Today is the day to call Chairman Enzi of the Senate HELP Committee

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Subj: Today is the day to call Chairman Enzi of the Senate HELP Committee Date: 8/3/2006 7:07:04 AM Eastern Standard Time From:

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Call Senator Enzi at the Senate HELP Committee TODAY

(202) 224-5375

Please remember to call Senator Enzi at the Senate HELP committee TODAY and voice your concern that more research with better data must be done before the FDA approves these PMAs. Ask to speak to the staff person responsible for matters relating to the FDA and silicone breast implants. We need to make sure that Senator Enzi, Chairman for the Senate HELP committee, understands the importance requiring better research before the FDA approves the pre-market approval applications (PMAs) for silicone breast implants. When you call, please begin by thanking the Senator for sharing his report on the silicone implant PMAs.Then let the staff person you speak to know that you are concerned that the report does not go far enough. Specifically, explain how you think the report needs to address important concerns that were not covered, but should be. Please familiarize yourself with the concerns we have about the report (below) before you make your call. After you complete your call, please email us

info@... to let us know you made your call and how it went.Our concerns about what is not in Senator Enzi's report are: • Lack of Clinical Data for Some of the Implant Models. Ask the Committee to investigate why the FDA accepted PMAs for implant styles that were not included in the Core study, the companies' clinical studies.

o While the companies provided some data their adjunct studies, the FDA's PMA reviewers pointed out that these studies were flawed. o Therefore, the FDA is considering approving some models with absolutely no reliable clinical safety data.• Lack of Long-Term Safety Data. While the Committee's report partially substantiated concerns regarding the weaknesses of the Sharpe/Collis study, which was used by Mentor as its long-term data, it did not address the larger issue of how the FDA could consider approving SBIs without long-term data for reconstruction and revision patients (who were excluded from the Sharpe/Collis study) who tend to have much higher rupture rates than augmentation patients.

o Both Mentor and Inamed failed to provide adequate data on the long-term safety of SBIs.o The Committee's report is correct that there are no legal requirements for companies to adhere to every recommendation of an FDA Guidance Document. However, the concern is that the FDA published an official Guidance Document describing the kind of research necessary to prove safety, but in issuing approvable letters, the FDA seems to have ignored several of the most important scientific requests in that document, for example: new platinum research and better long-term safety data. o The FDA's own review of the data in the PMAs presented at the Advisory Panel meeting clearly concluded both Inamed and Mentor inadequately addressed the concerns that formed the basis for the Agency's past refusals. Both companies failed to provide satisfactory data about long-term safety — despite FDA requests for this information since 1992. o Approval for Mentor's product would be an unwarranted, 180-degree departure from FDA's longstanding and consistent treatment of this issue--a position that thus far has been fully consistent with longstanding FDA policies and practices, and with the latest and best Agency science. o The Federal Food Drug & Cosmetic Act ( " FFDCA " ), in turn, requires FDA to deny any application for approval of a Class III device if " there is a lack of showing [by the applicant] of reasonable assurance that [the device] is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. " 21 U.S.C. § 360e(d)(2)(A). o So the key question is: On what basis did the FDA send an approvable letter to Mentor?• Ask for an investigation by the HELP committee because you believe that Congress must fulfill its oversight responsibility and assure a transparent process. Women in this country must be assured that the FDA's decisions on silicone gel breast implants are based on a careful review of the merits of the scientific data regarding the products' safety and efficacy. And the public also needs to know that Congress will uphold its duty to ensure that the FDA is fulfilling this responsibility. After you complete your call, please email us info@... to let us know you made your call and how it went.