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SEPTEMBER 22, 2005
1:11 AM

CONTACT:  National Organization for Women
Lisa Bennett, 202-628-8669, ext. 123

FDA Poised to Approve Dangerous Implants, Shows Disdain for Women's Health

WASHINGTON - September 22 - "The FDA's continued contempt for women's health is astounding," said NOW president Kim Gandy after Tuesday's announcement that the agency had issued yet another "approvable" letter for risky silicone breast implants, this time to Inamed Corporation.

"This move by the Food and Drug Administration (FDA), which is charged with safeguarding our health and safety, is just the latest example of the agency's willingness to trade off public health for Bush administration priorities. Recently FDA granted preliminary approval to Mentor Corporation's similarly risky silicone gel-filled breast implant despite grossly insufficient safety data, and earlier this month the agency revealed it would continue stalling over approval of over-the-counter sales of emergency contraception. Any pretense of sound, scientific decision-making has disappeared from public view.

"Whether it's Vioxx or Bextra or silicone implants, the rule now is 'Buyer Beware,'" said Gandy. "The drug and device companies own the FDA and it is the companies' profit potential that rules the review and approval process - except when the profit motive is overridden by the White House morality police, as with the morning-after pill."

Though the approvable letter is not a final go-ahead for Inamed-and the same holds for a previous notice sent to Mentor Corporation-the process has taken this unfortunate step toward general marketing of a device which has not been demonstrated safe over the long term. In its news release about the Inamed approvable letter, the FDA stated that certain conditions still had to be met by the company-but declined to make those stipulations public.

The Food and Drug Administration's own scientific staff stated unequivocally at the advisory panel meetings in April that data submitted by both implant manufacturers did not demonstrate long-term safety. In January 2004 the FDA rejected a previous Inamed request to market its silicone breast implant and asked them for long-term data on the safety question.

There are indications that the breast implant makers are being asked to require women who receive implants be closely monitored and undergo frequent MRI exams to determine where the implant is ruptured and leaking. In the past, both companies have demonstrated a low commitment to monitoring breast implant patients and there is evidence that women who have attempted to report complications have been ignored.

Gandy noted that breast implants often rupture after 10 to 12 years of wear and because silicone leaks slowly and silently into the lymph nodes, brain and major organs through the blood stream, women need to be aware of the long-term health risks. Silicone gel contains toxic substances such as platinum and National Cancer Institute studies (2001) have shown higher rates of brain and lung cancer among women with implants (both silicone and saline implants).

In addition, there is the problem of insufficient studies about implants and autoimmune diseases such as fibromyalgia, lupus and rheumatoid arthritis that need to be addressed. These types of illnesses are commonly reported by women who have received breast implants.

Further, re-operation is often required because of infections, hardening of tissues around the implants, migration of the implant, rupture and other complications. One Canadian study found that more than half of the women with implants needed a subsequent operation, while 23 percent had undergone two operations and 17 percent had four or more additional surgeries. Re-operation rates among mastectomy patients with implants are very high as well. Insurance usually does not cover re-operation costs related to breast augmentation and companies often deny coverage to any illness or injuries that could be related to implants.

"Most studies submitted to the FDA have been conducted by the manufacturers of implants who obviously have a vested interested and whose findings are frequently biased and misleading," Gandy added. "We must reform this heavy reliance on industry, which interferes with sound scientific decision-making by the FDA."


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