by Russell Mokhiber and Robert Weissman
November 8, 2003
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; www.corporatepredators.org).
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