This is making me sick. It's emotionally wearing to think about all of this. But I want to help mom. (she's been without cancer for years, but now is dealing with implant complications, which in some ways seem worse right now...to me.)
...regarding breast cancer reconstruction patients...
from National Research Center (http://www.center4research.org/2011/06/2011-fda-update-on-silicone-gel-breast-implant-safety-many-unanswered-questions/)"
"The huge number of patients who are “missing” from many of these studies, and especially the Mentor studies, are such a problem that these results would not be publishable in any peer-reviewed journal."
"In addition, It seems that some of the studies did did not ask about many of the complications that women with leaking implants have complained about in testimony before the FDA, such as joint pain, hair loss, and other autoimmune symptoms. By focusing on the diagnosis of rare diseases rather than on symptoms that are more likely, some of the studies seem designed to result in an “implants are safe” conclusion rather than a “complications can be devastating “ conclusion."
Annual MRIs
from National Organization for Women (http://www.now.org/issues/health/052605MentorDefects.html):
"May 26, 2005
By Shelley Whitcher, Legal Intern
A major manufacturer of breast implants, Mentor Corporation, hid information of defective implants from the Food and Drug Administration (FDA) and consumers, say two former employees. According to a recent New York Times article ("Implant Maker Hid Defects, Workers Said" by Gardiner Harris, May 22, 2005), Mentor purposely withheld important information about its safety record and distributed contaminated products.
The depositions of two former Mentor employees were taken during a lawsuit brought by Kim Hoffman, who claimed that her Mentor implants had made her sick. Although the suit was eventually dismissed, Hoffman provided the depositions to The New York Times last week.
John C. Karjanis, the former product evaluation manager for Mentor, stated under oath that "top executives instructed him to destroy reports detailing the high rupture rates and poor quality of some types of implants because the products 'are in the customers.'" Karjanis also stated that one Mentor manufacturing executive attempted to obtain approval of defective products through fraudulent documents. When confronted by Karjanis, the executive admitted to trying to get one past him.
Moreover, Karjanis stated that Mentor "suppressed a report finding that some implant models had a high failure rate," and that factory workers also hid defective products in the ceiling tiles in an effort to conceal how often the plant failed to make the products properly.
During the two years that Karjanis served as the product evaluation manager, Mentor "never met basic quality standards for implant manufacturing." Karjanis also asserts that Mentor may have received contaminated silicone from its supplier; and, shockingly, Mentor's implant packaging was sometimes infested with fleas, which came in contact with the implants' surface.
As if faulty products and flea contamination weren't enough, Mentor also lied about its rupture complaints according to Cynthia Fain, a Mentor employee for more than three years who supervised the rupture complaint unit. According to Fain, Mentor received more than 3,000 rupture complaints each year she was with the company. Mentor, however, only reports a total of 8,060 rupture complaints from 1985 to September 2003. Fain says this discrepancy exists because Mentor disregards complaints from women who fail to complete a form allowing Mentor to inspect their extracted implants.
In April, the FDA's General and Plastic Surgery Devices Advisory Panel raised serious public health concerns about silicone breast implants while reviewing an application from Mentor to market their implants to the general public. Currently, silicone breast implants are available only to breast cancer reconstruction patients and women who already have implants and want them replaced. They must also enroll in a clinical trial. Silicone breast implants were taken off the general market in 1992 following numerous reports and lawsuits when breast implant patients became ill.
The advisory panel inexplicably voted for Mentor's pre-market application. FDA scientists reporting to the panel, however, criticized the data from Mentor for failing to sufficiently respond to questions regarding the long-term safety of their products. In other words, there was no basis for the advisory panel determining that Mentor had provided sufficient evidence to demonstrate that their product was reasonably safe for women over the long term.
Read more on NOW's work on breast implants."
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