Myrl Jeffcoat myrlj@jps.net

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June 13, 2005

Beatrix Shishido
94-184 Anania Drive, Apartment 343
Mililani, Hawaii 96789-2025

Dear Beatrix:

Thank you for contacting me in regard to the Food and Drug Administration's (FDA) impending decision on silicone breast implants. I appreciate having your opinion on this important matter.

In April 2005, the FDA Advisory Panel considered whether the FDA should approve silicone gel breast implants made by Inamed Corporation and Mentor Corporation. All women have the option of saline breast implants, which are FDA approved. Breast cancer patients have access to a range of reconstruction options, including silicone breast implants.

The FDA Advisory Panel recommended 7-2 to approve Mentor's application and recommended 5-4 disapproval of Inamed's application. It is expected that Acting FDA Commissioner Lester Crawford will make the final decision once he is confirmed as commissioner by the Senate. The bottom line is: the FDA threshold is "safe and effective". With the high rupture rates in the manufacturer's core studies, I don't think that suggests effectiveness. Why allow the unrestricted sale of silicone breast implants for cosmetic reasons until clinical trials have been completed and their safety has been proven? This concern has prompted me to support a letter that was sent to Acting FDA Commissioner Crawford. I've included the text for your review:

We are writing regarding the recent split decision on silicone breast implants by the FDA's General and Plastic Surgery Devices Panel. While the Advisory Panel voted against recommending approval of Inamed's devices and voted to recommend approval of Mentor's devices, FDA scientists found that BOTH companies failed to sufficiently respond to questions regarding the long-term safety of their products. We are extremely concerned about the FDA scientists' findings on the safety of these devices and we strongly urge you to give our concerns careful consideration before making a decision making a decision on the full approval of silicone breast implants.

In voting to recommend approval of Mentor's devices, the Panel attached nine complex conditions that must be met upon approval. However, we are aware that such conditions have proven to be ineffective or unenforceable and thus cannot serve as a substitute for long-term clinical data. A March 18th report by the FDA's Center for Devices and Radiological Health revealed that the agency had little idea whether device manufacturers were fulfilling their obligations to conduct studies on the safety of products once they were on the market. The agency could not find evidence that more than half the manufacturers had performed the required studies. The report also acknowledged FDA's lack of authority to enforce compliance. Given the FDA report's findings, we are concerned that approval of silicone breast implants approval based on conditions of approval that are not likely to be enforced would be disingenuous.

We are also told that FDA scientists' written summaries of both company's devices presented compelling evidence that silicone breast implants have not been proven safe. In January 2004, the FDA sent Inamed a "non-approvable" letter for its 2003 application and issued a draft guidance document that specified FDA scientists' concerns regarding the lifetime of the devices, rupture rates and gel migration. The guidance document specifically asked the manufacturers to provide data on rate of rupture over the lifetime of the device and health consequences of rupture, but as FDA's reviewers stated, both companies failed to collect enough information to sufficiently answer the agency's questions.

In addition, it is our understanding that both Inamed and Mentor refused to provide tissue samples from patients to show where silicone migrates in the body and both refused to obtain information related to pediatric complications of children born to women with silicone breast implants as the guidance requested.

We are equally concerned about comments made by FDA's own scientists at the Advisory Panel. Overall, the FDA concluded that the Inamed's Core Study data "are of limited value" and that the published articles referred to by Inamed "do not completely address all the health consequences of rupture." FDA scientists also concluded that the Mentor Core Study data "are of limited value" in assessing health consequences and that the published articles referred to by Mentor "do not completely address all the health consequences of rupture, and the literature is not specific to Mentor implants." However, Mentor's Core Study shows that after only two years, 25% of reconstruction patients and 12% of augmentation patients can expect to undergo a second surgery related to their implants.

We have also been told that Mentor eliminated the data from women whose implants were removed and not replaced in its Core Study. Previous studies have shown that women who had their implants removed without replacement are among the most likely to have experienced rupture and complications from the devices. Is it also your understanding that Mentor's Core Study in fact eliminated this data?

Lastly, we find it troubling that Mentor's application for pre-market approval included implant styles 4000 and 8000, yet these models were not included in the company's Core Study - the primary clinical data set for the pre-market approval application. Mentor provided some data on Style 4000 from its Adjunct study, a study in which the FDA reviewers found that 90% of patients were lost to follow-up. Does this mean that there is no reliable data about the rupture rate, leakage or complications for four of the six Mentor implant models the FDA's Advisory Panel recommended for approval?

In light of recent controversies involving antidepressant, Vioxx, Bextra and heart defibrillators, we are extremely concerned that FDA approval of either company's devices will undermine the FDA's credibility. In addition to FDA scientists' concerns about flawed short-term data and the lack of long-term data, we hope you will give strong consideration to our questions and concerns before making a decision of FDA approval of silicone breast implants.

If FDA approves silicone breast implants for general use, there will be no incentive for manufacturers to do adequate research and develop a safer implant. There is no need to rush these products to the market. You can be assured that I will continue to monitor this health and consumer safety issue very closely. Again, mahalo for taking the time to share your views with me. Please do not hesitate to contact me again in the future.

Sincerely,

Neil Abercrombie
Member of Congress

Mahalo again for contacting me. As your Representative in the United States Congress, it is a privilege and an honor to serve you.
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