http://www.phxnews.com/fullstory.php?article=24008

Today we call on the United States Congress to step in and fully
investigate the entire circumstances surrounding the U.S. Food and
Drug Administration (FDA) decision to send an approvable letter
regarding dangerous silicone gel breast implants — from the
allegations of fraud and deception made under oath by managers of the
company that makes these implants, to the role of a senior manager at
the FDA who acted more like a representative of the manufacturer than
a person carrying out a public trust.

In their extensive public relations campaign to pressure the FDA to
approve risky silicone gel-filled breast implants, while denigrating
the women's health advocates who are demanding long-term safety data,
manufacturers are attempting to position implants as a "choice" that
women must be free to make.

No reasonable person would suggest that untested drugs be sold to
anyone who'll pay the price, on the basis that it's their "choice" to
use a drug that hasn't been proven safe. If that were permitted, there
would be charlatans on every corner peddling their cures for cancer,
and making a lot of people sick. Come to think of it, that's exactly
what these breast implant companies are doing — making a lot of women
sick.

And the FDA seems to be on its way to helping them, with its reckless
decision to issue Mentor Corporation an approvable letter to market
their implants. The FDA's own scientific staff told the Advisory Panel
considering the Mentor application in April that the company's data
were not sufficient to demonstrate long-term safety of their product.
And nothing has changed — except that the public has heard allegations
from former Mentor staff, via the New York Times, that implant data
was falsified or manipulated to eliminate bad results.

Women will risk a lifetime of grave complications from faulty breast
implants because the Bush administration and their appointees value
short-term profits over women's long-term health. Bush-appointed FDA
Commissioner Lester Crawford is rewarding a company that has been
accused by former employees of falsifying and withholding data about
these implants, and was the subject of a long criminal investigation
by the very agency he heads.

The FDA is not being coy about its political agenda. The testimony of
women who suffered from silicone-gel leakage and migration to other
organs, painful capsular contraction and disfigurement, and increased
risk of death from suicide, brain cancer and lung cancer — all which
have been documented by clinical research and recognized by FDA staff
— apparently don't offset the lobbying campaign directed at political
appointees like Commissioner Crawford by their corporate supporters.

What happened to the FDA that once protected women from the cruelty of
thalidomide and other dangerous drugs — putting public health above
the greed of corporate interests? The FDA must not place corporate
profits over women's lives and safety.

It's an insult to suggest that women need to have the "choice" to put
a dangerous product into their bodies — without even enough data to
demonstrate safety over the reasonable life of the product. It's no
"choice" when the long-term safety data has been withheld from the
public — or worse, when there is every indication that the safety data
has been manipulated. Reality: There is no silicone gel-filled breast
implant that has been shown to be "safe."

Mentor conveniently "lost" thousands of women in a prior clinical
trial on this implant product — is it reasonable to assume that many
of these "lost" women may have experienced problems with rupture,
leakage, capsular contracture or other serious injuries and illnesses
due to their implants? Apparently Mentor did not want FDA reviewers or
the general public to know about what might have happened to these
women. In fact, there are indications that they intentionally omitted
from their studies any woman who was made so miserable by her implants
that she did not replace them after removal. Only women who replaced
their removed implants with new implants were included in the data.

According to the New York Times, Mentor Corporation — once the subject
of a criminal investigation — is alleged to have falsified information
about their implants, hidden defective implants from government
investigators and changed their data to minimize the rupture problem.
According to that report, a former Mentor product manager testified
under oath that "top executives instructed him to destroy reports
detailing the high rupture rates and poor quality of some types of
implants" and another manager accused Mentor of dramatically
underreporting failure rates of their implants.

Extending the deception even further, the FDA stated that the
approvable letter would be issued with specific conditions that Mentor
must satisfy: presumably expensive MRI procedures that might or might
not detect rupture or leakage and other procedures that may be
difficult to assure. The agency has no authority to enforce these
conditions; so in actuality there are no future assurances of implant
safety or even of the gathering of helpful safety data.

Approval of a device that is potentially harmful for hundreds of
thousands of women is both duplicitous and dangerous — taken by the
federal agency whose main mission is to safeguard the public's health.

Former FDA Commissioner Mark McClellan set a standard of safety in
2004. The FDA's own review of the data in the companies' applications
presented at the Advisory Panel meeting clearly concluded both Mentor
and a second company, Inamed Corp., failed to meet the standard
established by Commissioner McClellan. The FDA's clear shift in
precedent marks a change in the agency's mission to protect the
public's health: it is now buyer beware.

It is time for Congress to step in and conduct a thorough
investigation of how the FDA came to make this compromised and
deceptive decision. NOW has also sent the agency a Freedom of
Information Act (FOIA) request for copies of documents pertaining to
the criminal investigation of Mentor Corporation and is asking for
details about the specified conditions under which the FDA approvable
letter to Mentor has been offered. We are asking the Food and Drug
Administration to withdraw the Mentor approvable letter, to open its
files to Congress, and to comply with our requests.

Women deserve the facts — without them, there is NO real choice.