Say No to Silicone
By Russell Mokhiber and Robert Weissman

Eleven years ago, the U.S. Food and Drug Administration announced it was
pulling silicone breast implants from the market, leaving them available
only to breast cancer survivors who needed them for reconstruction or to
women enrolled in limited clinical studies.

The reason for the action, announced then-FDA Commissioner David
Kessler, was that, under the law, "these types of products have to be
shown by their manufacturer to be safe and effective before they may be
distributed and used.  Some people argue that the devices have to be
proven unsafe before the FDA can act to protect patients against their
use. This is not so. The burden of proof is an affirmative one and it
rests with the manufacturer. In this instance, the manufacturers have
not shown these devices to be safe."

Although silicone breast implants had been on the market for three
decades, Kessler said, "the list of unanswered questions is long."

"We do not know how long these devices will last," he said.

"We know that some of these implants will rupture, but we don't know how
many of them will rupture," he pointed out.

And, he said, "We don't know whether there is any link between the
implants and immune-related disorders and other systemic diseases."

"Until these basic questions are satisfactorily answered, we cannot
approve these devices."

Fast forward to the present.

Dow Corning, the leading manufacturer of silicone implants more than a
decade ago, is in bankruptcy.

Inamed, a California-based company, is now seeking marketing
authorization from the FDA for silicone breast implants.

More than a decade has passed since the FDA restricted sales of silicone
implants, but Inamed only submitted to FDA three years worth of data
from a study projected to continue for 10 years. The company sells
silicone implants in Europe and more than 60 countries worldwide, but it
hasn't collected any safety information from women in those countries
that is of high enough quality to submit to FDA.

As a result, we still don't know the answers to many of the questions
Kessler identified, and most of what we do know is frightening.

What we do know is that painful breast hardening which can lead to
deformity, dead tissue, loss of nipple sensation, infections and rashes
are common complications from silicone implants.

We know that rupture rates leading silicone to spread throughout the
body are extremely high over the long term -- occurring in more than
half or two thirds of women after 10 years, according to two studies.

We don't know whether there is any link between the implants and
immune-related disorders and other systemic diseases, though there is
worrying evidence that they do.

We started to ask Inamed spokesperson Peter Nicholson about these
matters, but he'd only say that the data Inamed submitted to the FDA was
available on the web, and the company would not be commenting further.

Inamed's data are indeed striking.

Even though the company reported on only three year's test results, the
numbers show significant short-term problems. After just three years,
one in five augmentation patients and almost half of reconstruction
patients required additional surgeries.

Inamed's data did not show particularly high rupture rates during the
three-year period of study -- in no small part because it only provided
MRIs to about a third of the women in the study, and silicone rupture
can only be detected through MRIs.

Inamed's data were replete with other flaws. For example, the company
misleadingly claimed a low incidence of lactation problems, by comparing
the incidence of problems to the overall population of women receiving
augmentation, not just those who tried to breastfeed.

These and other problems were pointed out by advocacy groups at an FDA
advisory committee hearing convened last month to issue a recommendation
on whether Inamed’s marketing application should be approved.

The advisory committee also heard heart-wrenching testimony from more
than two dozen women with silicone implants. They described the extreme
pain and life-changing problems they have suffered as a result of
silicone implants in terms that could fail to move only those with
hardened hearts. And several highlighted an important economic component
-- health insurance plans generally do not cover surgeries to remove
implants for augmentation patients, placing a huge financial burden on
sick women.

Nonetheless, the advisory panel, a quarter of whom are plastic surgeons,
and at least one of whom was swayed by empty promises from Inamed to do
ongoing follow-up research, voted 9-6 to recommend the FDA approve
Inamed’s request.

The failure for a larger majority to support the application leaves it
awkward for FDA to recommend approval.

Inamed’s chances of approval worsened last week, when Dr. Thomas Whalen,
the non-voting chair of the advisory panel, in a highly unusual move,
sent a letter to FDA commissioner Mark McClellan. Whalen called the
panel decision "misguided," emphasizing the lack of data on long-term
safety. He felt "morally compelled" to urge the FDA to deny approval, he
told reporters.

Now the decision rests with FDA Commissioner Mark McClellan.

The law hasn’t changed since the time the FDA ordered silicone implants
off the market. The agency faces the same choice it faced in 1992, with
little new information – and much of the recent information indicating
the implants' hazards.

If the FDA upholds its obligation under the law to approve products only
that afford "a reasonable assurance of safety," it has no choice but to
deny approval.

You can help influence the decision. Send a message to FDA Commissioner
McClellan urging him not to approve Inamed’s application. You can do
this from the website of the Command Trust Network, an information
clearinghouse on implants, at: <http://www.commandtrust.org>.


Russell Mokhiber is editor of the Washington, D.C.-based Corporate Crime
Reporter, http://www.corporatecrimereporter.com. Robert Weissman is
editor of the Washington, D.C.-based Multinational Monitor,
http://www.multinationalmonitor.org. They are co-authors of Corporate
Predators: The Hunt for MegaProfits and the Attack on Democracy (Monroe,
Maine: Common Courage Press; http://www.corporatepredators.org).

(c) Russell Mokhiber and Robert Weissman

This article is posted at:
<http://lists.essential.org/pipermail/corp-focus/2003/000166.html>.
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