Truth About Breats Implants

The Facts Are:

The manufacturers' own documents reveal a calculated cover-up and campaign of deceit on the safety of silicone implants.
They have refused to comply with the law requiring them to prove that implants are safe and effective. Women were told that this product would last a lifetime, but the rupture rate is extraordinarily high. About 100,000 women have manifested illnesses, with the common link being that they all have silicone breast implants. Two recent studies could not disprove the link between silicone implants and diseases such as lupus and rheumatoid arthritis. The studies failed to ask women uniform questions and failed to employ standard laboratory testing.

Manufacturers have Known for Years that Leaking Silicone Poses Health Hazards

Dow Corning, the leading manufacturer of implants, ignored doctors' complaints about leaking implants for years. A 1975 Dow Corning memo states that demonstration implants were "bleeding" and instructed sales staff to wash such implants with soap and water and towel dry before letting doctors handle them.

A 1977 memo relates how a Dow Corning employee told plastic surgeons "with crossed fingers, that Dow Corning too had an active contracture/gel migration study underway. This apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies." In fact, Dow Corning was not studying contracture, a complication that occurs when the scar around the implant contracts.

In 1983, Dow Corning's Head of Biomaterial Safety wrote top company management: "However, I want to emphasize that to my knowledge, we have no valid long-term implant data to substantiate the safety of gels for long-term implant use." This statement was made 21 years after Dow Corning first put silicone implants on the market and assured women that implants were safe.

In a 1987 study, the Medtox Project Report, Dow Corning acknowledged that the chronic reactions to silicone seen in test animals could trigger auto-immune-type diseases in humans.

In a Bristol-Myers Squibb document from 1985, a company employee states: "Polyurethane has no real history of implantation without deterioration and we know deterioration products of polyurethane are toxic and in some cases carcinogenic. Whether they are released in such low levels as to be no threat to the human body -- time will tell."

A 3M document from 1976 states that "It appears virtually no
documented safety and efficacy data exist on [Don McGhan's] implant products." McGhan's breast implant company, McGhan Medical Corp., was purchased by 3M.

Manufacturers Refuse to Comply with the Law

Dr. David Kessler, commissioner of the Food and Drug Administration, reiterated in testimony before Congress in August 1995 that "the law requires manufacturers to prove affirmatively, with valid scientific data evaluated by FDA, that their devices are safe and effective." Why have the manufacturers consistently failed to comply?

Dr. Kessler wrote in the Journal of the American Medical Association in 1993 that "the adverse effects data on silicone gel implants submitted by the manufacturers were so poor that the FDA could not determine whether these devices were safe and effective." He added that the manufacturers' documents suggested that there were inadequate quality control procedures to prevent safety problems and
that problems had been evident for years.

Breast Implants have an Extremely High Rupture Rate, and thus are Defective

Manufacturers told women that implants would last a lifetime and that ruptures occurred less than 1 percent of the time. But studies published in the American Journal of Radiology in 1992 and the Annals of Plastic Surgery in 1995 reveal a rupture rate of 5 to 51 percent. A third study, published in Plastic and Reconstructive Surgery in 1993, ties rupture to the age of the implant. Of implants aged one to nine years, 35.7 percent had ruptured. Of those aged 10 to 17 years, 95.7 percent had ruptured.

FDA Commissioner Kessler wrote in the Journal of the American Medical Association in 1993 that: "Even with a conservative rupture rate of 5 percent, some 75,000 of the estimated 1 to 2 million women with implants would be at risk for potentially serious adverse health effects. That is not a safety standard that the FDA can accept."

Thousands of Women Suffering Illnesses Constitute more
than 'Anecdotes'

Dr. Kessler of FDA states that studies have shown that silicone gel is a potent stimulant to the immune system and could generate antibodies that attack collagen, a component of connective tissue. In 1992, the FDA received more than 23,000 reports of problems with implants, including complaints of "bleeding" implants, connective tissue disorders that could lead to arthritis-like pain and swelling in the joints, fibrous tissue spreading around the implants, and swelling of skin and limbs.

Steven R. Weiner, associate professor of medicine at the University of California at Los Angeles, asserted in August 1994 that once you see these women, that's all it takes to be convinced silicone implants can make them sick .... There's no one who has seen a large number of these women who disagrees."

Safety concerns prompted France in May 1995 to halt the importation, manufacture, sale or use of silicone-gel breast implants. In May, the Ministry of Health stated that implants filled with any product other than physiologic saline could rupture and "result in grave danger." France will not allow implants back on the market "until they have been definitely shown without risk to the user."

Two recent studies are fatally flawed

One of the most-cited papers used to criticize the link between silicone implants and connective tissue diseases suffers from fundamental flaws. The "Mayo Clinic" study published in June 1994

(1) failed to ask women uniform questions or employ standard laboratory testing;

(2) failed to look for the "atypical" signs and symptoms suffered by women with silicone poisoning;

(3) admitted that the control group (749 women with implants and 1,498 without) was insufficient and that an accurate study would require 62,000 women with implants and 124,000 without over 10 years;

(4) suggested an implant failure rate in excess of 30 percent (of the 749 women with implants, 257 had surgical revisions); and

(5) concluded that "No statistically valid conclusions can be drawn from this study."

Further, the study is at least subject to question since it was
financed in part by the Plastic Surgery Educational Foundation, the educational arm of the American Society of Plastic and Reconstructive Surgeons. This group has been given hundreds of thousands of dollars for research by implant manufacturers.

A study published in June 1995 -- the "Harvard" study -- suffers from similar flaws. Specifically, it
(1) failed to ask women uniform questions or use standard laboratory testing;

(2) failed to look for signs of "atypical" connective-tissue diseases, the symptoms of which do not fall into any clear diagnostic category;

(3) studied
too few women with breast implants (1,183 women with implants, 876 of which were silicone gel filled); and (4) failed to account for the fact that women with silicone implants may not manifest illnesses during the first eight years after implantation.

Further, as with the Mayo Clinic study, author bias is at issue. Two authors of the Harvard study have admitted under threat of perjury that they are paid consultants to breast implant makers. Also, Dow Corning has donated $5 million to Boston's Brigham and Women's Hospital, which played a key role in this study. source: www.siegfriedandjensen.co...lants.html

If you or anyone you know has any further questions or problems ... please visit our forum
Implant Info Net

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Frequently Asked Questions

Q:What is the chemical composition of a saline- filled breast implant shell?

A:According to the Office of Device Evaluation (ODE), the office responsible for conducting scientific reviews of medical devices and radiation emitting products, the following is what is in a saline-filled breast implant shell:

1. 80% high molecular weight silicones

2. 20% finely powdered silica

3. catalyst: small amounts (50-100 parts per million) of a tin or platinum

4. impurities: -small amounts of (1-500 parts per million) of various smaller silicones -trace amounts of (<5 parts per million) of volatile (readily evaporating) materials like xylene and other organic compounds (impurities) -trace amounts (<5 parts per million) of metals (impurities)

Q: How do saline implants cause systemic symptoms?

A: The shell surrounding a saline implant is a silicone polymer that can break down due to a lipolysis reaction or disruption. The silicone from the shell migrates into the capsule surrounding the implants. Cells in the immune system called macrophages pick up the silicone, break it down into Silica, and then distribute this chemical throughout the body.A chronic illness may develop that can affect every organ system in the body. Some patients with saline breast
implants have autoimmune, immune, and neurological disorders similar to patients with silicone breast implants.

Chemical sensitivity also occurs in patients with saline breast
implants.

Due to immune dysfunction, a patient with saline breast implants may also have systemic fungal and atypical bacterial infections.

Q: Why did several doctors tell me that my implants were safe and weren't responsible for my symptoms before I was properly diagnosed with a silicone-related disease?

A:Many physicians are unaware that silicone or saline implants can cause systemic symptoms in patients.Silicone-related disease is a controversial topic in medicine.Medical textbooks,medical dictionaries, etc. do not contain any information about illnesses caused by implants. Also,many physicians think that implants would not be F.D.A. approved if they were not safe.

Several years ago, you probably wouldn't have found a physician who could diagnose or provide treatment for illnesses associated with silicone implants.Fortunately, some doctors now understand the systemic symptoms associated with implants.

Q: How many patients with implants have a silicone-related disease? The manufacturers of silicone implants state that the percentage of autoimmune and neurological disorders in implant recipients is the same as the percentage in the general population.

Research regarding silicone implants is ongoing, but it is now
estimated by reputable sources that 25-30% of all implant recipients will develop an autoimmune condition.This statistic is much higher than the percentage disclosed by the manufacturers.

Q: What is a "gel bleed"?

A "gel bleed" occurs when the silicone gel in breast implants slowly leaks through the semi-permeable membrane envelope. The gel then migrates to the capsular area around the implants. Cells in the immune system called macrophages pick up the gel, break it down into Silica and Silicon, and then distribute these chemicals throughout the body. The result is immune dysfunction. The silicone gel also causes oxidants to form that can damage DNA, enzyme systems, and cell walls.
A chronic illness may develop that can affect every organ of the body.

For more information please read Silicone Arthritis and Related
Diseases by Stephen B. Edelson,M.D. et al.

Q: Which types of silicone implants are associated with illnesses?

A:All silicone implants can cause illnesses.This includes
cerebrospinal fluid shunt tubing, slow release hormone implants, cardiac valves, intraocular lens implants, testicular prostheses, penile implants, digital joint arthroplasty prostheses, breast implants, pectoral implants, buttock implants, calf implants, malar implants,jaw implants, and chin implants. Saline implants also can cause systemic symptoms because they have a silicone elastomer shell.

Q: How do implants affect a patient's career, personal life, and mental abilities?

A:Silicone-related diseases can affect every aspect of a patient's life. Some patients may be unable to work because of the debilitating symptoms that they have.Interpersonal relationships may be affected too. Many patients also have cognitive dysfunction and some develop psychological problems; both of these symptoms may occur in patients
with silicone induced immune dysfunction syndrome.

Some patients with silicone-related diseases only develop a few symptoms and have a normal life, but others are completely disabled.

Q:I have been diagnosed with a silicone-related disease.When will I begin to feel better after my implants are removed?

A:Most patients notice an improvement in their health immediately following surgery.Others improve but do not completely recover. A few remain disabled after explantation.Improvement depends on the age of the patient, health before implantation, and the duration of the illness. Significant laboratory and clinical improvement should occur
within the first two years after explantation.

Q: Where can I report an illness or complication that is caused by my implants?

A: Medwatch is the Food and Drug Administration's program for reporting serious reactions and problems with medical products, such as drugs and medical devices.

Q:Where can I find current information on breast implants?

A:The Center for Devices and Radiological Health (CDRH) Breast Implant Listserv provides current information on breast implants. The CDRH distributes a monthly newsletter via email to their subscribers.

http://www.fda.gov/CDRH/

Q:What are the complications associated with chin implants?

A:Complications associated with chin implants include the following: bone erosion,nerve damage, hematoma, seroma, infection, implant displacement,asymmetry, mobility, bleeding,swelling,bruising, and silicone-related diseases.

Q:What are the complications associated with cheek implants?

A:Complications include resorption of the bone under the implant,nerve damage,blood clot formation, bruising, swelling,bleeding, infection, and silicone-related diseases.

Q: What diagnostic tests are available for silicone?
A:Please refer to the section "Diagnostic Tests For Silicone-Related Diseases" on this website.

Q: What illnesses are associated with silicone implants?

A:Clinical syndromes resembling the following disorders are associated with silicone implants:systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's disease, polymyositis, mixed connective tissue disease, multiple sclerosis ,and other neurological disorders.

Chemical sensitivity is also associated with implants.

Some patients with immune dysfunction caused by silicone implants have fungal infections(ie systemic candidiasis) and atypical bacterial infections.

Q: What are the symptoms of a silicone-related disease?

A:According to Andrew W. Campbell, M.D. , Medical Director of the Center for Immune, Environmental, and Toxic Disorders,these are the most common symptoms experienced by 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.

Q: What should I know about implants before I have surgery?

A:First,you should consider the reason(s) why you want to have implants. You should have plastic surgery because you want to enhance your appearance or because you need to have it for reconstructive purposes.Do not have plastic surgery because someone else (ie your spouse) wants you to do it. Also, there is a condition called "body dysmorphic disorder" that affects some patients who have plastic
surgery. Patients with body dysmorphic disorder or B.D.D. have an altered perception of their appearance (ie.they may have an obsession with a minor physical imperfection which may be imagined)that can affect their ability to have a normal life.You shouldn't have surgery if you think that you may have B.D.D.

Next, you need to find a plastic surgeon who has experience with the procedure that you want. Ask your physician how many of his/her patients have had the same procedure. Ask to see photos of other patients who have had the same procedure performed by that doctor. Ask to speak to other patients who were satisfied with the outcome of their surgeries.

Finally,you need to understand the complications that may occur with the procedure that you are having. Ask your plastic surgeon to discuss complications and silicone-related diseases with you before you have surgery.

Q: I have a silicone-related disease and I feel like my family and friends do not understand what I am going through.I feel "alone".

A: Joining a support network can help you to cope with the medical and personal problems that you are experiencing. Support groups are located on the internet. There are also chat forums on the internet now where patients can interact with each for advice and compassion.

You're not alone.

You need to explain to your family and friends what is happening to you. Maybe they do not understand how serious your condition is. Provide information to them about your disease. Show them websites and articles that you have regarding silicone-related diseases.

These illnesses not only have an impact on the patient's life, but also can affect others who are close to them. Perhaps you should encourage your family and friends to join a support network with you.

Q: If I have a silicone-related disease and I decide to have children, will they be affected too?

A:It is possible that if you have children, they might be ill from the toxic effects of silicone. The number of children who are affected by "second generation silicone-related diseases" is unknown at this time.Smalley et al investigated T cell proliferative responses to silicone dioxide (silica) in 24 childen born to silicone gel breast implant recipients. The authors found that T cells were significantly stimulated by silicone dioxide. A second part of their study consisted of the investigation of 11 children, four born before implantation, and seven born after implantation. None of the pre-implant offspring showed T cell responses to silica while five of the seven post-implant children were positive in this test