poisoned breasts part 2

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Subject: Poisoned Breasts - Part 2

2. Implants will likely rupture and leak within ten years of placement.

In 1995, then FDA Commissioner . A. Kessler, M.D., stated that the rupture rate of silicone implants ranges between 5% and 51% and that "unfortunately we do not know with any confidence where within that range the real rupture rate lies."

When 51 implants were removed, one to 17 years after implantation, 27 were found to have ruptured, 7 were leaking and only 17 were in good condition; all implants older than ten years were leaking or ruptured. (Plastic Reconstructive Surgery 91:5 [April 1993], 828-834.)

Based on an examination of 350 silicone implants, doctors found that 63% of those implants in place for 12 years or more were not intact. (Plastic and Reconstructive Surgery 00:6 [1997], 1597-1601.)

According to Lu-Feng, M.D. of Mt. Sinai Medical Center in Cleveland, Ohio, in evidence presented to the PSC, 11% of implants which have been in the body less than seven years rupture, but of those in the body more than seven years, 61% rupture.

Deformities such as holes or cracks were found in 40% of 1,717 breast implants after six years of use and in 95% after 12 years of use. (Canadian Journal of Plastic Surgeons [spring 1997].)

When breast implants from 300 patients were examined, 71% had either rupture or silicone bleed, or both, and 63% of 592 implants, when removed, were found to have ruptures. This led researchers to conclude: "We have found and predict that most implants have lost or will lose the integrity of the silicone shell between eight and 14 years, leaving free silicone [in and out of the capsule] in the breast." (ls of Plastic Surgery 34:1 [January 1995], 1-6.)

Based on an examination of 217 silicone implants removed during a four-year period, physicians concluded that, either from leakage or rupture, 40% failed within six years of implantation, and 95% within 12 years. (Canadian Journal of Plastic Surgery 4:1 [1996], 55-58.)

Using magnetic resonance spectroscopy, researchers found that among 39 women with implants, 20 (51%) had ruptured implants and 27 (69%) had evidence of silicone in their livers. (Radiology 201:3 [December 1996], 777-783.)

Complications of implants requiring further surgery are likely within five years based on a study of 749 women with silicone implants. During a median span of 7.8 years after implantation, 27% of the women underwent 450 implant-related surgeries; 79% of these surgeries were needed to address a complication, most frequently among which were capsular contraction (tightening of scar tissue around the implant) and rupture. (New England Journal of Medicine 336:10 [March 6, 1997], 677-682.)

French researchers found that "the well-described leakage occurring through the silicone envelope allows the silicone gel to diffuse to multiple anatomic areas in the body," producing a cellular response that includes the formation of a capsule around the implant. (Revue de Medecine Interne 18:12 [1997], 955-966.)

3. Silicone migrates from the rupture site throughout the body.

As early as 1956, Dow Chemical researchers knew that liquid silicone, when injected into the body, migrates to all the major organss, including the spleen, heart, lung and brain. (PSC Record No. 0006.)

Studies by both Dow Corning and Dow Chemical in 1970 confirmed that silicone, after injection, migrates to the bone marrow of animals and changes brain weight. They also showed that silicone particles migrate from a human finger joint into the lymph odes. (PSC Record No. 0018, 7038.)

Researchers at Baylor College of Medicine in Texas found that silicone is widely distributed throughout the body of mice after a single injection, migrating to ten different organs from the brain to the uterus and persisting in these organs over time. (American Journal of Pathology 152:3 [March, 1998], 645-649.)

Researchers at the Medical College of Wisconsin in Milwaukee found that following silicone implant rupture, silicone gel migrated into the arm of a woman, where it produced nerve pain, dysfunction, and fibrosis. (Plastic Reconstructive Surgery 89:5 [May 1992], 949-952.)

Physicians at Massachusetts General Hospital in town, using magnetic resonance imaging, found that "a significant amount of free silicone" had migrated from an implant (not noticeably ruptured) into the liver and spleen of a woman. (Magnetic Resonance Medicine 36:3 [september 1996], 498-501. Researchers also found that silicone in the liver could be detected in the first three to four years after a woman received her implant. (Magnetic Resonance Medicine 33:1 [January 1995], 8-17.)

Of 39 women with silicone implants, 27 (69%) showed signs of silicone in their livers, and of the 20 whose implants had ruptured, silicone was detected in the livers of 17 (85%). In other words, whether the implants rupture or not, silicone leaks and migrates to the liver. (Radiology 201 [1996] 777-783; PSC Record No. 0050.)

In 1989, studies by Dow Corning sowed that silicone, given orally to rats, increased liver size and weight by up to 45% and suggested the enlargement might be interpreted as a carcinogenic response. (PSC Record No. 0482.)

4. Silicone produces abnormalities in immune system functioning.

Silicone elicits antibody responses and "immunological abnormalities," according to a study of 40 women who had received implants more than ten years earlier. Amont these women, 60% had an elevated ratio of helper T cells to suppressor T cells; 20% had a blockage in particular functions of T cells and natural killer cells. (Toxicology Industrial Health 8:6 [November/December 1992], 415-429.)

Scientists at the University of California at reported that evidence suggests that the degradation products of silicone inactivate CD8+ suppressor T cells (key immune cells) and thereby lead to an inflammatory state in the body. (Food and Chemical Toxicology 32:11 [November 1994], 1089-1100.)

The activity of natural killer cells is "significantly suppressed" in at least 50% of women with silicone implants observed in a study; this puts the women at a high risk of developing cancer. The same effect was demonstrated in animals; it was reversed upon removal of the silicone. (Toxicology and Industrial Health 10:3 [May/June 1994], 149-154.)

High levels of anti-nuclear antibodies (ANAs), immune markers associated with lupus erythematosus, were observed in ten of 11 women with implants reporting autoimmune symptoms. (Lancet 340:8831 [November 28, 1992], 1304-1307.)

When 500 women with silicone implants were examined, 30% tested positive for ANA levels; those women also had rheumatic symptoms. The results strongly suggested "immune activation in women with silicone implants." (Current Topics in Microbiological Immunology 210 [1996], 277-282.)

Based on a study of 3,380 breast implant recipients, scientists state there is a six-fold increased likelihood that testing these women will show elevated ANAs; the longer the implant has been in place, the greater the likelihood. (Current Topics in Microbiological Immunology 210 [1996], 337-353.)

In a study of 111 women (with and without implants), those with implants had a "statistically significant elevation" of anti-silicone antibodies (immune cells focused against silicone as a foreign substance in the body); the highest levels were observed in women with noticeable implant rupture or leakage. (FASEB 7:13 [October 1993], 1265-1268.)

Researchers at the University of Wisconsin at Madison School of Medicine reported that "autoantibodies of unclear significance may be found in 5% to 30% of women with silicone breast implants." (Archives of Internal Medicine 153:23 [December 1993], 2638-2644.)

Researchers at Monash University in Clayton, , in Australia, found that women with silicone implants (70 were studied) have elevated levels of autoantibodies to collagen, in a manner highly similar to women with lupus and rheumatoid arthritis. (Current Topics in Microbiological Immunology 210 [1996], 307-316.)

Among 310 symptomatic women with silicone implants, there were elevated levels of "novel autoreactive antibodies to silicone associated antigens" (a specific type of heightened immune response) compared to healthy women without implants. (Current Topics in Microbiological Immunology 210 [1996], 327-336.)

Scientists at the Technical University of Munich in Germany examined 239 breast implant recipients and found the following immunological abnormalities: levels of complement C3 were elevated in 42% of the women; complement C4 was elevated in 21%; and antithyroglobulin (an antibody that attacks a suhstance in the thyroid gland) was higher in 28%. (ls of Plastic Surgery 36:5 [May 1996], 512-518.)

When silicone leaks from implants, immune cells form granulomas (miscroscopic lumps) around the droplets; the granulomas are capable of severely disrupting the immune system. Silicone plays the role of an "adjuvant," providing "constant nonspecific stimulation of the immune system." (Journal of Investigative Surgery 9:1 [January/February 1996], 1-12.)