The Return of Silicone Gel Breast Implants?

By Amy Allina
Less than a year after the Food and Drug Administration (FDA) rejected an application for approval of silicone gel-filled breast implants, implants are back. When the FDA turned down the silicone implant application in 2004, it also directed implant manufacturers to conduct research that will answer questions about the safety of the device over its lifetime. But barely eight months passed before two implant manufacturers again asked the agency to review applications for general use of silicone breast implants.
In April 2005, the FDA convened an advisory panel to review and discuss these applications from the manufacturers Inamed and Mentor. Medical reviews prepared for the panel by FDA scientists found that both companies failed to respond sufficiently to questions that the agency had asked regarding the long-term safety of their products. ‘These data are of limited value to address the rupture rate over the lifetime of the device due to the short duration of follow-up,’ FDA staff scientists wrote in their medical review of the Mentor product.
The Mentor application was, in fact, weaker than Inamed's in three important respects: Mentor only provided rupture data through two years; it appears that Mentor cherry-picked data by dropping women from its research if they had problems with their implants; and Mentor’s core study didn’t include four of the six implant models for which is it seeking FDA approval -- which means that it didn’t provide the FDA with adequate data on those products.
Moreover, a recent New York Times article disclosed new information that Mentor may have falsified safety data on implants in the past. According to sworn depositions from former employees, Mentor withheld information about high breast implant rupture rates from the FDA. Two former Mentor employees have testified that the rates of rupture were significantly higher than reported to the FDA and that Mentor deliberately falsified reports, destroyed records, and hid physical evidence of implant problems. If Mentor destroyed data and distorted the rupture rates of the Siltex textured implants – for which it now seeks FDA approval – then the data in its current application may be suspect. This concern about suppressing data that indicates problems is made worse by Mentor’s poor track record of follow-up in its studies that has already been well documented.
But, in an unexpected -- and scientifically unsupported -- turn of events, the FDA panel issued a split decision favoring the Mentor application. Panel members voted to reject the Inamed application, saying that the company needed to provide more data; and they voted to recommend approval of the Mentor application, although they attached a long list of conditions to the approval. These conditions, including a requirement that silicone gel implants should only be provided by board-certified, specially trained surgeons, reflect the advisory panel's on-going safety concerns about these devices. They also reflect the panel’s wishful thinking, since the FDA doesn’t have the authority either to require or enforce some of the conditions its advisors said were necessary for the safe use of the silicone implants.
At current rates, nearly five percent of all women ages 18-50 will get breast implants over the next ten years. That’s more than three million women, and young women are hopping onto the plastic surgery bandwagon at an alarming rate. Silicone breast implants are currently available only for cancer survivors and through clinical trials. FDA approval would increase the potential market exponentially.
The stakes are particularly high for women who receive implants after mastectomy. Research has shown that they will have higher rates of complications from the surgery and more ruptured implants (requiring additional surgery) than women who get breast implants for augmentation. (See the NWHN's fact sheet on “Breast Implants for Reconstruction,” available on our website: http://www.nwhn.org/publications/fact_details.php?fid=19).
Now, the decision is up to the FDA. It can either support its own scientists by turning down the silicone breast implant applications or it can support the breast implant industry by allowing these unproven devices back onto the market. A decision is expected by mid-July.
To get an update about what’s happening with breast implants or learn more about the NWHN's concerns about the safety of silicone breast implants and inappropriate industry influence over the FDA’s handling of these applications, go to our website: http://www.nwhn.org/action/silicone.php.
Amy Allina is the NWHN’s Director of Programs.