The truth behind breast implants

[Guest guest]

http://www.maryalice.com/cases/implants.html

Case Facts THE OTHER SIDE OF THE STORY THE TRUTH BEHIND BREAST IMPLANTS

What The Breast Implant Makers Don't Want You To Know Despite spending millions of dollars to portray themselves as defenseless "victims," the breast implant makers cannot deny that the real victims here are the thousands of women with implants who were deliberately lied to and who are now suffering debilitating illnesses. The facts are:

the manufacturers' own documents reveal a calculated coverup 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; and 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 autoimmune-type diseases in humans.

In a Bristol-Myers Squibb document from 1985, a company employee states: "Polyurethanes have no real history of implantation without deterioration and we know deterioration products of polyurethanes 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. 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 ls 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.

R. Weiner, associate professor of medicine at the University of California at Los Angeles, asserted in August 1994 that "[o]nce 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 can 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.

Reprinted with Permission from The Association of Trial Lawyers of America