- livido reticularis :a lace-like pattern on the arms or legs caused by abnormalities of blood vessels
- abnormal neurological examination with increased or decreased deep tendon reflexes, and signs of nerve damage.
LABORATORY TESTING FOR SILICONE INDUCED IMMUNE DYSFUNCTION SYNDROME
Silicone antibodies
The effects of silicone have been described in several studies. That these effects are linked to Silicone Induced Immune Dysfunction Syndrome (S.I.I.D.S.) has also been established. Silicone antibodies in serum confirms the exposure to silicone. We studied 520 women and published these findings recently showing the significant relationship. It is important to look for four types of silicone antibodies, IgA, IgG, IgM, and IgE.
Autoimmune antibodies
Autoimmune-like disease caused by silicone implanted medical devices has been described extensively in the literature. Breast implants are not the only implants that may lead to immune and autoimmune disease. All silicone implants can cause autoimmune-like disease states.
Immune system
Certain tests, specifically a subpopulation of lymphocytes and their function, have been shown to be abnormal in patients with silicone implants. Controlled studies have shown a decrease in the function of Natural Killer Cell Activity in patients with silicone implants and a return to normal levels after
explantation. Significant abnormalities in T-Helper/T-Suppressor ratios have also been demonstrated indicating an immune dysregulation. All of the above contribute to confirming the diagnosis of Silicone Induced Immune Dysfunction Syndrome.
TREATMENT
Anyone suffering from Silicone Induced Immune Dysfunction Syndrome should have their implant(s) removed. The surgery should also include removal of the entire capsule surrounding the implant(s). This may alleviate some symptoms, especially breast pain and tenderness. Care should be taken from then on to allow the immune system to recuperate by avoiding the ingestions, absorption and inhalation of chemicals. This includes nicotine, caffeine, alcohol, artificial preservatives, artificial food colorings, artificial sweeteners, artificial flavorings, household cleaning solvents, sprays, etc. Eating fresh foods, preferably organically grown, avoids pesticide contamination. In short, live and eat like grandma and grandpa did.
The medical treatment should focus on immune restoration. It is preferable to repair the damage done to the immune system than to prescribe medication for every symptom. As every person’s immune system is unique and different, there is no " boiler plate" method. At our Center, each patient is individually evaluated and treatment is tailored to repair that person’s damages.
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