After the Food, Drug and Cosmetics Act was passed in 1976, the F.D.A. did not regulate breast implant manufacturers because the law did not affect them, since they were already on the market.
Thus, the manufacturers did not have to provide any safety information to the government. As a consequence, Breast Implants were sold UNCHECKED for many years!!
Medical ramifications substantial data exists indicating that Breast Implants are responsible for causing many serious Medical Complications including, but not limited to Breast Cancer; Liver Cancer, as a result of a Chemical Reaction in the body caused by materials used in the implant sack; Immune Deficiencies; Lumps throughout the body as a result of silicone leakage transferred through the Lymphatic System to different parts of the body including, the neck, arms, legs, armpits; Scleroderma, the toughening of the outer portion of the skin and sensitivity of the hands, fingers, toes and feet; Lupus, accompanied by rashes, swollen glands, hair loss, kidney and lung damage; Central Nervous System Disorders; and Chronic Arthritis.
Further, an overwhelming majority of women that have Breast Implants suffer from Capsular Contracture which is the formation of hard fibers causing a type of scar tissue in the breast. As a result, the breasts become sensitive, painful, uneven in size and lumpy.
Additionally, proof exists that the Silicone Implant sacks rupture. This requires surgical intervention to remove the Implants and Capsules both. This experience, expence, and operation is unexpected, and fees are at a much higher rate than the initial costs of insertion. The FDA has stated the rupture rate is over 70% now, which means most women with breast implants can expect a rupture during their lifetime.
Finally, detection of Cancer causing lumps
becomes difficult when a women has breast implants.
The difficulty in diagnosing Cancer increases the
risk of breast cancer among implant patients.
Review of the medical literature and scientific data
indicates that it has been known
since the late 1960's and early 1970's that the
Medical Problems discussed above resulted from the
use of silicone breast implants.
Animal studies conducted in the late 1960's showed that Silicone caused Cancer. Nevertheless, the manufacturers of Breast Implants did not warn the public of these risks. Some warnings were published starting in the late 1970's and into the 1980's, but the warnings were solely provided for the medical field and usually written in a way that the average person would not understand. Moreover, the risks were never fully disclosed to the patient. Even to this day, women are signing concent form on the same day of surgery...
Every woman considering implants should discuss the risks as well as the benefits with her doctors before undergoing implant surgery. Time should be allowed well before the date of surgery to carefully read and consider the patient information sheet, the patient product insert for her implant, and the informed consent form.
It is also advisable for the patient to discuss options with the Health Insurance Company to find out if coverage will pay for complications from implantation, and if the Insurance Company will cover explantations. Some do not, and the patient should be informed that they may be become uninsurable after this proceedure.
Today, more women than ever are having breast implants. The industry has moved from silicone to saline implants, marketing the saline implants as a newer, much safer innovation for women. But saline implants aren't necessarily safer, Companies in the breast implant field are now "buying science" by providing money for research into the field.
Through this method, they attempt to show that there is no causal relationship between auto-immune diseases and breast implants, despite textbook evidence to the contrary. It behooves large corporations to pay large sums of money for these studies, and to PR firms to promote and coverup their injustices.