Re: Fw: Platinum Research needed

[Guest guest]

Well, blow me over! I am very pleased to see this letter from Senators Kennedy, Rodham Clinton, Barbara Boxer, Landrieu, and Jeff Bingaman. I really didn't think they cared that much, so, this is great! I hope they receive the responses they are looking for. As we all know, the FDA has a habit of not responding to questions. I'll be waiting to hear what happens with this one! Martha, should we write these senators, thanking them for their concerns? I know I recently wrote one Congressman from Missouri, and I got a note back saying if I didn't live in the district, the letter wouldn't be read. I don't want to waste my time, but I do want to say Thank you! What do you think?

Patty

----- Original Message -----

From: MARTHA

BreastImplantNews ; ParfumGigi@...

Cc: ; info@...

Sent: Wednesday, March 19, 2003 8:37 PM

Subject: Fw: Platinum Research needed

Senator Kennedy's letter follows:

Mark McClellan, M.D., Ph.D

Commissioner

U.S. Food and Drug Administration 5600 Fishers Lane

Rockville, MD 20857

Dear Dr. McClellan:

We are writing about the FDA's oversight of breast implants. Specifically, we have several questions about FDA's approval of saline breast implants, FDA's upcoming review of applications for approval of silicone breast implants, and significant gaps in our knowledge about the safety of these products.

(1) FDA approved Mentor Corporation's premarket approval application for saline breast implants in May 2000. We understand that, at the time, FDA was conducting a criminal investigation that implicated Mentor's conduct of clinical trials that produced the data for that approval. Why didn't FDA invoke its Application Integrity Policy, both to delay approval of Mentor's premarket approval application and to require clinical data about which there were no questions of integrity or reliability? Although no criminal charges arose out of this investigation, has FDA nonetheless found evidence to question the integrity or reliability of clinical data used to approve Mentor's saline breast implants?

(2) We understand that, when approving the saline breast implants, FDA considered there to be no alternative device available to meet the public health need of treating, for example breast cancer survivors seeking reconstructive surgery. Considering the needs of breast cancer survivors seeking reconstructive surgery, will silicone breast implants need to show a higher level of safety and effectiveness than if saline breast implants were not available?

(3) We understand that breast implant manufacturers have used incorrect identifiers (identifiers assigned to other device manufacturers) when reporting adverse events for their breast implants under the agency's medical device reporting system. Has FDA investigated these violations? If not, why not? If so, what did it find? How have losses of adverse event data caused by use of incorrect identifiers affected FDA's ability to monitor and assess the safety of saline breast implants and review the safety of silicone breast implants?

(4) We understand that the agency has permitted alternative summary reporting for breast implant adverse events when these products have been under clinical investigation or before at least 2 years after approval, contrary to stated agency policy. Why did the agency permit such summary reporting in these situations? Why is such summary reporting appropriate for an implanted device, whose long term use raises issues about safety and effectiveness that cannot be answered, and may not even come to light, within 2 years of approval? How does the consequent loss of adequate adverse event data affect FDA's ability to assess the safety of saline breast implants post-approval and, in the context of approving silicone breast implants, their safety?

(5) We understand that breast implants under investigational device exemptions are routinely promoted in advertisements that, although they may comply narrowly with requirements for advertisements to seek clinical subjects, suggest to patients that they will be receiving an approved product, not an investigational product to be studied in a clinical trial. Have these promotional activities in effect lead to the inappropriate distribution of investigational medical devices? How has FDA responded? How will these activities affect FDA's review or approval of applications seeking to market these devices?

(6) Significant loss to follow up in clinical trials for a device can leave gaps in the data about the safety and effectiveness of the product. We understand loss to follow-up to be a problem not only for breast implants but also for temporomandibular joint implants. Indeed, the gaps in the data due to loss to follow-up raised concerns among members of FDA's advisory committees reviewing these products. Despite these concerns, FDA has approved these products. Some have charged that these data gaps amount to lack of a showing of reasonable assurance of safety and effectiveness. How does FDA respond to these charges?

Please provide responses to these questions, with supporting documentation where appropriate, by April 4, 2003. If you have any questions about this request, please contact Dorsey of Senator Kennedy's staff at 202/224-6064.

Thank you for your timely response to this request.

Sincerely,

Senator M. Kennedy

Senator Jeff Bingaman

Senator Hillary Rodham Clinton

Senator Barbara Boxer

Senator L. Landrieu